Orange Book Companionģ
What's New for Vol. 42, Supp. 12
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.


ANNOVERA (RING) (VAGINAL) ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Contraceptives:Contraceptives, Other == progestin/estrogen CHC
NDA Applicant: THERAPEUTICSMD INC      NDA No.: 209627  Prod. No.: 001 RX (0.013MG/24HR;0.15MG/24HR)
PatentsExpirationChange
Pat. No. 11529308 DP*
System for providing birth control
Pat. Sub. Date(s): 001: Dec 21, 2022
Claim Types: Device
Jun 21, 2039New patent for this product

AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone == Central Nervous System Agents:Central Nervous System, Other == sigma-1 agonist
NDA Applicant: AXSOME      NDA No.: 215430  Prod. No.: 001 RX (105MG;45MG)
PatentsExpirationChange
Pat. No. 11517542
Bupropion as a modulator of drug activity
Pat. Sub. Date(s): 001: Dec 21, 2022
Claim Types: Method of use
Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Nov 5, 2034New patent for this product
Pat. No. 11517543
Bupropion as a modulator of drug activity
Pat. Sub. Date(s): 001: Dec 21, 2022
Claim Types: Method of use
Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Nov 5, 2034New patent for this product
Pat. No. 11524007
Bupropion as a modulator of drug activity
Pat. Sub. Date(s): 001: Dec 21, 2022
Claim Types: Method of use
Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Nov 5, 2034New patent for this product
Pat. No. 11524008
Bupropion as a modulator of drug activity
Pat. Sub. Date(s): 001: Dec 21, 2022
Claim Types: Method of use
Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Nov 5, 2034New patent for this product

BENDAMUSTINE HYDROCHLORIDE (POWDER) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ACCORD HLTHCARE      NDA No.: 205574  Prod. No.: 001 RX (25MG/VIAL); 002 RX (100MG/VIAL)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Jun 5, 2023New exclusivity for this product

BIJUVA (CAPSULE) (ORAL) ESTRADIOL; PROGESTERONE
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins == Infertility Agents == progesterone
NDA Applicant: MAYNE PHARMA      NDA No.: 210132  Prod. No.: 001 RX (1MG;100MG)
PatentsExpirationChange
Pat. No. 11529360 DP*
Natural combination hormone replacement formulations and therapies
Pat. Sub. Date(s): 001: Dec 21, 2022
Claim Types: Formulation
Nov 21, 2032New patent for this product

COTELLIC (TABLET) (ORAL) COBIMETINIB FUMARATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: GENENTECH INC      NDA No.: 206192  Prod. No.: 001 RX (EQ 20MG BASE)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-902: Treatment of adult patients with histiocytic neoplasmsOct 28, 2025New exclusivity for this product

CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
Drug Classes: Antifungals
NDA Applicant: ASTELLAS      NDA No.: 207500  Prod. No.: 002 RX (74.5MG)
PatentsExpirationChange
Pat. No. 10206879 DP*
Active ingredient containing stabilised solid forms and method for the production thereof
Pat. Sub. Date(s): 002: Dec 21, 2022
Claim Types: Formulation
Sep 14, 2027New strength or variation of this product
Pat. No. 10603280 DP*
Active ingredient containing stabilised solid medicinal forms and methods for the production thereof
Pat. Sub. Date(s): 002: Dec 21, 2022
Claim Types: Formulation
Sep 14, 2027New strength or variation of this product
Pat. No. 10812238 DS*
Configurable reference signals
Pat. Sub. Date(s): 002: Dec 21, 2022
Claim Types: Device
Comments: Most likely a typo; looks like should be 6,812,238
Oct 31, 2025New strength or variation of this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Mar 6, 2025 GAINNew strength or variation of this product
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) Mar 6, 2027 GAINNew strength or variation of this product

DEFINITY; DEFINITY RT (INJECTABLE) (INTRAVENOUS) PERFLUTREN
NDA Applicant: LANTHEUS MEDCL      NDA No.: 021064  Prod. No.: 001 RX (6.52MG/ML); 002 RX (6.52MG/ML)
PatentsExpirationChange
Pat. No. 11529431
Methods for making ultrasound contrast agents
Pat. Sub. Date(s): All strengths: Jan 9, 2023
Claim Types: Diagnostic or surgical method
Use Code: U-665: Method of using the drug substance/drug product for ultrasound imaging
Mar 16, 2037New patent for this product

DROSPIRENONE (TABLET, CHEWABLE) (ORAL) DROSPIRENONE
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins
NDA Applicant: EXELTIS USA INC      NDA No.: 216285  Prod. No.: 001 RX (3.5MG)
PatentsExpirationChange
Pat. No. 11504334 DP*
Synthetic progestogens and pharmaceutical compositions comprising the same
Pat. Sub. Date(s): 001: Dec 16, 2022
Claim Types: Formulation
Jun 28, 2031New patent for this product

EPINEPHRINE (SOLUTION) (INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: BPI LABS      NDA No.: 205029  Prod. No.: 001 RX (1MG/ML (1MG/ML))
PatentsExpirationChange
Pat. No. 10004700 DP* DLR*
More potent and less toxic formulations of epinephrine and methods of medical use
Pat. Sub. Date(s): 001: Jun 29, 2018
Claim Types: Method of use; Formulation
Use Code: U-2325: Emergency treatment of allergic reactions (Type 1), including anaphylaxis; a method of treating allergic reaction, anaphylaxis, anaphylactic shock, or combination thereof by an injection of at least one dosage of the injectable liquid pharmaceutical
Aug 14, 2034New Delisting Request flag
Pat. No. 10039728 DLR*
More potent and less toxic formulations of epinephrine and methods of medical use
Pat. Sub. Date(s): 001: Aug 7, 2018
Claim Types: Method of use
Use Code: U-1828: Increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock
Aug 14, 2034New Delisting Request flag

FINTEPLA (SOLUTION) (ORAL) FENFLURAMINE HYDROCHLORIDE
Drug Classes: Anticonvulsants:Anticonvulsants, Other
NDA Applicant: ZOGENIX INC      NDA No.: 212102  Prod. No.: 001 RX (EQ 2.2MG BASE/ML)
PatentsExpirationChange
Pat. No. 10452815 DLR*
Control system for control of distribution of medication
Pat. Sub. Date(s): 001: Jul 24, 2020
Claim Types: Electronic system for controlling distribution of fenfluramine
Use Code: U-2859: Use of cardiac monitoring and restricted distribution of fenfluramine to mitigate risk of cardiovascular toxicity in the treatment of seizures associated with Dravet syndrome
Dec 29, 2038 *PEDNew Delisting Request flag
Pat. No. 10950331
Control system for control of distribution of medication
Pat. Sub. Date(s): None
Claim Types: Method of improving a treatment
Use Code: U-3098: Treatment of refractory epilepsy patients with fenfluramine that reduces the risk of cardiovascular toxicity by using cardiac monitoring and restricted distribution
Mar 28, 2036 *PEDThis patent is no longer listed for this product

GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: ALNYLAM PHARMS INC      NDA No.: 212194  Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))
PatentsExpirationChange
Pat. No. 11530408 DS* DP*
Therapeutic compositions
Pat. Sub. Date(s): 001: Jan 6, 2023
Claim Types: Composition
May 18, 2024New patent for this product

IBRANCE (CAPSULE) (ORAL) PALBOCICLIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: PFIZER      NDA No.: 207103  Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)
PatentsExpirationChange
Pat. No. 7456168
2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones
Pat. Sub. Date(s): All strengths: Feb 26, 2015
Claim Types: Method of use
Use Code: U-1998: Treating HR-pos., HER2-neg. advanced or metastatic breast cancer with palbociclib in combo with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or fulvestrant in women with disease progression after endocrine therapy
Use Code: U-2515: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men, or with fulvestrant in pts with disease progression after endocrine therapy
Use Code: U-3501: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor in pts as initial endocrine-based therapy or with fulvestrant with disease progression after endocrine therapy
Jan 16, 2023New Use Code

IBRANCE (TABLET) (ORAL) PALBOCICLIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: PFIZER      NDA No.: 212436  Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)
PatentsExpirationChange
Pat. No. 7456168
2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones
Pat. Sub. Date(s): All strengths: Nov 26, 2019
Claim Types: Method of use
Use Code: U-2515: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men, or with fulvestrant in pts with disease progression after endocrine therapy
Use Code: U-3501: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor in pts as initial endocrine-based therapy or with fulvestrant with disease progression after endocrine therapy
Jan 16, 2023New Use Code

JAKAFI (TABLET) (ORAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == Janus kinase (JAK) inhibitor == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.: 202192  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE)
PatentsExpirationChange
Pat. No. 7598257 DS* DP*
Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Pat. Sub. Date(s): All strengths: Dec 1, 2011
Claim Types: Compound; Method of use
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
Jun 24, 2028 *PEDNew expiration date. Was previously Dec 24, 2027
Pat. No. 8415362 DS* DP*
Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): 001: Apr 29, 2013; 002: None
Claim Types: Compound
Jun 24, 2028 *PEDNew expiration date. Was previously Dec 24, 2027
Pat. No. 8722693 DS* DP*
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Pat. Sub. Date(s): All strengths: Jun 3, 2014
Claim Types: Compound; Composition; New polymorph, salt or hydrate; Formulation
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028
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): All strengths: 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)
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028; New Use Code
Pat. No. 8829013
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Pat. Sub. Date(s): All strengths: Sep 24, 2014
Claim Types: Method of use
Use Code: U-1201: For the treatment of intermediate or high-risk myelofibrosis
Use Code: U-1622: For the treatment of polycythemia vera
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
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028
Pat. No. 9079912
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): All strengths: 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)
Jun 12, 2027 *PEDNew expiration date. Was previously Dec 12, 2026
Pat. No. 9814722
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Pat. Sub. Date(s): All strengths: Jun 12, 2019
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-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Jun 12, 2027 *PEDNew expiration date. Was previously Dec 12, 2026
Pat. No. 10016429
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Pat. Sub. Date(s): All strengths: Jun 12, 2019
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-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-872: Addition of the indication of treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and olderMar 22, 2025 PEDNew expiration date. Was previously Sep 22, 2024
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-238: Treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and olderNov 24, 2026 PEDNew expiration date. Was previously May 24, 2026
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-373: Treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and olderMar 22, 2029 PEDNew expiration date. Was previously Sep 22, 2028

JAKAFI (TABLET) (ORAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == Janus kinase (JAK) inhibitor == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.: 202192  Prod. No.: 003 RX (EQ 15MG BASE); 004 RX (EQ 20MG BASE); 005 RX (EQ 25MG BASE)
PatentsExpirationChange
Pat. No. 7598257 DS* DP*
Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Pat. Sub. Date(s): All strengths: Dec 1, 2011
Claim Types: Compound; Method of use
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
Jun 24, 2028 *PEDNew expiration date. Was previously Dec 24, 2027
Pat. No. 8415362 DS* DP*
Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): All strengths: None
Claim Types: Compound
Jun 24, 2028 *PEDNew expiration date. Was previously Dec 24, 2027
Pat. No. 8722693 DS* DP*
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Pat. Sub. Date(s): All strengths: Jun 3, 2014
Claim Types: Compound; Composition; New polymorph, salt or hydrate; Formulation
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028
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): All strengths: 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)
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028; New Use Code
Pat. No. 8829013
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Pat. Sub. Date(s): All strengths: Sep 24, 2014
Claim Types: Method of use
Use Code: U-1201: For the treatment of intermediate or high-risk myelofibrosis
Use Code: U-1622: For the treatment of polycythemia vera
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
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028
Pat. No. 9079912
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): All strengths: 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)
Jun 12, 2027 *PEDNew expiration date. Was previously Dec 12, 2026
Pat. No. 9814722
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Pat. Sub. Date(s): All strengths: Jun 12, 2019
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-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Jun 12, 2027 *PEDNew expiration date. Was previously Dec 12, 2026
Pat. No. 10016429
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Pat. Sub. Date(s): All strengths: Jun 12, 2019
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-3230: For treatment of steroid-refractory acute graft-versus-host disease (AGVHD)
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-238: Treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and olderNov 24, 2026 PEDNew expiration date. Was previously May 24, 2026
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-373: Treatment of chronic graft-versus-host disease (CGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and olderMar 22, 2029 PEDNew expiration date. Was previously Sep 22, 2028

KLISYRI (OINTMENT) (TOPICAL) TIRBANIBULIN
Drug Classes: microtubule inhibitor
NDA Applicant: ALMIRALL      NDA No.: 213189  Prod. No.: 001 RX (1%)
PatentsExpirationChange
Pat. No. 11497750
Methods of treating and/or preventing actinic keratosis
Pat. Sub. Date(s): 001: Dec 14, 2022
Claim Types: Method of use
Use Code: U-3015: Topical treatment of actinic keratosis of the face or scalp
Mar 12, 2038New patent for this product

KRAZATI (TABLET) (ORAL) ADAGRASIB
NDA Applicant: MIRATI THERAPS      NDA No.: 216340  Prod. No.: 001 RX (200MG)
PatentsExpirationChange
Pat. No. 10689377 DS* DP*
KRas G12C inhibitors
Pat. Sub. Date(s): 001: Dec 20, 2022
Claim Types: Compound; Method of use
Use Code: U-3490: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an fda approved test, who have received at least one prior systemic therapy
May 17, 2037New product in Orange Book

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. 9433624
Methods and compositions for the treatment of metabolic disorders
Pat. Sub. Date(s): 001: Oct 5, 2016
Claim Types: Method of administration
Use Code: U-1589: Method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia
May 17, 2025 *PEDNew expiration date. Was previously Nov 17, 2024

KUVAN (POWDER) (ORAL) SAPROPTERIN DIHYDROCHLORIDE [GENERIC AB]
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == phenylalanine hydroxylase activator
NDA Applicant: BIOMARIN PHARM      NDA No.: 205065  Prod. No.: 001 RX (100MG/PACKET); 002 RX (500MG/PACKET)
PatentsExpirationChange
Pat. No. 9216178 DP*
Dry blend formulation of tetrahydrobiopterin
Pat. Sub. Date(s): All strengths: Jan 15, 2016
Claim Types: Formulation
May 1, 2033 *PEDNew expiration date. Was previously Nov 1, 2032
Pat. No. 9433624
Methods and compositions for the treatment of metabolic disorders
Pat. Sub. Date(s): All strengths: Oct 5, 2016
Claim Types: Method of administration
Use Code: U-1589: Method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia
May 17, 2025 *PEDNew expiration date. Was previously Nov 17, 2024

LYVISPAH (GRANULES) (ORAL) BACLOFEN
Drug Classes: Antispasticity Agents == gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: AMNEAL      NDA No.: 215422  Prod. No.: 001 RX (5MG/PACKET); 002 RX (10MG/PACKET); 003 RX (20MG/PACKET)
PatentsExpirationChange
Pat. No. 11491125 DP*
Baclofen formulations and methods of minimizing patient exposure to metabolite variations
Pat. Sub. Date(s): All strengths: Dec 5, 2022
Claim Types: Formulation; Method of use
Use Code: U-3488: Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity
Use Code: U-3489: Treatment of spasticity resulting from spinal cord injuries and other spinal cord diseases
Sep 29, 2041New patent for this product

MYCAPSSA (CAPSULE, DELAYED RELEASE) (ORAL) OCTREOTIDE ACETATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == somatostatin analog
NDA Applicant: AMRYT      NDA No.: 208232  Prod. No.: 001 RX (EQ 20MG BASE)
PatentsExpirationChange
Pat. No. 11510963
Method of treating diseases
Pat. Sub. Date(s): 001: Dec 19, 2022
Claim Types: Method of use
Use Code: U-2857: Use of oral octreotide for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide
Feb 3, 2036New patent for this product

NARCAN (SPRAY, METERED) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: EMERGENT      NDA No.: 208411  Prod. No.: 002 DISC (2MG/SPRAY**)
PatentsExpirationChange
Pat. No. 9480644 DP* DLR*
Nasal drug products and methods of their use
Pat. Sub. Date(s): 002: Jan 30, 2017
Claim Types: Device; Formulation; Method of use
Use Code: U-1903: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Mar 16, 2035New Delisting Request flag
Pat. No. 9707226 DP* DLR*
Nasal drug products and methods of their use
Pat. Sub. Date(s): 002: Jul 18, 2017
Claim Types: Method of use; Method of administration; Formulation
Use Code: U-1903: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Mar 16, 2035New Delisting Request flag

OLUMIANT (TABLET) (ORAL) BARICITINIB
Drug Classes: Immunological Agents:Immunological Agents, Other == Janus kinase (JAK) inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 207924  Prod. No.: 001 RX (2MG); 002 RX (1MG); 003 RX (4MG)
PatentsExpirationChange
Pat. No. 9737469
Methods for treating hair loss disorders
Pat. Sub. Date(s): All strengths: Jan 9, 2023
Claim Types: Method of use
Use Code: U-3500: Treatment of adult patients with severe alopecia areata
Mar 29, 2033New patent for this product

OPZELURA (CREAM) (TOPICAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == Janus kinase (JAK) inhibitor == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.: 215309  Prod. No.: 001 RX (EQ 1.5% BASE)
PatentsExpirationChange
Pat. No. 7598257 DS* DP*
Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Compound; Method of use
Jun 24, 2028 *PEDNew expiration date. Was previously Dec 24, 2027
Pat. No. 8415362 DS* DP*
Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Compound
Jun 24, 2028 *PEDNew expiration date. Was previously Dec 24, 2027
Pat. No. 8722693 DS* DP*
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Compound; Composition; New polymorph, salt or hydrate; Formulation
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028
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: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028
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: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
Jun 12, 2027 *PEDNew expiration date. Was previously Dec 12, 2026
Pat. No. 9974790
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
Jun 12, 2027 *PEDNew expiration date. Was previously Dec 12, 2026
Pat. No. 10610530
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
Dec 12, 2028 *PEDNew expiration date. Was previously Jun 12, 2028
Pat. No. 10639310
Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Jun 12, 2027 *PEDNew expiration date. Was previously Dec 12, 2026
Pat. No. 10758543 DP*
Topical formulation for a JAK inhibitor
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Formulation
Nov 20, 2031 *PEDNew expiration date. Was previously May 20, 2031
Pat. No. 10869870
Topical formulation for a JAK inhibitor
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
Nov 20, 2031 *PEDNew expiration date. Was previously May 20, 2031
Pat. No. 11219624 DP*
Topical formulation for a JAK inhibitor
Pat. Sub. Date(s): 001: Feb 8, 2022
Claim Types: Formulation; Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Nov 20, 2031 *PEDNew expiration date. Was previously May 20, 2031
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-896: Indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and olderJan 18, 2026 PEDNew expiration date. Was previously Jul 18, 2025
Exclusivity Code: NP - New product Mar 21, 2025 PEDNew expiration date. Was previously Sep 21, 2024

OTREXUP (SOLUTION) (SUBCUTANEOUS) METHOTREXATE
Drug Classes: Antineoplastics:Antineoplastics, Other == Immunological Agents:Immunosuppressants == folate analog metabolic inhibitor
NDA Applicant: OTTER PHARMS      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)); 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))
PatentsExpirationChange
Pat. No. 11497753 DP*
Hazardous agent injection system
Pat. Sub. Date(s): All strengths: Dec 13, 2022
Claim Types: Device
Mar 19, 2030New patent for this product

PEDMARK (SOLUTION) (INTRAVENOUS) SODIUM THIOSULFATE
NDA Applicant: FENNEC PHARMS INC      NDA No.: 212937  Prod. No.: 001 RX (12.5GM/100ML (125MG/ML))
PatentsExpirationChange
Pat. No. 11510984 DP*
Anhydrous sodium thiosulfate and formulations thereof
Pat. Sub. Date(s): 001: Dec 14, 2022
Claim Types: Formulation
Jul 1, 2039New patent for this product

PLENVU (FOR SOLUTION) (ORAL) ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other == osmotic laxative
NDA Applicant: SALIX      NDA No.: 209381  Prod. No.: 001 RX (7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM)
PatentsExpirationChange
Pat. No. 11529368 DP*
Colonoscopy‚¨preparation
Pat. Sub. Date(s): 001: Jan 11, 2023
Claim Types: Formulation
Use Code: U-2310: For cleansing of the colon in preparation for colonoscopy in adults
Mar 9, 2032New patent for this product

QELBREE (CAPSULE, EXTENDED RELEASE) (ORAL) VILOXAZINE HYDROCHLORIDE
Drug Classes: selective norepeinephrine reuptake inhibitor
NDA Applicant: SUPERNUS PHARMS      NDA No.: 211964  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 200MG BASE)
PatentsExpirationChange
Pat. No. 11458143
Method of treatment of attention deficit/hyperactivity disorder (ADHD)
Pat. Sub. Date(s): All strengths: Oct 7, 2022
Claim Types: Method of use
Use Code: U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Sep 4, 2029New Use Code

REZLIDHIA (CAPSULE) (ORAL) OLUTASIDENIB
NDA Applicant: RIGEL PHARMS INC      NDA No.: 215814  Prod. No.: 001 RX (150MG)
PatentsExpirationChange
Pat. No. 9834539 DS* DP*
Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Compound; Composition; Method of use
Use Code: U-3497: A method of treating a cancer where the cancer is acute myeloid leukemia (AML)
Sep 18, 2035New product in Orange Book
Pat. No. 10414752 DP*
Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Composition; Formulation
Sep 18, 2035New product in Orange Book
Pat. No. 10532047 DS*
Solid forms of ((S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Composition; New polymorph, salt or hydrate
May 16, 2039New product in Orange Book
Pat. No. 10550098 DP*
Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Product-by-process; Process; Composition
Sep 18, 2035New product in Orange Book
Pat. No. 10959994 DP*
Solid forms of ((S)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Formulation
May 16, 2039New product in Orange Book
Pat. No. 11013733
Inhibiting mutant isocitrate dehydrogenase 1 (mlDH-1)
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Method of use
Use Code: U-3496: A method of treating a cancer characterized by an IDH1 mutation where the cancer is acute myeloid leukemia (AML)
May 16, 2039New product in Orange Book
Pat. No. 11013734
Treating patients harboring an isocitrate dehydrogenase-1 (IDH-1) mutation
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Method of use
Use Code: U-3495: A method of treating acute myeloid leukemia (AML) in patients with an isocitrate dehydrogenase-1 (IDH1) mutation
May 16, 2039New product in Orange Book
Pat. No. 11376246
Inhibiting mutant IDH-1
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Method of use
Use Code: U-3495: A method of treating acute myeloid leukemia (AML) in patients with an isocitrate dehydrogenase-1 (IDH1) mutation
May 16, 2039New product in Orange Book
Pat. No. 11497743
Treating patients harboring an isocitrate dehydrogenase 1 (IDH-1) mutation
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Method of use
Use Code: U-3495: A method of treating acute myeloid leukemia (AML) in patients with an isocitrate dehydrogenase-1 (IDH1) mutation
May 16, 2039New product in Orange Book
Pat. No. 11498913 DP*
Pyridin-2(1H)-one quinolinone derivatives as mutant-isocitrate dehydrogenase inhibitors
Pat. Sub. Date(s): 001: Jan 3, 2023
Claim Types: Composition; Product-by-process
Sep 18, 2035New product in Orange Book

RHOFADE (CREAM) (TOPICAL) OXYMETAZOLINE HYDROCHLORIDE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: EPI HLTH      NDA No.: 208552  Prod. No.: 001 RX (1%)
PatentsExpirationChange
Pat. No. 11517560
Stabilized oxymetazoline formulations and their uses
Pat. Sub. Date(s): 001: Dec 29, 2022
Claim Types: Method of use
Use Code: U-3494: Once daily topical treatment of persistent facial erythema associated with rosacea in female adults
Jun 11, 2035New patent for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: ABBVIE INC      NDA No.: 211675  Prod. No.: 001 RX (15MG)
PatentsExpirationChange
Pat. No. 11512092
Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Pat. Sub. Date(s): 001: Dec 16, 2022
Claim Types: Method of use
Use Code: U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers
Use Code: U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers
Use Code: U-3487: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to one or more tnf blockers
Oct 17, 2036New patent for this product

SLYND (TABLET) (ORAL) DROSPIRENONE
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins
NDA Applicant: EXELTIS USA INC      NDA No.: 211367  Prod. No.: 001 RX (4MG)
PatentsExpirationChange
Pat. No. 11504334 DP*
Synthetic progestogens and pharmaceutical compositions comprising the same
Pat. Sub. Date(s): 001: Dec 16, 2022
Claim Types: Formulation
Jun 28, 2031New patent for this product

SYMPAZAN (FILM) (ORAL) CLOBAZAM
Drug Classes: Anticonvulsants:Gamma-aminobutyric Acid (GABA) Augmenting Agents == benzodiazepine
NDA Applicant: OTTER PHARMS      NDA No.: 210833  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG)
PatentsExpirationChange
Pat. No. 11541002 DP*
Oral film compositions and dosage forms having precise active dissolution profiles
Pat. Sub. Date(s): All strengths: Jan 4, 2023
Claim Types: Formulation
Use Code: U-724: Method of treating seizures
Sep 5, 2039New patent for this product

TAGRISSO (TABLET) (ORAL) OSIMERTINIB MESYLATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 208065  Prod. No.: 001 RX (EQ 40MG BASE); 002 RX (EQ 80MG BASE)
PatentsExpirationChange
Pat. No. 11524951 DS* DP*
2-(2,4,5-substituted-anilino)pyrimidine compounds
Pat. Sub. Date(s): All strengths: Jan 11, 2023
Claim Types: Compound; Composition
Jul 25, 2032New patent for this product

TASCENSO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) FINGOLIMOD LAURYL SULFATE
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == sphingosine 1-phosphate receptor modulator
NDA Applicant: HANDA      NDA No.: 214962  Prod. No.: 002 RX (EQ 0.5MG BASE)
PatentsExpirationChange
Pat. No. 9925138 DP*
Stable solid fingolimod dosage forms
Pat. Sub. Date(s): 002: Dec 16, 2022
Claim Types: Formulation; Product-by-process; Formulation claimed by its inherent performace characteristics
Jan 19, 2036New strength or variation of this product
Pat. No. 10555902
Stable fingolimod dosage forms
Pat. Sub. Date(s): 002: Dec 16, 2022
Claim Types: Method of use
Use Code: U-3493: The treatment of relapsing forms of multiple sclerosis (MS) in patients 10 years of age and older
Jan 19, 2036New strength or variation of this product
Pat. No. 10925829 DP*
Stable solid fingolimod dosage forms
Pat. Sub. Date(s): 002: Dec 16, 2022
Claim Types: Formulation claimed by its inherent performace characteristics
Jan 19, 2036New strength or variation of this product

TASIMELTEON (CAPSULE) (ORAL) TASIMELTEON [GENERIC AB]
Drug Classes: Sleep Disorder Agents:Sleep Promoting Agents == melatonin receptor agonist
NDA Applicant: APOTEX CORP      NDA No.: 211607  Prod. No.: 001 RX (20MG)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Jun 27, 2023New product in Orange Book

TAZVERIK (TABLET) (ORAL) TAZEMETOSTAT HYDROBROMIDE
Drug Classes: Antineoplastics:Antineoplastics, Other == methyltransferase inhibitor
NDA Applicant: EPIZYME INC      NDA No.: 211723  Prod. No.: 001 RX (EQ 200MG BASE)
PatentsExpirationChange
Pat. No. 8410088 DS* DP*
Aryl- or heteroaryl-substituted benzene compounds
Pat. Sub. Date(s): 001: Feb 19, 2020
Claim Types: Compound; Composition
Aug 25, 2034New expiration date. Was previously Apr 13, 2032
Pat. No. 11491163
Salt form of a human histone methyltransferase EZH2 inhibitor
Pat. Sub. Date(s): 001: Dec 8, 2022
Claim Types: Method of use
Use Code: U-3491: Method of treating lymphoma√x
Use Code: U-3492: Method of treating sarcoma
Apr 11, 2033New patent for this product

TRIKAFTA (COPACKAGED) (TABLET) (ORAL) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == cystic fibrosis transmembrane conductance regulator (CFTR) potentiator
NDA Applicant: VERTEX PHARMS INC      NDA No.: 212273  Prod. No.: 001 RX (100MG,75MG,50MG; 150MG); 002 RX (50MG,37.5MG,25MG; 75MG)
PatentsExpirationChange
Pat. No. 11517564 DP*
Methods of treatment for cystic fibrosis
Pat. Sub. Date(s): All strengths: Jan 5, 2023
Claim Types: Method of use; Composition; Formulation
Use Code: U-3498: Treatment of cystic fibrosis in patients aged 6 years and older who have in the CFTR gene at least one F508DEL mutation or a mutation that is responsive based on in vitro data by administering daily ELX (200 mg or 100 mg); TEZ; and IVA
Dec 8, 2037New patent for this product

UPNEEQ (SOLUTION/DROPS) (OPHTHALMIC) OXYMETAZOLINE HYDROCHLORIDE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: RVL PHARMS      NDA No.: 212520  Prod. No.: 001 RX (0.1%)
PatentsExpirationChange
Pat. No. 11541036 DP*
Oxymetazoline compositions
Pat. Sub. Date(s): 001: Jan 5, 2023
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Dec 16, 2039New patent for this product

VANCOMYCIN HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) VANCOMYCIN HYDROCHLORIDE
Drug Classes: Antibacterials:Antibacterials, Other == glycopeptide antibacterial
NDA Applicant: XELLIA PHARMS APS      NDA No.: 211962  Prod. No.: 001 RX (EQ 500MG BASE/100ML (EQ 5MG BASE/ML)); 002 RX (EQ 1GM BASE/200ML (EQ 5MG BASE/ML)); 003 RX (EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)); 004 RX (EQ 2GM BASE/400ML (EQ 5MG BASE/ML)); 005 RX (EQ 750MG BASE/150ML (EQ 5MG BASE/ML)); 006 RX (EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)); 007 RX (EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML))
PatentsExpirationChange
Pat. No. 11517609
Glycopeptide compositions
Pat. Sub. Date(s): All strengths: Dec 15, 2022
Claim Types: Method of use
Use Code: U-282: Method of treating bacterial infections
Nov 6, 2035New patent for this product

VELPHORO (TABLET, CHEWABLE) (ORAL) FERRIC OXYHYDROXIDE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: VIFOR FRESENIUS      NDA No.: 205109  Prod. No.: 001 RX (EQ 500MG IRON)
PatentsExpirationChange
Pat. No. 11234938 DP*
Pharmaceutical composition, comprising phosphate binder particles
Pat. Sub. Date(s): 001: Feb 17, 2022
Claim Types: Formulation claimed by its inherent performace characteristics
May 26, 2035 *PEDNew expiration date. Was previously Nov 26, 2034
Pat. No. 11446252 DP*
Pharmaceutical composition, comprising phosphate binder particles
Pat. Sub. Date(s): 001: Sep 20, 2022
Claim Types: Formulation claimed by its inherent performace characteristics
May 26, 2035 *PEDNew expiration date. Was previously Nov 26, 2034

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); 002 RX (15MG); 003 RX (20MG); 004 RX (2.5MG)
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-284: Revisions to the labeling to include results from Galileo trialSep 10, 2023 PEDNew expiration date. Was previously Mar 10, 2023

XYOSTED (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TESTOSTERONE ENANTHATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ANTARES PHARMA INC      NDA No.: 209863  Prod. No.: 001 RX (50MG/0.5ML (50MG/0.5ML)); 002 RX (75MG/0.5ML (75MG/0.5ML)); 003 RX (100MG/0.5ML (100MG/0.5ML))
PatentsExpirationChange
Pat. No. 11497753 DP*
Hazardous agent injection system
Pat. Sub. Date(s): All strengths: Dec 14, 2022
Claim Types: Device
Mar 19, 2030New patent for this product

ZONISADE (SUSPENSION) (ORAL) ZONISAMIDE
Drug Classes: Anticonvulsants:Sodium Channel Agents == antiepileptic drug (AED)
NDA Applicant: AZURITY      NDA No.: 214273  Prod. No.: 001 RX (100MG/5ML)
PatentsExpirationChange
Pat. No. 11529333 DP*
Oral pharmaceutical composition comprising zonisamide and process of preparation thereof
Pat. Sub. Date(s): 001: Dec 27, 2022
Claim Types: Formulation
Aug 18, 2038New patent 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 effectiveness 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: 17 January 2023
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