Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11529308 DP* System for providing birth control Pat. Sub. Date(s): 001: Dec 21, 2022 Claim Types: Device | Jun 21, 2039 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2034 | New 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, 2034 | New 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, 2034 | New 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, 2034 | New 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)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Jun 5, 2023 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11529360 DP* Natural combination hormone replacement formulations and therapies Pat. Sub. Date(s): 001: Dec 21, 2022 Claim Types: Formulation | Nov 21, 2032 | New 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)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: I - New Indication: I-902: Treatment of adult patients with histiocytic neoplasms | Oct 28, 2025 | New exclusivity for this product |
CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
Drug Classes: Antifungals
NDA Applicant: ASTELLAS NDA No.: 207500 Prod. No.: 002 RX (74.5MG)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2027 | New 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, 2027 | New 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, 2025 | New strength or variation of this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NCE - New chemical entity | Mar 6, 2025 GAIN | New 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 GAIN | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2037 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2031 | New 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))
| Patents | Expiration | Change |
|---|---|---|
| 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, 2034 | New 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, 2034 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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 *PED | New 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 *PED | This 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))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11530408 DS* DP* Therapeutic compositions Pat. Sub. Date(s): 001: Jan 6, 2023 Claim Types: Composition | May 18, 2024 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2023 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2023 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New expiration date. Was previously Jun 12, 2028 |
| Exclusivity | Expiration | Change |
| 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 older | Mar 22, 2025 PED | New 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 older | Nov 24, 2026 PED | New 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 older | Mar 22, 2029 PED | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New expiration date. Was previously Jun 12, 2028 |
| Exclusivity | Expiration | Change |
| 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 older | Nov 24, 2026 PED | New 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 older | Mar 22, 2029 PED | New 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%)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2038 | New patent for this product |
KRAZATI (TABLET) (ORAL) ADAGRASIB
NDA Applicant: MIRATI THERAPS NDA No.: 216340 Prod. No.: 001 RX (200MG)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2037 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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 *PED | New 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)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9216178 DP* Dry blend formulation of tetrahydrobiopterin Pat. Sub. Date(s): All strengths: Jan 15, 2016 Claim Types: Formulation | May 1, 2033 *PED | New 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 *PED | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2041 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2036 | New 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**)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2035 | New 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, 2035 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2033 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New expiration date. Was previously May 20, 2031 |
| Exclusivity | Expiration | Change |
| 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 older | Jan 18, 2026 PED | New expiration date. Was previously Jul 18, 2025 |
| Exclusivity Code: NP - New product | Mar 21, 2025 PED | New 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))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11497753 DP* Hazardous agent injection system Pat. Sub. Date(s): All strengths: Dec 13, 2022 Claim Types: Device | Mar 19, 2030 | New 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))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11510984 DP* Anhydrous sodium thiosulfate and formulations thereof Pat. Sub. Date(s): 001: Dec 14, 2022 Claim Types: Formulation | Jul 1, 2039 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2032 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2029 | New Use Code |
REZLIDHIA (CAPSULE) (ORAL) OLUTASIDENIB
NDA Applicant: RIGEL PHARMS INC NDA No.: 215814 Prod. No.: 001 RX (150MG)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2035 | New 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, 2035 | New 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, 2039 | New 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, 2035 | New 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, 2039 | New 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, 2039 | New 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, 2039 | New 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, 2039 | New 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, 2039 | New 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, 2035 | New 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%)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2035 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2036 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2031 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2039 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2032 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2036 | New 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, 2036 | New 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, 2036 | New 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)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Jun 27, 2023 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2034 | New 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 lymphomaÃx Use Code: U-3492: Method of treating sarcoma | Apr 11, 2033 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2037 | New 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%)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2039 | New 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))
| Patents | Expiration | Change |
|---|---|---|
| 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, 2035 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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 *PED | New 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 *PED | New 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)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: M - Miscellaneous: M-284: Revisions to the labeling to include results from Galileo trial | Sep 10, 2023 PED | New 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))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11497753 DP* Hazardous agent injection system Pat. Sub. Date(s): All strengths: Dec 14, 2022 Claim Types: Device | Mar 19, 2030 | New 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)
| Patents | Expiration | Change |
|---|---|---|
| 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, 2038 | New patent for this product |