Orange Book Companion
Patent Expiration View

Products whose next patent expiration is in 2019

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

Products tagged as GENERIC have had a generic equivalent approved for at least one strength of the product.


LATUDA (TABLET) (ORAL) LURASIDONE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 200603  Prod. No.: 001 RX (40MG); 003 RX (20MG); 005 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 5532372 DS* [Extended 5 years]
Imide derivatives, and their production and use
Claim Types: Compound
Jan 2, 2019 *PED 
Pat. No. 9815827 Agent for treatment of schizophrenia
Claim Types: Method of use
Feb 20, 2024U-2166: Treatment of major depressive episodes associated with bipolar I disorder
U-543: Treatment of schizophrenia
Pat. No. 9174975 Remedy for integration dysfunction syndrome
Claim Types: Method of use
Aug 20, 2024 *PEDU-1770: Treatment of schizophrenia with improvement in negative symptoms and/or cognitive dysfunction of schizophrenia
Pat. No. RE45573 DS* Process for producing imide compound
Claim Types: Product-by-process; Process
Dec 23, 2025 *PED 
Pat. No. 9555027 DP* Pharmaceutical composition
Claim Types: Formulation; Process; Method of use
May 26, 2026U-543: Treatment of schizophrenia
Pat. No. 9907794 DP* Pharmaceutical composition
Claim Types: Formulation
May 26, 2026 
Pat. No. 8729085 DP* Pharmaceutical composition
Claim Types: Formulation
Nov 26, 2026 *PED 
Pat. No. 8883794 DP* Pharmaceutical composition
Claim Types: Formulation
Nov 26, 2026 *PED 
Pat. No. 9827242 Method of treatment for mental disorders
Claim Types: Method of use
May 23, 2031U-2199: Treatment of schizophrenia with improvement in attention function in schizophrenia
U-2201: Treatment of bipolar depression with improvement in attention function in bipolar disorder
Pat. No. 9259423 Method of treatment for mental disorders
Claim Types: Method of use
Nov 23, 2031 *PEDU-1822: Treatment of schizophrenia or bipolar depression with improvement in attention function in schizophrenia and/or bipolar disorder
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 27, 2020 PEDM-195: Revisions to the pediatric use section of the labeling reflecting lack of efficacy for irritability associated with autistic disorder in pediatric patients ages 6-17
Exclusivity Code: NPP - New patient populationJul 27, 2020 PED 
Exclusivity Code: NPP - New patient populationMar 5, 2021 

LATUDA (TABLET) (ORAL) LURASIDONE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 200603  Prod. No.: 002 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 5532372 DS* [Extended 5 years]
Imide derivatives, and their production and use
Claim Types: Compound
Jan 2, 2019 *PED 
Pat. No. 9815827 Agent for treatment of schizophrenia
Claim Types: Method of use
Feb 20, 2024U-2166: Treatment of major depressive episodes associated with bipolar I disorder
U-543: Treatment of schizophrenia
Pat. No. 9174975 Remedy for integration dysfunction syndrome
Claim Types: Method of use
Aug 20, 2024 *PEDU-1770: Treatment of schizophrenia with improvement in negative symptoms and/or cognitive dysfunction of schizophrenia
Pat. No. RE45573 DS* Process for producing imide compound
Claim Types: Product-by-process; Process
Dec 23, 2025 *PED 
Pat. No. 9555027 DP* Pharmaceutical composition
Claim Types: Formulation; Process; Method of use
May 26, 2026U-543: Treatment of schizophrenia
Pat. No. 9907794 DP* Pharmaceutical composition
Claim Types: Formulation
May 26, 2026 
Pat. No. 8729085 DP* Pharmaceutical composition
Claim Types: Formulation
Nov 26, 2026 *PED 
Pat. No. 8883794 DP* Pharmaceutical composition
Claim Types: Formulation
Nov 26, 2026 *PED 
Pat. No. 9827242 Method of treatment for mental disorders
Claim Types: Method of use
May 23, 2031U-2199: Treatment of schizophrenia with improvement in attention function in schizophrenia
U-2201: Treatment of bipolar depression with improvement in attention function in bipolar disorder
Pat. No. 9259423 Method of treatment for mental disorders
Claim Types: Method of use
Nov 23, 2031 *PEDU-1822: Treatment of schizophrenia or bipolar depression with improvement in attention function in schizophrenia and/or bipolar disorder
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJul 27, 2020 PED 
Exclusivity Code: NPP - New patient populationMar 5, 2021 

LATUDA (TABLET) (ORAL) LURASIDONE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 200603  Prod. No.: 004 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 5532372 DS* [Extended 5 years]
Imide derivatives, and their production and use
Claim Types: Compound
Jan 2, 2019 *PED 
Pat. No. 9815827 Agent for treatment of schizophrenia
Claim Types: Method of use
Feb 20, 2024U-2166: Treatment of major depressive episodes associated with bipolar I disorder
U-543: Treatment of schizophrenia
Pat. No. 9174975 Remedy for integration dysfunction syndrome
Claim Types: Method of use
Aug 20, 2024 *PEDU-1770: Treatment of schizophrenia with improvement in negative symptoms and/or cognitive dysfunction of schizophrenia
Pat. No. RE45573 DS* Process for producing imide compound
Claim Types: Product-by-process; Process
Dec 23, 2025 *PED 
Pat. No. 9555027 DP* Pharmaceutical composition
Claim Types: Formulation; Process; Method of use
May 26, 2026U-543: Treatment of schizophrenia
Pat. No. 9907794 DP* Pharmaceutical composition
Claim Types: Formulation
May 26, 2026 
Pat. No. 8729085 DP* Pharmaceutical composition
Claim Types: Formulation
Nov 26, 2026 *PED 
Pat. No. 8883794 DP* Pharmaceutical composition
Claim Types: Formulation
Nov 26, 2026 *PED 
Pat. No. 9827242 Method of treatment for mental disorders
Claim Types: Method of use
May 23, 2031U-2199: Treatment of schizophrenia with improvement in attention function in schizophrenia
U-2201: Treatment of bipolar depression with improvement in attention function in bipolar disorder
Pat. No. 9259423 Method of treatment for mental disorders
Claim Types: Method of use
Nov 23, 2031 *PEDU-1822: Treatment of schizophrenia or bipolar depression with improvement in attention function in schizophrenia and/or bipolar disorder

EXELON (FILM, EXTENDED RELEASE) (TRANSDERMAL) RIVASTIGMINE [GENERIC AB]
Drug Classes: cholinesterase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 022083  Prod. No.: 001 RX (4.6MG/24HR); 002 RX (9.5MG/24HR); 005 RX (13.3MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6316023 DP* TTS containing an antioxidant
Claim Types: Formulation; Device
Jan 8, 2019 
Pat. No. 6335031 DP* TTS containing an antioxidant
Claim Types: Formulation; Device; Process
Jan 8, 2019 

TYKERB (TABLET) (ORAL) LAPATINIB DITOSYLATE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 022059  Prod. No.: 001 RX (EQ 250MG BASE)
PatentsExpirationPatented Use
Pat. No. 6727256 DS* DP* Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors
Claim Types: Compound; Composition; Method of use
Jan 8, 2019U-1429: Treatment of patients with breast cancer whose tumors overexpress the her2 receptor
U-800: Treatment of patients with advanced or metastatic breast cancer whose tumors overexpress her2 and who have received prior therapy including anthracycline, a taxane and trastuzumab
Pat. No. 8513262 DS* DP* Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors
Claim Types: Compound; Composition; Formulation
Jan 8, 2019 
Pat. No. 6713485 DS* DP* [Extended 630 days (1.7 years)]
Heterocyclic compounds
Claim Types: Compound; Method of use; Composition
Sep 29, 2020U-1429: Treatment of patients with breast cancer whose tumors overexpress the her2 receptor
U-800: Treatment of patients with advanced or metastatic breast cancer whose tumors overexpress her2 and who have received prior therapy including anthracycline, a taxane and trastuzumab
Pat. No. 7157466 DS* DP* Quinazoline ditosylate salt compounds
Claim Types: Compound; New polymorph, salt or hydrate; Composition
Nov 19, 2021 
Pat. No. 8821927 DS* DP* Pharmaceutical composition
Claim Types: Product-by-process
Sep 18, 2029 

DEFINITY (INJECTABLE) (INTRAVENOUS) PERFLUTREN
Drug Classes: ultrasound contrast agent
NDA Applicant: LANTHEUS MEDCL      NDA No.: 021064  Prod. No.: 001 RX (6.52MG/ML)
PatentsExpirationPatented Use
Pat. No. 8685441 Preparation of a lipid blend and a phospholipid suspension containing the lipid blend
Claim Types: Method of use
Jan 13, 2019U-665: Method of using the drug substance/drug product for ultrasound imaging
Pat. No. 9545457 Preparation of a lipid blend and a phospholipid suspension containing the lipid blend
Claim Types: Diagnostic or surgical method
Jan 13, 2019U-665: Method of using the drug substance/drug product for ultrasound imaging
Pat. No. 8658205 DP* Preparation of a lipid blend and a phospholipid suspension containing the lipid blend
Claim Types: Formulation
Jun 18, 2019 
Pat. No. 9789210 Methods for making ultrasound contrast agents
Claim Types: Diagnostic or surgical method
Mar 16, 2037U-665: Method of using the drug substance/drug product for ultrasound imaging

LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC      NDA No.: 020517  Prod. No.: 003 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7429559 DP* Controlled release composition and method of producing the same
Claim Types: Formulation
Jan 13, 2019 
Pat. No. 8815801 DP* Controlled release composition and method of producing the same
Claim Types: Formulation
Jun 28, 2022 
Pat. No. 8921326 DP* Sustained-release composition and method for producing the same
Claim Types: Formulation
Feb 5, 2031U-1666: Palliative treatment of prostate cancer

ZIPSOR (CAPSULE) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: ASSERTIO      NDA No.: 022202  Prod. No.: 001 RX (25MG)
PatentsExpirationPatented Use
Pat. No. 6287594 DP* Oral liquid compositions
Claim Types: Formulation
Jan 15, 2019 
Pat. No. 6365180 DP* Oral liquid compositions
Claim Types: Formulation; Method of improving a treatment
Jul 15, 2019U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 7662858 Method of treating post-surgical acute pain
Claim Types: Method of administration
Feb 24, 2029U-1035: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 7884095 Method of treating post-surgical acute pain
Claim Types: Method of use
Feb 24, 2029U-1111: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 7939518 Method of treating post-surgical acute pain
Claim Types: Method of use
Feb 24, 2029U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 8110606 Method of treating post-surgical acute pain
Claim Types: Method of use
Feb 24, 2029U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 8623920 Method of treating post-surgical acute pain
Claim Types: Method of administration
Feb 24, 2029U-1482: Diclofenac potassium for relief of mild to moderate acute pain
Pat. No. 9561200 Method of treating post-surgical acute pain
Claim Types: Method of use
Feb 24, 2029U-1482: Diclofenac potassium for relief of mild to moderate acute pain

GLEEVEC (CAPSULE) (ORAL) IMATINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 021335  Prod. No.: 001 DISC (EQ 50MG BASE**); 002 DISC (EQ 100MG BASE**)
PatentsExpirationPatented Use
Pat. No. RE43932 DS* DP* Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
Claim Types: New polymorph, salt or hydrate; Composition
Jan 16, 2019 *PED 
Pat. No. 6894051 DS* DP* Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes forits manufacture and its use
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Nov 23, 2019 *PEDU-649: A method for treating a tumor disease
Pat. No. 6958335 Treatment of gastrointestinal stromal tumors
Claim Types: Method of use
Jun 19, 2022 *PEDU-791: GLEEVEC is also indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)

GLEEVEC (TABLET) (ORAL) IMATINIB MESYLATE [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 021588  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 400MG BASE)
PatentsExpirationPatented Use
Pat. No. RE43932 DS* DP* Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use
Claim Types: New polymorph, salt or hydrate; Composition
Jan 16, 2019 *PED 
Pat. No. 6894051 DS* DP* Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes forits manufacture and its use
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Nov 23, 2019 *PEDU-649: A method for treating a tumor disease
Pat. No. 6958335 Treatment of gastrointestinal stromal tumors
Claim Types: Method of use
Jun 19, 2022 *PEDU-1883: Treatment of gastrointestinal stromal tumors (GIST)
U-791: GLEEVEC is also indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 25, 2020ODE-40: Treatment of pediatric patients with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia (ph+ ALL) in combination with chemotherapy, approved under NDA #21588/s-037

FOSAMAX (SOLUTION) (ORAL) ALENDRONATE SODIUM
NDA Applicant: MERCK      NDA No.: 021575  Prod. No.: 001 DISC (EQ 70MG BASE/75ML**)
PatentsExpirationPatented Use
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
Jan 17, 2019 *PED 
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
Jan 17, 2019 *PED 
Pat. No. 6225294 Method for inhibiting bone resorption
Claim Types: Kit
Jan 17, 2019 *PED 

FOSAMAX PLUS D (TABLET) (ORAL) ALENDRONATE SODIUM; CHOLECALCIFEROL
Drug Classes: vitamin D
NDA Applicant: MERCK      NDA No.: 021762  Prod. No.: 001 RX (EQ 70MG BASE;2,800 IU)
PatentsExpirationPatented Use
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
Jan 17, 2019 *PEDU-647: Treatment of osteoporosis in post menopausal women and/or the treatment to increase bone mass in men with osteoporosis

TEKTURNA (TABLET) (ORAL) ALISKIREN HEMIFUMARATE
Drug Classes: renin inhibitor
NDA Applicant: NODEN PHARMA      NDA No.: 021985  Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 300MG BASE)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jan 21, 2019 *PEDU-3: Treatment of hypertension
Pat. No. 8617595 DP* Galenic formulations of organic compounds
Claim Types: Formulation; Method of use; Process
Aug 19, 2026 *PED 

TEKTURNA HCT (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Drug Classes: renin inhibitor; thiazide diuretic
NDA Applicant: NODEN PHARMA      NDA No.: 022107  Prod. No.: 001 RX (EQ 150MG BASE;12.5MG); 002 RX (EQ 150MG BASE;25MG); 003 RX (EQ 300MG BASE;12.5MG); 004 RX (EQ 300MG BASE;25MG)
PatentsExpirationPatented Use
Pat. No. 5559111 DS* DP* [Extended 1204 days (3.3 years)]
.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
Claim Types: Compound; Composition; Method of use
Jan 21, 2019 *PEDU-3: Treatment of hypertension
Pat. No. 9023893 DP* Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
Claim Types: Formulation
Mar 3, 2022 
Pat. No. 8618172 DP* Galenical formulations of organic compounds
Claim Types: Formulation
Jul 13, 2028 

BONJESTA (TABLET, EXTENDED RELEASE) (ORAL) DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Drug Classes: antihistamine; Vitamin B6 analog
NDA Applicant: DUCHESNAY      NDA No.: 209661  Prod. No.: 001 RX (20MG;20MG)
PatentsExpirationPatented Use
Pat. No. 7560122 DP* Pharmaceutical dosage form bearing pregnancy-friendly indicia
Claim Types: Formulation
Jan 25, 2019 
Pat. No. 9089489 DP* Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Claim Types: Formulation; Method of use
Feb 18, 2033U-1382: Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
Pat. No. 9375404 DP* Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Claim Types: Formulation; Method of use
Feb 18, 2033U-1382: Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
Pat. No. 9526703 DP* Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Claim Types: Formulation; Method of use
Feb 18, 2033U-1382: Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
Pat. No. 9937132 DP* Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Claim Types: Method of use
Feb 18, 2033U-1382: Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management

DICLEGIS (TABLET, DELAYED RELEASE) (ORAL) DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: antihistamine; Vitamin B6 analog
NDA Applicant: DUCHESNAY      NDA No.: 021876  Prod. No.: 001 RX (10MG;10MG)
PatentsExpirationPatented Use
Pat. No. 7560122 DP* Pharmaceutical dosage form bearing pregnancy-friendly indicia
Claim Types: Formulation
Jan 25, 2019 
Pat. No. 6340695 DP* Rapid onset formulation
Claim Types: Formulation; Method of use
Jun 21, 2021U-1382: Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management

APTIVUS (CAPSULE) (ORAL) TIPRANAVIR
Drug Classes: HIV protease inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021814  Prod. No.: 001 RX (250MG)
PatentsExpirationPatented Use
Pat. No. 6231887 DP* Pharmaceutical composition for acidic lipophilic compounds in a form of a self-emulsifying formulation
Claim Types: Formulation
Jan 27, 2019 *PED 
Pat. No. 5852195 DS* [Extended 1278 days (3.5 years)]
Pyranone compounds useful to treat retroviral infections
Claim Types: Compound
Dec 22, 2019 *PED 
Pat. No. 6147095 Method for improving the pharmacokinetics of tipranavir
Claim Types: Method of use
Apr 29, 2020 *PEDU-670: Treatment of HIV-1 infection by the co-administration of tipranavir and ritonavir.

LEVEMIR FLEXPEN (INJECTABLE) (SUBCUTANEOUS) INSULIN DETEMIR RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: NOVO NORDISK INC      NDA No.: 021536  Prod. No.: 002 DISC (300 UNITS/3ML (100 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. RE43834 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. 6004297 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. 5750497 DS* DP* [Extended 1497 days (4.1 years)]
Acylated insulin
Claim Types: Compound; Formulation; Method of use
Jun 16, 2019U-668: LEVEMIR is a long-acting basal insulin analog that is indicated in the treatment of patients with diabetes mellitus
Pat. No. RE41956 DP* Dose setting limiter
Claim Types: Device
Jan 21, 2021 
Pat. No. 9265893 DP* Injection button
Claim Types: Device
Sep 23, 2032 

NORDITROPIN NORDIFLEX (INJECTABLE) (INJECTION) SOMATROPIN RECOMBINANT
Drug Classes: recombinant human growth hormone
NDA Applicant: NOVO NORDISK INC      NDA No.: 021148  Prod. No.: 004 DISC (5MG/1.5ML); 005 DISC (10MG/1.5ML); 006 DISC (15MG/1.5ML)
PatentsExpirationPatented Use
Pat. No. 6004297 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. 6235004 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. RE41956 DP* Dose setting limiter
Claim Types: Device
Jan 21, 2021 

NORDITROPIN NORDIFLEX (INJECTABLE) (INJECTION) SOMATROPIN RECOMBINANT
Drug Classes: recombinant human growth hormone
NDA Applicant: NOVO NORDISK INC      NDA No.: 021148  Prod. No.: 007 DISC (30MG/3ML)
PatentsExpirationPatented Use
Pat. No. RE43834 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. 6004297 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. RE41956 DP* Dose setting limiter
Claim Types: Device
Jan 21, 2021 

NOVOLOG FLEXPEN (INJECTABLE) (SUBCUTANEOUS) INSULIN ASPART RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: NOVO NORDISK INC      NDA No.: 020986  Prod. No.: 003 RX (300 UNITS/3ML (100 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. RE43834 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. 6004297 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. RE41956 DP* Dose setting limiter
Claim Types: Device
Jan 21, 2021 
Pat. No. 9265893 DP* Injection button
Claim Types: Device
Sep 23, 2032 

NOVOLOG MIX 70/30 FLEXPEN (INJECTABLE) (SUBCUTANEOUS) INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: NOVO NORDISK INC      NDA No.: 021172  Prod. No.: 004 RX (210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. RE43834 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. 6004297 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. RE41956 DP* Dose setting limiter
Claim Types: Device
Jan 21, 2021 
Pat. No. 9265893 DP* Injection button
Claim Types: Device
Sep 23, 2032 

VICTOZA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE RECOMBINANT
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NORDISK INC      NDA No.: 022341  Prod. No.: 001 RX (18MG/3ML (6MG/ML))
PatentsExpirationPatented Use
Pat. No. RE43834 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. 6004297 DP* Injection syringe
Claim Types: Device
Jan 28, 2019 
Pat. No. RE41956 DP* Dose setting limiter
Claim Types: Device
Jan 21, 2021 
Pat. No. 8846618 DP* Stable formulation of modified GLP-1
Claim Types: Formulation; Process
Jun 27, 2022 
Pat. No. 6268343 DS* DP* [Extended 5 years]
Derivatives of GLP-1 analogs
Claim Types: Compound; Composition; Formulation; Method of use
Aug 22, 2022U-968: A method for improving glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 8114833 DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Claim Types: Formulation; Process
Aug 13, 2025 
Pat. No. 9265893 DP* Injection button
Claim Types: Device
Sep 23, 2032 
Pat. No. 9968659 Liraglutide in cardiovascular conditions
Claim Types: Method of use
Jan 9, 2037U-2313: Method of reducing the risk of cardiovascular death, non-fatal myocardial infarction, and/or non-fatal stroke in adults with Type 2 diabetes mellitus and established cardiovascular disease by administering liraglutide
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 25, 2020I-750: Reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes mellitus and established cardiovascular disease
Exclusivity Code: M - MiscellaneousApr 22, 2019M-176: Information added to the labeling describing trial NN2211-3916, a trial evaluating the safety and efficacy of liraglutide in subjects with Type 2 diabetes and moderate renal impairment

AGGRASTAT (INJECTABLE) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: platelet aggregation inhibitor
NDA Applicant: MEDICURE      NDA No.: 020912  Prod. No.: 001 DISC (EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6136794 Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist
Claim Types: Method of use
Jan 29, 2019 
Pat. No. 6770660 Method for inhibiting platelet aggregation
Claim Types: Method of administration; Method of use
May 1, 2023U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

AGGRASTAT (SOLUTION) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: platelet aggregation inhibitor
NDA Applicant: MEDICURE      NDA No.: 020912  Prod. No.: 002 RX (EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6136794 Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist
Claim Types: Method of use
Jan 29, 2019U-1898: Method of inhibiting platelet aggregation with AGGRASTAT (tirofiban hydrochloride)
Pat. No. 6770660 Method for inhibiting platelet aggregation
Claim Types: Method of administration; Method of use
May 1, 2023U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

AGGRASTAT (INJECTABLE) (INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes: platelet aggregation inhibitor
NDA Applicant: MEDICURE      NDA No.: 020913  Prod. No.: 002 RX (EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)); 003 RX (EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)) NDA No.: 020913  Prod. No.: 001 DISC (EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6136794 Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist
Claim Types: Method of use
Jan 29, 2019 
Pat. No. 6770660 Method for inhibiting platelet aggregation
Claim Types: Method of administration; Method of use
May 1, 2023U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS

GLYXAMBI (TABLET) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor; dipeptidyl peptidase 4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 206073  Prod. No.: 001 RX (10MG;5MG); 002 RX (25MG;5MG)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1651: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1651: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin
Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Method of use
Aug 12, 2023U-1651: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin
Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Formulation; Method of use
Aug 12, 2023U-1653: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin (with or without metformin)
U-1654: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin (with or without insulin or a sulfonylurea)
Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)]
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Compound; Composition
May 2, 2025 
Pat. No. 7579449 DS* Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Claim Types: Compound
Nov 5, 2025 
Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Claim Types: Compound; Process; Product-by-process
Nov 26, 2025 
Pat. No. 7713938 DS* DP* Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for
Claim Types: New polymorph, salt or hydrate; Composition; Process
Apr 15, 2027 
Pat. No. 8673927 Uses of DPP-IV inhibitors
Claim Types: Method of use
May 4, 2027U-1652: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin
Pat. No. 9173859 DP* Uses of DPP IV inhibitors
Claim Types: Method of use; Method of administration; Formulation
May 4, 2027U-1772: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin
Pat. No. 8551957 DP* Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Claim Types: Composition; Method of use; Formulation; Method of administration
Oct 14, 2029U-1651: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin
Pat. No. 9949998 Pharmaceutical composition, methods for treating and uses thereof
Claim Types: Method of use
Jun 11, 2034U-2290: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=EGFR<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 2, 2019I-739: To reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and established cardiovascular disease
Exclusivity Code: NC - New combinationJan 30, 2018 
Exclusivity Code: NCE - New chemical entityAug 1, 2019 

JANUMET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide; dipeptidyl peptidase 4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 022044  Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (1GM;EQ 50MG BASE)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1996: Improvement of glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1996: Improvement of glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1996: Improvement of glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Compound; Composition; Method of use
Jul 26, 2022U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor
Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Formulation; Method of use
Jul 26, 2022U-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin
U-1038: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin and a PPAR-gamma agonist
U-803: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin
Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process
Nov 24, 2026U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor
Pat. No. 8414921 DP* Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin
Claim Types: Formulation; Method of use
Jul 21, 2028U-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin

JANUMET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide; dipeptidyl peptidase 4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 202270  Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (1GM;EQ 50MG BASE); 003 RX (1GM;EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1996: Improvement of glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1996: Improvement of glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1996: Improvement of glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Compound; Composition; Method of use
Jul 26, 2022U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate
Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Formulation; Method of use
Jul 26, 2022U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate
Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process
Nov 24, 2026U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate

JANUVIA (TABLET) (ORAL) SITAGLIPTIN PHOSPHATE
Drug Classes: dipeptidyl peptidase 4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021995  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 50MG BASE); 003 RX (EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1997: Improvement of glycemic control in adults with Type 2 diabetes mellitus in combination with metformin and/or a ppar-gamma agonist and/or sulfonylurea and/or insulin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1997: Improvement of glycemic control in adults with Type 2 diabetes mellitus in combination with metformin and/or a ppar-gamma agonist and/or sulfonylurea and/or insulin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1945: Improvement of glycemic control in adults with Type 2 diabetes mellitus in combination with metformin.
Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Compound; Composition; Method of use
Jul 26, 2022U-774: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor
Pat. No. 7125873 Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Formulation; Method of use
Jul 26, 2022U-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin
U-1037: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with a PPAR-gamma agonist
U-1038: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin and a PPAR-gamma agonist
U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea
Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process
Nov 24, 2026U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor

JENTADUETO (TABLET) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase 4 (DPP-4) inhibitor; biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201281  Prod. No.: 001 RX (2.5MG;500MG); 002 RX (2.5MG;850MG); 003 RX (2.5MG;1GM)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1039: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1039: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1039: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin
Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Method of use
Aug 12, 2023U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor
Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Formulation; Method of use
Aug 12, 2023U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea
Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)]
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Compound; Composition
May 2, 2025 
Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Claim Types: Compound; Process; Product-by-process
Nov 26, 2025 
Pat. No. 8673927 Uses of DPP-IV inhibitors
Claim Types: Method of use
May 4, 2027U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
Pat. No. 9173859 DP* Uses of DPP IV inhibitors
Claim Types: Method of use; Method of administration; Formulation
May 4, 2027U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Claim Types: Formulation
Apr 2, 2029 
Pat. No. 10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Claim Types: Method of use
Apr 2, 2029U-2339: Use of a pharmaceutical composition comprising linagliptin, metformin and a basic amino acid to treat Type 2 diabetes mellitus
Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Claim Types: Composition; Formulation
May 21, 2030 
Pat. No. 8846695 Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
Claim Types: Method of use
Jun 4, 2030U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin

JENTADUETO XR (TABLET, EXTENDED RELEASE) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase 4 (DPP-4) inhibitor; biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 208026  Prod. No.: 001 RX (2.5MG;1GM); 002 RX (5MG;1GM)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-803: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-803: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-803: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin
Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Claim Types: Composition
Jun 20, 2020 
Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Method of use
Aug 12, 2023U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor
Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Formulation; Method of use
Aug 12, 2023U-1853: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and, optionally, a sulfonylurea
Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)]
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Compound; Composition
May 2, 2025 
Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Claim Types: Compound; Process; Product-by-process
Nov 26, 2025 
Pat. No. 8673927 Uses of DPP-IV inhibitors
Claim Types: Method of use
May 4, 2027U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
Pat. No. 9173859 DP* Uses of DPP IV inhibitors
Claim Types: Method of use; Method of administration; Formulation
May 4, 2027U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
Pat. No. 9415016 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Claim Types: Formulation
Apr 2, 2029 
Pat. No. 10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Claim Types: Method of use
Apr 2, 2029U-2339: Use of a pharmaceutical composition comprising linagliptin, metformin and a basic amino acid to treat Type 2 diabetes mellitus
Pat. No. 9155705 DP* DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Claim Types: Composition; Formulation
May 21, 2030 
Pat. No. 9555001 DP* Pharmaceutical composition and uses thereof
Claim Types: Formulation; Method of use
Mar 6, 2033U-1967: Method of treating Type 2 diabetes in patients with insufficient glycemic control despite therapy with one or more conventional antihyperglycemic agents by administering linagliptin in combination with metformin
U-1968: Method of treating Type 2 diabetes in patients who have not been previously treated with an antihyperglycemic agent by administering linagliptin in combination with metformin

JUVISYNC (TABLET) (ORAL) SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Drug Classes: HMG CoA-reductase inhibitor; dipeptidyl peptidase 4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 202343  Prod. No.: 001 DISC (10MG;EQ 100MG BASE**); 002 DISC (20MG;EQ 100MG BASE**); 003 DISC (40MG;EQ 100MG BASE**); 004 DISC (10MG;EQ 50MG BASE**); 005 DISC (20MG;EQ 50MG BASE**); 006 DISC (40MG;EQ 50MG BASE**)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1189: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with metformin
U-1190: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with insulin
U-1191: Method of treating Type 2 diabete mellitis in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with an agent acting on an ATP-dependent channel in beta cells such as a sulfonylurea(including glipizide, glimepiride & glyburide)
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1189: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with metformin
Pat. No. 8168637 DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes
Claim Types: Formulation; Method of use
Jun 26, 2022U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate
Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Compound; Composition; Method of use
Jul 26, 2022U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate
Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Formulation; Method of use
Jul 26, 2022U-1189: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with metformin
U-1190: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with insulin
U-1192: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with a sulfonylurea (such as glipizide, glimepiride and glyburide)
U-1193: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate, in combination with a PPAR-gamma agonist (such as pioglitazone and rosiglitazone)
Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process
Apr 11, 2026U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate

KAZANO (TABLET) (ORAL) ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor; biguanide
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 203414  Prod. No.: 001 RX (EQ 12.5MG BASE;500MG); 002 RX (EQ 12.5MG BASE;1GM)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1336: Methods of treating diabetes comprising administering a dipeptidyl peptidase inhibitor and metformin
Pat. No. 8173663 [Extended 262 days (0.7 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Mar 15, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Compound
Jun 24, 2025 
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8900638 DP* Solid preparation comprising alogliptin and metformin hydrochloride
Claim Types: Formulation; Process
May 24, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 5, 2019M-177: Information added to the labeling describing examine, a trial evaluating cardiovascular ischemic risks associated with alogliptin use in patients with Type 2 diabetes at high risk of ischemic cardiovascular disease
Exclusivity Code: NCE - New chemical entityJan 25, 2018 

NESINA (TABLET) (ORAL) ALOGLIPTIN BENZOATE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022271  Prod. No.: 001 RX (EQ 6.25MG BASE); 002 RX (EQ 12.5MG BASE); 003 RX (EQ 25MG BASE)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1336: Methods of treating diabetes comprising administering a dipeptidyl peptidase inhibitor and metformin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Compound
Mar 15, 2025 
Pat. No. 8173663 [Extended 262 days (0.7 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Dec 2, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8697125 DP* Tablet preparation without causing a tableting trouble
Claim Types: Formulation; Process; Product-by-process
Jun 16, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 5, 2019M-177: Information added to the labeling describing examine, a trial evaluating cardiovascular ischemic risks associated with alogliptin use in patients with Type 2 diabetes at high risk of ischemic cardiovascular disease
Exclusivity Code: NCE - New chemical entityJan 25, 2018 

OSENI (TABLET) (ORAL) ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022426  Prod. No.: 001 RX (EQ 25MG BASE;EQ 15MG BASE); 002 RX (EQ 25MG BASE;EQ 30MG BASE); 003 RX (EQ 25MG BASE;EQ 45MG BASE); 004 RX (EQ 12.5MG BASE;EQ 15MG BASE); 005 RX (EQ 12.5MG BASE;EQ 30MG BASE)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1336: Methods of treating diabetes comprising administering a dipeptidyl peptidase inhibitor and metformin
Pat. No. 6329404 DP* [Extended 5 years]
Pharmaceutical composition
Claim Types: Composition; Method of use
Jun 19, 2021U-1334: Methods of treating diabetes comprising administering an insulin sensitivity enhancer such as pioglitazone in combination with an insulin secretion enhancer
Pat. No. 8173663 [Extended 262 days (0.7 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Mar 15, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Compound
Mar 15, 2025 
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8637079 DP* Solid preparation comprising alogliptin and pioglitazone
Claim Types: Formulation
Jun 4, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 5, 2019M-177: Information added to the labeling describing examine, a trial evaluating cardiovascular ischemic risks associated with alogliptin use in patients with Type 2 diabetes at high risk of ischemic cardiovascular disease
Exclusivity Code: NCE - New chemical entityJan 25, 2018 

OSENI (TABLET) (ORAL) ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor; peroxisome proliferator-activated receptor (PPAR) alpha agonist; peroxisome proliferator-activated receptor (PPAR) gamma agonist; thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022426  Prod. No.: 006 RX (EQ 12.5MG BASE;EQ 45MG BASE)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1335: Methods of modifying glucose metabolism and treating diabetes comprising administering a dipeptidyl peptidase inhibitor and one or more other therapeutic agents such as metformin
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1336: Methods of treating diabetes comprising administering a dipeptidyl peptidase inhibitor and metformin
Pat. No. 8173663 [Extended 262 days (0.7 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Method of use
Mar 15, 2025U-1338: Method of treating diabetes comprising administering a compound such as alogliptin
Pat. No. 8288539 DS* [Extended 101 days (0.3 years)]
Dipeptidyl peptidase inhibitors
Claim Types: Compound
Mar 15, 2025 
Pat. No. 7807689 DS* DP* Dipeptidyl peptidase inhibitors
Claim Types: Compound; Composition; Drug in a container; Method of use
Jun 27, 2028U-1337: Method of treating diabetes comprising administering alogliptin
Pat. No. 8637079 DP* Solid preparation comprising alogliptin and pioglitazone
Claim Types: Formulation
Jun 4, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 5, 2019M-177: Information added to the labeling describing examine, a trial evaluating cardiovascular ischemic risks associated with alogliptin use in patients with Type 2 diabetes at high risk of ischemic cardiovascular disease
Exclusivity Code: NCE - New chemical entityJan 25, 2018 

STEGLUJAN (TABLET) (ORAL) ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
Drug Classes: dipeptidyl peptidase 4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 209805  Prod. No.: 001 RX (5MG;EQ 100MG BASE); 002 RX (15MG;EQ 100MG BASE)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-2215: Ertugliflozin in combination with sitagliptin and in further combination with metformin as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-2216: Ertugliflozin and sitagliptin in combination as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-2215: Ertugliflozin in combination with sitagliptin and in further combination with metformin as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Claim Types: Compound; Composition; Method of use
Jul 26, 2022U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes
Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process
Nov 24, 2026U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes
Pat. No. 8080580 DS* DP* Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use
Jul 13, 2030U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes
Pat. No. 9308204 DP* Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Claim Types: Formulation
Oct 21, 2030 
Pat. No. 9439901 Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Claim Types: Method of use
Oct 21, 2030U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 19, 2022 

TRADJENTA (TABLET) (ORAL) LINAGLIPTIN
Drug Classes: dipeptidyl peptidase 4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201280  Prod. No.: 001 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 6890898 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1270: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with insulin (with or without metformin and/or pioglitazone)
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7078381 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1270: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with insulin (with or without metformin and/or pioglitazone)
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7459428 Method of regulating glucose metabolism, and reagents related thereto
Claim Types: Method of use
Feb 2, 2019U-1270: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with insulin (with or without metformin and/or pioglitazone)
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Method of use
Aug 12, 2023U-1270: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with insulin (with or without metformin and/or pioglitazone)
U-774: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor
Pat. No. 8178541 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Formulation; Method of use
Aug 12, 2023U-1244: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with sulfonlyurea
U-1245: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with pioglitazone
U-1270: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with insulin (with or without metformin and/or pioglitazone)
U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea
Pat. No. 7407955 DS* DP* [Extended 629 days (1.7 years)]
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Claim Types: Compound; Composition
May 2, 2025 
Pat. No. 8883805 DP* Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Claim Types: Compound; Process; Product-by-process
Nov 26, 2025 
Pat. No. 8673927 Uses of DPP-IV inhibitors
Claim Types: Method of use
May 4, 2027U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
Pat. No. 9173859 DP* Uses of DPP IV inhibitors
Claim Types: Method of use; Method of administration; Formulation
May 4, 2027U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
U-1768: Method of treating Type 2 diabetes mellitus by administering linagliptin
Pat. No. 9486526 Treatment for diabetes in patients inappropriate for metformin therapy
Claim Types: Method of use; Method of administration
Aug 5, 2029U-1915: Method of treating Type 2 diabetes mellitus in patients with severe chronic renal impairment and who are ineligible for metformin therapy by administering linagliptin
Pat. No. 10034877 Treatment for diabetes in patients inappropriate for metformin therapy
Claim Types: Method of use
Aug 5, 2029U-2347: Treatment of Type 2 diabetes mellitus in a patient with renal impairment and for whom metformin therapy is inappropriate by administering linagliptin without dose adjustment
Pat. No. 8846695 Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
Claim Types: Method of use
Jun 4, 2030U-1503: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with metformin
Pat. No. 8853156 Treatment for diabetes in patients inappropriate for metformin therapy
Claim Types: Method of use
Mar 5, 2031U-1642: Method of treating Type 2 diabetes mellitus in patients with severe chronic renal impairment and for whom metformin therapy is inappropriate by administering linagliptin

AURYXIA (TABLET) (ORAL) FERRIC CITRATE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: KERYX BIOPHARMS      NDA No.: 205874  Prod. No.: 001 RX (EQ 210MG IRON)
PatentsExpirationPatented Use
Pat. No. 5753706 DP* Methods for treating renal failure
Claim Types: Method of use; Formulation
Feb 3, 2019U-1577: Control of serum phosphorous levels
Pat. No. 7767851 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Product-by-process; Composition; Formulation
Feb 18, 2024 
Pat. No. 8299298 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Claim Types: Formulation
Feb 18, 2024 
Pat. No. 8338642 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Compound; Composition; Formulation; Method of use
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8609896 DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation
Feb 18, 2024 
Pat. No. 8754257 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation
Feb 18, 2024 
Pat. No. 8754258 DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Formulation
Feb 18, 2024 
Pat. No. 8846976 Ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8901349 Ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9050316 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of use
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9328133 DS* DP* Ferric organic compounds, uses thereof and methods of making same
Claim Types: Composition; Formulation; Method of use
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 9757416 DS* DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Claim Types: Method of administration
Feb 18, 2024U-1577: Control of serum phosphorous levels
Pat. No. 8093423 Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Claim Types: Method of use
Apr 21, 2026U-1577: Control of serum phosphorous levels
Pat. No. 9387191 DP* Ferric citrate dosage forms
Claim Types: Formulation
Jul 21, 2030 

ZOSYN IN PLASTIC CONTAINER (INJECTABLE) (INJECTION) PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Drug Classes: penicillin class antibacterial; beta lactamase inhibitor
NDA Applicant: WYETH PHARMS      NDA No.: 050750  Prod. No.: 001 RX (EQ 40MG BASE/ML;EQ 5MG BASE/ML); 002 RX (EQ 60MG BASE/ML;EQ 7.5MG BASE/ML); 003 RX (EQ 4GM BASE/100ML;EQ 500MG BASE/100ML)
PatentsExpirationPatented Use
Pat. No. 6207661 DP* Premixed formulation of piperacillin sodium and tazobactam sodium injection
Claim Types: Formulation; Process
Feb 22, 2019 
Pat. No. 6900184 DP* Compositions containing pipercillin and tazobactam useful for injection
Claim Types: Formulation; Method of use; Process
Apr 14, 2023U-282: Method of treating bacterial infections
Pat. No. 7915229 DP* Compositions containing piperacillin and tazobactam useful for injection
Claim Types: Formulation
Apr 14, 2023 
Pat. No. 8133883 DP* Compositions containing piperacillin and tazobactam useful for injection
Claim Types: Formulation; Method of use
Apr 14, 2023U-282: Method of treating bacterial infections

FORADIL (POWDER) (INHALATION) FORMOTEROL FUMARATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: NOVARTIS      NDA No.: 020831  Prod. No.: 001 DISC (0.012MG/INH)
PatentsExpirationPatented Use
Pat. No. 6488027 Powder inhaler
Claim Types: Device
Mar 8, 2019 
Pat. No. 6887459 Aerosol composition comprising formoterol
Claim Types: Method of use
Nov 28, 2020U-762: Treatment of chronic obstructive pulmonary disease

SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.: 021929  Prod. No.: 002 RX (0.16MG/INH;0.0045MG/INH)
PatentsExpirationPatented Use
Pat. No. 7897646 Use for budesonide and formoterol
Claim Types: Method of use
Mar 9, 2019 *PEDU-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 8461211 Use for budesonide and formoterol
Claim Types: Method of use
Mar 9, 2019 *PEDU-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 7367333 DP* Inhalation device
Claim Types: Device
May 11, 2019 *PED 
Pat. No. 7967011 DP* Inhalation device
Claim Types: Device
Feb 11, 2022 *PED 
Pat. No. 7759328 DP* Composition for inhalation
Claim Types: Formulation; Method of use
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 8143239 DP* Composition for inhalation
Claim Types: Device; Method of administration
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 8575137 DP* Composition for inhalation
Claim Types: Formulation; Method of use; Device
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 8875699 DP* Inhaler cap strap
Claim Types: Device
May 10, 2025 *PED 
Pat. No. 7587988 DP* Inhaler device counter
Claim Types: Device
Oct 10, 2026 *PED 
Pat. No. 8387615 DP* Inhaler cap strap
Claim Types: Device
Sep 26, 2027 *PED 
Pat. No. 8528545 DP* Inhaler device that reduces the risk for miscounting a dosage
Claim Types: Device
Apr 16, 2029 *PED 
Pat. No. 8616196 DP* Inhalation device and a method for assembling said inhalation device
Claim Types: Device; Process
Oct 7, 2029 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 11, 2020M-210: Information added to labeling to support the use of SYMBICORT to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD)
Exclusivity Code: M - MiscellaneousDec 20, 2020M-214: Information added to the clinical trials section of the labeling regarding a postmarketing safety and efficacy study evaluating the risk of serious asthma-related events

MYCAMINE (INJECTABLE) (INTRAVENOUS) MICAFUNGIN SODIUM
Drug Classes: echinocandin antifungal
NDA Applicant: ASTELLAS      NDA No.: 021506  Prod. No.: 002 RX (EQ 50MG BASE/VIAL); 003 RX (EQ 100MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 6107458 DS* DP* [Extended 1265 days (3.5 years)]
Cyclic hexapeptides having antibiotic activity
Claim Types: Compound; Process; Composition; Method of use
Mar 16, 2019U-650: Treatment of esophageal candidiasis and prophylaxis of candida infections in HSCT patients
U-845: Treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis and abscesses
Pat. No. 6774104 DP* Stabilized pharmaceutical composition in lyophilized form
Claim Types: ; Composition; Process; Product-by-process; Method of use
Jan 8, 2021U-650: Treatment of esophageal candidiasis and prophylaxis of candida infections in HSCT patients
U-845: Treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis and abscesses

SYMLIN (INJECTABLE) (SUBCUTANEOUS) PRAMLINTIDE ACETATE
Drug Classes: amylin analog
NDA Applicant: ASTRAZENECA AB      NDA No.: 021332  Prod. No.: 002 RX (EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)); 003 RX (EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)) NDA No.: 021332  Prod. No.: 001 DISC (EQ 3MG BASE/5ML (EQ 600MCG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 5686411 DS* DP* [Extended 1586 days (4.3 years)]
Amylin agonist peptides and uses therefor
Claim Types: Compound; Method of use; Composition
Mar 16, 2019U-638: Treatment of diabetes with an amylin agonist, including with insulin

SYNRIBO (POWDER) (SUBCUTANEOUS) OMACETAXINE MEPESUCCINATE
NDA Applicant: TEVA PHARMS INTL      NDA No.: 203585  Prod. No.: 001 RX (3.5MG/VIAL)
PatentsExpirationPatented Use
Pat. No. RE45128 DS* DP* Cephalotaxane derivatives and their processes of preparation and purification
Claim Types: Formulation; Method of use
Mar 16, 2019U-1576: Treatment of leukemia
Pat. No. 6987103 [Extended 1216 days (3.3 years)]
Treatment of chronic myelogenous leukmia, resistant or intolerant to ST1571, involving homoharringtonine alone or combined with other agents
Claim Types: Method of use
Oct 26, 2026U-1300: Treatment of patients with tyrosine kinase inhibitor (TKI) resistant or intolerant chronic myeloid/myelogenous leukemia (CML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 26, 2019ODE-32: Treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI)

NEUPRO (FILM, EXTENDED RELEASE) (TRANSDERMAL) ROTIGOTINE
NDA Applicant: UCB INC      NDA No.: 021829  Prod. No.: 001 RX (2MG/24HR); 002 RX (4MG/24HR); 003 RX (6MG/24HR); 004 RX (1MG/24HR); 005 RX (3MG/24HR); 006 RX (8MG/24HR)
PatentsExpirationPatented Use
Pat. No. 7413747 DP* Transdermal therapeutic system for treating Parkinsonism
Claim Types: Formulation
Mar 18, 2019 
Pat. No. 6699498 DP* Transdermal therapeutic systems having improved stability and their production
Claim Types: Formulation
Nov 27, 2020 
Pat. No. 6884434 DP* [Extended 743 days (2 years)]
Transdermal therapeutic system which contains a d2 agonist and which is provided for treating parkinsonism, and a method for the production thereof
Claim Types: Formulation
Mar 30, 2021 
Pat. No. 8617591 DP* Transdermal delivery system for the administration of rotigotine
Claim Types: Drug in a container; Method of use
Jul 22, 2023U-1474: A method for the treatment of a patient suffering from a disease treatable with rotigotine, comprising applying the claimed transdermal delivery system (TDS) to the skin of the patient
Pat. No. 8246980 DP* Transdermal delivery system
Claim Types: Formulation
Nov 27, 2025 
Pat. No. 8246979 DP* Transdermal delivery system for the administration of rotigotine
Claim Types: Formulation; Method of use
Sep 1, 2027U-1272: Treatment of signs and symptoms of Parkinson's disease by application of claimed transdermal system
U-1273: Treatment of restless legs syndrome by application of claimed transdermal delivery system
Pat. No. 9925150 DP* Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine
Claim Types: Formulation; Process
Mar 1, 2032 

ILUVIEN (IMPLANT) (INTRAVITREAL) FLUOCINOLONE ACETONIDE
Drug Classes: corticosteroid
NDA Applicant: ALIMERA SCIENCES INC      NDA No.: 201923  Prod. No.: 001 RX (0.19MG)
PatentsExpirationPatented Use
Pat. No. 6217895 DP* Method for treating and/or preventing retinal diseases with sustained release corticosteroids
Claim Types: Method of use; Device
Mar 22, 2019U-1597: Treatment of diabetic macular edema
Pat. No. 6548078 DP* Method for treating and/or preventing retinal diseases with sustained release corticosteroids
Claim Types: Method of use; Device
Mar 22, 2019U-1597: Treatment of diabetic macular edema
Pat. No. 8252307 DP* Method for treating and/or preventing retinal diseases with sustained release corticosteroids
Claim Types: Device
Jun 27, 2019 
Pat. No. 6375972 DP* Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof
Claim Types: Device; Method of administration
Apr 26, 2020U-1597: Treatment of diabetic macular edema
Pat. No. 8871241 DP* Injectable sustained release delivery devices
Claim Types: Device
Aug 12, 2027 

RETISERT (IMPLANT) (INTRAVITREAL) FLUOCINOLONE ACETONIDE
Drug Classes: corticosteroid
NDA Applicant: BAUSCH AND LOMB      NDA No.: 021737  Prod. No.: 001 RX (0.59MG)
PatentsExpirationPatented Use
Pat. No. 6217895 DP* Method for treating and/or preventing retinal diseases with sustained release corticosteroids
Claim Types: Method of use; Device
Mar 22, 2019U-708: Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye
Pat. No. 6548078 DP* Method for treating and/or preventing retinal diseases with sustained release corticosteroids
Claim Types: Method of use; Device
Mar 22, 2019U-708: Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye

ASTAGRAF XL (CAPSULE, EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ASTELLAS      NDA No.: 204096  Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 5MG BASE)
PatentsExpirationPatented Use
Pat. No. 6440458 DP* Sustained release preparations
Claim Types: Formulation
Mar 25, 2019 
Pat. No. 6576259 DP* Sustained release formulation containing tacrolimus
Claim Types: Formulation; Method of administration; Method of use
Mar 25, 2019U-1420: Method of once a day administration
Pat. No. 6884433 DP* Sustained release formulations containing tacrolimus
Claim Types: Formulation
Mar 25, 2019U-1420: Method of once a day administration
Pat. No. 8551522 DP* Sustained-release formulation
Claim Types: Formulation
Mar 25, 2019 

ULORIC (TABLET) (ORAL) FEBUXOSTAT
Drug Classes: xanthine oxidase inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021856  Prod. No.: 001 RX (40MG); 002 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 5614520 DS* DP* [Extended 5 years]
2-arylthiazole derivatives and pharmaceutical composition thereof
Claim Types: Compound; Composition
Mar 25, 2019U-954: Chronic management of hyperuricemia in patients with gout. Not recommended for the treatment of asymptomatic hyperuricemia
Pat. No. 6225474 DS* Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and method of producing the same
Claim Types: New polymorph, salt or hydrate; Compound; Process
Jun 18, 2019 
Pat. No. 7361676 DP* Solid preparation containing single crystal form
Claim Types: Formulation; Process
Mar 8, 2024 
Pat. No. 8372872 Methods for concomitant treatment of theophylline and febuxostat
Claim Types: Method of administration
Sep 8, 2031U-1346: Use of febuxostat for the management of hyperuricemia in patients suffering from gout and, when used with theophylline without the need for dose adjustment of theophylline
Pat. No. 9107912 Methods for concomitant treatment of theophylline and febuxostat
Claim Types: Method of use
Sep 8, 2031U-1346: Use of febuxostat for the management of hyperuricemia in patients suffering from gout and, when used with theophylline without the need for dose adjustment of theophylline
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAug 15, 2020M-205: Information added to the labeling regarding randomized, multicenter, double-blind, placebo-controlled studies on patients with severe renal impairment

FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: CEPHALON      NDA No.: 021947  Prod. No.: 001 RX (EQ 0.1MG BASE)
PatentsExpirationPatented Use
Pat. No. 6200604 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-767: Management of breakthrough pain in patients with cancer
Pat. No. 6974590 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-767: Management of breakthrough pain in patients with cancer
Pat. No. 8728441 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-1514: Management of breakthrough pain in patients with cancer by buccal or sublingual administration of fentanyl
Pat. No. 8753611 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-1514: Management of breakthrough pain in patients with cancer by buccal or sublingual administration of fentanyl
Pat. No. 8765100 DP* Transmucosal effervescent
Claim Types: Formulation
Mar 26, 2019 
Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Dec 30, 2024 
Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Jun 15, 2028 
Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates
Claim Types: Formulation
Jun 15, 2028 

FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: CEPHALON      NDA No.: 021947  Prod. No.: 002 RX (EQ 0.2MG BASE); 003 RX (EQ 0.4MG BASE); 004 RX (EQ 0.6MG BASE); 005 RX (EQ 0.8MG BASE)
PatentsExpirationPatented Use
Pat. No. 6200604 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-767: Management of breakthrough pain in patients with cancer
Pat. No. 6974590 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-767: Management of breakthrough pain in patients with cancer
Pat. No. 8728441 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-1514: Management of breakthrough pain in patients with cancer by buccal or sublingual administration of fentanyl
Pat. No. 8753611 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-1514: Management of breakthrough pain in patients with cancer by buccal or sublingual administration of fentanyl
Pat. No. 8765100 DP* Transmucosal effervescent
Claim Types: Formulation
Mar 26, 2019 
Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Dec 30, 2024 
Pat. No. 8119158 DP* Effervescent oral fentanyl dosage form and methods of administering fentanyl
Claim Types: Formulation; Method of use; Process
Dec 30, 2024 
Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Jun 15, 2028 
Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates
Claim Types: Formulation
Jun 15, 2028 

FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: CEPHALON      NDA No.: 021947  Prod. No.: 006 DISC (EQ 0.3MG BASE**)
PatentsExpirationPatented Use
Pat. No. 6200604 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-767: Management of breakthrough pain in patients with cancer
Pat. No. 6974590 Sublingual buccal effervescent
Claim Types: Method of use
Mar 26, 2019U-767: Management of breakthrough pain in patients with cancer

GLUCOTROL XL (TABLET, EXTENDED RELEASE) (ORAL) GLIPIZIDE [GENERIC AB]
Drug Classes: sulfonylurea
NDA Applicant: PFIZER      NDA No.: 020329  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (2.5MG)
PatentsExpirationPatented Use
Pat. No. RE44459 Method for lowering blood glucose
Claim Types: Method of administration
Mar 26, 2019U-1431: Method of treating hyperglycemia to improve glycemic control in a patient by oral admin of once a day osmotic dosage form of glipizide with polyethylene oxide, hydroxypropylmethylcellulose, cellulose acetate, and sodium chloride

LOKELMA (FOR SUSPENSION) (ORAL) SODIUM ZIRCONIUM CYCLOSILICATE
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 207078  Prod. No.: 001 RX (5GM/PACKET ); 002 RX (10GM/PACKET)
PatentsExpirationPatented Use
Pat. No. 6332985 Process for removing toxins from bodily fluids using zirconium or titanium microporous compositions
Claim Types: Method of use
Mar 29, 2019U-2312: Treatment of hyperkalemia in adults
Pat. No. 8808750 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 9844567 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 9861658 Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Method of use
Feb 10, 2032U-2312: Treatment of hyperkalemia in adults
Pat. No. 8802152 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Apr 19, 2032 
Pat. No. 8877255 DS* Microporous zirconium silicate for the treatment of hyperkalemia
Claim Types: Formulation
Oct 22, 2033 
Pat. No. 9592253 DS* Extended use zirconium silicate compositions and methods of use thereof
Claim Types: Product-by-process; Method of use
Oct 14, 2035U-2312: Treatment of hyperkalemia in adults
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 18, 2023 

BESIVANCE (SUSPENSION/DROPS) (OPHTHALMIC) BESIFLOXACIN HYDROCHLORIDE
Drug Classes: quinolone antimicrobial
NDA Applicant: BAUSCH AND LOMB      NDA No.: 022308  Prod. No.: 001 RX (EQ 0.6% BASE)
PatentsExpirationPatented Use
Pat. No. 6699492 DP* Quinolone carboxylic acid compositions and related methods of treatment
Claim Types: Formulation; Method of use; Process
Mar 31, 2019U-80: Method of treating ocular bacterial infections
Pat. No. 6685958 DP* Quinolone carboxylic acid compositions and related methods of treatment
Claim Types: Formulation; Method of use
Jun 29, 2021U-80: Method of treating ocular bacterial infections
Pat. No. 8937062 Compositions and methods for treating, reducing, ameliorating, or preventing infections caused by antibacterial drug-resistant bacteria
Claim Types: Method of use
Nov 13, 2029U-80: Method of treating ocular bacterial infections
Pat. No. 8604020 DP* Fluoroquinolone carboxylic acid molecular crystals
Claim Types: New polymorph, salt or hydrate
Mar 12, 2030 
Pat. No. 8415342 Besifloxacin ophthalmic composition for the treatment or control of infection
Claim Types: Method of use
Nov 7, 2030U-80: Method of treating ocular bacterial infections
Pat. No. 8481526 DS* Fluoroquinolone carboxylic acid molecular crystals
Claim Types: New polymorph, salt or hydrate; Process
Jan 9, 2031 

DUAVEE (TABLET) (ORAL) BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
Drug Classes: estrogen agonist/antagonist
NDA Applicant: WYETH PHARMS      NDA No.: 022247  Prod. No.: 001 RX (EQ 20MG BASE;0.45MG)
PatentsExpirationPatented Use
Pat. No. 5998402 DS* DP* 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indoles as estrogenic agents
Claim Types: Compound; Composition; Method of use
Apr 4, 2019U-594: Prevention of postmenopausal osteoporosis
Pat. No. 6479535 DP* 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations
Claim Types: Formulation; Method of use
May 6, 2019U-594: Prevention of postmenopausal osteoporosis
U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause
Pat. No. 8815934 DP* 2-Phenyl-1-[4-(2-Aminoethoxy)-Benzyl]-Indole and estrogen formulations
Claim Types: Composition
May 6, 2019 
Pat. No. 7683051 DS* DP* Crystalline polymorph of bazedoxifene acetate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process; Product-by-process
Mar 10, 2027U-594: Prevention of postmenopausal osteoporosis
U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 13, 2018 

EXJADE (TABLET, FOR SUSPENSION) (ORAL) DEFERASIROX [GENERIC AB]
Drug Classes: iron chelator
NDA Applicant: NOVARTIS      NDA No.: 021882  Prod. No.: 001 RX (125MG); 002 RX (250MG); 003 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 6465504 DS* DP* [Extended 650 days (1.8 years)]
Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators
Claim Types: Compound; Composition
Apr 5, 2019 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 23, 2020ODE-39: Treatment of chronic iron overload in patients 10 yrs. & older with non-transfusion dependent thalassemia (ntdt) syndromes and with a liver iron concentration of at least 5 mg of iron per gram of liver dry weight & serum ferritin greater than 300 mcg/l.

JADENU (TABLET) (ORAL) DEFERASIROX
Drug Classes: iron chelator
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 206910  Prod. No.: 001 RX (90MG); 002 RX (180MG); 003 RX (360MG)
PatentsExpirationPatented Use
Pat. No. 6465504 DS* DP* [Extended 650 days (1.8 years)]
Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators
Claim Types: Compound; Composition
Apr 5, 2019 
Pat. No. 9283209 DS* DP* Oral formulations of deferasirox
Claim Types: Formulation
Nov 21, 2034 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 23, 2020ODE-39: Treatment of chronic iron overload in patients 10 yrs. & older with non-transfusion dependent thalassemia (ntdt) syndromes and with a liver iron concentration of at least 5 mg of iron per gram of liver dry weight & serum ferritin greater than 300 mcg/l.

JADENU SPRINKLE (GRANULE) (ORAL) DEFERASIROX
Drug Classes: iron chelator
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 207968  Prod. No.: 001 RX (90MG); 002 RX (180MG); 003 RX (360MG)
PatentsExpirationPatented Use
Pat. No. 6465504 DS* DP* [Extended 650 days (1.8 years)]
Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators
Claim Types: Compound; Composition
Apr 5, 2019 

FEMCON FE (TABLET, CHEWABLE) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE [GENERIC AB]
Drug Classes: estrogen; progestin
NDA Applicant: APIL      NDA No.: 021490  Prod. No.: 001 RX (0.035MG;0.4MG)
PatentsExpirationPatented Use
Pat. No. 6667050 DP* Chewable oral contraceptive
Claim Types: Formulation; Method of use
Apr 6, 2019U-1: Prevention of pregnancy

LO MINASTRIN FE (TABLET, CHEWABLE, TABLET) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: estrogen; progestin
NDA Applicant: APIL      NDA No.: 204654  Prod. No.: 001 DISC (0.01MG,0.01MG,N/A;1MG,N/A,N/A)
PatentsExpirationPatented Use
Pat. No. 6667050 DP* Chewable oral contraceptive
Claim Types: Formulation; Method of use
Apr 6, 2019U-1: Prevention of pregnancy
Pat. No. 7704984 Extended estrogen dosing contraceptive regimen
Claim Types: Method of administration
Feb 2, 2029U-1: Prevention of pregnancy

MINASTRIN 24 FE (TABLET, CHEWABLE) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE [GENERIC AB]
Drug Classes: estrogen; progestin
NDA Applicant: APIL      NDA No.: 203667  Prod. No.: 001 RX (0.02MG;1MG)
PatentsExpirationPatented Use
Pat. No. 6667050 DP* Chewable oral contraceptive
Claim Types: Formulation; Method of use
Apr 6, 2019U-1: Prevention of pregnancy

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (TABLET, CHEWABLE) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE [GENERIC AB]
Drug Classes: estrogen; progestin
NDA Applicant: APIL      NDA No.: 022573  Prod. No.: 001 RX (0.025MG;0.8MG)
PatentsExpirationPatented Use
Pat. No. 6667050 DP* Chewable oral contraceptive
Claim Types: Formulation; Method of use
Apr 6, 2019U-828: Prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception

TUXARIN ER (TABLET, EXTENDED RELEASE) (ORAL) CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
Drug Classes: histamine-1 (H1) receptor antagonist; opioid agonist
NDA Applicant: SPRIASO LLC      NDA No.: 206323  Prod. No.: 001 DISC (8MG;54.3MG)
PatentsExpirationPatented Use
Pat. No. 6383471 DP* Compositions and methods for improved delivery of ionizable hydrophobic therapeutic agents
Claim Types: Formulation; Process; Method of administration
Apr 6, 2019U-1716: Treatment of cough and symptoms associated with upper respiratory allergies or a common cold with codeine phosphate and chlorpheniramine maleate orally administered extended release tablets
Pat. No. 6248363 DP* Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
Claim Types: Formulation; Method of administration
Nov 23, 2019U-1716: Treatment of cough and symptoms associated with upper respiratory allergies or a common cold with codeine phosphate and chlorpheniramine maleate orally administered extended release tablets
Pat. No. 9066942 Oral dosage forms for oxygen-containing active agents and oxyl-containing polymer
Claim Types: Method of use
Jan 3, 2032U-1716: Treatment of cough and symptoms associated with upper respiratory allergies or a common cold with codeine phosphate and chlorpheniramine maleate orally administered extended release tablets
Pat. No. 9107921 DP* Oral dosage forms for oxygen containing active agents and oxyl-containing polymers
Claim Types: Formulation
Jan 3, 2032 

XEPI (CREAM) (TOPICAL) OZENOXACIN
Drug Classes: quinolone antimicrobial
NDA Applicant: FERRER INTERNACIONAL      NDA No.: 208945  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 6335447 DS* Quinolonecarboxylic acid derivatives or salts thereof
Claim Types: Compound
Apr 6, 2019 
Pat. No. 9399014 Pharmaceutical topical compositions
Claim Types: Method of use
Dec 15, 2029U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
Pat. No. 9180200 DP* Pharmaceutical topical compositions
Claim Types: Formulation; Method of use
Jan 29, 2032U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 11, 2022 

PRILOSEC (CAPSULE, DELAYED REL PELLETS) (ORAL) OMEPRAZOLE
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 019810  Prod. No.: 001 DISC (20MG**); 002 DISC (40MG**); 003 DISC (10MG**)
PatentsExpirationPatented Use
Pat. No. 6147103 Omeprazole process and compositions thereof
Claim Types: Formulation
Apr 9, 2019 *PED 
Pat. No. 6166213 Omeprazole process and compositions thereof
Claim Types: Product-by-process; Process
Comments: Omeprazole produced by the claimed process that has less than a specified level of residual solvent
Apr 9, 2019 *PED 
Pat. No. 6191148 Omerazole process and compositions thereof
Claim Types: Formulation
Comments: Omeprazole having specified purity and residual solvent levels
Apr 9, 2019 *PED 
Pat. No. 6150380 Crystalline form of omeprazole
Claim Types: New polymorph, salt or hydrate; Composition; Process
May 10, 2019 *PED 

FLECTOR (PATCH) (TOPICAL) DICLOFENAC EPOLAMINE
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: INST BIOCHEM      NDA No.: 021234  Prod. No.: 001 RX (1.3%)
PatentsExpirationPatented Use
Pat. No. 5607690 DP* [Extended 5 years]
External anti-inflammatory and analgesic plaster preparation
Claim Types: Formulation; Process
Apr 13, 2019 

BANZEL (SUSPENSION) (ORAL) RUFINAMIDE
NDA Applicant: EISAI INC      NDA No.: 201367  Prod. No.: 001 RX (40MG/ML)
PatentsExpirationPatented Use
Pat. No. 7750028 Crystal modifications of 1-(2,6-difluorobenzyl)-1H-1, 2,3-triazole-4-carboxamide
Claim Types: Method of use
Apr 19, 2019 *PEDU-106: Treatment of epilepsy
Pat. No. 6740669 DS* DP* [Extended 819 days (2.2 years)]
Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic
Claim Types: New polymorph, salt or hydrate; Composition
May 14, 2023 *PED 

ROGAINE, MEN'S; WOMEN'S ROGAINE (AEROSOL, FOAM) (TOPICAL) MINOXIDIL [GENERIC OTC]
Drug Classes: arteriolar vasodilator
NDA Applicant: JOHNSON AND JOHNSON      NDA No.: 021812  Prod. No.: 001 OTC (5%); 002 OTC (5%)
PatentsExpirationPatented Use
Pat. No. 6946120 DP* Pharmaceutical composition
Claim Types: Formulation; Method of use
Apr 20, 2019U-702: Topical aerosol hair regrowth treatment

OMNARIS (SPRAY, METERED) (NASAL) CICLESONIDE
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 022004  Prod. No.: 001 RX (0.05MG/INH)
PatentsExpirationPatented Use
Pat. No. 6939559 DP* Pharmaceutical composition for application to mucosa
Claim Types: Formulation
Apr 21, 2019 
Pat. No. 7235247 DP* Pharmaceutical composition for application to mucosa
Claim Types: Formulation
Apr 21, 2019 
Pat. No. 8383611 DP* Ciclesonide containing aqueous pharmaceutical composition
Claim Types: Formulation
Oct 20, 2020 
Pat. No. 6767901 DP* Ciclesonide contained pharmaceutical composition for application to mucosa
Claim Types: Formulation
Oct 21, 2020 
Pat. No. 8371292 Use of ciclesonide for the treatment of respiratory diseases
Claim Types: Method of use
Feb 1, 2028U-1356: Treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. treatment of nasal symptoms associated w perennial allergic rhinitis in adults and adolescents 12 years of age and older

ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: SHIRE      NDA No.: 021303  Prod. No.: 001 RX (2.5MG;2.5MG;2.5MG;2.5MG); 002 RX (5MG;5MG;5MG;5MG); 003 RX (7.5MG;7.5MG;7.5MG;7.5MG); 004 RX (6.25MG;6.25MG;6.25MG;6.25MG); 005 RX (1.25MG;1.25MG;1.25MG;1.25MG); 006 RX (3.75MG;3.75MG;3.75MG;3.75MG)
PatentsExpirationPatented Use
Pat. No. RE41148 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Apr 21, 2019 *PED 
Pat. No. RE42096 DP* Oral pulsed dose drug delivery system
Claim Types: Formulation
Apr 21, 2019 *PED 
Pat. No. 6322819 Oral pulsed dose drug delivery system
Claim Types: Formulation
Apr 21, 2019 *PED 
Pat. No. 6605300 Oral pulsed dose drug delivery system
Claim Types: Formulation
Apr 21, 2019 *PED 

CETROTIDE (INJECTABLE) (INJECTION) CETRORELIX
Drug Classes: gonadotropin releasing hormone (GnRH) antagonist
NDA Applicant: EMD SERONO INC      NDA No.: 021197  Prod. No.: 001 RX (EQ 0.25MG BASE/ML) NDA No.: 021197  Prod. No.: 002 DISC (EQ 3MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 6319192 Method for the treatment of fertility disorders
Claim Types: Method of use
Apr 23, 2019U-426: Prevention of premature LH surges in women undergoing controlled ovarian stimulation

PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 022291  Prod. No.: 001 RX (EQ 25MG ACID)
PatentsExpirationPatented Use
Pat. No. 6280959 DS* DP* Metal complexes
Claim Types: Method of use; Process; Composition; Product-by-process; Compound
Apr 30, 2019 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7452874 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Process
Nov 24, 2021 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7790704 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)]
Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
May 20, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Method of use
Nov 21, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Claim Types: Compound; Composition; Method of use; Formulation; Process
Jan 13, 2026 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1619: Treatment of immune (idiopathic) thrombocytopenia (ITP)
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleDec 11, 2018 PEDD-149: Dosing information added to the labeling regarding pediatric patients 6 years and older with ITP
Exclusivity Code: I - New IndicationDec 11, 2018 PEDI-711: Inclusion of pediatric patients ages 6 yrs and older for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2022 PEDODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 022291  Prod. No.: 002 RX (EQ 50MG ACID)
PatentsExpirationPatented Use
Pat. No. 6280959 DS* DP* Metal complexes
Claim Types: Method of use; Process; Composition; Product-by-process; Compound
Apr 30, 2019 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7452874 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Process
Nov 24, 2021 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7790704 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)]
Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
May 20, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Method of use
Nov 21, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Claim Types: Compound; Composition; Method of use; Formulation; Process
Jan 13, 2026 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1619: Treatment of immune (idiopathic) thrombocytopenia (ITP)
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleDec 11, 2018 PEDD-149: Dosing information added to the labeling regarding pediatric patients 6 years and older with ITP
Exclusivity Code: I - New IndicationDec 11, 2018 PEDI-711: Inclusion of pediatric patients ages 6 yrs and older for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2022 PEDODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 022291  Prod. No.: 003 RX (EQ 75MG ACID)
PatentsExpirationPatented Use
Pat. No. 6280959 DS* DP* Metal complexes
Claim Types: Method of use; Process; Composition; Product-by-process; Compound
Apr 30, 2019 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7452874 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Process
Nov 24, 2021 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7790704 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)]
Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
May 20, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Method of use
Nov 21, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Claim Types: Compound; Composition; Method of use; Formulation; Process
Jan 13, 2026 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1619: Treatment of immune (idiopathic) thrombocytopenia (ITP)
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleDec 11, 2018 PEDD-149: Dosing information added to the labeling regarding pediatric patients 6 years and older with ITP
Exclusivity Code: I - New IndicationDec 11, 2018 PEDI-711: Inclusion of pediatric patients ages 6 yrs and older for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2022 PEDODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 022291  Prod. No.: 004 RX (EQ 12.5MG ACID)
PatentsExpirationPatented Use
Pat. No. 6280959 DS* DP* Metal complexes
Claim Types: Method of use; Process; Composition; Product-by-process; Compound
Apr 30, 2019 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7452874 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Process
Nov 24, 2021 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7790704 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)]
Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
May 20, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Method of use
Nov 21, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Claim Types: Compound; Composition; Method of use; Formulation; Process
Jan 13, 2026 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1619: Treatment of immune (idiopathic) thrombocytopenia (ITP)
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleDec 11, 2018 PEDD-149: Dosing information added to the labeling regarding pediatric patients 6 years and older with ITP
Exclusivity Code: I - New IndicationDec 11, 2018 PEDI-711: Inclusion of pediatric patients ages 6 yrs and older for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2022 PEDODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 022291  Prod. No.: 005 RX (EQ 100MG ACID)
PatentsExpirationPatented Use
Pat. No. 6280959 DS* DP* Metal complexes
Claim Types: Method of use; Process; Composition; Product-by-process; Compound
Apr 30, 2019 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7452874 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Process
Nov 24, 2021 *PEDU-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7790704 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)]
Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
May 20, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP)
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Method of use
Nov 21, 2023 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Claim Types: Compound; Composition; Method of use; Formulation; Process
Jan 13, 2026 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
U-930: Treatment of idiopathic thrombocytopenic purpura (ITP)
Pat. No. 8052995 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Formulation; Process; Method of use
Feb 1, 2028 *PEDU-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleDec 11, 2018 PEDD-149: Dosing information added to the labeling regarding pediatric patients 6 years and older with ITP
Exclusivity Code: I - New IndicationDec 11, 2018 PEDI-711: Inclusion of pediatric patients ages 6 yrs and older for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2022 PEDODE-75: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

PROMACTA (FOR SUSPENSION) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 207027  Prod. No.: 001 RX (EQ 25MG ACID/PACKET)
PatentsExpirationPatented Use
Pat. No. 6280959 DS* DP* Metal complexes
Claim Types: Method of use; Process; Composition; Product-by-process; Compound
Apr 30, 2019 *PEDU-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7332481 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7452874 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Process
Nov 24, 2021 *PED 
Pat. No. 7473686 DS* DP* Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
Nov 24, 2021 *PEDU-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7790704 Thrombopoietin mimetics
Claim Types: Method of use
Nov 24, 2021 *PEDU-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7160870 DS* DP* [Extended 347 days (1 years)]
Thrombopoietin mimetics
Claim Types: Compound; Composition; Method of use; Process
May 20, 2023 *PEDU-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7795293 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Claim Types: Method of use
Nov 24, 2023 *PEDU-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Claim Types: Compound; Composition; Method of use; Formulation; Process
Jan 13, 2026 *PEDU-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp)
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleDec 11, 2018 PEDD-149: Dosing information added to the labeling regarding pediatric patients 6 years and older with ITP
Exclusivity Code: I - New IndicationDec 11, 2018 PEDI-711: Inclusion of pediatric patients ages 6 yrs and older for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2022 PEDODE-74: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy

VISIONBLUE (SOLUTION) (OPHTHALMIC) TRYPAN BLUE
Drug Classes: diagnostic dye
NDA Applicant: DORC      NDA No.: 021670  Prod. No.: 001 RX (0.06%)
PatentsExpirationPatented Use
Pat. No. 6720314 Use of a vital dye for facilitating surgical procedures for cataract extraction
Claim Types: Diagnostic or surgical method
May 7, 2019U-2321: A method of applying trypan blue onto an outer surface of the anterior lens capsule to facilitate removal of the lens substance
Pat. No. 6367480 Methods for visualizing the anterior lens capsule of the human eye
Claim Types: Method of use
Oct 26, 2019U-2321: A method of applying trypan blue onto an outer surface of the anterior lens capsule to facilitate removal of the lens substance

TARCEVA (TABLET) (ORAL) ERLOTINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: OSI PHARMS      NDA No.: 021743  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. RE41065 DS* DP* Alkynl and azido-substituted 4-anilinoquinazolines
Claim Types: Compound; Composition; Method of use; Process
May 8, 2019 *PED 
Pat. No. 5747498 DS* DP* [Extended 1251 days (3.4 years)]
Alkynyl and azido-substituted 4-anilinoquinazolines
Claim Types: Compound; Composition; Method of use; Process
May 8, 2019 *PEDU-659: Treatment of locally advanced or metastatic non small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen
Pat. No. 6900221 DS* DP* Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinaminehydrochloride, methods of production, and pharmaceutical uses thereof
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
May 9, 2021 *PEDU-1046: Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based chemotherapy
U-1403: First-line treatment of metastatic non smal-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an FDA-approved test
U-659: Treatment of locally advanced or metastatic non small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen
U-875: First-line treatment of locally advanced unresectable or metastatic pancreatic cancer, in combination with gemcitabine
Pat. No. 7087613 Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride
Claim Types: Method of use
May 9, 2021 *PEDU-1045: Maintenance treatment in patients with locally advanced or metastatic NSCLC who have not progressed on 1st-line treatment with platinum-based chemotherapy
U-1403: First-line treatment of metastatic non smal-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an FDA-approved test
U-659: Treatment of locally advanced or metastatic non small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleMay 20, 2019D-164: Updates to the dosage and administration, dose modifications section of the labeling
Exclusivity Code: M - MiscellaneousJun 1, 2019M-181: Update to the dosage and administration, patient selection (2.1), section of the package insert to include the use of an FDA-approved plasma test for the identification of EGFR exon 19 deletion or exon 21 (l858R) substitution mutations
Exclusivity Code: M - MiscellaneousOct 18, 2019M-190: Information added to the clinical studies section of the labeling regarding the lack of efficacy of TARCEVA in maintenance treatment of patients without EGFR mutations

INVEGA SUSTENNA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) PALIPERIDONE PALMITATE
Drug Classes: atypical antipsychotic
NDA Applicant: JANSSEN PHARMS      NDA No.: 022264  Prod. No.: 001 RX (39MG/0.25ML (39MG/0.25ML)); 002 RX (78MG/0.5ML (78MG/0.5ML)); 003 RX (117MG/0.75ML (117MG/0.75ML)); 004 RX (156MG/ML (156MG/ML)); 005 RX (234MG/1.5ML (156MG/ML))
PatentsExpirationPatented Use
Pat. No. 6555544 DP* Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters
Claim Types: Formulation; Method of use
May 10, 2019 *PEDU-543: Treatment of schizophrenia
Pat. No. 9439906 Dosing regimen associated with long acting injectable paliperidone esters
Claim Types: Method of administration
Jan 26, 2031U-1901: Treatment of schizoaffective disorder as a monotherapy and as an adjunct to mood stabilizers or antidepressants
U-543: Treatment of schizophrenia
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 20, 2020M-215: Information added to the labeling regarding the comparison of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to treatment failure in adults with schizophrenia who have been incarcerated

TOVIAZ (TABLET, EXTENDED RELEASE) (ORAL) FESOTERODINE FUMARATE [GENERIC AB]
NDA Applicant: PFIZER      NDA No.: 022030  Prod. No.: 001 RX (4MG); 002 RX (8MG)
PatentsExpirationPatented Use
Pat. No. 7384980 DS* DP* Derivatives of 3,3-diphenylpropylamines
Claim Types: Compound; Composition; Method of use
May 11, 2019U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 7855230 Derivatives of 3,3-diphenylpropylamines
Claim Types: Method of use
May 11, 2019U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 7985772 DS* DP* Derivatives of 3,3-diphenylpropylamines
Claim Types: Compound; Method of use; Composition
May 11, 2019U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 8338478 DS* DP* Derivatives of 3,3-diphenylpropylamines
Claim Types: Compound; Method of use; Composition
May 11, 2019U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 6858650 DS* [Extended 1149 days (3.1 years)]
Stable salts of novel derivatives of 3,3-diphenylpropylamines
Claim Types: Compound; Process; Method of use
Jul 3, 2022U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 7807715 DP* Pharmaceutical compositions comprising fesoterodine
Claim Types: Formulation; Method of use
Jun 7, 2027U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 8088398 DP* Pharmaceutical compositions comprising fesoterodine
Claim Types: Formulation; Method of use
Jun 7, 2027U-913: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Pat. No. 8501723 DP* Pharmaceutical compositions comprising fesoterodine
Claim Types: Formulation
Jun 7, 2027 

PULMICORT RESPULES (SUSPENSION) (INHALATION) BUDESONIDE [GENERIC AN]
Drug Classes: corticosteroid
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 020929  Prod. No.: 001 RX (0.25MG/2ML); 002 RX (0.5MG/2ML); 003 RX (1MG/2ML)
PatentsExpirationPatented Use
Pat. No. 7524834 DP* Sterile powders, formulations, and methods for producing the same
Claim Types: Formulation; Method of use
May 11, 2019 *PEDU-966: Treatment of asthma (maintenance and prophylactic therapy)
Pat. No. 6598603 Method for treating respiratory diseases
Claim Types: Method of use; Kit
Jun 23, 2019 *PEDU-529: Once daily treatment of asthma with nebulized budesonide
Pat. No. 6899099 Method for treating a respiratory disease
Claim Types: Kit; Method of use
Jun 23, 2019 *PEDU-529: Once daily treatment of asthma with nebulized budesonide

SYMBICORT (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Drug Classes: corticosteroid; beta-2 adrenergic agonist
NDA Applicant: ASTRAZENECA      NDA No.: 021929  Prod. No.: 001 RX (0.08MG/INH;0.0045MG/INH)
PatentsExpirationPatented Use
Pat. No. 7367333 DP* Inhalation device
Claim Types: Device
May 11, 2019 *PED 
Pat. No. 7967011 DP* Inhalation device
Claim Types: Device
Feb 11, 2022 *PED 
Pat. No. 7759328 DP* Composition for inhalation
Claim Types: Formulation; Method of use
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 8143239 DP* Composition for inhalation
Claim Types: Device; Method of administration
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 8575137 DP* Composition for inhalation
Claim Types: Formulation; Method of use; Device
Jul 29, 2023 *PEDU-2001: Use for the treatment of asthma in patients 6 years of age and older
U-2002: Use for maintenance treatment of chronic obstructive pulmonary disease
U-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease
Pat. No. 8875699 DP* Inhaler cap strap
Claim Types: Device
May 10, 2025 *PED 
Pat. No. 7587988 DP* Inhaler device counter
Claim Types: Device
Oct 10, 2026 *PED 
Pat. No. 8387615 DP* Inhaler cap strap
Claim Types: Device
Sep 26, 2027 *PED 
Pat. No. 8528545 DP* Inhaler device that reduces the risk for miscounting a dosage
Claim Types: Device
Apr 16, 2029 *PED 
Pat. No. 8616196 DP* Inhalation device and a method for assembling said inhalation device
Claim Types: Device; Process
Oct 7, 2029 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 11, 2020M-210: Information added to labeling to support the use of SYMBICORT to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD)
Exclusivity Code: M - MiscellaneousDec 20, 2020M-214: Information added to the clinical trials section of the labeling regarding a postmarketing safety and efficacy study evaluating the risk of serious asthma-related events
Exclusivity Code: NPP - New patient populationJul 27, 2020 PED 

EPANOVA (CAPSULE) (ORAL) OMEGA-3-CARBOXYLIC ACIDS
Drug Classes: omega-3 fatty acid
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 205060  Prod. No.: 001 DISC (1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS)
PatentsExpirationPatented Use
Pat. No. 5792795 DP* Treatment of inflammatory bowel disease using oral dosage forms of omega-3 polyunsaturated acids
Claim Types: Formulation; Method of use
May 13, 2019 
Pat. No. 5948818 DP* Treatment of inflammatory bowel disease using oral dosage forms of omega-3 polyunsaturated acids
Claim Types: Formulation; Method of use
May 13, 2019 
Pat. No. 7960370 DP* Type A gelatin capsule containing PUFA in free acid form
Claim Types: Formulation
Feb 7, 2025 
Pat. No. 8383678 DP* Type a gelatin capsule containing PUFA in free acid form
Claim Types: Formulation; Method of use
Feb 7, 2025U-1511: Treatment of hypertriglyceridemia
Pat. No. 9012501 DP* Type A gelatin capsule containing PUFA in free acid form
Claim Types: Formulation; Method of use
Feb 7, 2025U-1511: Treatment of hypertriglyceridemia
Pat. No. 9132112 DP* Type A gelatin capsule containing PUFA in free acid form
Claim Types: Formulation; Method of use
Feb 7, 2025U-1511: Treatment of hypertriglyceridemia
Pat. No. 9050308 DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Claim Types: Method of treatment
Jan 4, 2033U-1511: Treatment of hypertriglyceridemia
Pat. No. 9050309 DS* DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Claim Types: Formulation
Jan 4, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 5, 2019 

VESICARE (TABLET) (ORAL) SOLIFENACIN SUCCINATE [GENERIC AB]
Drug Classes: muscarinic antagonist
NDA Applicant: ASTELLAS      NDA No.: 021518  Prod. No.: 001 RX (5MG); 002 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6017927 DS* DP* [Extended 1058 days (2.9 years)]
Quinuclidine derivatives and medicinal composition thereof
Claim Types: Compound; Composition
May 19, 2019 *PED 

RANEXA (TABLET, EXTENDED RELEASE) (ORAL) RANOLAZINE
Drug Classes: antianginal
NDA Applicant: GILEAD      NDA No.: 021526  Prod. No.: 001 RX (1GM); 002 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 6303607 Method for administering a sustained release ranolanolazine formulation
Claim Types: Method of use
May 27, 2019U-705: Treating chronic angina by administering an extended release form of ranolazine
Pat. No. 6369062 DP* Sustained release ranolazine formulations
Claim Types: Formulation
May 27, 2019 
Pat. No. 6479496 Methods for treating angina with ranolazine
Claim Types: Method of use
May 27, 2019U-705: Treating chronic angina by administering an extended release form of ranolazine
Pat. No. 6503911 DP* Sustained release ranolazine formulations
Claim Types: Formulation
May 27, 2019 
Pat. No. 6525057 Sustained release ranolazine formulations
Claim Types: Method of use
May 27, 2019U-705: Treating chronic angina by administering an extended release form of ranolazine
Pat. No. 6562826 Sustained release ranolazine formulations
Claim Types: Method of use
May 27, 2019U-705: Treating chronic angina by administering an extended release form of ranolazine
Pat. No. 6617328 DP* Sustained release ranolazine formulations
Claim Types: Formulation; Process
May 27, 2019 
Pat. No. 6620814 Sustained release ranolazine formulations
Claim Types: Method of use
May 27, 2019U-705: Treating chronic angina by administering an extended release form of ranolazine
Pat. No. 6852724 Sustained release ranolazine formulations
Claim Types: Method of use
May 27, 2019U-705: Treating chronic angina by administering an extended release form of ranolazine
Pat. No. 6864258 Sustained release ranolazine formulations
Claim Types: Method of use
May 27, 2019U-705: Treating chronic angina by administering an extended release form of ranolazine

RESCRIPTOR (TABLET) (ORAL) DELAVIRDINE MESYLATE
Drug Classes: HIV nonnucleoside analog reverse transcriptase inhibitor (HIV-1 NNRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 020705  Prod. No.: 002 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 6177101 Delavirdine high strength tablet formulation
Claim Types: Formulation
Jun 7, 2019 

MOTRIN, CHILDREN'S COLD (SUSPENSION) (ORAL) IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: nonsteroidal anti-inflammatory drug; alpha adrenergic agonist
NDA Applicant: J AND J CONSUMER INC      NDA No.: 021128  Prod. No.: 001 OTC (100MG/5ML;15MG/5ML)
PatentsExpirationPatented Use
Pat. No. 6211246 Rapidly absorbed liquid compositions
Claim Types: Method of improving a formulation; Formulation
Jun 10, 2019 

HALAVEN (SOLUTION) (INTRAVENOUS) ERIBULIN MESYLATE
Drug Classes: microtubule inhibitor
NDA Applicant: EISAI INC      NDA No.: 201532  Prod. No.: 001 RX (1MG/2ML (0.5MG/ML))
PatentsExpirationPatented Use
Pat. No. 6469182 Intermediates in the preparation of macrocyclic analogs
Claim Types: Method of use
Jun 16, 2019U-1096: Treatment of patients with metastatic breast cancer
U-1812: Treatment of patients with unresectable or metastatic liposarcoma
Pat. No. 7470720 DP* Methods and compositions for use in treating cancer
Claim Types: Composition; Formulation
Jun 16, 2019 
Pat. No. 8097648 Methods and compositions for use in treating cancer
Claim Types: Method of use
Jan 22, 2021U-1096: Treatment of patients with metastatic breast cancer
Pat. No. 6214865 DS* [Extended 1495 days (4.1 years)]
Macrocyclic analogs and methods of their use and preparation
Claim Types: Compound; Process
Jul 20, 2023 
Pat. No. RE46965 DP* Intermediates for the preparation of analogs of Halichondrin B
Claim Types: Compound; Composition
Jan 8, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 28, 2019I-721: Treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
Exclusivity Code: ODE - Orphan drug exclusivityJan 28, 2023ODE-107: Treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracyclne-containing regimen

LEVEMIR (INJECTABLE) (SUBCUTANEOUS) INSULIN DETEMIR RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: NOVO NORDISK INC      NDA No.: 021536  Prod. No.: 001 RX (1000 UNITS/10ML (100 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. 5750497 DS* DP* [Extended 1497 days (4.1 years)]
Acylated insulin
Claim Types: Compound; Formulation; Method of use
Jun 16, 2019U-668: LEVEMIR is a long-acting basal insulin analog that is indicated in the treatment of patients with diabetes mellitus

LEVEMIR FLEXTOUCH (INJECTABLE) (SUBCUTANEOUS) INSULIN DETEMIR RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: NOVO NORDISK INC      NDA No.: 021536  Prod. No.: 005 RX (300 UNITS/3ML (100 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. 5750497 DS* DP* [Extended 1497 days (4.1 years)]
Acylated insulin
Claim Types: Compound; Formulation; Method of use
Jun 16, 2019U-668: LEVEMIR is a long-acting basal insulin analog that is indicated in the treatment of patients with diabetes mellitus
Pat. No. 6899699 DP* Automatic injection device with reset feature
Claim Types: Device; Method of administration
Jan 2, 2022 
Pat. No. 8672898 DP* Automatic injection device with reset feature
Claim Types: Device
Jan 2, 2022 
Pat. No. 9486588 DP* Automatic injection device with reset feature
Claim Types: Device
Jan 2, 2022 
Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Oct 20, 2025 
Pat. No. 9108002 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Jan 20, 2026 
Pat. No. 9616180 DP* Automatic injection device with a top release mechanism
Claim Types: Device
Jan 20, 2026 
Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Jan 20, 2026 
Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Jul 17, 2026 
Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Claim Types: Device
Jul 17, 2026 
Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen
Claim Types: Device; Method of use
Aug 3, 2026 
Pat. No. 7686786 DP* Dial-down mechanism for wind-up pen
Claim Types: Device
Aug 3, 2026 
Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display
Claim Types: Device
Feb 27, 2027 
Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism
Claim Types: Device
Sep 27, 2027 
Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen
Claim Types: Device
Feb 1, 2032 

LEVEMIR INNOLET; LEVEMIR PENFILL (INJECTABLE) (SUBCUTANEOUS) INSULIN DETEMIR RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: NOVO NORDISK INC      NDA No.: 021536  Prod. No.: 003 DISC (300 UNITS/3ML (100 UNITS/ML)); 004 DISC (300 UNITS/3ML (100 UNITS/ML))
PatentsExpirationPatented Use
Pat. No. 5750497 DS* DP* [Extended 1497 days (4.1 years)]
Acylated insulin
Claim Types: Compound; Formulation; Method of use
Jun 16, 2019U-668: LEVEMIR is a long-acting basal insulin analog that is indicated in the treatment of patients with diabetes mellitus

CLOBEX (SHAMPOO) (TOPICAL) CLOBETASOL PROPIONATE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: GALDERMA LABS      NDA No.: 021644  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 7316810 DP* Foaming composition for washing and treating hair and/or scalp based on an active principle
Claim Types: Formulation
Jun 17, 2019 
Pat. No. 8066975 DP* Foaming composition for washing and treating hair and/or scalp based on an active principle
Claim Types: Formulation
Jun 17, 2019 
Pat. No. 8066976 DP* Foaming compositions for hair care
Claim Types: Formulation
Jun 17, 2019 
Pat. No. 7700081 Foaming compositions for hair care
Claim Types: Method of use
Jan 3, 2022U-1044: Topical treatment of scalp psoriasis

ABELCET (INJECTABLE, LIPID COMPLEX) (INJECTION) AMPHOTERICIN B
Drug Classes: lipid-based polyene antifungal
NDA Applicant: LEADIANT BIOSCI INC      NDA No.: 050724  Prod. No.: 001 RX (5MG/ML)
PatentsExpirationPatented Use
Pat. No. 6406713 DS* Methods of preparing low-toxicity drug-lipid complexes
Claim Types: Process
Jun 18, 2019 

DYLOJECT (SOLUTION) (INTRAVENOUS) DICLOFENAC SODIUM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: JAVELIN PHARMS INC      NDA No.: 022396  Prod. No.: 001 DISC (37.5MG/ML (37.5MG/ML))
PatentsExpirationPatented Use
Pat. No. 6407079 DP* Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation
Claim Types: Formulation; Process
Jun 18, 2019 
Pat. No. 8946292 Formulations of low dose diclofenac and beta-cyclodextrin
Claim Types: Method of use
Mar 22, 2027U-1659: Management of pain

SPORANOX (SOLUTION) (ORAL) ITRACONAZOLE [GENERIC AA]
Drug Classes: azole antifungal
NDA Applicant: JANSSEN PHARMS      NDA No.: 020657  Prod. No.: 001 RX (10MG/ML)
PatentsExpirationPatented Use
Pat. No. 6407079 Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation
Claim Types: Formulation; Process
Jun 18, 2019 

SPORANOX (INJECTABLE) (INJECTION) ITRACONAZOLE
Drug Classes: azole antifungal
NDA Applicant: JANSSEN PHARMS      NDA No.: 020966  Prod. No.: 001 DISC (10MG/ML)
PatentsExpirationPatented Use
Pat. No. 6407079 Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation
Claim Types: Formulation; Process
Jun 18, 2019 

DEPAKOTE ER (TABLET, EXTENDED RELEASE) (ORAL) DIVALPROEX SODIUM [GENERIC AB]
NDA Applicant: ABBVIE      NDA No.: 021168  Prod. No.: 001 RX (EQ 500MG VALPROIC ACID)
PatentsExpirationPatented Use
Pat. No. 6419953 Controlled release formulation of divalproex sodium
Claim Types: Formulation; Process; Method of use
Jun 18, 2019 *PED 
Pat. No. 6511678 Controlled release formulation of divalproex sodium
Claim Types: Formulation; Method of use
Jun 18, 2019 *PED 
Pat. No. 6528090 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation
Jun 18, 2019 *PED 
Pat. No. 6528091 Controlled release formulation of divalproex sodium
Claim Types: Method of use
Jun 18, 2019 *PEDU-106: Treatment of epilepsy
Pat. No. 6713086 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation; Method of use
Jun 18, 2019 *PEDU-579: Treatment of epilepsy and/or migraine.
Pat. No. 6720004 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation
Jun 18, 2019 *PED 

DEPAKOTE ER (TABLET, EXTENDED RELEASE) (ORAL) DIVALPROEX SODIUM [GENERIC AB]
NDA Applicant: ABBVIE      NDA No.: 021168  Prod. No.: 002 RX (EQ 250MG VALPROIC ACID)
PatentsExpirationPatented Use
Pat. No. 6511678 Controlled release formulation of divalproex sodium
Claim Types: Formulation; Method of use
Jun 18, 2019 *PED 
Pat. No. 6528090 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation
Jun 18, 2019 *PED 
Pat. No. 6713086 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation; Method of use
Jun 18, 2019 *PEDU-579: Treatment of epilepsy and/or migraine.
Pat. No. 6720004 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation
Jun 18, 2019 *PED 

EVOTAZ (TABLET) (ORAL) ATAZANAVIR SULFATE; COBICISTAT
Drug Classes: HIV protease inhibitor; CYP3A inhibitor
NDA Applicant: BRISTOL-MYERS SQUIBB      NDA No.: 206353  Prod. No.: 001 RX (EQ 300MG BASE;150MG)
PatentsExpirationPatented Use
Pat. No. 6087383 DS* DP* Bisulfate salt of HIV protease inhibitor
Claim Types: Compound; Composition
Jun 21, 2019 *PED 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Sep 3, 2029U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Oct 4, 2032 

REYATAZ (CAPSULE) (ORAL) ATAZANAVIR SULFATE [GENERIC AB]
Drug Classes: HIV protease inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 021567  Prod. No.: 002 RX (EQ 150MG BASE); 003 RX (EQ 200MG BASE); 004 RX (EQ 300MG BASE) NDA No.: 021567  Prod. No.: 001 DISC (EQ 100MG BASE**)
PatentsExpirationPatented Use
Pat. No. 6087383 DS* DP* Bisulfate salt of HIV protease inhibitor
Claim Types: Compound; Composition
Jun 21, 2019 *PED 

REYATAZ (POWDER) (ORAL) ATAZANAVIR SULFATE
Drug Classes: HIV protease inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 206352  Prod. No.: 001 RX (EQ 50MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6087383 DS* DP* Bisulfate salt of HIV protease inhibitor
Claim Types: Compound; Composition
Jun 21, 2019 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMar 24, 2019 PED 

LEXISCAN (SOLUTION) (INTRAVENOUS) REGADENOSON
Drug Classes: adenosine receptor agonist
NDA Applicant: ASTELLAS      NDA No.: 022161  Prod. No.: 001 RX (0.4MG/5ML (0.08MG/ML))
PatentsExpirationPatented Use
Pat. No. 6642210 DS* DP* 2-(N-pyrazolo)adenosines with application as adenosine A2A receptor agonists
Claim Types: Compound; Method of use; Composition
Jun 22, 2019U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
Pat. No. 7144872 DS* DP* N-pyrazole A.sub.2A receptor agonists
Claim Types: Compound; Method of use
Jun 22, 2019U-116: Method of myocardial imaging
U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
U-870: Method of producing coronary vasodilation without peripheral vasodilation
Pat. No. 7183264 DP* N-pyrazole A2A receptor agonists
Claim Types: Method of use; Composition
Jun 22, 2019U-116: Method of myocardial imaging
U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
U-870: Method of producing coronary vasodilation without peripheral vasodilation
Pat. No. 7582617 Myocardial perfusion imaging method
Claim Types: Method of use
Jun 22, 2019U-1003: A method of myocardial perfusion imaging and increasing coronary blood flow
Pat. No. 7655636 Use of A2A adenosine receptor agonists
Claim Types: Method of use; Method of administration
Jun 22, 2019U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
Pat. No. 7655637 DS* DP* N-pyrazole A.sub.2A receptor agonists
Claim Types: Compound; Method of use; Composition
Jun 22, 2019U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
Pat. No. 7683037 Myocardial perfusion imaging method
Claim Types: Method of use
Jun 22, 2019U-1042: Method for stimulating coronary vasodilation for purposes of imaging the heart
Pat. No. 8106029 Use of A.sub.2A adenosine receptor agonists
Claim Types: Method of use
Jun 22, 2019U-1042: Method for stimulating coronary vasodilation for purposes of imaging the heart
Pat. No. 8133879 DP* Myocardial perfusion imaging methods and compositions
Claim Types: Formulation
Jun 22, 2019 
Pat. No. 8183226 Myocardial perfusion imaging method
Claim Types: Method of administration
Jun 22, 2019U-116: Method of myocardial imaging
Pat. No. 8470801 Myocardial perfusion imaging methods and compositions
Claim Types: Method of use
Jun 22, 2019U-116: Method of myocardial imaging
Pat. No. 8536150 Methods of myocardial perfusion imaging
Claim Types: Diagnostic or surgical method
Jun 22, 2019U-116: Method of myocardial imaging
Pat. No. 9045519 DP* N-pyrazole A.sub.2A receptor agonists
Claim Types: Composition; Formulation
Jun 22, 2019 
Pat. No. 9289446 DP* Myocardial perfusion imaging methods and compositions
Claim Types: Formulation; Kit; Drug in a container; Method of use
Jun 22, 2019U-116: Method of myocardial imaging
Pat. No. 6403567 DS* DP* [Extended 1024 days (2.8 years)]
N-pyrazole A2A adenosine receptor agonists
Claim Types: Compound; Composition; Method of use
Apr 10, 2022U-869: Method for stimulating coronoary vasodilation for purposes of imaging the heart
Pat. No. 8106183 DS* Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs
Claim Types: New polymorph, salt or hydrate; Process
Feb 2, 2027 
Pat. No. 9085601 DP* Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Claim Types: Composition
Feb 2, 2027 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJan 17, 2020M-194: Information added to the labeling regarding use of regadenoson administration following an inadequate exercise stress test as compared to regadenoson alone

NATROBA (SUSPENSION) (TOPICAL) SPINOSAD
Drug Classes: pediculicide
NDA Applicant: PARAPRO LLC      NDA No.: 022408  Prod. No.: 001 RX (0.9%)
PatentsExpirationPatented Use
Pat. No. 6342482 DP* Formulations for controlling human lice
Claim Types: Formulation
Jun 22, 2019U-1105: Topical treatment of head lice infestation in patients four (4) years of age and older
Pat. No. 7030095 DP* Pediculicidal and ovacidal treatment compositions and methods for killing head lice and their eggs
Claim Types: Method of use
Jul 2, 2021U-1105: Topical treatment of head lice infestation in patients four (4) years of age and older
Pat. No. 6063771 DP* [Extended 1494 days (4.1 years)]
Formulations for controlling human lice
Claim Types: Formulation; Method of use
Jul 25, 2023U-1670: NATROBA topical suspension is a pediculicide indicated for the topical treatment of head lice infestation in patients six (6) months of age and older.

PREZCOBIX (TABLET) (ORAL) COBICISTAT; DARUNAVIR ETHANOLATE
Drug Classes: CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: JANSSEN PRODS      NDA No.: 205395  Prod. No.: 001 RX (150MG;EQ 800MG BASE)
PatentsExpirationPatented Use
Pat. No. 9889115 Fitness assay and associated methods
Claim Types: Method of improving a treatment
Jun 23, 2019U-1660: Treatment of HIV-1 infection in adults with no darunavir resistance-associated substitutions
Pat. No. 7470506 Fitness assay and associated methods
Claim Types: Method of use
Dec 23, 2019 *PEDU-1660: Treatment of HIV-1 infection in adults with no darunavir resistance-associated substitutions
Pat. No. 8597876 Method of treating HIV infection
Claim Types: Method of use
Dec 23, 2019 *PEDU-1660: Treatment of HIV-1 infection in adults with no darunavir resistance-associated substitutions
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Aug 16, 2024 *PED 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Jun 26, 2027 *PED 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Sep 3, 2029U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Oct 4, 2032 

PREZISTA (TABLET) (ORAL) DARUNAVIR ETHANOLATE [GENERIC AB]
Drug Classes: HIV protease inhibitor
NDA Applicant: JANSSEN PRODS      NDA No.: 021976  Prod. No.: 002 RX (EQ 600MG BASE)
PatentsExpirationPatented Use
Pat. No. 9889115 Fitness assay and associated methods
Claim Types: Method of improving a treatment
Jun 23, 2019U-1305: Treatment of HIV-1 infection in adult patients, and treatment of HIV-1 infection in pediatric patients 3 years of age and older, co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents
Pat. No. 7470506 Fitness assay and associated methods
Claim Types: Method of use
Dec 23, 2019 *PEDU-1209: Treatment of human immunodeficiency virus (HIV) infection in adult patients, and treatment of human immunodeficiency virus (HIV) infection in pediatric patients 3 years of age and older
U-1305: Treatment of HIV-1 infection in adult patients, and treatment of HIV-1 infection in pediatric patients 3 years of age and older, co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents
U-935: Treatment of human immunodeficiency virus (HIV) infection in adult patients, and treatment of human immunodeficiency virus (HIV) in pediatric patients 6 years of age and older
Pat. No. 8597876 Method of treating HIV infection
Claim Types: Method of use
Dec 23, 2019 *PEDU-1305: Treatment of HIV-1 infection in adult patients, and treatment of HIV-1 infection in pediatric patients 3 years of age and older, co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Aug 16, 2024 *PED 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Jun 26, 2027 *PED 

PREZISTA (TABLET) (ORAL) DARUNAVIR ETHANOLATE
Drug Classes: HIV protease inhibitor
NDA Applicant: JANSSEN PRODS      NDA No.: 021976  Prod. No.: 004 RX (EQ 75MG BASE); 005 RX (EQ 150MG BASE); 006 RX (EQ 800MG BASE)
PatentsExpirationPatented Use
Pat. No. 9889115 Fitness assay and associated methods
Claim Types: Method of improving a treatment
Jun 23, 2019U-1305: Treatment of HIV-1 infection in adult patients, and treatment of HIV-1 infection in pediatric patients 3 years of age and older, co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents
Pat. No. 7470506 Fitness assay and associated methods
Claim Types: Method of use
Dec 23, 2019 *PEDU-1209: Treatment of human immunodeficiency virus (HIV) infection in adult patients, and treatment of human immunodeficiency virus (HIV) infection in pediatric patients 3 years of age and older
U-1305: Treatment of HIV-1 infection in adult patients, and treatment of HIV-1 infection in pediatric patients 3 years of age and older, co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents
U-935: Treatment of human immunodeficiency virus (HIV) infection in adult patients, and treatment of human immunodeficiency virus (HIV) in pediatric patients 6 years of age and older
Pat. No. 8597876 Method of treating HIV infection
Claim Types: Method of use
Dec 23, 2019 *PEDU-1305: Treatment of HIV-1 infection in adult patients, and treatment of HIV-1 infection in pediatric patients 3 years of age and older, co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Aug 16, 2024 *PED 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Jun 26, 2027 *PED 

PREZISTA (SUSPENSION) (ORAL) DARUNAVIR ETHANOLATE
Drug Classes: HIV protease inhibitor
NDA Applicant: JANSSEN PRODS      NDA No.: 202895  Prod. No.: 001 RX (EQ 100MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. 9889115 Fitness assay and associated methods
Claim Types: Method of improving a treatment
Jun 23, 2019U-1305: Treatment of HIV-1 infection in adult patients, and treatment of HIV-1 infection in pediatric patients 3 years of age and older, co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents
Pat. No. 7470506 Fitness assay and associated methods
Claim Types: Method of use
Dec 23, 2019 *PEDU-1209: Treatment of human immunodeficiency virus (HIV) infection in adult patients, and treatment of human immunodeficiency virus (HIV) infection in pediatric patients 3 years of age and older
U-1305: Treatment of HIV-1 infection in adult patients, and treatment of HIV-1 infection in pediatric patients 3 years of age and older, co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents
Pat. No. 8597876 Method of treating HIV infection
Claim Types: Method of use
Dec 23, 2019 *PEDU-1305: Treatment of HIV-1 infection in adult patients, and treatment of HIV-1 infection in pediatric patients 3 years of age and older, co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Aug 16, 2024 *PED 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Jun 26, 2027 *PED 

SYMTUZA (TABLET) (ORAL) COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: CYP3A inhibitor; HIV protease inhibitor; HIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI); HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI); HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: JANSSEN PRODS      NDA No.: 210455  Prod. No.: 001 RX (150MG;EQ 800MG BASE;200MG;EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 7470506 Fitness assay and associated methods
Claim Types: Method of use
Jun 23, 2019U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 8597876 Method of treating HIV infection
Claim Types: Method of use
Jun 23, 2019U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 9889115 Fitness assay and associated methods
Claim Types: Method of improving a treatment
Jun 23, 2019U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Claim Types: Method of use
Nov 4, 2020U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Claim Types: Compound; Formulation
Mar 9, 2021 
Pat. No. 7803788 Prodrugs of phosphonate nucoleotide analogues
Claim Types: Method of use
Feb 2, 2022U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 7390791 DS* DP* Prodrugs of phosphonate nucleotide analogues
Claim Types: Compound; Composition; Formulation
May 7, 2022 
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Feb 16, 2024 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Dec 26, 2026 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Sep 3, 2029U-2353: Tx of HIV-1 infection using a composition containing a PK enhancer that inhibits cytochrome P450 monooxygenates in adults who have no prior antiretroviral tx history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
U-2364: Treatment of HIV-1 infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase in adults who have no prior antiretroviral treatment history
U-2365: Treatment of HIV-1 infection using a composition containing a pharmacokinetic enhancer that inibits cytochrome P450 monooxygenase in adults who are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process
Aug 15, 2032U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate
Claim Types: Formulation; Method of use
Aug 15, 2032U-2352: Treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or are virologically suppressed on a stable antiretroviral regimen for at least 6 months
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Oct 4, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationJul 17, 2020 
Exclusivity Code: NCE - New chemical entityNov 5, 2020 

RISPERDAL CONSTA (INJECTABLE) (INTRAMUSCULAR) RISPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: JANSSEN PHARMS      NDA No.: 021346  Prod. No.: 001 RX (25MG/VIAL); 002 RX (37.5MG/VIAL); 003 RX (50MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6194006 DP* Preparation of microparticles having a selected release profile
Claim Types: Product-by-process; Process
Jun 30, 2019 *PED 
Pat. No. 6379703 DP* Preparation of microparticles having a selected release profile
Claim Types: Product-by-process; Process
Jun 30, 2019 *PED 
Pat. No. 6596316 DP* Preparation of microparticles having a selected release profile
Claim Types: Product-by-process; Process
Jun 30, 2019 *PED 
Pat. No. 6667061 DP* Preparation of injectable suspensions having improved injectability
Claim Types: Formulation
Nov 25, 2020 *PED 

RISPERDAL CONSTA (INJECTABLE) (INTRAMUSCULAR) RISPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: JANSSEN PHARMS      NDA No.: 021346  Prod. No.: 004 RX (12.5MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6194006 DP* Preparation of microparticles having a selected release profile
Claim Types: Product-by-process; Process
Jun 30, 2019 *PED 
Pat. No. 6379703 DP* Preparation of microparticles having a selected release profile
Claim Types: Product-by-process; Process
Jun 30, 2019 *PED 
Pat. No. 6596316 DP* Preparation of microparticles having a selected release profile
Claim Types: Product-by-process; Process
Jun 30, 2019 *PED 

EXFORGE (TABLET) (ORAL) AMLODIPINE BESYLATE; VALSARTAN [GENERIC AB]
Drug Classes: dihydropyridine calcium channel blocker; angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 021990  Prod. No.: 002 RX (EQ 5MG BASE;160MG); 003 RX (EQ 10MG BASE;160MG); 004 RX (EQ 5MG BASE;320MG); 005 RX (EQ 10MG BASE;320MG)
PatentsExpirationPatented Use
Pat. No. 6395728 DP* Method of treatment and pharmaceutical composition
Claim Types: Method of use; Composition; Formulation
Jul 8, 2019 

VISTOGARD (GRANULE) (ORAL) URIDINE TRIACETATE
Drug Classes: antimetabolite; nucleoside analog antiviral; nucleoside metabolic inhibitor; pyrimidine analog
NDA Applicant: WELLSTAT THERAP      NDA No.: 208159  Prod. No.: 001 RX (10GM/PACKET)
PatentsExpirationPatented Use
Pat. No. 6258795 DP* Acylated uridine and cytidine and uses thereof
Claim Types: Compound; Composition; Formulation
Jul 10, 2019 
Pat. No. 7776838 Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides
Claim Types: Method of use
Aug 17, 2027U-1791: Emergency treatment of adult & pediatric patients following fluorouracil or capecitabine overdose,or who exhibit early-onset,severe or life-threatening cardiac or cns toxicity or unusually severe adverse reactions within 96 hours
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 4, 2020 
Exclusivity Code: NP - New productDec 11, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityDec 11, 2022ODE-104: Emergency tx of pts following a FU or capecitabine od, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac system or cns, and/or early-onset, unusually severe ar w/in 96 hrs following the end of FU or capecitabine admin.

XURIDEN (GRANULE) (ORAL) URIDINE TRIACETATE
Drug Classes: antimetabolite; nucleoside analog antiviral; nucleoside metabolic inhibitor; pyrimidine analog
NDA Applicant: WELLSTAT THERAP      NDA No.: 208169  Prod. No.: 001 RX (2GM/PACKET)
PatentsExpirationPatented Use
Pat. No. 6258795 DP* Acylated uridine and cytidine and uses thereof
Claim Types: Compound; Composition; Formulation
Jul 10, 2019 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 4, 2020 
Exclusivity Code: ODE - Orphan drug exclusivitySep 4, 2022ODE-98: Treatment of hereditary orotic aciduria

ZYRTEC-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: J AND J CONSUMER INC      NDA No.: 021150  Prod. No.: 002 OTC (5MG;120MG)
PatentsExpirationPatented Use
Pat. No. 6469009 DP* Pharmaceutical compositions for the treatment of rhinitis
Claim Types: Composition; Method of use
Jul 13, 2019U-295: Treatment of seasonal and perennial allergic rhinitis symptoms
Pat. No. 7014867 DP* Tablet comprising cetirizine and pseudoephedrine
Claim Types: Formulation
Jun 10, 2022 
Pat. No. 7226614 Tablet comprising cetirizine and pseudoephedrine
Claim Types: Method of use
Jun 10, 2022U-295: Treatment of seasonal and perennial allergic rhinitis symptoms

FIRAZYR (INJECTABLE) (SUBCUTANEOUS) ICATIBANT ACETATE
Drug Classes: bradykinin B2 receptor antagonist
NDA Applicant: SHIRE ORPHAN THERAP      NDA No.: 022150  Prod. No.: 001 RX (EQ 30MG BASE/3ML (EQ 10MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 5648333 DS* DP* [Extended 5 years]
Peptides having bradykinin antagonist action
Claim Types: Compound; Method of use; Composition
Jul 15, 2019U-1187: Treatment of pathological state by antagonizing bradykinin receptor including treatment of acute attacks of hereditary angioedema (HAE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityAug 25, 2018ODE-14: Treatment of acute attacks of hereditary angioedema in adults 18 years of age and older

ADEMPAS (TABLET) (ORAL) RIOCIGUAT
Drug Classes: soluble guanylate cyclase (sGC) stimulator
NDA Applicant: BAYER HLTHCARE      NDA No.: 204819  Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (1.5MG); 004 RX (2MG); 005 RX (2.5MG)
PatentsExpirationPatented Use
Pat. No. 6743798 DS* DP* Substituted pyrazole derivatives condensed with six-membered heterocyclic rings
Claim Types: Compound; Method of use; Composition
Jul 16, 2019 
Pat. No. 7173037 DS* DP* [Extended 1319 days (3.6 years)]
Carbamate-substituted pyrazolopyridines
Claim Types: Compound; Process; Composition; Formulation; Method of use
Dec 4, 2026 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 8, 2018 
Exclusivity Code: ODE - Orphan drug exclusivityOct 8, 2020ODE-53: Treatment of adults with pulmonary arterial hypertension (PAH) who group 1, to improve exercise capacity, who functional class and to delay clinical worsening.

NOXAFIL (TABLET, DELAYED RELEASE) (ORAL) POSACONAZOLE
Drug Classes: azole antifungal
NDA Applicant: MERCK SHARP DOHME      NDA No.: 205053  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 5661151 DS* DP* [Extended 1788 days (4.9 years)]
Tetrahydrofuran antifungals
Claim Types: Compound; Composition
Jul 19, 2019U-1454: Prophylaxis of invasive aspergillus and candida infections

NOXAFIL (SOLUTION) (INTRAVENOUS) POSACONAZOLE
Drug Classes: azole antifungal
NDA Applicant: MERCK SHARP DOHME      NDA No.: 205596  Prod. No.: 001 RX (300MG/16.7ML (18MG/ML))
PatentsExpirationPatented Use
Pat. No. 5661151 DS* DP* [Extended 1788 days (4.9 years)]
Tetrahydrofuran antifungals
Claim Types: Compound; Composition
Jul 19, 2019U-1454: Prophylaxis of invasive aspergillus and candida infections
Pat. No. 8410077 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Composition; Compound; Product-by-process; Formulation
Mar 13, 2029 
Pat. No. 9750822 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Formulation; Composition
Mar 13, 2029 
Pat. No. 9358297 DP* Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Claim Types: Formulation; Method of use
Jun 24, 2031U-1454: Prophylaxis of invasive aspergillus and candida infections
Pat. No. 9023790 DP* Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Claim Types: Formulation; Method of use
Jul 4, 2031U-1698: Prophylaxis of invasive aspergillus and candida infections
Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Formulation; Product-by-process; Process
Feb 27, 2033 

VIEKIRA PAK (COPACKAGED) (TABLET, TABLET) (ORAL) DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor; hepatitis C virus (HCV) NS3/4A protease inhibitor; CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 206619  Prod. No.: 001 RX (EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Jul 19, 2019 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Nov 10, 2020 
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Aug 25, 2024 
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Aug 25, 2024 
Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Sep 17, 2028U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 9139536 Anti-infective agents and uses thereof
Claim Types: Method of use
Nov 9, 2028U-1753: Treatment of HCV infection using dasabuvir
Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof
Claim Types: Compound; Composition; Method of use
May 17, 2029U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Sep 10, 2029U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Jun 10, 2030U-1687: Treatment of hcv infection using ombitasvir
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Apr 10, 2031 
Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Apr 10, 2031U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Jun 9, 2031 
Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Apr 13, 2032 
Pat. No. 8466159 Methods for treating HCV
Claim Types: Method of use; Method of administration
Sep 4, 2032U-1637: Treatment of hcv infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8492386 Methods for treating HCV
Claim Types: Method of use; Method of administration
Sep 4, 2032U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 8680106 Methods for treating HCV
Claim Types: Method of administration; Method of use
Sep 4, 2032U-1637: Treatment of hcv infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8685984 Methods for treating HCV
Claim Types: Method of administration; Method of use
Sep 4, 2032U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 9629841 DP* Formulations of pyrimidinedione derivative compounds
Claim Types: Composition; Method of use
Oct 18, 2033U-1753: Treatment of HCV infection using dasabuvir
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleApr 22, 2019D-163: Dosing to include patients with chronic HCV genotype 1a infection with compensated (Child-Pugh A) cirrhosis and genotype 1B with or without compensated (Child-Pugh A) cirrhosis
Exclusivity Code: NCE - New chemical entityDec 19, 2019 

VIEKIRA XR (TABLET, EXTENDED RELEASE) (ORAL) DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor; hepatitis C virus (HCV) NS3/4A protease inhibitor; CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 208624  Prod. No.: 001 RX (EQ 200MG BASE;8.33MG;50MG;33.33MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Jul 19, 2019 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Nov 10, 2020 
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Aug 25, 2024 
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Aug 25, 2024 
Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Sep 17, 2028U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 9139536 Anti-infective agents and uses thereof
Claim Types: Method of use
Nov 9, 2028U-1753: Treatment of HCV infection using dasabuvir
Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof
Claim Types: Compound; Composition; Method of use
May 17, 2029U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Sep 10, 2029U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Jun 10, 2030U-1687: Treatment of hcv infection using ombitasvir
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Apr 10, 2031 
Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Apr 10, 2031U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Jun 9, 2031 
Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Apr 13, 2032 
Pat. No. 8466159 Methods for treating HCV
Claim Types: Method of use; Method of administration
Sep 4, 2032U-1637: Treatment of hcv infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8492386 Methods for treating HCV
Claim Types: Method of use; Method of administration
Sep 4, 2032U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 8680106 Methods for treating HCV
Claim Types: Method of administration; Method of use
Sep 4, 2032U-1637: Treatment of hcv infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8685984 Methods for treating HCV
Claim Types: Method of administration; Method of use
Sep 4, 2032U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 9333204 DP* Solid antiviral dosage forms
Claim Types: Formulation; Method of use
Jan 2, 2035U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
Pat. No. 9744170 DP* Solid antiviral dosage forms
Claim Types: Formulation; Method of use
Jan 2, 2035U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 19, 2019 

ROZEREM (TABLET) (ORAL) RAMELTEON [GENERIC AB]
Drug Classes: melatonin receptor agonist
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021782  Prod. No.: 001 RX (8MG)
PatentsExpirationPatented Use
Pat. No. 6034239 DS* DP* [Extended 868 days (2.4 years)]
Tricyclic compounds, their production and use
Claim Types: Compound; Process; Composition; Method of use
Jul 22, 2019U-674: Method of treating insomnia characterized by difficulty with sleep onset

CARDIOTEC (INJECTABLE) (INJECTION) TECHNETIUM TC-99M TEBOROXIME KIT
NDA Applicant: BRACCO      NDA No.: 019928  Prod. No.: 001 DISC (N/A)
PatentsExpirationPatented Use
Pat. No. 6056941 DP* Kit for the preparation of technetium TC 99m teboroxime myocardial perfusion agent
Claim Types: Kit
Jul 28, 2019 

MAKENA (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) HYDROXYPROGESTERONE CAPROATE
Drug Classes: progestin
NDA Applicant: AMAG PHARMA USA      NDA No.: 021945  Prod. No.: 004 RX (275MG/1.1ML (250MG/ML))
PatentsExpirationPatented Use
Pat. No. RE44846 DP* Needle assisted jet injector
Claim Types: Device
Aug 10, 2019 
Pat. No. 8562564 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 9180259 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 9533102 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 9629959 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 8021335 DP* Prefilled syringe jet injector
Claim Types: Device
Oct 4, 2026 
Pat. No. 9789257 DP* Needle assisted injection device having reduced trigger force
Claim Types: Device
Feb 11, 2034 
Pat. No. 9844558 Methods of reducing risk of preterm birth
Claim Types: Method of use
May 2, 2036U-2236: Reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth

OTREXUP (SOLUTION) (SUBCUTANEOUS) METHOTREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ANTARES PHARMA INC      NDA No.: 204824  Prod. No.: 001 RX (10MG/0.4ML (10MG/0.4ML)); 002 RX (15MG/0.4ML (15MG/0.4ML)); 003 RX (20MG/0.4ML (20MG/0.4ML)); 004 RX (25MG/0.4ML (25MG/0.4ML))
PatentsExpirationPatented Use
Pat. No. RE44847 DP* Needle assisted jet injector
Claim Types: Method of use
Aug 10, 2019U-1442: Subcutaneous injection of methotrexate
Pat. No. RE44846 DP* Needle assisted jet injector
Claim Types: Device
Aug 10, 2019 
Pat. No. 7744582 DP* Needle assisted jet injector
Claim Types: Method of administration
Aug 10, 2019U-1442: Subcutaneous injection of methotrexate
Pat. No. 7776015 DP* Needle assisted jet injector
Claim Types: Device
Aug 10, 2019 
Pat. No. 6746429 DP* Needle assisted jet injector
Claim Types: Device
Apr 12, 2020 
Pat. No. 8562564 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 9533102 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 9629959 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 8021335 DP* Prefilled syringe jet injector
Claim Types: Device
Oct 4, 2026 
Pat. No. 8480631 DP* Hazardous agent injection system
Claim Types: Device; Method of administration
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 8579865 DP* Hazardous agent injection system
Claim Types: Device; Method of use
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 8945063 DP* Hazardous agent injection system
Claim Types: Device; Method of administration
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 9421333 DP* Hazardous agent injection system
Claim Types: Device; Method of use; Method of administration
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate

OTREXUP (SOLUTION) (SUBCUTANEOUS) METHOTREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ANTARES PHARMA INC      NDA No.: 204824  Prod. No.: 006 RX (12.5MG/0.4ML (12.5MG/0.4ML)); 007 RX (17.5MG/0.4ML (17.5MG/0.4ML)); 008 RX (22.5MG/0.4ML (22.5MG/0.4ML)) NDA No.: 204824  Prod. No.: 005 DISC (7.5MG/0.4ML (7.5MG/0.4ML))
PatentsExpirationPatented Use
Pat. No. RE44847 DP* Needle assisted jet injector
Claim Types: Method of use
Aug 10, 2019U-1442: Subcutaneous injection of methotrexate
Pat. No. RE44846 DP* Needle assisted jet injector
Claim Types: Device
Aug 10, 2019 
Pat. No. 6746429 DP* Needle assisted jet injector
Claim Types: Device
Apr 12, 2020 
Pat. No. 8562564 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 9533102 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 9629959 DP* Prefilled syringe jet injector
Claim Types: Device
Jan 24, 2026 
Pat. No. 8021335 DP* Prefilled syringe jet injector
Claim Types: Device
Oct 4, 2026 
Pat. No. 8480631 DP* Hazardous agent injection system
Claim Types: Device; Method of administration
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 8579865 DP* Hazardous agent injection system
Claim Types: Device; Method of use
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 8945063 DP* Hazardous agent injection system
Claim Types: Device; Method of administration
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 9421333 DP* Hazardous agent injection system
Claim Types: Device; Method of use; Method of administration
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate

TYZEKA (TABLET) (ORAL) TELBIVUDINE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI)
NDA Applicant: NOVARTIS      NDA No.: 022011  Prod. No.: 001 DISC (600MG)
PatentsExpirationPatented Use
Pat. No. 6395716 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
Claim Types: Method of use
Aug 10, 2019U-782: Treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistant elevations in serum aminotransferases (alt or ast) or histologically active disease
Pat. No. 6444652 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
Claim Types: Method of use; Compound; Composition; Formulation
Aug 10, 2019U-782: Treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistant elevations in serum aminotransferases (alt or ast) or histologically active disease
Pat. No. 6566344 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
Claim Types: Method of use; Formulation
Aug 10, 2019U-782: Treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistant elevations in serum aminotransferases (alt or ast) or histologically active disease
Pat. No. 7795238 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
Claim Types: Method of use
Aug 10, 2019U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 6569837 [Extended 442 days (1.2 years)]
.beta.-L-2'-deoxy pyrimidine nucleosides for the treatment of hepatitis B
Claim Types: Method of use
Oct 25, 2020U-782: Treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistant elevations in serum aminotransferases (alt or ast) or histologically active disease
U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 7589079 DS* DP* Crystalline and amorphous forms of beta-L-2'-deoxythymidine
Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation; Method of use
Sep 11, 2023U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 7858594 DS* DP* Crystalline and amorphous forms of beta-L-2'-deoxythymidine
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation; Method of use
Sep 11, 2023U-999: Treatment of chronic hepatitis B in adult patients

TYZEKA (SOLUTION) (ORAL) TELBIVUDINE
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV- NRTI)
NDA Applicant: NOVARTIS      NDA No.: 022154  Prod. No.: 001 DISC (100MG/5ML)
PatentsExpirationPatented Use
Pat. No. 6395716 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
Claim Types: Method of use
Aug 10, 2019U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 6444652 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
Claim Types: Method of use; Compound; Composition; Formulation
Aug 10, 2019U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 6566344 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
Claim Types: Method of use; Formulation
Aug 10, 2019U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 7795238 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
Claim Types: Method of use
Aug 10, 2019U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 6569837 [Extended 442 days (1.2 years)]
.beta.-L-2'-deoxy pyrimidine nucleosides for the treatment of hepatitis B
Claim Types: Method of use
Oct 25, 2020U-999: Treatment of chronic hepatitis B in adult patients
Pat. No. 7858594 DS* DP* Crystalline and amorphous forms of beta-L-2'-deoxythymidine
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation; Method of use
Sep 11, 2023U-999: Treatment of chronic hepatitis B in adult patients

XIFAXAN (TABLET) (ORAL) RIFAXIMIN
Drug Classes: rifamycin antibacterial
NDA Applicant: SALIX PHARMS      NDA No.: 022554  Prod. No.: 001 RX (550MG)
PatentsExpirationPatented Use
Pat. No. 6861053 Methods of diagnosing or treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth
Claim Types: Method of use
Aug 11, 2019U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 7452857 Methods of treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth
Claim Types: Method of use
Aug 11, 2019U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 7605240 Methods of treating diarrhea and bloating caused by small intestinal bacterial overgrowth
Claim Types: Method of use
Aug 11, 2019U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 7718608 Methods of treating a subject suffering from irritable bowel syndrome
Claim Types: Method of use
Aug 11, 2019U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 7935799 Methods of treating diarrhea caused by small intestinal bacterial overgrowth
Claim Types: Method of use
Aug 11, 2019U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 7045620 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations
Claim Types: New polymorph, salt or hydrate; Process
Jun 19, 2024 
Pat. No. 7612199 DS* DP* Polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Jun 19, 2024 
Pat. No. 7902206 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation
Jun 19, 2024 
Pat. No. 8158644 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation; New polymorph, salt or hydrate
Jun 19, 2024 
Pat. No. 8158781 DS* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Jun 19, 2024 
Pat. No. 8835452 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Jun 19, 2024 
Pat. No. 8853231 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition
Jun 19, 2024 
Pat. No. 7915275 Use of polymorphic forms of rifaximin for medical preparations
Claim Types: Method of use
Feb 23, 2025U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 7906542 DS* DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation
Jun 1, 2025 
Pat. No. 8518949 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Product-by-process; Composition; Formulation
Feb 27, 2026 
Pat. No. 8741904 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Feb 27, 2026U-1526: The treatment of patients with travelers' diarrhea (TD) or the reduction in risk of overt hepatic encephalopathy (HE) recurrence
U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 9271968 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Feb 27, 2026 
Pat. No. 8193196 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Formulation; Method of use; New polymorph, salt or hydrate; Process
Sep 2, 2027U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 8309569 Methods for treating diarrhea-associated irritable bowel syndrome
Claim Types: Method of use
Jul 18, 2029U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 8829017 Methods of treating traveler's diarrhea and hepatic encephalopathy
Claim Types: Method of use
Jul 24, 2029U-1562: Treatment of patients with hepatic encephalopathy (he)
Pat. No. 8946252 Methods of treating traveler's diarrhea and hepatic encephalopathy
Claim Types: Method of use
Jul 24, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 9629828 Methods of treating traveler's diarrhea and hepatic encephalopathy
Claim Types: Method of use
Jul 24, 2029U-1994: Reduction in risk of overt hepatic encephalopathy (HE) in adults
Pat. No. 8642573 Methods of treating hepatic encephalopathy
Claim Types: Method of administration
Oct 2, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 8969398 Methods of treating hepatic encephalopathy
Claim Types: Method of use
Oct 2, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 9421195 Methods of treating hepatic encephalopathy
Claim Types: Method of use; Method of administration
Mar 10, 2030U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 27, 2018I-709: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults

TORISEL (SOLUTION) (INTRAVENOUS) TEMSIROLIMUS [GENERIC AP]
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 022088  Prod. No.: 001 RX (25MG/ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. RE44768 DS* DP* Rapamycin hydroxyesters
Claim Types: Compound; Method of use
Aug 15, 2019 *PED 
Pat. No. 5362718 DS* DP* [Extended 1764 days (4.8 years)]
Rapamycin hydroxyesters
Claim Types: Compound; Method of use; Composition
Aug 15, 2019 *PED 
Pat. No. 8299116 DP* CCI-779 concentrate formulations
Claim Types: Formulation
Jan 25, 2024 *PED 
Pat. No. 8455539 DP* CCI-779 concentrate formulations
Claim Types: Formulation
Jan 25, 2024 *PED 
Pat. No. 8722700 DP* CCI-779 formulations for parenteral administration
Claim Types: Method of administration; Formulation; Process
Jan 25, 2024 *PED 
Pat. No. 8026276 DP* Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant
Claim Types: Formulation
Jul 20, 2026 *PED 
Pat. No. 8791097 Anti-tumor activity of CCI-779 in papillary renal cell cancer
Claim Types: Method of use
Nov 10, 2032 *PEDU-1550: Method of treating metastatic papillary renal cell carcinoma with temsirolimus.
U-1551: Method of treating papillary renal cell carcinoma with temsirolimus, in the absence of interferon alpha.

GILENYA (CAPSULE) (ORAL) FINGOLIMOD HYDROCHLORIDE
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: NOVARTIS      NDA No.: 022527  Prod. No.: 001 RX (EQ 0.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 5604229 DS* [Extended 5 years]
2-amino-1,3-propanediol compound and immunosuppressant
Claim Types: Compound; Method of use
Aug 18, 2019 *PEDU-1086: Treatment of autoimmune disease
Pat. No. 8324283 DP* Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol
Claim Types: Method of use
Sep 29, 2026 *PED 
Pat. No. 9187405 S1P receptor modulators for treating relapsing-remitting multiple sclerosis
Claim Types: Method of use
Dec 25, 2027 *PEDU-1086: Treatment of autoimmune disease
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationNov 11, 2021 PED 

GILENYA (CAPSULE) (ORAL) FINGOLIMOD HYDROCHLORIDE
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: NOVARTIS      NDA No.: 022527  Prod. No.: 002 RX (EQ 0.25MG BASE)
PatentsExpirationPatented Use
Pat. No. 5604229 DS* [Extended 5 years]
2-amino-1,3-propanediol compound and immunosuppressant
Claim Types: Compound; Method of use
Aug 18, 2019 *PEDU-1086: Treatment of autoimmune disease
Pat. No. 9592208 DP* Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
Claim Types: Formulation; Method of use
Sep 30, 2032 *PEDU-2315: Treatment of multiple sclerosis in the pediatric patient population with 0.25 mg fingolimod
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthNov 11, 2021 PED 

GONAL-F (INJECTABLE) (SUBCUTANEOUS) FOLLITROPIN ALFA/BETA
Drug Classes: gonadotropin
NDA Applicant: EMD SERONO      NDA No.: 020378  Prod. No.: 004 RX (1,050 IU/VIAL); 005 RX (450 IU/VIAL)
PatentsExpirationPatented Use
Pat. No. 7563763 DP* FSH and FSH variant formulations, products and methods
Claim Types: Method of administration; Method of use; Kit
Aug 23, 2019 

GONAL-F RFF REDI-JECT (INJECTABLE) (SUBCUTANEOUS) FOLLITROPIN ALFA/BETA
Drug Classes: gonadotropin
NDA Applicant: EMD SERONO      NDA No.: 021684  Prod. No.: 001 RX (300 IU/0.5ML); 002 RX (450 IU/0.75ML); 003 RX (900 IU/1.5ML)
PatentsExpirationPatented Use
Pat. No. 7446090 DP* FSH formulation
Claim Types: Drug in a container; Formulation; Process
Aug 23, 2019 
Pat. No. 7741268 DP* Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant
Claim Types: Formulation
Apr 2, 2024 

STRIANT (TABLET, EXTENDED RELEASE) (BUCCAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: AUXILIUM PHARMS LLC      NDA No.: 021543  Prod. No.: 001 RX (30MG)
PatentsExpirationPatented Use
Pat. No. 6248358 Bioadhesive progressive hydration tablets and methods of making and using the same
Claim Types: Formulation; Method of administration; Method of use; Process
Aug 23, 2019U-527: Method of delivering an active ingredient using a progressive hydration bioadhesive

TOPAMAX; TOPAMAX SPRINKLE (CAPSULE) (ORAL) TOPIRAMATE [GENERIC AB]
NDA Applicant: JANSSEN PHARMS      NDA No.: 020844  Prod. No.: 001 RX (15MG); 002 RX (25MG) NDA No.: 020844  Prod. No.: 003 DISC (50MG)
PatentsExpirationPatented Use
Pat. No. 7125560 Pharmaceutical composition of topiramate
Claim Types: Method of use
Sep 1, 2019 *PEDU-766: Treatment of seizures

EMEND (POWDER) (INTRAVENOUS) FOSAPREPITANT DIMEGLUMINE
NDA Applicant: MERCK AND CO INC      NDA No.: 022023  Prod. No.: 001 DISC (EQ 115MG BASE/VIAL**)
PatentsExpirationPatented Use
Pat. No. 5691336 DS* DP* [Extended 1826 days (5 years)]
Morpholine compounds are prodrugs useful as tachykinin receptor antagonists
Claim Types: Compound; Composition; Method of use
Sep 4, 2019 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationOct 3, 2021 PED 

EMEND (POWDER) (INTRAVENOUS) FOSAPREPITANT DIMEGLUMINE [GENERIC AP]
NDA Applicant: MERCK AND CO INC      NDA No.: 022023  Prod. No.: 002 RX (EQ 150MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 5691336 DS* DP* [Extended 1826 days (5 years)]
Morpholine compounds are prodrugs useful as tachykinin receptor antagonists
Claim Types: Compound; Composition; Method of use
Sep 4, 2019 *PEDU-2265: Prevention of nausea and vomiting associated with HEC and MEC in adult and pediatric patients
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleFeb 1, 2019D-155: Single IV dose of fosaprepitant 150mg dosed concomitantly with 5HT3 receptor antagonist & corticosteroid for prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy
Exclusivity Code: NPP - New patient populationOct 3, 2021 PED 

FINACEA (AEROSOL, FOAM) (TOPICAL) AZELAIC ACID
NDA Applicant: BAYER HLTHCARE      NDA No.: 207071  Prod. No.: 001 RX (15%)
PatentsExpirationPatented Use
Pat. No. 6730288 DP* Mousse composition
Claim Types: Formulation
Sep 8, 2019 
Pat. No. 8722021 DP* Foamable carriers
Claim Types: Formulation
Oct 24, 2023 
Pat. No. 8900554 DP* Foamable composition and uses thereof
Claim Types: Composition
Oct 24, 2023 
Pat. No. 8435498 Penetrating pharmaceutical foam
Claim Types: Method of administration
Mar 1, 2024U-1727: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea
Pat. No. 7700076 DP* Penetrating pharmaceutical foam
Claim Types: Formulation
Sep 18, 2027 
Pat. No. 9265725 DP* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Claim Types: Formulation
Dec 8, 2027 
Pat. No. 9211259 Antibiotic kit and composition and uses thereof
Claim Types: Method of use; Method of administration
Feb 28, 2029U-1796: Topical treatment of inflammatory papules and pustules of mild to moderate rosacea
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJul 29, 2018 

OLUX E (AEROSOL, FOAM) (TOPICAL) CLOBETASOL PROPIONATE [GENERIC AB2]
Drug Classes: corticosteroid
NDA Applicant: MYLAN PHARMS INC      NDA No.: 022013  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 6730288 DP* Mousse composition
Claim Types: Formulation
Sep 8, 2019 
Pat. No. 7029659 DP* Mousse composition
Claim Types: Formulation; Device
Sep 8, 2019 
Pat. No. 8962000 DP* Microemulsion and sub-micron emulsion process and compositions
Claim Types: Formulation; Method of use
Aug 31, 2025U-1410: Treatment of corticosteroid-responsive dermatoses
Pat. No. 8460641 DP* Microemulsion process and composition
Claim Types: Formulation; Method of use
Nov 5, 2028U-1410: Treatment of corticosteroid-responsive dermatoses

VERDESO (AEROSOL, FOAM) (TOPICAL) DESONIDE
Drug Classes: corticosteroid
NDA Applicant: AQUA PHARMS      NDA No.: 021978  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 6730288 DP* Mousse composition
Claim Types: Formulation
Sep 8, 2019 
Pat. No. 7029659 DP* Mousse composition
Claim Types: Formulation; Device
Sep 8, 2019 
Pat. No. 8962000 DP* Microemulsion and sub-micron emulsion process and compositions
Claim Types: Formulation; Method of use
Aug 31, 2025U-1412: Treatment of atopic dermatitis
Pat. No. 9492384 DP* Microemulsion and sub-micron emulsion process and compositions
Claim Types: Formulation; Method of use
Aug 31, 2025U-1412: Treatment of atopic dermatitis
Pat. No. 8460641 DP* Microemulsion process and composition
Claim Types: Formulation; Method of use
Nov 5, 2028U-1412: Treatment of atopic dermatitis

BEPREVE (SOLUTION/DROPS) (OPHTHALMIC) BEPOTASTINE BESILATE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: BAUSCH AND LOMB INC      NDA No.: 022288  Prod. No.: 001 RX (1.5%)
PatentsExpirationPatented Use
Pat. No. 6780877 DS* DP* [Extended 633 days (1.7 years)]
Acid addition salt of optically active piperidine compound and process for preparing the same
Claim Types: Compound; Composition
Sep 19, 2019 
Pat. No. 8877168 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Claim Types: Formulation
Jul 30, 2023 
Pat. No. 8784789 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Claim Types: Formulation
Sep 5, 2024 

ABSTRAL (TABLET) (SUBLINGUAL) FENTANYL CITRATE [GENERIC AB]
Drug Classes: opioid agonist
NDA Applicant: SENTYNL THERAPS INC      NDA No.: 022510  Prod. No.: 001 RX (EQ 0.1MG BASE); 002 RX (EQ 0.2MG BASE); 003 RX (EQ 0.3MG BASE); 004 RX (EQ 0.4MG BASE); 005 RX (EQ 0.6MG BASE); 006 RX (EQ 0.8MG BASE)
PatentsExpirationPatented Use
Pat. No. 6759059 DP* Fentanyl composition for the treatment of acute pain
Claim Types: Formulation; Method of use
Sep 24, 2019U-767: Management of breakthrough pain in patients with cancer
Pat. No. 6761910 DP* Pharmaceutical composition for the treatment of acute disorders
Claim Types: Formulation; Method of use
Sep 24, 2019U-767: Management of breakthrough pain in patients with cancer
Pat. No. 7910132 DP* Pharmaceutical composition for the treatment of acute disorders
Claim Types: Method of use
Sep 24, 2019U-767: Management of breakthrough pain in patients with cancer

EDLUAR (TABLET) (SUBLINGUAL) ZOLPIDEM TARTRATE [GENERIC AB]
Drug Classes: gamma-aminobutyric acid (GABA) A agonist
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 021997  Prod. No.: 001 RX (5MG); 002 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6761910 DP* Pharmaceutical composition for the treatment of acute disorders
Claim Types: Formulation; Method of use
Sep 24, 2019U-674: Method of treating insomnia characterized by difficulty with sleep onset
Pat. No. 8512747 Pharmaceutical composition for the treatment of acute disorders
Claim Types: Method of administration
Sep 24, 2019U-674: Method of treating insomnia characterized by difficulty with sleep onset
Pat. No. 9597281 Pharmaceutical formulations useful in the treatment of insomnia
Claim Types: Method of use
Apr 6, 2027U-674: Method of treating insomnia characterized by difficulty with sleep onset
Pat. No. 9265720 Pharmaceutical formulations useful in the treatment of insomnia
Claim Types: Method of use
Feb 25, 2031U-674: Method of treating insomnia characterized by difficulty with sleep onset

NERLYNX (TABLET) (ORAL) NERATINIB MALEATE
Drug Classes: kinase inhibitor
NDA Applicant: PUMA BIOTECH      NDA No.: 208051  Prod. No.: 001 RX (EQ 40MG BASE)
PatentsExpirationPatented Use
Pat. No. 6288082 DS* DP* Substituted 3-cyanoquinolines
Claim Types: Compound; Method of use; Composition
Sep 24, 2019U-2043: Extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy
Pat. No. 7982043 Protein tyrosine kinase enzyme inhibitors
Claim Types: Method of use
Oct 8, 2025U-2043: Extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy
Pat. No. 7399865 DS* DP* Protein tyrosine kinase enzyme inhibitors
Claim Types: Compound; Composition
Dec 29, 2025 
Pat. No. 9139558 Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Claim Types: Method of use; Process
Oct 15, 2028U-2043: Extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy
Pat. No. 9630946 Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quin- olinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Claim Types: Method of use
Oct 15, 2028U-2043: Extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy
Pat. No. 10035788 Maleate salts of (E)-N-{4[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quino- linyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
Claim Types: Method of use
Oct 15, 2028U-2043: Extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy
Pat. No. 9211291 Treatment regimen utilizing neratinib for breast cancer
Claim Types: Method of use; Method of administration
Mar 24, 2030U-2043: Extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy
Pat. No. 8790708 DP* Coated tablet formulations and uses thereof
Claim Types: Formulation; Method of use
Nov 5, 2030U-2043: Extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy
Pat. No. 8518446 DP* Coated tablet formulations and uses thereof
Claim Types: Method of use; Process
Nov 20, 2030U-2043: Extended adjuvant treatment of adult patients with early stage her2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab base therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 17, 2022 

ZUBSOLV (TABLET) (SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug Classes: partial opioid agonist; opioid antagonist
NDA Applicant: OREXO US INC      NDA No.: 204242  Prod. No.: 001 RX (EQ 1.4MG BASE;EQ 0.36MG BASE); 002 RX (EQ 5.7MG BASE;EQ 1.4MG BASE); 003 RX (EQ 8.6MG BASE;EQ 2.1MG BASE); 004 RX (EQ 11.4MG BASE;EQ 2.9MG BASE); 005 RX (EQ 2.9MG BASE;EQ 0.71MG BASE); 006 RX (EQ 0.7MG BASE;EQ 0.18MG BASE)
PatentsExpirationPatented Use
Pat. No. 8454996 Pharmaceutical composition for the treatment of acute disorders
Claim Types: Method of administration
Sep 24, 2019U-1421: Sublingual administration of a pharmaceutical composition comprising buprenorphine
Pat. No. 8658198 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: New polymorph, salt or hydrate; Formulation; Method of use; Method of administration
Dec 3, 2027U-1494: Sublingual or buccal administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8470361 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: Formulation; Method of use
May 22, 2030U-1425: Sublingual administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8940330 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation; Process
Sep 18, 2032 
Pat. No. 9259421 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Sep 18, 2032 
Pat. No. 9439900 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Sep 18, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 10, 2018I-713: Revisions to the labeling to permit the use of ZUBSOLV as initial ('induction') treatment of opioid dependence

INTELENCE (TABLET) (ORAL) ETRAVIRINE
Drug Classes: HIV nonnucleoside analog reverse transcriptase inhibitor (HIV-1 NNRTI)
NDA Applicant: JANSSEN R AND D      NDA No.: 022187  Prod. No.: 001 RX (100MG); 002 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 7887845 DP* Antiviral compositions
Claim Types: Formulation; Process; Drug in a container
Sep 25, 2019 *PED 
Pat. No. 8003789 DS* DP* HIV replication inhibiting pyrimidines
Claim Types: Compound; Composition; Process; Method of use
May 1, 2020 *PED 
Pat. No. 6878717 HIV replication inhibiting pyrimidines
Claim Types: Method of use
May 5, 2020 *PEDU-1016: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents
U-1237: Combo w/ other antiretrovirals for tx of HIV-1 in antiretroviral tx-experienced pt 6 years up, who have evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other antiretrovirals
U-2354: Combination with other antiretrovirals (ATV) for treatment of HIV-1 in atv treatment-experienced patients 2 years and older with evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other ATV
U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents
Pat. No. 7037917 DS* DP* [Extended 404 days (1.1 years)]
HIV replication inhibiting pyrimidines
Claim Types: Compound; Composition; Formulation; Process; Method of use
Jun 13, 2021 *PEDU-1016: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents
U-1237: Combo w/ other antiretrovirals for tx of HIV-1 in antiretroviral tx-experienced pt 6 years up, who have evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other antiretrovirals
U-2354: Combination with other antiretrovirals (ATV) for treatment of HIV-1 in atv treatment-experienced patients 2 years and older with evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other ATV
U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents

INTELENCE (TABLET) (ORAL) ETRAVIRINE
Drug Classes: HIV nonnucleoside analog reverse transcriptase inhibitor (HIV-1 NNRTI)
NDA Applicant: JANSSEN R AND D      NDA No.: 022187  Prod. No.: 003 RX (25MG)
PatentsExpirationPatented Use
Pat. No. 7887845 DP* Antiviral compositions
Claim Types: Formulation; Process; Drug in a container
Sep 25, 2019 *PED 
Pat. No. 8003789 DS* DP* HIV replication inhibiting pyrimidines
Claim Types: Compound; Composition; Process; Method of use
May 1, 2020 *PED 
Pat. No. 6878717 HIV replication inhibiting pyrimidines
Claim Types: Method of use
May 5, 2020 *PEDU-1016: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents
U-1237: Combo w/ other antiretrovirals for tx of HIV-1 in antiretroviral tx-experienced pt 6 years up, who have evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other antiretrovirals
U-2354: Combination with other antiretrovirals (ATV) for treatment of HIV-1 in atv treatment-experienced patients 2 years and older with evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other ATV
U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents
Pat. No. 7037917 DS* DP* [Extended 404 days (1.1 years)]
HIV replication inhibiting pyrimidines
Claim Types: Compound; Composition; Formulation; Process; Method of use
Jun 13, 2021 *PEDU-1237: Combo w/ other antiretrovirals for tx of HIV-1 in antiretroviral tx-experienced pt 6 years up, who have evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other antiretrovirals
U-2354: Combination with other antiretrovirals (ATV) for treatment of HIV-1 in atv treatment-experienced patients 2 years and older with evidence of viral replication and HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitor and other ATV

MOBIC (SUSPENSION) (ORAL) MELOXICAM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021530  Prod. No.: 001 DISC (7.5MG/5ML)
PatentsExpirationPatented Use
Pat. No. 6184220 DP* Oral suspension of pharmaceutical substance
Claim Types: Formulation
Sep 25, 2019 *PED 

TIMOLOL MALEATE (SOLUTION, GEL FORMING/DROPS) (OPHTHALMIC) TIMOLOL MALEATE
Drug Classes: beta adrenergic blocker
NDA Applicant: SANDOZ INC      NDA No.: 020963  Prod. No.: 001 RX (EQ 0.25% BASE); 002 RX (EQ 0.5% BASE)
PatentsExpirationPatented Use
Pat. No. 6174524 DP* Gelling ophthalmic compositions containing xanthan gum
Claim Types: Formulation
Sep 26, 2019 *PED 

PLIAGLIS (CREAM) (TOPICAL) LIDOCAINE; TETRACAINE
Drug Classes: amide local anesthetic; antiarrhythmic; ester local anesthetic
NDA Applicant: TARO PHARMS      NDA No.: 021717  Prod. No.: 001 RX (7%;7%)
PatentsExpirationPatented Use
Pat. No. 6528086 DP* Methods and apparatus for drug delivery involving phase changing formulations
Claim Types: Method of use; Formulation
Sep 28, 2019 

VIIBRYD (TABLET) (ORAL) VILAZODONE HYDROCHLORIDE
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 022567  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 5532241 DS* DP* [Extended 5 years]
Piperidines and piperazines
Claim Types: Compound; Composition
Sep 29, 2019 
Pat. No. 7834020 DS* DP* Polymorphic forms of 1-'4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Jun 5, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8193195 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl) butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Claim Types: Method of use
Jun 5, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8236804 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl)piperazine hydrochloride
Claim Types: Method of use
Jun 5, 2022U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8673921 DS* DP* Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Claim Types: Compound; Composition; Method of use
Jun 5, 2022 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleMar 16, 2018D-146: Change in target dosing to 20mg to 40mg orally once daily

PRECEDEX (INJECTABLE) (INJECTION) DEXMEDETOMIDINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: HOSPIRA      NDA No.: 021038  Prod. No.: 001 RX (EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6716867 Use of dexmedetomidine for ICU sedation
Claim Types: Method of use
Oct 1, 2019 *PEDU-1472: Intensive care unit sedation, including sedation of non-intubated patients prior to and/or during surgical and other procedures

PRECEDEX (INJECTABLE) (INJECTION) DEXMEDETOMIDINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: HOSPIRA      NDA No.: 021038  Prod. No.: 002 RX (EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)); 003 RX (EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6716867 Use of dexmedetomidine for ICU sedation
Claim Types: Method of use
Oct 1, 2019 *PEDU-1472: Intensive care unit sedation, including sedation of non-intubated patients prior to and/or during surgical and other procedures
Pat. No. 10016396 DP* Dexmedetomidine premix formulation
Claim Types: Drug in a container
Jan 4, 2032 
Pat. No. 8242158 DP* Dexmedetomidine premix
Claim Types: Formulation; Drug in a container
Jul 4, 2032 *PED 
Pat. No. 8338470 DP* Dexmedetomidine premix
Claim Types: Formulation; Drug in a container
Jul 4, 2032 *PED 
Pat. No. 8455527 Methods of treatment using a dexmedetomidine premix formulation
Claim Types: Method of use; Method of administration
Jul 4, 2032 *PEDU-421: Use for sedation
Pat. No. 8648106 DP* Dexmedetomidine premix formulation
Claim Types: Formulation
Jul 4, 2032 *PED 
Pat. No. 9320712 DP* Dexmedetomidine premix formulation
Claim Types: Formulation
Jul 4, 2032 *PED 
Pat. No. 9616049 DP* Dexmedetomidine premix formulation
Claim Types: Drug in a container
Jul 4, 2032 *PED 

PRECEDEX (INJECTABLE) (INJECTION) DEXMEDETOMIDINE HYDROCHLORIDE
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: HOSPIRA      NDA No.: 021038  Prod. No.: 004 RX (EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 6716867 Use of dexmedetomidine for ICU sedation
Claim Types: Method of use
Oct 1, 2019 *PEDU-1472: Intensive care unit sedation, including sedation of non-intubated patients prior to and/or during surgical and other procedures
Pat. No. 8242158 DP* Dexmedetomidine premix
Claim Types: Formulation; Drug in a container
Jul 4, 2032 *PED 
Pat. No. 8338470 DP* Dexmedetomidine premix
Claim Types: Formulation; Drug in a container
Jul 4, 2032 *PED 
Pat. No. 8455527 Methods of treatment using a dexmedetomidine premix formulation
Claim Types: Method of use; Method of administration
Jul 4, 2032 *PEDU-421: Use for sedation
Pat. No. 8648106 DP* Dexmedetomidine premix formulation
Claim Types: Formulation
Jul 4, 2032 *PED 
Pat. No. 9320712 DP* Dexmedetomidine premix formulation
Claim Types: Formulation
Jul 4, 2032 *PED 
Pat. No. 9616049 DP* Dexmedetomidine premix formulation
Claim Types: Drug in a container
Jul 4, 2032 *PED 

BONIVA (TABLET) (ORAL) IBANDRONATE SODIUM
NDA Applicant: HOFFMANN LA ROCHE      NDA No.: 021455  Prod. No.: 001 DISC (EQ 2.5MG BASE**)
PatentsExpirationPatented Use
Pat. No. 6294196 DP* Pharmaceutical composition containing diphosphonic acid or salt thereof
Claim Types: Formulation
Oct 7, 2019 

BONIVA (TABLET) (ORAL) IBANDRONATE SODIUM [GENERIC AB]
NDA Applicant: HOFFMANN LA ROCHE      NDA No.: 021455  Prod. No.: 002 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 6294196 DP* Pharmaceutical composition containing diphosphonic acid or salt thereof
Claim Types: Formulation
Oct 7, 2019 
Pat. No. 7192938 Method of treatment using bisphosphonic acid
Claim Types: Method of use
May 6, 2023U-798: Treatment and prevention of osteoporosis in postmenopausal women by once-monthly oral administration of ibandronate sodium monohydrate equivalent to 150mg of ibandronic acid
Pat. No. 7410957 Method of treatment using bisphosphonic acid
Claim Types: Method of use
May 6, 2023U-887: Treatment and prevention of osteoporosis
Pat. No. 7718634 Method of treatment using bisphosphonic acid
Claim Types: Method of use
May 6, 2023U-642: Treatment and prevention of osteoporosis

CUTIVATE (LOTION) (TOPICAL) FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: FOUGERA PHARMS      NDA No.: 021152  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 7300669 DP* Fluticasone lotion having improved vasoconstrictor activity
Claim Types: Formulation
Oct 20, 2019U-835: Relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients one year of age or older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJan 16, 2018 

DENAVIR (CREAM) (TOPICAL) PENCICLOVIR
Drug Classes: nucleoside analog HSV DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant: MYLAN PHARMS INC      NDA No.: 020629  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 6469015 Pharmaceutical formulation
Claim Types: Formulation; Method of use
Oct 22, 2019U-501: Treatment of recurrent Herpes Labialis (cold sores) in adults
Pat. No. 6579981 Antiviral guanine derivatives
Claim Types: Composition; Method of use; Formulation
Jun 17, 2020U-501: Treatment of recurrent Herpes Labialis (cold sores) in adults

AVELOX (TABLET) (ORAL) MOXIFLOXACIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: quinolone antimicrobial
NDA Applicant: BAYER HLTHCARE      NDA No.: 021085  Prod. No.: 001 RX (EQ 400MG BASE)
PatentsExpirationPatented Use
Pat. No. 6610327 DP* Pharmaceutical moxifloxacin preparation
Claim Types: Formulation; Process; Method of use
Oct 29, 2019U-298: Method of combating bacteria in a patient
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 27, 2019M-185: Updates to the labeling to include results of a trial to evaluate the safety of moxifloxacin in pediatric patients with complicated intra-abdominal infections

FOCALIN XR (CAPSULE, EXTENDED RELEASE) (ORAL) DEXMETHYLPHENIDATE HYDROCHLORIDE [GENERIC AB]
Drug Classes: central nervous system stimulant
NDA Applicant: NOVARTIS      NDA No.: 021802  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (15MG); 005 RX (30MG); 006 RX (40MG); 007 RX (35MG); 008 RX (25MG)
PatentsExpirationPatented Use
Pat. No. 6228398 DP* Multiparticulate modified release composition
Claim Types: Formulation; Method of use
Nov 1, 2019U-676: Method of treating attention deficit disorder using oral administration of a bi-modal or pulsatile release composition
Pat. No. 6730325 DP* Multiparticulate modified release composition
Claim Types: Formulation; Method of use
Nov 1, 2019U-676: Method of treating attention deficit disorder using oral administration of a bi-modal or pulsatile release composition

RITALIN LA (CAPSULE, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [GENERIC AB1]
Drug Classes: central nervous system stimulant
NDA Applicant: NOVARTIS      NDA No.: 021284  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG); 004 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 6228398 DP* Multiparticulate modified release composition
Claim Types: Formulation; Method of use
Nov 1, 2019U-472: Treatment of attention deficit hyperactivity disorder using methylphenidate bi-modal release profile extended-release capsules

ZOHYDRO ER (CAPSULE, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE
Drug Classes: opioid agonist
NDA Applicant: PERNIX IRELAND PAIN      NDA No.: 202880  Prod. No.: 001 RX (10MG ); 002 RX (15MG ); 003 RX (20MG); 004 RX (30MG ); 005 RX (40MG); 006 RX (50MG )
PatentsExpirationPatented Use
Pat. No. 6228398 DP* Multiparticulate modified release composition
Claim Types: Formulation; Method of use
Nov 1, 2019 
Pat. No. 6902742 DP* Multiparticulate modified release composition
Claim Types: Formulation; Method of use
Nov 1, 2019 
Pat. No. 9265760 Treating pain in patients with hepatic impairment
Claim Types: Method of use; Method of administration
Jul 25, 2033U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9326982 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Jul 25, 2033U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9333201 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Jul 25, 2033U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9339499 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Jul 25, 2033U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9421200 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Jul 25, 2033U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9433619 Treating pain in patients with hepatic impairment
Claim Types: Method of administration
Jul 25, 2033U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9610286 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Jul 25, 2033U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 10028946 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Jul 25, 2033U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9132096 DP* Abuse resistant pharmaceutical compositions
Claim Types: Formulation
Sep 12, 2034 
Pat. No. 9452163 Abuse resistant pharmaceutical compositions
Claim Types: Method of use
Sep 12, 2034U-55: Treatment of pain
Pat. No. 9486451 Abuse resistant pharmaceutical compositions
Claim Types: Method of use
Sep 12, 2034U-55: Treatment of pain
Pat. No. 9713611 DP* Abuse resistant pharmaceutical compositions
Claim Types: Formulation; Method of use
Sep 12, 2034U-55: Treatment of pain

PRILOSEC (FOR SUSPENSION, DELAYED RELEASE) (ORAL) OMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: COVIS PHARMA BV      NDA No.: 022056  Prod. No.: 001 RX (EQ 2.5MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole
Claim Types: Formulation; Method of use; Process
Nov 3, 2019U-1817: Pediatric use ages 1 month to 2 years, GERD and erosive esophagitis
U-864: Pediatric use ages 1-2 years, GERD and erosive esophagitis

PRILOSEC (FOR SUSPENSION, DELAYED RELEASE) (ORAL) OMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: COVIS PHARMA BV      NDA No.: 022056  Prod. No.: 002 RX (EQ 10MG BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole
Claim Types: Formulation; Method of use; Process
Nov 3, 2019U-864: Pediatric use ages 1-2 years, GERD and erosive esophagitis

PRILOSEC OTC (TABLET, DELAYED RELEASE) (ORAL) OMEPRAZOLE MAGNESIUM [GENERIC OTC]
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS      NDA No.: 021229  Prod. No.: 001 OTC (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 6428810 Pharmaceutical formulation comprising omeprazole
Claim Types: Formulation; Method of use; Process
Nov 3, 2019 
Pat. No. 6403616 Chemical process and pharmaceutical formulation
Claim Types: Product-by-process; Method of use; Process
Nov 15, 2019 

TESTODERM TTS (FILM, EXTENDED RELEASE) (TRANSDERMAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ALZA      NDA No.: 020791  Prod. No.: 001 DISC (5MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6348210 Methods for transdermal drug administration
Claim Types: Method of administration
Nov 10, 2019U-440: Method for transdermal administration of a drug through non-scrotal skin using a transdermal drug delivery device containing the drug and having an adhesive surface

LUMASON (FOR SUSPENSION) (INTRAVENOUS) SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES
NDA Applicant: BRACCO      NDA No.: 203684  Prod. No.: 001 RX (60.7MG/25MG)
PatentsExpirationPatented Use
Pat. No. 5686060 DS* DP* Stable microbubble suspensions comprising saturated phospholipids for ultrasound echography
Claim Types: Formulation
Nov 11, 2019 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMar 31, 2019I-728: Expanded indication for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
Exclusivity Code: NCE - New chemical entityOct 10, 2019 

AMELUZ (GEL) (TOPICAL) AMINOLEVULINIC ACID HYDROCHLORIDE
Drug Classes: porphyrin precursor
NDA Applicant: BIOFRONTERA      NDA No.: 208081  Prod. No.: 001 RX (10%)
PatentsExpirationPatented Use
Pat. No. 6559183 DP* Nano-emulsion of 5-aminolevulinic acid
Claim Types: Formulation; Kit; Process; Method of use; Diagnostic or surgical method
Nov 12, 2019U-804: Treatment of actinic keratoses by photodynamic therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 10, 2019 

ENDOMETRIN (INSERT) (VAGINAL) PROGESTERONE
Drug Classes: progestin; progesterone; progesterone agonist/antagonist
NDA Applicant: