Orange Book Companion (R)
What's New for Vol. 41, Supp. 11
Changes to patent and exclusivity information

In the What's New that logged-in subscribers see, the tradename of each drug is a link to the full patent/exclusivity portfolio of the drug. If you would like that have that very useful feature, please subscribe! It is only $295/year for your whole company or organization! Click the link at the top of this page for more info.

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


ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
PatentsExpirationChange
Pat. No. 11154553
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Pat. Sub. Date(s): All strengths: Nov 17, 2021
Claim Types: Method of use
Use Code: U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
Use Code: U-3245: Maintenance monotherapy treatment of bipolar I disorder
Use Code: U-814: Treatment of schizophrenia
Sep 24, 2033New patent for this product

AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 004 RX (0.055MG/INH;EQ 0.014MG BASE/INH); 005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationChange
Pat. No. 11173259 DP*
Drug delivery device with electronics and power management
Pat. Sub. Date(s): All strengths: Dec 8, 2021
Claim Types: Device
Jul 6, 2040New patent for this product

ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 004 RX (0.055MG/INH); 005 RX (0.113MG/INH); 006 RX (0.232MG/INH)
PatentsExpirationChange
Pat. No. 11173259 DP*
Drug delivery device with electronics and power management
Pat. Sub. Date(s): All strengths: Dec 8, 2021
Claim Types: Device
Jul 6, 2040New patent for this product

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 001 DISC (0.055MG/INH)
ExclusivityExpirationChange
Exclusivity Code: NPP - New patient population Jan 9, 2025 PEDNew exclusivity for this product

ARMONAIR RESPICLICK (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 007 DISC (0.03MG/INH)
PatentsExpirationChange
Pat. No. 7540282 DP*
Reservoir pressure system for medicament inhaler
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Device
Nov 6, 2023 *PEDNew expiration date. Was previously May 6, 2023
Pat. No. 8651103 DP*
Dry powder inhalation apparatus
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Device
Sep 26, 2028 *PEDNew expiration date. Was previously Mar 26, 2028
Pat. No. 8714149 DP*
Airflow adaptor for a breath-actuated dry powder inhaler
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Device
Aug 25, 2032 *PEDNew expiration date. Was previously Feb 25, 2032
Pat. No. 8978966 DP*
Dose counters for inhalers, inhalers and methods of assembly thereof
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Device
Jul 13, 2032 *PEDNew expiration date. Was previously Jan 13, 2032
Pat. No. 9216260 DP*
Dose counters for inhalers, inhalers and methods of assembly thereof
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Device
Dec 28, 2031 *PEDNew expiration date. Was previously Jun 28, 2031
Pat. No. 9463288 DP*
Dry powder inhalation apparatus
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Device
Nov 19, 2025 *PEDNew expiration date. Was previously May 19, 2025
Pat. No. 9616024 DP*
Process for preparing a medicament
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Product-by-process; Device
Mar 1, 2025 *PEDNew expiration date. Was previously Sep 1, 2024
Pat. No. 9731087 DP*
Dose counter for inhaler having a bore and shaft arrangement
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Device
Nov 18, 2031 *PEDNew expiration date. Was previously May 18, 2031
Pat. No. 10022510 DP*
Dose counters for inhalers, inhalers and methods of assembly thereof
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Device
Nov 18, 2031 *PEDNew expiration date. Was previously May 18, 2031
Pat. No. 10124131 DP*
Dose counter for inhaler having an anti-reverse rotation actuator
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Part of a dosage form; Device
Nov 18, 2031 *PEDNew expiration date. Was previously May 18, 2031
Pat. No. 10195375 DP*
Airflow adaptor for a breath-actuated dry powder inhaler
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Part of a dosage form; Device
Aug 14, 2031 *PEDNew expiration date. Was previously Feb 14, 2031
Pat. No. 10561808 DP*
Dose counter for inhaler having an anti-reverse rotation actuator
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Part of a dosage form
Jul 1, 2032 *PEDNew expiration date. Was previously Jan 1, 2032
Pat. No. 10765820 DP*
Dry powder inhalation apparatus
Pat. Sub. Date(s): 007: Aug 5, 2021
Claim Types: Device
Nov 19, 2025 *PEDNew expiration date. Was previously May 19, 2025

ATROPINE SULFATE (SOLUTION/DROPS) (OPHTHALMIC) ATROPINE SULFATE [GENERIC AT]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: APOTEX INC      NDA No.: 215624  Prod. No.: 001 RX (1%)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy May 25, 2022New product in Orange Book

BALCOLTRA (TABLET) (ORAL) ETHINYL ESTRADIOL; LEVONORGESTREL
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Contraceptives:Contraceptives, Other == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins == progestin-containing intrauterine device (IUD)
NDA Applicant: AVION PHARMS      NDA No.: 208612  Prod. No.: 001 RX (0.02MG;0.1MG)
PatentsExpirationChange
Pat. No. 7838042 DS*
Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions
Pat. Sub. Date(s): 001: Nov 30, 2021
Claim Types: Method of administration; Process
Use Code: U-3251: Administration of ferrous bisglycinate tablets
Jun 1, 2027New patent for this product

BRUKINSA (CAPSULE) (ORAL) ZANUBRUTINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: BEIGENE      NDA No.: 213217  Prod. No.: 001 RX (80MG)
PatentsExpirationChange
Pat. No. 9447106 DS* DP*
Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Pat. Sub. Date(s): 001: Nov 20, 2019
Claim Types: Compound; Composition; Method of use; Formulation
Use Code: U-1745: For the treatment of patients with waldenstrom's macroglobulinemia
Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen
Apr 22, 2034New Use Code
Pat. No. 10570139 DS* DP*
Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Pat. Sub. Date(s): 001: Jun 4, 2021
Claim Types: Method of use
Use Code: U-1745: For the treatment of patients with waldenstrom's macroglobulinemia
Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen
Apr 22, 2034New Use Code
Pat. No. 11142528 DS* DP*
Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Pat. Sub. Date(s): 001: Nov 12, 2021
Claim Types: Composition; Method of use
Use Code: U-1745: For the treatment of patients with waldenstrom's macroglobulinemia
Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen
Apr 22, 2034New patent for this product

BYETTA (INJECTABLE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.: 021773  Prod. No.: 001 RX (300MCG/1.2ML (250MCG/ML)); 002 RX (600MCG/2.4ML (250MCG/ML))
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-232: Information added to section 8.4 of the labeling to describe the results from pediatric studiesNov 4, 2024New exclusivity for this product

CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
Drug Classes: Antifungals
NDA Applicant: ASTELLAS      NDA No.: 207500  Prod. No.: 001 RX (186MG)
PatentsExpirationChange
Pat. No. 10206879 DP*
Active ingredient containing stabilised solid forms and method for the production thereof
Pat. Sub. Date(s): 001: Dec 3, 2021
Claim Types: Formulation
Sep 14, 2027New patent for this product
Pat. No. 10603280 DP*
Active ingredient containing stabilised solid medicinal forms and methods for the production thereof
Pat. Sub. Date(s): 001: Dec 3, 2021
Claim Types: Formulation
Sep 14, 2027New patent for this product

DETECTNET (SOLUTION) (INTRAVENOUS) COPPER DOTATATE CU-64
Drug Classes: Contraceptives:Contraceptives, Other == copper-containing intrauterine device (IUD) == radioactive diagnostic agent
NDA Applicant: RADIOMEDIX      NDA No.: 213227  Prod. No.: 001 RX (4mL (1mCi/ML))
PatentsExpirationChange
Pat. No. 11160888
PET tracer for imaging of neuroendocrine tumors
Pat. Sub. Date(s): 001: Dec 1, 2021
Claim Types: Diagnostic or surgical method
Use Code: U-2951: Use of Cu-64 dotatate with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETS) in adult patients
Aug 23, 2032New patent for this product

DEXTENZA (INSERT) (OPHTHALMIC) DEXAMETHASONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid
NDA Applicant: OCULAR THERAPEUTIX      NDA No.: 208742  Prod. No.: 001 RX (0.4MG)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-876: Treatment of ocular itching associated with allergic conjunctivitisOct 7, 2024New exclusivity for this product

DYANAVEL XR (TABLET, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
NDA Applicant: TRIS PHARMA INC      NDA No.: 210526  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 15MG BASE); 004 RX (EQ 20MG BASE)
PatentsExpirationChange
Pat. No. 8337890 DP*
Modified release formulations containing drug-ion exchange resin complexes
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Claim Types: Formulation
Mar 15, 2027New product in Orange Book
Pat. No. 8747902 DP*
Modified release formulations containing drug-ion exchange resin complexes
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Claim Types: Formulation
Mar 15, 2027New product in Orange Book
Pat. No. 9675704 DP*
Modified release formulations containing drug-ion exchange resin complexes
Pat. Sub. Date(s): All strengths: Nov 22, 2021
Claim Types: Formulation
Mar 15, 2027New product in Orange Book

EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.: 022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))
PatentsExpirationChange
Pat. No. 11179336 DP*
Manufacturing of bupivacaine multivesicular liposomes
Pat. Sub. Date(s): All strengths: Nov 30, 2021
Claim Types: Formulation; Method of use
Use Code: U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
Jan 22, 2041New patent for this product

GIAPREZA (SOLUTION) (INTRAVENOUS) ANGIOTENSIN II ACETATE
Drug Classes: Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors == Cardiovascular Agents:Angiotensin II Receptor Antagonists == vasoconstrictor
NDA Applicant: LA JOLLA PHARMA      NDA No.: 209360  Prod. No.: 001 RX (EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML))
PatentsExpirationChange
Pat. No. 9572856
Method of treating low blood pressure
Pat. Sub. Date(s): 001: Jan 22, 2018
Claim Types: Method of use
Use Code: U-2221: Treating refractory hypotension with about 20 ng/kg/min angiotensin II in a patient receiving vasopressor
Jul 18, 2031New expiration date. Was previously Nov 20, 2030

JAKAFI (TABLET) (ORAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.: 202192  Prod. No.: 001 RX (EQ 5MG BASE)
PatentsExpirationChange
Pat. No. 8822481
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Pat. Sub. Date(s): 001: Sep 24, 2014
Claim Types: Method of use
Use Code: U-1573: Use of ruxolitinib (JAKAFI) for inhibiting Janus associated kinases (JAKS) JAK1 and/or JAK2.
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Jun 12, 2028New Use Code
Pat. No. 9079912
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): 001: Aug 4, 2015
Claim Types: Method of use
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Dec 12, 2026Deleted Use Code(s): U-1573, U-1721

JAKAFI (TABLET) (ORAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.: 202192  Prod. No.: 002 RX (EQ 10MG BASE)
PatentsExpirationChange
Pat. No. 8822481
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Pat. Sub. Date(s): 002: Sep 24, 2014
Claim Types: Method of use
Use Code: U-1573: Use of ruxolitinib (JAKAFI) for inhibiting Janus associated kinases (JAKS) JAK1 and/or JAK2.
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Jun 12, 2028New Use Code
Pat. No. 9079912
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): 002: Aug 4, 2015
Claim Types: Method of use
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Dec 12, 2026Deleted Use Code(s): U-1573, U-1721

JAKAFI (TABLET) (ORAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.: 202192  Prod. No.: 003 RX (EQ 15MG BASE)
PatentsExpirationChange
Pat. No. 8822481
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Pat. Sub. Date(s): 003: Sep 24, 2014
Claim Types: Method of use
Use Code: U-1573: Use of ruxolitinib (JAKAFI) for inhibiting Janus associated kinases (JAKS) JAK1 and/or JAK2.
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Jun 12, 2028New Use Code
Pat. No. 9079912
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): 003: Aug 4, 2015
Claim Types: Method of use
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Dec 12, 2026Deleted Use Code(s): U-1573, U-1721

JAKAFI (TABLET) (ORAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.: 202192  Prod. No.: 004 RX (EQ 20MG BASE)
PatentsExpirationChange
Pat. No. 8822481
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Pat. Sub. Date(s): 004: Sep 24, 2014
Claim Types: Method of use
Use Code: U-1573: Use of ruxolitinib (JAKAFI) for inhibiting Janus associated kinases (JAKS) JAK1 and/or JAK2.
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Jun 12, 2028New Use Code
Pat. No. 9079912
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): 004: Aug 4, 2015
Claim Types: Method of use
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Dec 12, 2026Deleted Use Code(s): U-1573, U-1721

JAKAFI (TABLET) (ORAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.: 202192  Prod. No.: 005 RX (EQ 25MG BASE)
PatentsExpirationChange
Pat. No. 8822481
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Pat. Sub. Date(s): 005: Sep 24, 2014
Claim Types: Method of use
Use Code: U-1573: Use of ruxolitinib (JAKAFI) for inhibiting Janus associated kinases (JAKS) JAK1 and/or JAK2.
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Jun 12, 2028New Use Code
Pat. No. 9079912
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): 005: Aug 4, 2015
Claim Types: Method of use
Use Code: U-3226: For treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy
Use Code: U-3227: For treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF
Use Code: U-3228: For treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea
Use Code: U-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Dec 12, 2026Deleted Use Code(s): U-1573, U-1721

KUVAN (TABLET) (ORAL) SAPROPTERIN DIHYDROCHLORIDE [GENERIC AB]
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == phenylalanine hydroxylase activator
NDA Applicant: BIOMARIN PHARM      NDA No.: 022181  Prod. No.: 001 RX (100MG)
PatentsExpirationChange
Pat. No. 7947681 DLR*
Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Pat. Sub. Date(s): None
Claim Types: Method of administration
Use Code: U-1156: To reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA)
May 17, 2025 *PEDThis patent is no longer listed for this product

MAKENA (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) HYDROXYPROGESTERONE CAPROATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins
NDA Applicant: COVIS      NDA No.: 021945  Prod. No.: 004 RX (275MG/1.1ML (250MG/ML))
PatentsExpirationChange
Pat. No. 11154562
Methods of reducing risk of preterm birth
Pat. Sub. Date(s): 004: Nov 17, 2021
Claim Types: Method of use
Use Code: U-2236: Reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
May 2, 2036New patent for this product

MAVYRET (PELLETS) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus (HCV) NS3/4A protease inhibitor == hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 215110  Prod. No.: 001 RX (50MG;20MG/PACKET)
ExclusivityExpirationChange
Exclusivity Code: D - New Dosing Schedule: D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 studyMar 26, 2023 PEDNew exclusivity for this product
Exclusivity Code: M - Miscellaneous: M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infectionOct 10, 2023 PEDNew exclusivity for this product
Exclusivity Code: NCE - New chemical entity Feb 3, 2023 PEDNew exclusivity for this product

NERLYNX (TABLET) (ORAL) NERATINIB MALEATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: PUMA BIOTECH      NDA No.: 208051  Prod. No.: 001 RX (EQ 40MG BASE)
PatentsExpirationChange
Pat. No. 7399865 DS* DP*
Protein tyrosine kinase enzyme inhibitors
Pat. Sub. Date(s): 001: Aug 8, 2017
Claim Types: Compound; Composition
Dec 29, 2030New expiration date. Was previously Dec 29, 2025

OPZELURA (CREAM) (TOPICAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.: 215309  Prod. No.: 001 RX (EQ 1.5% BASE)
ExclusivityExpirationChange
Exclusivity Code: NP - New product Sep 21, 2024New exclusivity for this product

OXTELLAR XR (TABLET, EXTENDED RELEASE) (ORAL) OXCARBAZEPINE
Drug Classes: Anticonvulsants:Sodium Channel Agents == antiepileptic drug (AED)
NDA Applicant: SUPERNUS PHARMS      NDA No.: 202810  Prod. No.: 001 RX (150MG); 002 RX (300MG); 003 RX (600MG)
PatentsExpirationChange
Pat. No. 11166960 DP*
Modified release preparations containing oxcarbazepine and derivatives thereof
Pat. Sub. Date(s): All strengths: Nov 24, 2021
Claim Types: Formulation
Apr 13, 2027New patent for this product

OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.: 209637  Prod. No.: 001 RX (2MG/1.5ML (1.34MG/ML)); 002 RX (4MG/3ML (1.34MG/ML))
PatentsExpirationChange
Pat. No. 8129343 DS* DP*
Acylated GLP-1 compounds
Pat. Sub. Date(s): 001: Dec 20, 2017; 002: Sep 24, 2020
Claim Types: Compound; Composition; Method of use
Use Code: U-2202: OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Dec 5, 2031New expiration date. Was previously Jan 29, 2029

PARSABIV (SOLUTION) (INTRAVENOUS) ETELCALCETIDE
Drug Classes: Metabolic Bone Disease Agents == calcium-sensing receptor agonist
NDA Applicant: KAI PHARMS INC      NDA No.: 208325  Prod. No.: 001 RX (2.5MG/0.5ML (2.5MG/0.5ML)); 002 RX (5MG/ML (5MG/ML)); 003 RX (10MG/2ML (5MG/ML))
PatentsExpirationChange
Pat. No. 11162500 DP*
Stable liquid formulation of AMG 416 (etelcalcetide)
Pat. Sub. Date(s): All strengths: Nov 12, 2021
Claim Types: Formulation
Jun 27, 2034New patent for this product

PROAIR DIGIHALER (POWDER, METERED) (INHALATION) ALBUTEROL SULFATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 205636  Prod. No.: 002 RX (EQ 0.09MG BASE/INH)
PatentsExpirationChange
Pat. No. 11173259 DP*
Drug delivery device with electronics and power management
Pat. Sub. Date(s): 002: Dec 8, 2021
Claim Types: Device
Jul 6, 2040New patent for this product

QBRELIS (SOLUTION) (ORAL) LISINOPRIL
Drug Classes: Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors == Cardiovascular Agents:Cardiovascular Combinations == angiotensin converting enzyme inhibitor
NDA Applicant: AZURITY      NDA No.: 208401  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationChange
Pat. No. 11179434 DP*
Lisinopril formulations
Pat. Sub. Date(s): 001: Nov 23, 2021
Claim Types: Formulation
Nov 6, 2035New patent for this product

RAYALDEE (CAPSULE, EXTENDED RELEASE) (ORAL) CALCIFEDIOL
Drug Classes: Metabolic Bone Disease Agents == vitamin D3 analog
NDA Applicant: EIRGEN      NDA No.: 208010  Prod. No.: 001 RX (0.03MG)
PatentsExpirationChange
Pat. No. 11154509
Methods for controlled release oral dosage of a vitamin D compound
Pat. Sub. Date(s): 001: Nov 17, 2021
Claim Types: Method of use
Use Code: U-3248: Treating secondary hyperparathyroidism in stage 3/4 chronic kidney disease with sustained release 25-hydroxyvitamin D to reduce the patient's serum parathyroid hormone level while avoiding PTH oversuppression
Apr 25, 2028New patent for this product

REZUROCK (TABLET) (ORAL) BELUMOSUDIL MESYLATE
NDA Applicant: KADMON PHARMS LLC      NDA No.: 214783  Prod. No.: 001 RX (EQ 200MG BASE)
PatentsExpirationChange
Pat. No. 8357693 DS* DP*
Pharmacokinetically improved compounds
Pat. Sub. Date(s): 001: Nov 17, 2021
Claim Types: Compound; Composition; Method of use
Use Code: U-3247: For the treatment of chronic graft versus hold disease
Oct 30, 2029New patent for this product
Pat. No. 9815820
Rho kinase inhibitors
Pat. Sub. Date(s): 001: Nov 17, 2021
Claim Types: Compound; Method of use
Use Code: U-3247: For the treatment of chronic graft versus hold disease
Oct 7, 2033New patent for this product
Pat. No. 10183931
Rho kinase inhibitors
Pat. Sub. Date(s): 001: Nov 17, 2021
Claim Types: Method of use
Use Code: U-3246: For the treatment of chronic graft versus host disease
Oct 7, 2033New patent for this product
Pat. No. 10696660
Rho kinase inhibitors
Pat. Sub. Date(s): 001: Nov 17, 2021
Claim Types: Method of use
Use Code: U-3246: For the treatment of chronic graft versus host disease
Oct 7, 2033New patent for this product

RYBELSUS (TABLET) (ORAL) SEMAGLUTIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.: 213051  Prod. No.: 001 RX (3MG); 002 RX (7MG); 003 RX (14MG)
PatentsExpirationChange
Pat. No. 8129343 DS* DP*
Acylated GLP-1 compounds
Pat. Sub. Date(s): All strengths: Oct 15, 2019
Claim Types: Compound; Composition; Method of use
Use Code: U-2628: Method of treating Type 2 diabetes mellitus
Dec 5, 2031New expiration date. Was previously Jan 29, 2029

SCEMBLIX (TABLET) (ORAL) ASCIMINIB HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.: 215358  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE)
PatentsExpirationChange
Pat. No. 8829195 DS*
Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1
Pat. Sub. Date(s): All strengths: Nov 19, 2021
Claim Types: Compound; Method of use
Use Code: U-3249: U-1374 treatment of Philadelphia chromosome positive chronic myeloid leukemia (PH+ CML)
May 13, 2033New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Oct 29, 2026New exclusivity for this product

SEGLENTIS (TABLET) (ORAL) CELECOXIB; TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: KOWA PHARMS      NDA No.: 213426  Prod. No.: 001 RX (56MG;44MG)
PatentsExpirationChange
Pat. No. 8598152 DS* DP*
Co-crystals of tramadol and coxibs
Pat. Sub. Date(s): 001: Nov 12, 2021
Claim Types: New polymorph, salt or hydrate; Composition
Apr 19, 2030New patent for this product
Pat. No. 8846744 DP*
Pharmaceutical compositions of co-crystals of tramadol and coxibs
Pat. Sub. Date(s): 001: Nov 12, 2021
Claim Types: Formulation; Process
Jun 3, 2031New patent for this product
Pat. No. 9012440 DS* DP*
Co-crystals of tramadol and coxibs
Pat. Sub. Date(s): 001: Nov 12, 2021
Claim Types: New polymorph, salt or hydrate; Composition
Apr 19, 2030New patent for this product
Pat. No. 10238668 DS* DP*
Co-crystals of tramadol and coxibis
Pat. Sub. Date(s): 001: Nov 12, 2021
Claim Types: New polymorph, salt or hydrate; Method of use
Use Code: U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib
Apr 19, 2030New patent for this product
Pat. No. 10245276 DS* DP*
Co-crystals of tramadol and coxibs
Pat. Sub. Date(s): 001: Nov 12, 2021
Claim Types: New polymorph, salt or hydrate; Composition
Apr 19, 2030New patent for this product
Pat. No. 10548909
Co-crystals of tramadol and coxibs
Pat. Sub. Date(s): 001: Nov 12, 2021
Claim Types: Method of use
Use Code: U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib
Apr 19, 2030New patent for this product

SPRITAM (TABLET, FOR SUSPENSION) (ORAL) LEVETIRACETAM
Drug Classes: Anticonvulsants:Anticonvulsants, Other
NDA Applicant: APRECIA PHARMS      NDA No.: 207958  Prod. No.: 001 RX (250MG); 002 RX (500MG); 003 RX (750MG); 004 RX (1GM)
PatentsExpirationChange
Pat. No. 11160786 DP*
Rapid disperse dosage form
Pat. Sub. Date(s): All strengths: Nov 30, 2021
Claim Types: Formulation
Mar 14, 2034New patent for this product

TRUSELTIQ (CAPSULE) (ORAL) INFIGRATINIB PHOSPHATE
NDA Applicant: HELSINN HLTHCARE      NDA No.: 214622  Prod. No.: 001 RX (25MG); 002 RX (100MG)
PatentsExpirationChange
Pat. No. 11160804 DP*
Pharmaceutical dosage forms
Pat. Sub. Date(s): All strengths: Dec 1, 2021
Claim Types: Product-by-process; Process
Dec 11, 2034New patent for this product

TWYNEO (CREAM) (TOPICAL) BENZOYL PEROXIDE; TRETINOIN
Drug Classes: Dermatological Agents:Topical Anti-infectives == Antineoplastics:Retinoids == Dermatological Agents:Acne and Rosacea Agents
NDA Applicant: SOL-GEL TECHNOLOGIES      NDA No.: 214902  Prod. No.: 001 RX (3%;0.1%)
PatentsExpirationChange
Pat. No. 8617580 DP*
Compositions for topical application comprising a peroxide and retinoid
Pat. Sub. Date(s): 001: Nov 24, 2021
Claim Types: Formulation; Kit
Feb 3, 2028New patent for this product
Pat. No. 10420743
Methods and compositions for the treatment of acne
Pat. Sub. Date(s): 001: Nov 24, 2021
Claim Types: Method of use
Use Code: U-3194: Topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older
Jul 12, 2038New patent for this product
Pat. No. 10653899 DP*
Core stabilized microcapsules, method of their preparation and uses thereof
Pat. Sub. Date(s): 001: Nov 24, 2021
Claim Types: Formulation; Method of use
Use Code: U-3194: Topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older
Dec 30, 2030New patent for this product

TYRVAYA (SOLUTION) (NASAL) VARENICLINE TARTRATE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == nicotinic receptor partial agonist
NDA Applicant: OYSTER POINT PHARMA      NDA No.: 213978  Prod. No.: 001 RX (EQ 0.03MG BASE/SPRAY)
ExclusivityExpirationChange
Exclusivity Code: NP - New product Oct 15, 2024New exclusivity for this product

TYVASO (SOLUTION) (INHALATION) TREPROSTINIL
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 022387  Prod. No.: 001 RX (0.6MG/ML)
PatentsExpirationChange
Pat. No. 8497393 DS* DLR*
Process to prepare treprostinil, the active ingredient in Remodulin.RTM
Pat. Sub. Date(s): None
Claim Types: Product-by-process
Dec 15, 2028This patent is no longer listed for this product

UPTRAVI (TABLET) (ORAL) SELEXIPAG
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacyclin receptor agonist
NDA Applicant: ACTELION      NDA No.: 207947  Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (0.8MG); 005 RX (1MG); 006 RX (1.2MG); 007 RX (1.4MG); 008 RX (1.6MG)
PatentsExpirationChange
Pat. No. 7205302 DS* DP*
Heterocyclic compound derivatives and medicines
Pat. Sub. Date(s): All strengths: Jan 19, 2016
Claim Types: Composition; Compound; Method of use
Use Code: U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag
Oct 31, 2026New expiration date. Was previously Apr 4, 2023

UPTRAVI (POWDER) (INTRAVENOUS) SELEXIPAG
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacyclin receptor agonist
NDA Applicant: ACTELION      NDA No.: 214275  Prod. No.: 001 RX (1.8MG/VIAL)
PatentsExpirationChange
Pat. No. 7205302 DS* DP*
Heterocyclic compound derivatives and medicines
Pat. Sub. Date(s): 001: Aug 27, 2021
Claim Types: Composition; Compound; Method of use
Use Code: U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag
Oct 31, 2026New expiration date. Was previously Apr 4, 2023

VERZENIO (TABLET) (ORAL) ABEMACICLIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 208716  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG); 004 RX (200MG)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-877: Indication for the use of abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early cancer (EBC) at high risk of recurrence and a KI-67 score>20% as determined by an FDA approved testOct 12, 2024New exclusivity for this product
Exclusivity Code: NPP - New patient population Oct 12, 2024New exclusivity for this product

VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: Gastrointestinal Agents:Anti-Diarrheal Agents == mu-opioid receptor agonist
NDA Applicant: ALLERGAN HOLDINGS      NDA No.: 206940  Prod. No.: 001 RX (75MG); 002 RX (100MG)
PatentsExpirationChange
Pat. No. 11160792 DP*
Opioid receptor modulator dosage formulations
Pat. Sub. Date(s): All strengths: Nov 24, 2021
Claim Types: Formulation
Mar 14, 2033New patent for this product

VUITY (SOLUTION) (OPHTHALMIC) PILOCARPINE HYDROCHLORIDE
Drug Classes: Dental and Oral Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == cholinergic agonist
NDA Applicant: ABBVIE INC      NDA No.: 214028  Prod. No.: 001 RX (1.25%)
PatentsExpirationChange
Pat. No. 10610518
Presbyopia treatments
Pat. Sub. Date(s): 001: Nov 24, 2021
Claim Types: Method of use
Use Code: U-3252: Use of VUITY for the treatment of presbyopia in adults
Apr 24, 2039New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NP - New product Oct 28, 2024New exclusivity for this product

WEGOVY (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.: 215256  Prod. No.: 001 RX (0.25MG/0.5ML (0.25MG/0.5ML)); 002 RX (0.5MG/0.5ML (0.5MG/0.5ML)); 003 RX (1MG/0.5ML (1MG/0.5ML)); 004 RX (1.7MG/0.75ML (1.7MG/0.75ML)); 005 RX (2.4MG/0.75ML (2.4MG/0.75ML))
PatentsExpirationChange
Pat. No. 8129343 DS* DP*
Acylated GLP-1 compounds
Pat. Sub. Date(s): All strengths: Jun 30, 2021
Claim Types: Compound; Composition; Method of use
Dec 5, 2031New expiration date. Was previously Jan 29, 2029

WELCHOL (FOR SUSPENSION) (ORAL) COLESEVELAM HYDROCHLORIDE [GENERIC AB]
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Cardiovascular Agents:Dyslipidemics, Other == bile acid sequestrant
NDA Applicant: DAIICHI SANKYO      NDA No.: 022362  Prod. No.: 002 RX (3.75GM/PACKET) NDA No.: 022362  Prod. No.: 001 DISC (1.875GM/PACKET**)
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-232: Information added to section 8.4 of the labeling to describe the results from pediatric studiesOct 20, 2024New exclusivity for this product

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: Blood Products and Modifiers:Anticoagulants == factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 022406  Prod. No.: 001 RX (10MG)
PatentsExpirationChange
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Pat. Sub. Date(s): 001: Aug 4, 2011
Claim Types: Compound; Process; Composition; Method of use
Use Code: U-1301: Treatment of deep vein thrombosis (DVT)
Use Code: U-1302: Treatment of pulmonary embolism (PE)
Feb 28, 2025 *PEDNew expiration date. Was previously Aug 28, 2024
Pat. No. 9415053 DP*
Solid, orally administrable pharmaceutical composition
Pat. Sub. Date(s): 001: Sep 14, 2016
Claim Types: Product-by-process; Process; Method of use
Use Code: U-1167: Prophylaxis of deep vein thrombosis (DVT)
Use Code: U-2142: Reduction in the risk of recurrence of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients at continued risk for recurrent DVT and/or after completion of initial treatment lasting at least 6 months
Use Code: U-2640: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding
May 13, 2025 *PEDNew expiration date. Was previously Nov 13, 2024
Pat. No. 9539218
Prevention and treatment of thromboembolic disorders
Pat. Sub. Date(s): 001: Feb 7, 2017
Claim Types: Method of use
Use Code: U-1957: Prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery, with once daily, rapid-release tablet administered for at least five consecutive days
Use Code: U-2143: After completion of initial treatment lasting at least 6 months, to reduce the risk of recurrence of deep vein thrombosis and/or pulmonary embolism in certain patients with once daily, rapid-release tablet administered for at least 5 consecutive days
Use Code: U-2641: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding with once daily, rapid-release tablet administered for at least 5 consecutive days
Aug 17, 2034 *PEDNew expiration date. Was previously Feb 17, 2034
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-810: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleedingApr 11, 2023 PEDNew expiration date. Was previously Oct 11, 2022
Exclusivity Code: I - New Indication: I-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PADFeb 23, 2025 PEDNew expiration date. Was previously Aug 23, 2024

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: Blood Products and Modifiers:Anticoagulants == factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 022406  Prod. No.: 002 RX (15MG)
PatentsExpirationChange
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Pat. Sub. Date(s): 002: Dec 2, 2011
Claim Types: Compound; Process; Composition; Method of use
Use Code: U-1301: Treatment of deep vein thrombosis (DVT)
Use Code: U-1302: Treatment of pulmonary embolism (PE)
Feb 28, 2025 *PEDNew expiration date. Was previously Aug 28, 2024
Pat. No. 9415053 DP*
Solid, orally administrable pharmaceutical composition
Pat. Sub. Date(s): 002: Sep 14, 2016
Claim Types: Product-by-process; Process; Method of use
Use Code: U-1200: Reducing the risk of stroke and systemic embolism
Use Code: U-1301: Treatment of deep vein thrombosis (DVT)
Use Code: U-1302: Treatment of pulmonary embolism (PE)
May 13, 2025 *PEDNew expiration date. Was previously Nov 13, 2024
Pat. No. 9539218
Prevention and treatment of thromboembolic disorders
Pat. Sub. Date(s): 002: Feb 7, 2017
Claim Types: Method of use
Use Code: U-1953: Reduce the risk of stroke in patients with nonvalvular atrial fibrillation with once daily, rapid-release tablet administered for at least five consecutive days
Aug 17, 2034 *PEDNew expiration date. Was previously Feb 17, 2034
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-810: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleedingApr 11, 2023 PEDNew expiration date. Was previously Oct 11, 2022
Exclusivity Code: I - New Indication: I-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PADFeb 23, 2025 PEDNew expiration date. Was previously Aug 23, 2024

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: Blood Products and Modifiers:Anticoagulants == factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 022406  Prod. No.: 003 RX (20MG)
PatentsExpirationChange
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Pat. Sub. Date(s): 003: Dec 2, 2011
Claim Types: Compound; Process; Composition; Method of use
Use Code: U-1301: Treatment of deep vein thrombosis (DVT)
Use Code: U-1302: Treatment of pulmonary embolism (PE)
Feb 28, 2025 *PEDNew expiration date. Was previously Aug 28, 2024
Pat. No. 9415053 DP*
Solid, orally administrable pharmaceutical composition
Pat. Sub. Date(s): 003: Sep 14, 2016
Claim Types: Product-by-process; Process; Method of use
Use Code: U-1200: Reducing the risk of stroke and systemic embolism
Use Code: U-1301: Treatment of deep vein thrombosis (DVT)
Use Code: U-1302: Treatment of pulmonary embolism (PE)
May 13, 2025 *PEDNew expiration date. Was previously Nov 13, 2024
Pat. No. 9539218
Prevention and treatment of thromboembolic disorders
Pat. Sub. Date(s): 003: Feb 7, 2017
Claim Types: Method of use
Use Code: U-1953: Reduce the risk of stroke in patients with nonvalvular atrial fibrillation with once daily, rapid-release tablet administered for at least five consecutive days
Use Code: U-1954: Treatment of deep vein thrombosis with once daily, rapid-release tablet administered for at least five consecutive days
Use Code: U-1955: Treatment of pulmonary embolism with once daily, rapid-release tablet administered for at least five consecutive days
Aug 17, 2034 *PEDNew expiration date. Was previously Feb 17, 2034
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-810: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleedingApr 11, 2023 PEDNew expiration date. Was previously Oct 11, 2022
Exclusivity Code: I - New Indication: I-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PADFeb 23, 2025 PEDNew expiration date. Was previously Aug 23, 2024

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: Blood Products and Modifiers:Anticoagulants == factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 022406  Prod. No.: 004 RX (2.5MG)
PatentsExpirationChange
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Pat. Sub. Date(s): 004: Nov 8, 2018
Claim Types: Compound; Process; Composition; Method of use
Feb 28, 2025 *PEDNew expiration date. Was previously Aug 28, 2024
Pat. No. 9415053 DP*
Solid, orally administrable pharmaceutical composition
Pat. Sub. Date(s): 004: Nov 8, 2018
Claim Types: Product-by-process; Process; Method of use
Use Code: U-2435: Reduction of risk of major cardiovascular events (CV death, MI, and stroke) in chronic CAD or PAD
Use Code: U-3205: Reduction of risk of major cardiovascular events (cardiovascular death, myocardial infarction and stroke) in patients with CAD
Use Code: U-3206: Reduction of risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD
May 13, 2025 *PEDNew expiration date. Was previously Nov 13, 2024
Pat. No. 10828310
Reducing the risk of cardiovascular events
Pat. Sub. Date(s): 004: Dec 9, 2020
Claim Types: Method of use
Use Code: U-3207: Reduction of risk of cardiovascular death, myocardial infarction, and stroke in patients with CAD by administering clinically proven effective amounts that are 2.5 mg rivaroxaban twice daily and 75-100 mg aspirin daily
Use Code: U-3208: Reduction of risk of myocardial infarction and ischemic stroke in patients with PAD by administering clinically proven effective amounts that are 2.5 mg rivaroxaban twice daily and 75-100 mg aspirin daily
Jul 31, 2039 *PEDNew expiration date. Was previously Jan 31, 2039
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-810: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleedingApr 11, 2023 PEDNew expiration date. Was previously Oct 11, 2022
Exclusivity Code: I - New Indication: I-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PADFeb 23, 2025 PEDNew expiration date. Was previously Aug 23, 2024

XATMEP (SOLUTION) (ORAL) METHOTREXATE SODIUM
Drug Classes: Antineoplastics:Antineoplastics, Other == Immunological Agents:Immunosuppressants == folate analog metabolic inhibitor
NDA Applicant: AZURITY      NDA No.: 208400  Prod. No.: 001 RX (EQ 2.5MG BASE/ML)
PatentsExpirationChange
Pat. No. 11116724
Methotrexate composition
Pat. Sub. Date(s): 001: Nov 23, 2021
Claim Types: Method of use
Use Code: U-1349: Treatment of juvenile rheumatoid arthritis
Use Code: U-1699: A method for treating acute lymphoblastic leukemia
Jan 2, 2033New patent for this product

XERAVA (POWDER) (INTRAVENOUS) ERAVACYCLINE DIHYDROCHLORIDE
Drug Classes: Antibacterials:Tetracyclines == tetracycline class antibacterial
NDA Applicant: TETRAPHASE PHARMS      NDA No.: 211109  Prod. No.: 002 RX (EQ 100MG BASE/VIAL)
ExclusivityExpirationChange
Exclusivity Code: GAIN - Generating Antibiotic Incentives Now Aug 27, 2028New exclusivity for this product
Exclusivity Code: NCE - New chemical entity Aug 27, 2023New exclusivity for this product

XIPERE (SUSPENSION) (INJECTION) TRIAMCINOLONE ACETONIDE
Drug Classes: Dental and Oral Agents == Dermatological Agents:Dermatitis and Pruritus Agents == Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids
NDA Applicant: CLEARSIDE      NDA No.: 211950  Prod. No.: 001 RX (40MG/ML)
ExclusivityExpirationChange
Exclusivity Code: NP - New product Oct 22, 2024New exclusivity for this product


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
DLR* NDA holder has requested delisting of the patent. However, FDA will not delist if doing so would adversely affect an ANDA applicant's eligibility for 180-day generic exclusivity. ANDA applicants must provide a patent certification for the patent, but 505(b)(2) applicants do not need to do so.
Last edited: 7 January 2022
2001-2022 Bruce A. Pokras, All rights reserved worldwide