What's New for Vol. 38, Supp. 06
Changes to patent and exclusivity information

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

The "[Img]" link takes you to the patent image at the EPO. However, please note that the EPO does not include Certificates of Correction.


ADMELOG SOLOSTAR (SOLUTION) INSULIN LISPRO
NDA Applicant: SANOFI-AVENTIS US      NDA No.:
209196  Prod. No.: 002 RX (300 UNITS/3ML (100 UNITS/ML))
PatentsExpirationChange
Pat. No. 9717852 DP* [Img]
Cartridge holder and pen-type injector
Claim Types: Device
Apr 8, 2033New patent for this product

AIRDUO RESPICLICK (POWDER) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
NDA Applicant: TEVA PHARM      NDA No.:
208799  Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH); 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationChange
Pat. No. 9987229 DP* [Img]
Process for preparing a medicament
Claim Types: Product-by-process; Process
Sep 1, 2024New patent for this product

ALIQOPA (POWDER) COPANLISIB DIHYDROCHLORIDE
NDA Applicant: BAYER HEALTHCARE      NDA No.:
209936  Prod. No.: 001 RX (60MG/VIAL)
PatentsExpirationChange
Pat. No. RE46856 DS* DP* [Img]
Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis
Claim Types: Compound; Composition; Kit; Method of use
Use Code: U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Oct 22, 2029New patent for this product
Pat. No. 8466283 DS* DP* [Img]
Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative d
Claim Types: Compound; Composition; Formulation; Drug in a container; Method of use
Use Code: U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Oct 22, 2029This patent is no longer listed for this product

APIDRA SOLOSTAR (INJECTABLE) INSULIN GLULISINE RECOMBINANT
NDA Applicant: SANOFI AVENTIS US      NDA No.:
021629  Prod. No.: 003 RX (300 UNITS/3ML)
PatentsExpirationChange
Pat. No. 9717852 DP* [Img]
Cartridge holder and pen-type injector
Claim Types: Device
Apr 8, 2033New patent for this product

AURYXIA (TABLET) FERRIC CITRATE
NDA Applicant: KERYX BIOPHARMS      NDA No.:
205874  Prod. No.: 001 RX (EQ 210MG IRON)
PatentsExpirationChange
Pat. No. 5753706 DP* [Img]
Methods for treating renal failure
Claim Types: Method of use; Formulation
Use Code: U-1577: Control of serum phosphorous levels
Feb 3, 2019New patent for this product

BAXDELA (TABLET) DELAFLOXACIN MEGLUMINE
NDA Applicant: MELINTA      NDA No.:
208610  Prod. No.: 001 RX (EQ 450MG BASE)
PatentsExpirationChange
Pat. No. 8497378 DS* [Img]
Process for making quinolone compounds
Claim Types: Process; Composition
Dec 28, 2029This patent is no longer listed for this product

BAXDELA (POWDER) DELAFLOXACIN MEGLUMINE
NDA Applicant: MELINTA      NDA No.: 208611  Prod. No.: 001 RX (EQ 300MG BASE/VIAL)
PatentsExpirationChange
Pat. No. 8497378 DS* [Img]
Process for making quinolone compounds
Claim Types: Process; Composition
Dec 28, 2029This patent is no longer listed for this product

BENDEKA (SOLUTION) BENDAMUSTINE HYDROCHLORIDE
NDA Applicant: EAGLE PHARMS      NDA No.:
208194  Prod. No.: 001 RX (100MG/4ML (25MG/ML))
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-179: Treatment of patients with CLL and treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab containing regimenDec 7, 2022New exclusivity for this product

BETHKIS (SOLUTION) TOBRAMYCIN
NDA Applicant: CHIESI USA INC      NDA No.:
201820  Prod. No.: 001 RX (300MG/4ML)
PatentsExpirationChange
Pat. No. 7696178 DP* [Img]
Optimised formulation of tobramycin for aerosolization
Claim Types: Formulation; Process
Sep 22, 2022New expiration date. Was previously Mar 17, 2023; New Drug Substance/Drug Product flag

BRAFTOVI (CAPSULE) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.:
210496  Prod. No.: 001 RX (50MG); 002 RX (75MG)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Jun 27, 2023New product in Orange Book

CINVANTI (EMULSION) APREPITANT
NDA Applicant: HERON THERAPS INC      NDA No.:
209296  Prod. No.: 001 RX (130MG/18ML (7.2MG/ML))
PatentsExpirationChange
Pat. No. 9974742 DP* [Img]
Emulsion formulations of an NK-1 receptor antagonist and uses thereof
Claim Types: Formulation; Process
Sep 18, 2035New patent for this product
Pat. No. 9974793 DP* [Img]
Emulsion formulations of aprepitant
Claim Types: Formulation
Sep 18, 2035New patent for this product
Pat. No. 9974794 DP* [Img]
Emulsion formulations of aprepitant
Claim Types: Formulation; Method of use
Use Code: U-2161: Treatment of nausea and vomiting, including the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly or moderately emetogenic cancer chemotherapy
Sep 18, 2035New patent for this product

DEXMEDETOMIDINE HYDROCHLORIDE (SOLUTION) DEXMEDETOMIDINE HYDROCHLORIDE
NDA Applicant: HQ SPCLT PHARMA      NDA No.:
206628  Prod. No.: 003 RX (EQ 200MG BASE/50ML (EQ 4MCG BASE/ML)); 004 RX (EQ 400MG BASE/100ML (EQ 4MCG BASE/ML))
PatentsExpirationChange
Pat. No. 9649296 DP* [Img]
Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container
Claim Types: Drug in a container; Formulation; Packaging or device material
Apr 20, 2036New strength or variation of this product
Pat. No. 9717796 DP* [Img]
Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container
Claim Types: Drug in a container; Formulation; Packaging or device material
Apr 20, 2036New strength or variation of this product

DOPTELET (TABLET) AVATROMBOPAG MALEATE
NDA Applicant: AKARX INC      NDA No.:
210238  Prod. No.: 001 RX (EQ 20MG BASE)
PatentsExpirationChange
Pat. No. 7638536 DS* DP* [Img]
2-Acylaminothiazole derivative or salt thereof
Claim Types: Compound; Composition
May 5, 2025New patent for this product
Pat. No. 8765764 [Img]
2-acylaminothiazole derivative or salt thereof
Claim Types: Method of use
Use Code: U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET
Jan 15, 2023New patent for this product

ESKATA (SOLUTION) HYDROGEN PEROXIDE
NDA Applicant: ACLARIS THERAPS INC      NDA No.:
209305  Prod. No.: 001 RX (40%)
PatentsExpirationChange
Pat. No. 9980983 [Img]
Peroxide formulations and methods and applicators for using the same
Claim Types: Method of use
Use Code: U-2205: Treatment of seborrheic keratoses that are raised
Apr 21, 2035New patent for this product

GATTEX KIT (POWDER) TEDUGLUTIDE RECOMBINANT
NDA Applicant: NPS PHARMS INC      NDA No.:
203441  Prod. No.: 001 RX (5MG/VIAL)
PatentsExpirationChange
Pat. No. 9987335 [Img]
Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Use Code: U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Nov 1, 2025New patent for this product
Pat. No. 9993528 [Img]
Treatment of short bowel syndrome patients with colon-in-continuity
Claim Types: Method of use
Use Code: U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support
Nov 1, 2025New patent for this product

GILENYA (CAPSULE) FINGOLIMOD HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.:
022527  Prod. No.: 001 RX (EQ 0.5MG BASE)
PatentsExpirationChange
Pat. No. 5604229 DS* [Img]
2-amino-1,3-propanediol compound and immunosuppressant
Claim Types: Compound; Method of use
Use Code: U-1086: Treatment of autoimmune disease
Feb 18, 2020 *PEDNew expiration date. Was previously Aug 18, 2019 *PED

GLUMETZA (TABLET, EXTENDED RELEASE) METFORMIN HYDROCHLORIDE [GENERIC AB3]
NDA Applicant: SANTARUS INC      NDA No.:
021748  Prod. No.: 002 RX (1GM)
PatentsExpirationChange
Pat. No. 6488962 DS* DP* [Img]
Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Claim Types: Composition
Jun 20, 2020This patent is no longer listed for this product

IMVEXXY (INSERT) ESTRADIOL
NDA Applicant: THERAPEUTICSMD INC      NDA No.:
208564  Prod. No.: 001 RX (0.004MG); 002 RX (0.01MG)
PatentsExpirationChange
Pat. No. 9180091 DP* [Img]
Soluble estradiol capsule for vaginal insertion
Claim Types: Formulation; Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Dec 20, 2033New patent for this product
Pat. No. 9289382 DP* [Img]
Vaginal inserted estradiol pharmaceutical compositions and methods
Claim Types: Formulation
Nov 21, 2032New patent for this product

INTELENCE (TABLET) ETRAVIRINE
NDA Applicant: JANSSEN R AND D      NDA No.:
022187  Prod. No.: 001 RX (100MG); 002 RX (200MG)
PatentsExpirationChange
Pat. No. 6878717 [Img]
HIV replication inhibiting pyrimidines
Claim Types: Method of use
Use Code: U-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
Use Code: 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
Use Code: U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents
May 5, 2020 *PEDNew expiration date. Was previously Nov 5, 2019
Pat. No. 7037917 DS* DP* [Img] [Extended 404 days (1.1 years)]
HIV replication inhibiting pyrimidines
Claim Types: Compound; Composition; Formulation; Process; Method of use
Use Code: U-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
Use Code: 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
Use Code: U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents
Jun 13, 2021 *PEDNew expiration date. Was previously Dec 13, 2020; New Drug Substance/Drug Product flag
Pat. No. 7887845 DP* [Img]
Antiviral compositions
Claim Types: Formulation; Process; Drug in a container
Sep 25, 2019 *PEDNew expiration date. Was previously Mar 25, 2019; New Drug Substance/Drug Product flag
Pat. No. 8003789 DS* DP* [Img]
HIV replication inhibiting pyrimidines
Claim Types: Compound; Composition; Process; Method of use
May 1, 2020 *PEDNew expiration date. Was previously Nov 1, 2019; New Drug Substance/Drug Product flag

INTELENCE (TABLET) ETRAVIRINE
NDA Applicant: JANSSEN R AND D      NDA No.: 022187  Prod. No.: 003 RX (25MG)
PatentsExpirationChange
Pat. No. 6878717 [Img]
HIV replication inhibiting pyrimidines
Claim Types: Method of use
Use Code: U-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
Use Code: 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
Use Code: U-256: Treatment of HIV infection in combination with one or more additional HIV antiviral agents
May 5, 2020 *PEDNew expiration date. Was previously Nov 5, 2019
Pat. No. 7037917 DS* DP* [Img] [Extended 404 days (1.1 years)]
HIV replication inhibiting pyrimidines
Claim Types: Compound; Composition; Formulation; Process; Method of use
Use Code: 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
Jun 13, 2021 *PEDNew expiration date. Was previously Dec 13, 2020; New Drug Substance/Drug Product flag
Pat. No. 7887845 DP* [Img]
Antiviral compositions
Claim Types: Formulation; Process; Drug in a container
Sep 25, 2019 *PEDNew expiration date. Was previously Mar 25, 2019; New Drug Substance/Drug Product flag
Pat. No. 8003789 DS* DP* [Img]
HIV replication inhibiting pyrimidines
Claim Types: Compound; Composition; Process; Method of use
May 1, 2020 *PEDNew expiration date. Was previously Nov 1, 2019; New Drug Substance/Drug Product flag

KYPROLIS (POWDER) CARFILZOMIB
NDA Applicant: ONYX THERAP      NDA No.:
202714  Prod. No.: 003 RX (10MG/VIAL)
PatentsExpirationChange
Pat. No. 7232818 DS* DP* [Img]
Compounds for enzyme inhibition
Claim Types: Compound; Composition
Apr 14, 2025New strength or variation of this product
Pat. No. 7417042 DS* DP* [Img]
Compounds for enzyme inhibition
Claim Types: Compound; Composition
Jul 20, 2026New strength or variation of this product
Pat. No. 7491704 [Img]
Compounds for enzyme inhibition
Claim Types: Method of use
Use Code: U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Use Code: U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
Apr 14, 2025New strength or variation of this product
Pat. No. 7737112 DP* [Img]
Composition for enzyme inhibition
Claim Types: Formulation
Dec 7, 2027New strength or variation of this product
Pat. No. 8129346 [Img]
Compounds for enzyme inhibition
Claim Types: Method of use
Use Code: U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Use Code: U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
Apr 14, 2025New strength or variation of this product
Pat. No. 8207125 DS* DP* [Img]
Compounds for enzyme inhibition
Claim Types: Compound; Composition; Formulation
Apr 14, 2025New strength or variation of this product
Pat. No. 8207126 DP* [Img]
Compounds for enzyme inhibition
Claim Types: Process; Product-by-process
Apr 14, 2025New strength or variation of this product
Pat. No. 8207127 [Img]
Compounds for enzyme inhibition
Claim Types: Method of use
Use Code: U-2319: KYPROLIS is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Use Code: U-2320: KYPROLIS is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy
Apr 14, 2025New strength or variation of this product
Pat. No. 8207297 DS* DP* [Img]
Compounds for enzyme inhibition
Claim Types: Process; Product-by-process
Apr 14, 2025New strength or variation of this product
Pat. No. 9493582 DP* [Img]
Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Formulation; Product-by-process; Process
Feb 27, 2033New strength or variation of this product
Pat. No. 9511109 [Img]
Combination therapy with peptide epoxyketones
Claim Types: Method of use
Use Code: U-1924: KYPROLIS is indicated in combination with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
Oct 21, 2029New strength or variation of this product

LEVOTHYROXINE SODIUM (POWDER) LEVOTHYROXINE SODIUM [GENERIC AP]
NDA Applicant: PIRAMAL CRITICAL      NDA No.:
206163  Prod. No.: 001 RX (100MCG/VIAL); 002 RX (500MCG/VIAL)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Sep 29, 2018New exclusivity for this product

LYNPARZA (TABLET) OLAPARIB
NDA Applicant: ASTRAZENECA PHARMS      NDA No.:
208558  Prod. No.: 001 RX (100MG); 002 RX (150MG)
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-180: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapyAug 17, 2024New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-181: Treatment of adult patients with deleterious or suspected deleterious germline brca-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapyAug 17, 2024New exclusivity for this product

MEKINIST (TABLET) TRAMETINIB DIMETHYL SULFOXIDE
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.:
204114  Prod. No.: 001 RX (EQ 0.5MG); 003 RX (EQ 2MG) NDA No.: 204114  Prod. No.: 002 DISC (EQ 1MG)
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-182: Trametinib is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resectionApr 30, 2025New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-183: Trametinib and dabrafenib in combination, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment optionsMay 4, 2025New exclusivity for this product

MEKTOVI (TABLET) BINIMETINIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.:
210498  Prod. No.: 001 RX (15MG)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Jun 27, 2023New product in Orange Book

MOXIDECTIN (TABLET) MOXIDECTIN
NDA Applicant: MDGH      NDA No.:
210867  Prod. No.: 001 RX (2MG)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Jun 13, 2023New product in Orange Book

NETSPOT (POWDER) GALLIUM DOTATATE GA-68
NDA Applicant: AAA USA INC      NDA No.:
208547  Prod. No.: 001 RX (2.1-5.5mCi/ML)
PatentsExpirationChange
Pat. No. 9375498 DP* [Img]
Process for the preparation of complexes of .sup.68Ga
Claim Types: Kit; Product-by-process; Drug in a container; Process
Aug 10, 2032New patent for this product

NOCDURNA (TABLET) DESMOPRESSIN ACETATE
NDA Applicant: FERRING PHARMS INC      NDA No.:
022517  Prod. No.: 001 RX (0.0277MG); 002 RX (0.0553MG)
ExclusivityExpirationChange
Exclusivity Code: NP - New product Jun 21, 2021New product in Orange Book

NORVIR (POWDER) RITONAVIR
NDA Applicant: ABBVIE INC      NDA No.:
209512  Prod. No.: 001 RX (100MG/PACKET)
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-184: Indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infectionJun 7, 2024New exclusivity for this product

NUPLAZID (CAPSULE) PIMAVANSERIN TARTRATE
NDA Applicant: ACADIA PHARMS INC      NDA No.:
210793  Prod. No.: 001 RX (EQ 34MG BASE)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Apr 29, 2021New product in Orange Book

OFIRMEV (SOLUTION) ACETAMINOPHEN [GENERIC AP]
NDA Applicant: MALLINCKRODT IP      NDA No.:
022450  Prod. No.: 001 RX (1GM/100ML (10MG/ML))
PatentsExpirationChange
Pat. No. 9987238 [Img]
Reduced dose intravenous acetaminophen
Claim Types: Method of use
Use Code: U-2261: Modified dosing regimen for the management of mild to moderate pain or management of moderate to severe pain as an adjunct to opioid analgesics
Nov 13, 2028New patent for this product

OLUMIANT (TABLET) BARICITINIB
NDA Applicant: ELI LILLY AND CO      NDA No.:
207924  Prod. No.: 001 RX (2MG)
PatentsExpirationChange
Pat. No. 8158616 DS* DP* [Img]
Azetidine and cyclobutane derivatives as JAK inhibito
Claim Types: Compound; Composition
Jun 8, 2030New patent for this product
Pat. No. 8420629 [Img]
Azetidine and cyclobutane derivatives as JAK inhibitors
Claim Types: Method of use
Use Code: U-247: Treatment of rheumatoid arthritis
Mar 10, 2029New patent for this product

OXYCONTIN (TABLET, EXTENDED RELEASE) OXYCODONE HYDROCHLORIDE
NDA Applicant: PURDUE PHARMA LP      NDA No.:
022272  Prod. No.: 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
PatentsExpirationChange
Pat. No. 7674799 DP* [Img]
Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Claim Types: Formulation
Mar 30, 2025This patent is no longer listed for this product
Pat. No. 7674800 DS* [Img]
Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Process; Product-by-process
Mar 30, 2025This patent is no longer listed for this product
Pat. No. 7683072 DS* [Img]
Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Claim Types: Compound
Mar 30, 2025This patent is no longer listed for this product
Pat. No. 7776314 DP* [Img]
Abuse-proofed dosage system
Claim Types: Formulation
Apr 19, 2025This patent is no longer listed for this product

PREVACID (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) LANSOPRAZOLE [GENERIC AB]
Drug Classes: DISORDERS, ACID/PEPTIC; GASTROINTESTINAL, MISCELLANEOUS
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
021428  Prod. No.: 001 RX (15MG); 002 RX (30MG)
PatentsExpirationChange
Pat. No. 9901546 DP* [Img]
Orally disintegrable tablets
Claim Types: Formulation
Nov 17, 2019 *PEDNew expiration date. Was previously May 17, 2019; New Drug Substance/Drug Product flag

PREZCOBIX (TABLET) COBICISTAT; DARUNAVIR ETHANOLATE
NDA Applicant: JANSSEN PRODS      NDA No.:
205395  Prod. No.: 001 RX (150MG;EQ 800MG BASE)
PatentsExpirationChange
Pat. No. 8148374 DS* DP* [Img]
Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Use Code: U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Sep 3, 2029New Use Code; New Drug Substance/Drug Product flag

RAVICTI (LIQUID) GLYCEROL PHENYLBUTYRATE
NDA Applicant: HORIZON THERAPS INC      NDA No.:
203284  Prod. No.: 001 RX (1.1GM/ML)
PatentsExpirationChange
Pat. No. 9962359 [Img]
Methods of therapeutic monitoring of nitrogen scavenging drugs
Claim Types: Method of use
Use Code: U-1816: Treatment of a urea cycle disorder
Sep 22, 2030New patent for this product

RUBRACA (TABLET) RUCAPARIB CAMSYLATE
NDA Applicant: CLOVIS ONCOLOGY INC      NDA No.:
209115  Prod. No.: 001 RX (EQ 200MG BASE); 002 RX (EQ 300MG BASE); 003 RX (EQ 250MG BASE)
PatentsExpirationChange
Pat. No. 9987285 DP* [Img]
High dosage strength tablets of rucaparib
Claim Types: Formulation
Aug 17, 2035New patent for this product

SOLIQUA 100/33 (SOLUTION) INSULIN GLARGINE; LIXISENATIDE
NDA Applicant: SANOFI-AVENTIS US      NDA No.:
208673  Prod. No.: 001 RX (300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML))
PatentsExpirationChange
Pat. No. 9717852 DP* [Img]
Cartridge holder and pen-type injector
Claim Types: Device
Apr 8, 2033New patent for this product

SYMDEKO (COPACKAGED) (TABLET, TABLET) IVACAFTOR; IVACAFTOR, TEZACAFTOR
NDA Applicant: VERTEX PHARMS INC      NDA No.:
210491  Prod. No.: 001 RX (150MG,N/A;150MG, 100MG)
PatentsExpirationChange
Pat. No. 9974781 DP* [Img]
Modulators of ATP-binding cassette transporters
Claim Types: Method of use; Composition
Use Code: U-2318: Treatment of cystic fibrosis in patients aged 12 and older, who are homozygous for the F508del mutation or have at least one CFTR gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor
Apr 9, 2027New patent for this product

TAFINLAR (CAPSULE) DABRAFENIB MESYLATE
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.:
202806  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE)
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-182: Trametinib is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resectionApr 30, 2025New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-183: Trametinib and dabrafenib in combination, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment optionsMay 4, 2025New exclusivity for this product

TASIGNA (CAPSULE) NILOTINIB HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.:
022068  Prod. No.: 003 RX (EQ 50MG BASE)
PatentsExpirationChange
Pat. No. 7169791 DS* DP* [Img]
Inhibitors of tyrosine kinases
Claim Types: Compound; Process; Composition
Use Code: U-836: A method for the treatment of leukemias
Jan 4, 2024 *PEDNew expiration date. Was previously Jul 4, 2023; New Drug Substance/Drug Product flag
Pat. No. 8163904 DS* DP* [Img]
Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
Claim Types: New polymorph, salt or hydrate; Process; Composition
Feb 23, 2029 *PEDNew expiration date. Was previously Aug 23, 2028; New Drug Substance/Drug Product flag
Pat. No. 8293756 DP* [Img]
Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Claim Types: Process; Product-by-process
Mar 25, 2028 *PEDNew expiration date. Was previously Sep 25, 2027; New Drug Substance/Drug Product flag
Pat. No. 8389537 DS* DP* [Img]
Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide
Claim Types: Method of use
Use Code: U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
Jan 18, 2027 *PEDNew expiration date. Was previously Jul 18, 2026; New Drug Substance/Drug Product flag
Pat. No. 8415363 DS* DP* [Img]
Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Use Code: U-1407: Treatment of newly diagnosed philadelphia chromosome positive chronic myeloid leukemia (PH + CML)
Jan 18, 2027 *PEDNew expiration date. Was previously Jul 18, 2026; New Drug Substance/Drug Product flag
Pat. No. 8501760 DS* DP* [Img]
Pharmaceutical compositions comprising nilotinib or its salt
Claim Types: Formulation
Jan 18, 2027 *PEDNew expiration date. Was previously Jul 18, 2026; New Drug Substance/Drug Product flag
Pat. No. 9061029 DS* DP* [Img]
Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
Claim Types: Method of use; Formulation
Use Code: U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
Oct 7, 2032 *PEDNew expiration date. Was previously Apr 7, 2032; New Drug Substance/Drug Product flag

TRI-LUMA (CREAM) FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
Drug Classes: DERMATOLOGICS
NDA Applicant: GALDERMA LABS LP      NDA No.:
021112  Prod. No.: 001 RX (0.01%;4%;0.05%)
PatentsExpirationChange
Pat. No. 7915243 DP* [Img]
Topical skin care composition
Claim Types: Formulation
Sep 8, 2023New expiration date. Was previously Mar 22, 2026; New Drug Substance/Drug Product flag
Pat. No. 7939516 DP* [Img]
Topical skin care composition
Claim Types: Formulation
Sep 8, 2023New expiration date. Was previously May 4, 2025; New Drug Substance/Drug Product flag
Pat. No. 8247395 DP* [Img]
Topical skin care composition
Claim Types: Formulation; Product-by-process
Oct 25, 2022New expiration date. Was previously Oct 22, 2022; New Drug Substance/Drug Product flag

VENCLEXTA (TABLET) VENETOCLAX
NDA Applicant: ABBVIE INC      NDA No.:
208573  Prod. No.: 001 RX (10MG); 002 RX (50MG); 003 RX (100MG)
PatentsExpirationChange
Pat. No. 9174982 [Img]
Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Claim Types: Method of use
Use Code: U-1835: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy
Use Code: U-2323: Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy
May 26, 2030New Use Code
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-782: Revisions to indication for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapyJun 8, 2021New exclusivity for this product
Exclusivity Code: M - Miscellaneous: M-228: Information added to the package insert regarding the revision of the monotherapy indication of venetoclaxJun 8, 2021New exclusivity for this product

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

VISTOGARD (GRANULE) URIDINE TRIACETATE
NDA Applicant: WELLSTAT THERAP      NDA No.:
208159  Prod. No.: 001 RX (10GM/PACKET)
PatentsExpirationChange
Pat. No. 6258795 DP* [Img]
Acylated uridine and cytidine and uses thereof
Claim Types: Compound; Composition; Formulation
Jul 10, 2019New expiration date. Was previously Jul 10, 2018; New Drug Substance/Drug Product flag

XELJANZ (TABLET) TOFACITINIB CITRATE
NDA Applicant: PF PRISM CV      NDA No.:
203214  Prod. No.: 001 RX (EQ 5MG BASE)
PatentsExpirationChange
Pat. No. 7842699 [Img]
Pyrrolo[2,3-D]pyrimidine compounds
Claim Types: Method of use
Use Code: U-2322: Treatment of adult patients with moderately to severely active ulcerative colitis (UC)
Dec 8, 2020New patent for this product

XELJANZ (TABLET) TOFACITINIB CITRATE
NDA Applicant: PF PRISM CV      NDA No.: 203214  Prod. No.: 002 RX (EQ 10MG BASE)
PatentsExpirationChange
Pat. No. 6956041 DP* [Img]
Pyrrolo[2,3-d]pyrimidine compounds
Claim Types: Composition; Method of use
Dec 8, 2020New patent for this product
Pat. No. 6965027 DS* [Img]
Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1 -yl}-3-oxo-propionitrile citrate
Claim Types: New polymorph, salt or hydrate; Process
Mar 25, 2023New patent for this product
Pat. No. 7265221 DS* [Img]
Pyrrolo[2,3-d]pyrimidine compounds
Claim Types: Compound
Dec 8, 2020New patent for this product
Pat. No. 7301023 DS* [Img]
Chiral salt resolution
Claim Types: Compound
May 23, 2022New patent for this product
Pat. No. 7842699 [Img]
Pyrrolo[2,3-D]pyrimidine compounds
Claim Types: Method of use
Use Code: U-2322: Treatment of adult patients with moderately to severely active ulcerative colitis (UC)
Dec 8, 2020New patent for this product
Pat. No. RE41783 DS* [Img]
Pyrrolo[2,3-D]pyrimidine compounds
Claim Types: Compound
Dec 8, 2025New patent for this product

XURIDEN (GRANULE) URIDINE TRIACETATE
NDA Applicant: WELLSTAT THERAP      NDA No.:
208169  Prod. No.: 001 RX (2GM/PACKET)
PatentsExpirationChange
Pat. No. 6258795 DP* [Img]
Acylated uridine and cytidine and uses thereof
Claim Types: Compound; Composition; Formulation
Jul 10, 2019New expiration date. Was previously Jul 10, 2018; New Drug Substance/Drug Product flag

YONDELIS (POWDER) TRABECTEDIN
NDA Applicant: JANSSEN PRODS      NDA No.:
207953  Prod. No.: 001 RX (1MG/VIAL)
PatentsExpirationChange
Pat. No. 8895557 DP* [Img]
Pharmaceutical formulations of ecteinascidin compounds
Claim Types: Formulation; Process
Jul 7, 2028 *PEDNew expiration date. Was previously Jan 7, 2028; New Drug Substance/Drug Product flag
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Apr 23, 2021 PEDNew expiration date. Was previously Oct 23, 2020
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-100: For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimenApr 23, 2023 PEDNew expiration date. Was previously Oct 23, 2022

YOSPRALA (TABLET, DELAYED RELEASE) ASPIRIN; OMEPRAZOLE
NDA Applicant: ARALEZ PHARMS      NDA No.:
205103  Prod. No.: 001 DISC (81MG;40MG); 002 DISC (325MG;40MG)
PatentsExpirationChange
Pat. No. 9987231 [Img]
Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Claim Types: Method of administration
Use Code: U-2324: For secondary prevention of cardiovascular and cerebrovascular events in patients at risk of developing aspirin-associated gastric ulcers
Jan 2, 2033New patent for this product

ZEMDRI (SOLUTION) PLAZOMICIN SULFATE
NDA Applicant: ACHAOGEN INC      NDA No.:
210303  Prod. No.: 001 RX (EQ 500MG BASE/10ML (EQ 50MG BASE/ML))
ExclusivityExpirationChange
Exclusivity Code: GAIN - Generating Antibiotic Incentives Now Jun 25, 2028New product in Orange Book
Exclusivity Code: NCE - New chemical entity Jun 25, 2023New product in Orange Book

ZERVIATE (SOLUTION/DROPS) CETIRIZINE HYDROCHLORIDE
NDA Applicant: EYEVANCE PHARMS      NDA No.:
208694  Prod. No.: 001 RX (EQ 0.24% BASE)
PatentsExpirationChange
Pat. No. 9993471 [Img]
Ophthalmic formulations of cetirizine and methods of use
Claim Types: Method of use
Use Code: U-1680: Treatment of ocular itching associated with allergic conjunctivitis
Mar 15, 2030New patent for this product


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
Last edited: 17 July 2018
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