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. 11903993 Ready-to-use bivalirudin compositions Pat. Sub. Date(s): 001: Feb 21, 2024 Claim Types: Method of administration Use Code: U-3817: Use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) | May 20, 2039 | New patent for this product |
| Pat. No. 11918622 Ready-to-use Bivalirudin Compositions Pat. Sub. Date(s): 001: Mar 6, 2024 Claim Types: Method of use Use Code: U-3817: Use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) | May 20, 2039 | New patent for this product |
ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: anticholinergic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 203975 Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Pat. Sub. Date(s): None Claim Types: Device | Apr 23, 2028 *PED | This patent is no longer listed for this product |
AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME NDA No.: 215430 Prod. No.: 001 RX (105MG;45MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11883373 Treatment of depression in certain patient populations Pat. Sub. Date(s): 001: Feb 8, 2024 Claim Types: Method of use Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder | Jan 23, 2043 | New patent for this product |
| Pat. No. 11896563 Bupropion and dextromethorphan for reduction of suicide risk in depression patients Pat. Sub. Date(s): 001: Feb 16, 2024 Claim Types: Method of use Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder | Dec 1, 2041 | New patent for this product |
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC NDA No.: 201739 Prod. No.: 001 RX (EQ 0.3MG/DELIVERY); 002 RX (EQ 0.15MG/DELIVERY); 003 RX (EQ 0.1MG/DELIVERY)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9149579 Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Method of administration Use Code: U-1758: Method of treating allergic reaction via injection | Jul 19, 2025 | This patent is no longer listed for this product |
| Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device; Method of administration Use Code: U-2092: Method for confirming dose delivery | May 23, 2027 | This patent is no longer listed for this product |
AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor == cephalosporin antibacterial
NDA Applicant: ALLERGAN NDA No.: 206494 Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7112592 DS* DP* [Extended 1413 days (3.9 years)] Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Pat. Sub. Date(s): 001: Mar 17, 2015 Claim Types: Compound; Composition; Method of use Use Code: U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium Use Code: U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium Use Code: U-282: Method of treating bacterial infections Use Code: U-3818: Treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adult and pediatric patients (at least 31 weeks gestational age) | Jan 7, 2026 | New Use Code |
BAFIERTAM (CAPSULE, DELAYED RELEASE) (ORAL) MONOMETHYL FUMARATE
NDA Applicant: BANNER LIFE SCIENCES NDA No.: 210296 Prod. No.: 001 RX (95MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11903918 Fumarate ester dosage forms with enhanced gastrointestinal tolerability Pat. Sub. Date(s): 001: Mar 1, 2024 Claim Types: Method of use Use Code: U-1384: Method of treating multiple sclerosis | Feb 27, 2035 | New patent for this product |
BALVERSA (TABLET) (ORAL) ERDAFITINIB
Drug Classes: kinase inhibitor
NDA Applicant: JANSSEN BIOTECH NDA No.: 212018 Prod. No.: 001 RX (3MG); 002 RX (4MG); 003 RX (5MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9464071 Pyrazolyl quinoxaline kinase inhibitors Pat. Sub. Date(s): All strengths: May 3, 2019 Claim Types: Method of use Use Code: U-3805: Treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy | Apr 28, 2031 | New Use Code |
| Pat. No. 10898482 DP* Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-di- amine Pat. Sub. Date(s): All strengths: Feb 19, 2021 Claim Types: Formulation; Method of use; Process Use Code: U-2518: Treatment of adults with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations and progressed during or following prior platinum-containing chemotherapy Use Code: U-3065: Treatment of adults with metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations and progressed during or following prior platinum-containing chemotherapy Use Code: U-3066: Treatment of adults with locally advanced or metastatic, surgically unresectable urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations and progressed during or following prior platinum-containing chemotherapy Use Code: U-3067: Treatment of adults with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 genetic alterations and progressed during or following prior platinum-containing chemotherapy Use Code: U-3805: Treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy Use Code: U-3806: Treatment of adults with metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy Use Code: U-3807: Treatment of adults with locally advanced or metastatic, surgically unresectable urothelial carcinoma with susceptible fgfr3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy | Feb 9, 2036 | New Use Code |
| Pat. No. 11077106 Cancer treatment Pat. Sub. Date(s): All strengths: Aug 27, 2021 Claim Types: Method of use Use Code: U-3196: Treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following prior platinum-containing chemotherapy, with dosing based on serum phosphate levels Use Code: U-3808: Treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, with dosing based on serum phosphate levels | Feb 2, 2038 | New Use Code |
| Pat. No. 11684620 Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N′-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine Pat. Sub. Date(s): All strengths: Jul 26, 2023 Claim Types: Method of use Use Code: U-3805: Treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy Use Code: U-3806: Treatment of adults with metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy Use Code: U-3807: Treatment of adults with locally advanced or metastatic, surgically unresectable urothelial carcinoma with susceptible fgfr3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy | Feb 9, 2036 | New Use Code; Deleted Use Code(s): U-2518, U-3065, U-3066, U-3067 |
| Exclusivity | Expiration | Change |
| Exclusivity Code: I - New Indication: I-930: Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy | Jan 19, 2027 | New exclusivity for this product |
BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD NDA No.: 204275 Prod. No.: 001 RX (0.1MG/INH;EQ 0.025MG BASE/INH); 002 RX (0.2MG/INH;EQ 0.025MG BASE/INH); 003 RX (0.05MG/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Pat. Sub. Date(s): None Claim Types: Device | Apr 23, 2028 *PED | This patent is no longer listed for this product |
BRUKINSA (CAPSULE) (ORAL) ZANUBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: BEIGENE NDA No.: 213217 Prod. No.: 001 RX (80MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11884674 Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Pat. Sub. Date(s): 001: Feb 28, 2024 Claim Types: Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma | Aug 15, 2037 | New patent for this product |
| Pat. No. 11911386 Methods Of Treating B-cell Proliferative Disorder Pat. Sub. Date(s): 001: Feb 28, 2024 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer | Jan 19, 2043 | New patent for this product |
CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: CUMBERLAND PHARMS NDA No.: 022348 Prod. No.: 002 RX (800MG/8ML (100MG/ML)); 003 RX (800MG/200ML (4MG/ML)) NDA No.: 022348 Prod. No.: 001 DISC (400MG/4ML (100MG/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NPP - New patient population | May 11, 2026 | New exclusivity for this product |
CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS NDA No.: 207500 Prod. No.: 001 RX (186MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Sep 6, 2020 PED | New expiration date. Was previously Mar 6, 2020 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-305: Treatment of invasive aspergillosis | Sep 6, 2022 PED | New expiration date. Was previously Mar 6, 2022 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-454: treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater | Jun 8, 2031 PED | New expiration date. Was previously Dec 8, 2030 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-458: Treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater | Jun 8, 2031 PED | New expiration date. Was previously Dec 8, 2030 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-90: Treatment of invasive mucormycosis in patients 18 years of age and older | Sep 6, 2022 PED | New expiration date. Was previously Mar 6, 2022 |
CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS NDA No.: 207500 Prod. No.: 002 RX (74.5MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Sep 6, 2020 PED | New expiration date. Was previously Mar 6, 2020 |
| 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) | Sep 6, 2022 PED | New expiration date. Was previously Mar 6, 2022 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-454: treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater | Jun 8, 2031 PED | New expiration date. Was previously Dec 8, 2030 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-458: Treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater | Jun 8, 2031 PED | New expiration date. Was previously Dec 8, 2030 |
CRESEMBA (POWDER) (INTRAVENOUS) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS NDA No.: 207501 Prod. No.: 001 RX (372MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Sep 6, 2020 PED | New expiration date. Was previously Mar 6, 2020 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-305: Treatment of invasive aspergillosis | Sep 6, 2022 PED | New expiration date. Was previously Mar 6, 2022 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-90: Treatment of invasive mucormycosis in patients 18 years of age and older | Sep 6, 2022 PED | New expiration date. Was previously Mar 6, 2022 |
EOHILIA (SUSPENSION) (ORAL) BUDESONIDE
Drug Classes: corticosteroid
NDA Applicant: TAKEDA PHARMS USA NDA No.: 213976 Prod. No.: 001 RX (2MG/10ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8324192 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Method of use Use Code: U-3820: Treatment of eosinophilic esophagitis | Aug 3, 2029 | New product in Orange Book |
| Pat. No. 8497258 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Method of use Use Code: U-3820: Treatment of eosinophilic esophagitis | Nov 9, 2026 | New product in Orange Book |
| Pat. No. 8679545 DP* Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Formulation | Nov 9, 2026 | New product in Orange Book |
| Pat. No. 8975243 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Method of use; Method of administration Use Code: U-3820: Treatment of eosinophilic esophagitis | Nov 9, 2026 | New product in Orange Book |
| Pat. No. 9050368 DP* Corticosteroid compositions Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Formulation; Kit; Formulation claimed by its inherent performace characteristics | Aug 1, 2029 | New product in Orange Book |
| Pat. No. 9119863 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Method of Use claimed by its inherent performace characteristics Use Code: U-3820: Treatment of eosinophilic esophagitis | Nov 9, 2026 | New product in Orange Book |
| Pat. No. 10293052 DP* Compositions for the treatment of gastrointestinal inflammation Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Formulation | Nov 22, 2028 | New product in Orange Book |
| Pat. No. 11197822 DP* Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Formulation | Nov 9, 2026 | New product in Orange Book |
| Pat. No. 11260064 DP* Stable corticosteroid compositions Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Formulation; Kit | Jan 10, 2039 | New product in Orange Book |
| Pat. No. 11357859 Compositions for the treatment of gastrointestinal inflammation Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Method of use Use Code: U-3820: Treatment of eosinophilic esophagitis | Nov 12, 2028 | New product in Orange Book |
| Pat. No. 11413296 DP* Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Formulation | Nov 9, 2026 | New product in Orange Book |
| Pat. No. 11564934 Stable corticosteroid compositions Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Method of use Use Code: U-3820: Treatment of eosinophilic esophagitis | Jan 10, 2039 | New product in Orange Book |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NP - New product | Feb 9, 2027 | New product in Orange Book |
EPSOLAY (CREAM) (TOPICAL) BENZOYL PEROXIDE
NDA Applicant: GALDERMA LABS LP NDA No.: 214510 Prod. No.: 001 RX (5%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11877997 Method for providing early onset of action in the treatment of rosacea Pat. Sub. Date(s): 001: Feb 16, 2024 Claim Types: Dosaage regimen Use Code: U-3356: Topical treatment of inflammatory lesions of rosacea in adults 18 years of age and older | Feb 19, 2040 | New patent for this product |
EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: AZURITY NDA No.: 209905 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (20MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11896562 Oral amphetamine composition Pat. Sub. Date(s): All strengths: Feb 16, 2024 Claim Types: Method of use Use Code: U-3299: Treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients | Mar 10, 2037 | New patent for this product |
FILSUVEZ (GEL) (TOPICAL) BIRCH TRITERPENES
NDA Applicant: CHIESI NDA No.: 215064 Prod. No.: 001 RX (10%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8828444 DP* Triterpene-containing oleogel-forming agent, triterpene-containing oleogel and method for producing a triterpene-containing oleogel Pat. Sub. Date(s): 001: Feb 16, 2024 Claim Types: Formulation; Process | Jun 21, 2025 | New patent for this product |
| Pat. No. 9352041 Use of an oleogel containing triterpene for healing wounds Pat. Sub. Date(s): 001: Feb 16, 2024 Claim Types: Method of use Use Code: U-3811: Use of birch triterpenes for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa | Nov 24, 2030 | New patent for this product |
| Pat. No. 9827214 Use of an oleogel containing triterpene for healing wounds Pat. Sub. Date(s): 001: Feb 16, 2024 Claim Types: Method of use Use Code: U-3811: Use of birch triterpenes for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa | Nov 24, 2030 | New patent for this product |
| Pat. No. 11083733 DP* Betulin-containing birch bark extracts and their formulation Pat. Sub. Date(s): 001: Feb 16, 2024 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics | Jan 4, 2039 | New patent for this product |
| Pat. No. 11266660 Betulin-containing birch bark extracts and their formulation Pat. Sub. Date(s): 001: Feb 16, 2024 Claim Types: Method of use Use Code: U-3811: Use of birch triterpenes for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa | Jan 4, 2039 | New patent for this product |
FLONASE SENSIMIST ALLERGY RELIEF (SPRAY, METERED) (NASAL) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: HALEON US HOLDINGS NDA No.: 022051 Prod. No.: 002 OTC (0.0275MG/SPRAY)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8752543 DP* Fluid dispensing device Pat. Sub. Date(s): None Claim Types: Device | Apr 5, 2026 | This patent is no longer listed for this product |
FRUZAQLA (CAPSULE) (ORAL) FRUQUINTINIB
NDA Applicant: TAKEDA PHARMS USA NDA No.: 217564 Prod. No.: 001 RX (1MG); 002 RX (5MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Nov 30, 2028 | New exclusivity for this product |
GALAFOLD (CAPSULE) (ORAL) MIGALASTAT HYDROCHLORIDE
NDA Applicant: AMICUS THERAP US NDA No.: 208623 Prod. No.: 001 RX (EQ 123MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11903938 DS* Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Mar 4, 2024 Claim Types: Compound; Method of use Use Code: U-2371: The treatment of Fabry patients | Aug 17, 2038 | New patent for this product |
INCRUSE ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: GLAXO GRP ENGLAND NDA No.: 205382 Prod. No.: 001 RX (EQ 0.0625MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Pat. Sub. Date(s): None Claim Types: Device | Oct 23, 2027 | This patent is no longer listed for this product |
| Pat. No. 8161968 DP* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device | Feb 5, 2028 | This patent is no longer listed for this product |
| Pat. No. 8534281 DP* Manifold for use in medicament dispenser Pat. Sub. Date(s): None Claim Types: Device | Mar 8, 2030 | This patent is no longer listed for this product |
IWILFIN (TABLET) (ORAL) EFLORNITHINE HYDROCHLORIDE
Drug Classes: antiprotozoal == decarboxylase inhibitor
NDA Applicant: USWM NDA No.: 215500 Prod. No.: 001 RX (EQ 192MG BASE)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-462: To reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy | Dec 13, 2030 | New exclusivity for this product |
IYUZEH (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST [Has competitive generic]
Drug Classes: prostaglandin analog
NDA Applicant: THEA PHARMA NDA No.: 216472 Prod. No.: 001 RX (0.005%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8637054 DP* Polymeric delivery system for a nonviscous prostaglandin-based solution without preservatives Pat. Sub. Date(s): 001: Feb 20, 2024 Claim Types: Formulation; Method of use; Drug in a container Use Code: U-446: Topical treatment of ocular hypertension and glaucoma | Jul 8, 2031 | New patent for this product |
JUBLIA (SOLUTION) (TOPICAL) EFINACONAZOLE [GENERIC AB]
Drug Classes: azole antifungal
NDA Applicant: BAUSCH NDA No.: 203567 Prod. No.: 001 RX (10%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11872218 Compositions and methods for treating diseases of the nail Pat. Sub. Date(s): 001: Feb 9, 2024 Claim Types: Method of use Use Code: U-1969: Topical treatment of onychomycosis of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes | Jan 3, 2028 | New patent for this product |
KERENDIA (TABLET) (ORAL) FINERENONE
Drug Classes: non-steroidal mineralocorticoid receptor antagonist (MRA)
NDA Applicant: BAYER HLTHCARE NDA No.: 215341 Prod. No.: 001 RX (10MG); 002 RX (20MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE49826 DS* Method for the preparation of (4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1-6-naphthyridine-3-carboxamide and the purification thereof for use as an active pharmaceutical ingredient Pat. Sub. Date(s): All strengths: Mar 1, 2024 Claim Types: Process; Compound; New polymorph, salt or hydrate; Product-by-process | Jul 29, 2035 | New patent for this product |
KYLEENA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: BAYER HLTHCARE NDA No.: 208224 Prod. No.: 001 RX (19.5MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11850182 DP* Inserter Pat. Sub. Date(s): 001: Feb 29, 2024 Claim Types: Kit; Method of administration; Method of use Use Code: U-3819: A method of preventing pregnancy by providing an intrauterine system (IUS), holding an inserter handle with one hand, inserting the IUS into the uterus, and moving a slider in the handle to release the IUS within the uterus | Sep 14, 2029 | New patent for this product |
| Pat. No. 9615965 DP* Inserter Pat. Sub. Date(s): None Claim Types: Device; Kit; Diagnostic or surgical method Use Code: U-2003: A method of positioning an intrauterine system by holding an inserter handle with one hand, advancing the inserter through the cervix and into the uterus, and retracting a slider on the handle to release the intrauterine system | Sep 16, 2029 | This patent is no longer listed for this product |
| Pat. No. 9668912 DP* Inserter Pat. Sub. Date(s): None Claim Types: Device | Apr 1, 2031 | This patent is no longer listed for this product |
| Pat. No. 10987244 DP* Inserter Pat. Sub. Date(s): None Claim Types: Device | Apr 1, 2031 | This patent is no longer listed for this product |
LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: AVADEL CNS NDA No.: 214755 Prod. No.: 001 RX (4.5GM/PACKET); 002 RX (6GM/PACKET); 003 RX (7.5GM/PACKET); 004 RX (9GM/PACKET)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11896572 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Feb 20, 2024 Claim Types: Formulation | Jul 21, 2037 | New patent for this product |
LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 208558 Prod. No.: 001 RX (100MG); 002 RX (150MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7449464 DS* DP* [Extended 1275 days (3.5 years)] Phthalazinone derivatives Pat. Sub. Date(s): All strengths: Sep 15, 2017 Claim Types: Compound; Composition | Sep 8, 2027 | New expiration date. Was previously Oct 11, 2024 |
MEKTOVI (TABLET) (ORAL) BINIMETINIB
NDA Applicant: ARRAY BIOPHARMA INC NDA No.: 210498 Prod. No.: 001 RX (15MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7777050 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors Pat. Sub. Date(s): 001: Jul 25, 2018 Claim Types: Compound; Composition | Mar 13, 2025 | New expiration date. Was previously Mar 13, 2024 |
MIRENA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: BAYER HLTHCARE NDA No.: 021225 Prod. No.: 001 RX (52MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11850182 DP* Inserter Pat. Sub. Date(s): 001: Feb 29, 2024 Claim Types: Kit; Method of administration; Method of use Use Code: U-3819: A method of preventing pregnancy by providing an intrauterine system (IUS), holding an inserter handle with one hand, inserting the IUS into the uterus, and moving a slider in the handle to release the IUS within the uterus | Sep 14, 2029 | New patent for this product |
| Pat. No. 9615965 DP* Inserter Pat. Sub. Date(s): None Claim Types: Device; Kit; Diagnostic or surgical method Use Code: U-2003: A method of positioning an intrauterine system by holding an inserter handle with one hand, advancing the inserter through the cervix and into the uterus, and retracting a slider on the handle to release the intrauterine system | Sep 16, 2029 | This patent is no longer listed for this product |
| Pat. No. 9668912 DP* Inserter Pat. Sub. Date(s): None Claim Types: Device | Apr 1, 2031 | This patent is no longer listed for this product |
| Pat. No. 10987244 DP* Inserter Pat. Sub. Date(s): None Claim Types: Device | Apr 1, 2031 | This patent is no longer listed for this product |
MOUNJARO (SOLUTION) (SUBCUTANEOUS) TIRZEPATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist == glucose-dependent insulinotropic polypeptide (GIP) receptor agonist
NDA Applicant: ELI LILLY AND CO NDA No.: 215866 Prod. No.: 007 RX (2.5MG/0.5ML (2.5MG/0.5ML)); 008 RX (5MG/0.5ML (5MG/0.5ML)); 009 RX (7.5MG/0.5ML (7.5MG/0.5ML)); 010 RX (10MG/0.5ML (10MG/0.5ML)); 011 RX (12.5MG/0.5ML (12.5MG/0.5ML)); 012 RX (15MG/0.5ML (15MG/0.5ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9474780 DS* DP* GIP and GLP-1 co-agonist compounds Pat. Sub. Date(s): All strengths: Aug 25, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-3378: MOUNJARO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus | Jan 5, 2036 | New patent for this product |
| Pat. No. 11357820 DS* DP* GIP/GLP1 agonist compositions Pat. Sub. Date(s): All strengths: Aug 25, 2023 Claim Types: Formulation; Method of use | Jun 14, 2039 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NCE - New chemical entity | May 13, 2027 | New exclusivity for this product |
MOUNJARO (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TIRZEPATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist == glucose-dependent insulinotropic polypeptide (GIP) receptor agonist
NDA Applicant: ELI LILLY AND CO NDA No.: 215866 Prod. No.: 001 RX (2.5MG/0.5ML (2.5MG/0.5ML)); 002 RX (5MG/0.5ML (5MG/0.5ML)); 003 RX (7.5MG/0.5ML (7.5MG/0.5ML)); 004 RX (10MG/0.5ML (10MG/0.5ML)); 005 RX (12.5MG/0.5ML (12.5MG/0.5ML)); 006 RX (15MG/0.5ML (15MG/0.5ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8734394 DP* Automatic injection device with delay mechanism including dual functioning biasing member Pat. Sub. Date(s): None Claim Types: Device | Feb 24, 2031 | This patent is no longer listed for this product |
| Pat. No. 9402957 DP* Automatic injection device with delay mechanism including dual functioning biasing member Pat. Sub. Date(s): None Claim Types: Device (Jepson claims) | Jun 29, 2031 | This patent is no longer listed for this product |
MYCAPSSA (CAPSULE, DELAYED RELEASE) (ORAL) OCTREOTIDE ACETATE
Drug Classes: somatostatin analog
NDA Applicant: CHIESI NDA No.: 208232 Prod. No.: 001 RX (EQ 20MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11890316 Oral octreotide therapy and contraceptive methods Pat. Sub. Date(s): 001: Mar 5, 2024 Claim Types: Method of administration Use Code: U-3232: Use of oral octreotide for long-term maintenance treatment in acromegaly patients while avoiding concomitant administration of levonorgestrel | Dec 28, 2040 | New patent for this product |
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 001 RX (10MG;14MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8168209 DP* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 001: Jan 22, 2015 Claim Types: Formulation | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 001: Jan 22, 2015 Claim Types: Method of administration Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8283379 DLR* Methods and compositions for the treatment of CNS-related conditions Pat. Sub. Date(s): 001: Jan 22, 2015 Claim Types: Method of use Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8329752 DP* Composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Formulation | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8362085 Method for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8598233 DP* Method for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Formulation | May 22, 2026 *PED | This patent is no longer listed for this product |
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 002 RX (10MG;28MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8168209 DP* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 002: Jan 22, 2015 Claim Types: Formulation | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 002: Jan 22, 2015 Claim Types: Method of administration Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8283379 DLR* Methods and compositions for the treatment of CNS-related conditions Pat. Sub. Date(s): 002: Jan 22, 2015 Claim Types: Method of use Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8329752 DP* DLR* Composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 002: Jan 22, 2015 Claim Types: Formulation | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8362085 DLR* Method for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 002: Jan 22, 2015 Claim Types: Method of use Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8598233 DP* DLR* Method for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 002: Jan 22, 2015 Claim Types: Formulation | May 22, 2026 *PED | New Delisting Request flag |
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 003 RX (10MG;7MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8168209 DP* Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Formulation | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8173708 Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Method of administration Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8283379 Methods and compositions for the treatment of CNS-related conditions Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8329752 DP* Composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Formulation | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8362085 Method for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8598233 DP* Method for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): None Claim Types: Formulation | May 22, 2026 *PED | This patent is no longer listed for this product |
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 206439 Prod. No.: 004 RX (10MG;21MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8168209 DP* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 004: Aug 16, 2016 Claim Types: Formulation | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 004: Aug 16, 2016 Claim Types: Method of administration Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8283379 DLR* Methods and compositions for the treatment of CNS-related conditions Pat. Sub. Date(s): 004: Aug 16, 2016 Claim Types: Method of use Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8329752 DP* DLR* Composition for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 004: Aug 16, 2016 Claim Types: Formulation | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8362085 DLR* Method for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 004: Aug 16, 2016 Claim Types: Method of use Use Code: U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type | May 22, 2026 *PED | New Delisting Request flag |
| Pat. No. 8598233 DP* DLR* Method for administering an NMDA receptor antagonist to a subject Pat. Sub. Date(s): 004: Aug 16, 2016 Claim Types: Formulation | May 22, 2026 *PED | New Delisting Request flag |
NITROGLYCERIN (OINTMENT) (INTRA-ANAL) NITROGLYCERIN [GENERIC AB]
Drug Classes: nitrate vasodilator
NDA Applicant: COSETTE NDA No.: 216103 Prod. No.: 001 RX (0.4%)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Aug 21, 2024 | New product in Orange Book |
OGSIVEO (TABLET) (ORAL) NIROGACESTAT HYDROBROMIDE
NDA Applicant: SPRINGWORKS NDA No.: 217677 Prod. No.: 001 RX (EQ 50MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11905255 DP* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof Pat. Sub. Date(s): 001: Feb 21, 2024 Claim Types: Composition | Aug 9, 2039 | New patent for this product |
OLUMIANT (TABLET) (ORAL) BARICITINIB
Drug Classes: 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. 8158616 DS* DP* [Extended 723 days (2 years)] Azetidine and cyclobutane derivatives as JAK inhibito Pat. Sub. Date(s): 001: Jun 20, 2018; 002: Oct 26, 2020; 003: May 26, 2022 Claim Types: Compound; Composition | May 31, 2032 | New expiration date. Was previously Jun 8, 2030 |
ONIVYDE (INJECTABLE, LIPOSOMAL) (INTRAVENOUS) IRINOTECAN HYDROCHLORIDE
Drug Classes: topoisomerase inhibitor
NDA Applicant: IPSEN NDA No.: 207793 Prod. No.: 001 RX (EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-463: For first-line treatment of adult patients with metastatic pancreatic adenocarcinoma | Feb 13, 2031 | New exclusivity for this product |
OSMOLEX ER (TABLET, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: ADAMAS OPERATIONS NDA No.: 209410 Prod. No.: 001 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11890261 Composition and method for treating neurological disease Pat. Sub. Date(s): All strengths: Mar 4, 2024 Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Use Code: U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients | Feb 15, 2038 | New patent for this product |
OXTELLAR XR (TABLET, EXTENDED RELEASE) (ORAL) OXCARBAZEPINE [GENERIC AB]
Drug Classes: antiepileptic drug (AED)
NDA Applicant: SUPERNUS PHARMS NDA No.: 202810 Prod. No.: 001 RX (150MG); 002 RX (300MG); 003 RX (600MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11896599 DP* Modified release preparations containing oxcarbazepine and derivatives thereof Pat. Sub. Date(s): All strengths: Feb 28, 2024 Claim Types: Formulation | Apr 13, 2027 | New patent for this product |
PIQRAY (TABLET) (ORAL) ALPELISIB
NDA Applicant: NOVARTIS NDA No.: 212526 Prod. No.: 001 RX (50MG); 002 RX (150MG); 003 RX (200MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8227462 DS* DP* [Extended 1327 days (3.6 years)] Pyrrolidine-1,2-dicarboxamide derivatives Pat. Sub. Date(s): All strengths: Jun 17, 2019 Claim Types: Compound; Method of use; Composition; Formulation Use Code: U-3809: In combination with fulvestrant for treatment of adults with HR-positive, HER-2-negative, PIK3CA-mutated, advanced or metastatic breast cancer | Apr 29, 2033 | New Use Code |
PREVYMIS (TABLET) (ORAL) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 209939 Prod. No.: 001 RX (240MG); 002 RX (480MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE46791 DS* DP* [Extended 1702 days (4.7 years)] Substituted dihydroquinazolines Pat. Sub. Date(s): All strengths: Apr 21, 2020 Claim Types: Compound; Process; Composition; Method of use | Jan 18, 2029 | New expiration date. Was previously May 22, 2024 |
PREVYMIS (SOLUTION) (INTRAVENOUS) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 209940 Prod. No.: 001 RX (240MG/12ML (20MG/ML)); 002 RX (480MG/24ML (20MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE46791 DS* DP* [Extended 1702 days (4.7 years)] Substituted dihydroquinazolines Pat. Sub. Date(s): All strengths: Apr 29, 2020 Claim Types: Compound; Process; Composition; Method of use | Jan 18, 2029 | New expiration date. Was previously May 22, 2024 |
PROVAYBLUE (SOLUTION) (INTRAVENOUS) METHYLENE BLUE [GENERIC AP]
NDA Applicant: PROVEPHARM SAS NDA No.: 204630 Prod. No.: 001 RX (50MG/10ML (5MG/ML)); 002 RX (10MG/2ML (5MG/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: M - Miscellaneous: M-303: Information added to the clinical studies section to fulfill a post-marketing requirement | Jan 8, 2027 | New exclusivity for this product |
QINLOCK (TABLET) (ORAL) RIPRETINIB
Drug Classes: kinase inhibitor
NDA Applicant: DECIPHERA PHARMS NDA No.: 213973 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11896585 DP* Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea Pat. Sub. Date(s): 001: Feb 27, 2024 Claim Types: Formulation | Dec 30, 2040 | New patent for this product |
| Pat. No. 11903933 DP* Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea Pat. Sub. Date(s): 001: Feb 27, 2024 Claim Types: Formulation | Dec 30, 2040 | New patent for this product |
RAYALDEE (CAPSULE, EXTENDED RELEASE) (ORAL) CALCIFEDIOL
NDA Applicant: EIRGEN NDA No.: 208010 Prod. No.: 001 RX (0.03MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9498486 Method for controlled release oral dosage of a vitamin D compound Pat. Sub. Date(s): 001: Dec 6, 2016 Claim Types: Method of use Use Code: U-3814: Use of sustained or extended release oral 25-hydroxyvitamin D3 in treating secondary hyperparathroidism in adult patients having chronic kidney disease stage 3 or 4 | Apr 25, 2028 | New Use Code |
| Pat. No. 11154509 Methods for controlled release oral dosage of a vitamin D compound Pat. Sub. Date(s): 001: Nov 17, 2021 Claim Types: Method of use Use Code: U-3815: Treating secondary hyperparathyroidism in stage 3 or 4 CKD with sustained release 25-hydroxyvitamin d to reduce the patient's serum parathyroid hormone level while avoiding PTH oversuppression | Apr 25, 2028 | New Use Code |
RYZUMVI (SOLUTION) (OPHTHALMIC) PHENTOLAMINE MESYLATE
Drug Classes: alpha adrenergic blocker
NDA Applicant: FAMYGEN LIFE SCI NDA No.: 217064 Prod. No.: 001 RX (EQ 0.75% BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11400077 Methods and compositions for treatment of presbyopia, mydriasis, and other ocular disorders Pat. Sub. Date(s): 001: Feb 1, 2024 Claim Types: Method of use Use Code: U-3804: Treatment of pharmacologically-induced mydriasis | Oct 25, 2039 | New patent for this product |
SKYLA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: BAYER HLTHCARE NDA No.: 203159 Prod. No.: 001 RX (13.5MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11850182 DP* Inserter Pat. Sub. Date(s): 001: Feb 29, 2024 Claim Types: Kit; Method of administration; Method of use Use Code: U-3819: A method of preventing pregnancy by providing an intrauterine system (IUS), holding an inserter handle with one hand, inserting the IUS into the uterus, and moving a slider in the handle to release the IUS within the uterus | Sep 14, 2029 | New patent for this product |
| Pat. No. 9615965 DP* Inserter Pat. Sub. Date(s): None Claim Types: Device; Kit; Diagnostic or surgical method Use Code: U-2003: A method of positioning an intrauterine system by holding an inserter handle with one hand, advancing the inserter through the cervix and into the uterus, and retracting a slider on the handle to release the intrauterine system | Sep 16, 2029 | This patent is no longer listed for this product |
| Pat. No. 9668912 DP* Inserter Pat. Sub. Date(s): None Claim Types: Device | Apr 1, 2031 | This patent is no longer listed for this product |
| Pat. No. 10987244 DP* Inserter Pat. Sub. Date(s): None Claim Types: Device | Apr 1, 2031 | This patent is no longer listed for this product |
SPRAVATO (SPRAY) (NASAL) ESKETAMINE HYDROCHLORIDE
NDA Applicant: JANSSEN PHARMS NDA No.: 211243 Prod. No.: 001 RX (EQ 28MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11883526 Esketamine for the treatment of depression Pat. Sub. Date(s): 001: Feb 16, 2024 Claim Types: Method of use Use Code: U-3812: Treatment of depression in MDD with acute suicidal ideation/behavior with nasally administered esketamine with oad in a patient who has missed a dose in the maintenance phase and had worsening depression symptoms by return to higher dosing schedule Use Code: U-3813: Treatment of trd with nasally administered esketamine in conjunction with an OAD in a patient who has missed a dose during the maintenance phase and had worsening of depression symptom by returning to higher dosing schedule | Feb 18, 2040 | New patent for this product |
SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA NDA No.: 211230 Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11865098 Methods and compositions for treating excessive sleepiness Pat. Sub. Date(s): All strengths: Feb 8, 2024 Claim Types: Method of use Use Code: U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) | Jun 1, 2038 | New patent for this product |
TAFINLAR (CAPSULE) (ORAL) DABRAFENIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 202806 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: I - New Indication: I-908: Treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600 mutation who require systemic therapy | Sep 16, 2026 PED | New expiration date. Was previously Mar 16, 2026 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-428: Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy | Sep 16, 2030 PED | New expiration date. Was previously Mar 16, 2030 |
TAFINLAR (TABLET, FOR SUSPENSION) (ORAL) DABRAFENIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 217514 Prod. No.: 001 RX (EQ 10MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7994185 DS* DP* Benzene sulfonamide thiazole and oxazole compounds Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Compound; Composition; Formulation; Method of use | Jul 20, 2030 *PED | New expiration date. Was previously Jan 20, 2030 |
| Pat. No. 8415345 DS* DP* Benzene sulfonamide thiazole and oxazole compounds Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Compound; Composition; Method of use; Process | Jul 20, 2030 *PED | New expiration date. Was previously Jan 20, 2030 |
| Pat. No. 8703781 DS* DP* Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Formulation; Method of use Use Code: U-3565: TAFINLAR is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy | Apr 15, 2031 *PED | New expiration date. Was previously Oct 15, 2030 |
| Pat. No. 8835443 Pyrimidine compound and medical use thereof Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Method of use Use Code: U-3565: TAFINLAR is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy | Dec 10, 2025 *PED | New expiration date. Was previously Jun 10, 2025 |
| Pat. No. 11504333 DP* Pharmaceutical composition Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Formulation | Dec 29, 2038 *PED | New expiration date. Was previously Jun 29, 2038 |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NP - New product | Sep 16, 2026 PED | New expiration date. Was previously Mar 16, 2026 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-428: Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy | Sep 16, 2030 PED | New expiration date. Was previously Mar 16, 2030 |
TALICIA (CAPSULE, DELAYED RELEASE) (ORAL) AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
Drug Classes: penicillin class antibacterial == proton pump inhibitor == rifamycin antimycobacterial
NDA Applicant: REDHILL NDA No.: 213004 Prod. No.: 001 RX (250MG;EQ 10MG BASE;12.5MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11878011 Method for eradicating Helicobacter pylori infection in patients regardless of body mass index Pat. Sub. Date(s): 001: Feb 21, 2024 Claim Types: Method of use Use Code: U-3816: Treatment of helicobacter pylori infection using the administered dosage forms in adults with different body mass index determinations | May 27, 2042 | New patent for this product |
TARPEYO (CAPSULE, DELAYED RELEASE) (ORAL) BUDESONIDE
Drug Classes: corticosteroid
NDA Applicant: CALLIDITAS NDA No.: 215935 Prod. No.: 001 RX (4MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11896719 Pharmaceutical compositions Pat. Sub. Date(s): 001: Feb 14, 2024 Claim Types: Method of use Use Code: U-3810: Reduction in loss of kidney function and reduction of proteinuria in adults with primary immunoglobulin a nephropathy (IGAN) who are at risk of disease progression, by release of budesonide from the formulation | Jan 23, 2043 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-464: To reduce the loss of kidney function in adults with primary immunoglobulin a nephropathy (IGAN) who are at risk for disease progression, excluding the use provided for in the indication approved on December 15, 2021 | Dec 20, 2030 | New exclusivity for this product |
TOBI PODHALER (POWDER) (INHALATION) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 201688 Prod. No.: 001 RX (28MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8069851 DP* Aeorosolization apparatus with air inlet shield Pat. Sub. Date(s): None Claim Types: Device | Sep 24, 2024 | This patent is no longer listed for this product |
TPOXX (CAPSULE) (ORAL) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES NDA No.: 208627 Prod. No.: 001 RX (200MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11890270 Polymorphic forms of ST-246 and methods of preparation Pat. Sub. Date(s): 001: Feb 27, 2024 Claim Types: Method of use Use Code: U-2346: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg | Aug 8, 2032 | New patent for this product |
TRELEGY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == anticholinergic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE NDA No.: 209482 Prod. No.: 001 RX (0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH); 002 RX (0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8113199 DP* Counter for use with a medicament dispenser Pat. Sub. Date(s): None Claim Types: Device | Apr 23, 2028 *PED | This patent is no longer listed for this product |
VELSIPITY (TABLET) (ORAL) ETRASIMOD ARGININE
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: PFIZER NDA No.: 216956 Prod. No.: 001 RX (EQ 2MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11884626 Crystalline L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta [b]indol-3-yl)acetic acid(Compound1) for use in S1P1 receptor-associated disorders Pat. Sub. Date(s): 001: Feb 28, 2024 Claim Types: Method of use Use Code: U-3731: A method for treating ulcerative colitis by administering a therapeutically effective amount of the form of estrasimod arginine as claimed | Jun 21, 2036 | New patent for this product |
WELIREG (TABLET) (ORAL) BELZUTIFAN
Drug Classes: hypoxia-inducible factor inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 215383 Prod. No.: 001 RX (40MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: I - New Indication: I-931: Treatment of adult patients with advanced renal cell carcinoma following a programmeddeath receptor-1 or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor | Dec 14, 2026 | New exclusivity for this product |
ZELSUVMI (GEL) (TOPICAL) BERDAZIMER SODIUM
NDA Applicant: LNHC NDA No.: 217424 Prod. No.: 001 RX (EQ 10.3% BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9289442 DP* Topical compositions Pat. Sub. Date(s): 001: Feb 2, 2024 Claim Types: Formulation; Method of use Use Code: U-3803: Method of application of topical pharmaceutical composition to treat dermatological condition | Jul 3, 2032 | New patent for this product |
| Pat. No. 9737561 Topical gels and methods of using the same Pat. Sub. Date(s): 001: Feb 2, 2024 Claim Types: Method of use Use Code: U-3802: Method of treating skin ailment with nitric oxide releasing macromolecules and hydrophilic gel | Aug 20, 2030 | New patent for this product |
| Pat. No. 9855211 DP* Topical compositions and methods of using the same Pat. Sub. Date(s): 001: Feb 2, 2024 Claim Types: Formulation; Kit; Method of improving a treatment Use Code: U-3800: Method of applying released nitric oxide to skin from combination including anhydrous alcohol gel Use Code: U-3801: Method of increasing release of nitric oxide from anhydrous alcohol gel | Feb 27, 2034 | New patent for this product |
| Pat. No. 10258564 Topical compositions and methods of using the same Pat. Sub. Date(s): 001: Feb 2, 2024 Claim Types: Method of use Use Code: U-3797: Method of topically reducing lesions with two separately stored components Use Code: U-3798: Method of topically reducing lesions with two separately stored components where one component includes a nitric oxide releasing compound Use Code: U-3799: Method of topically reducing lesions with two separately stored components where one component includes water | Nov 22, 2034 | New patent for this product |
| Pat. No. 10322081 Topical antiviral compositions and methods of using the same Pat. Sub. Date(s): 001: Feb 2, 2024 Claim Types: Method of use Use Code: U-3793: Method of administering a nitric oxide releasing api in a combination topical composition Use Code: U-3794: Method of treating and/or preventing viral infection with a topical composition including a nitric oxide releasing API Use Code: U-3795: Method of treating and/or preventing molluscum contagiosum with a topical composition including a nitric oxide releasing API Use Code: U-3796: Method of preventing and/or reducing appearance and/or size of malignant lesion with a topical composition including a nitric oxide releasing API | Jul 10, 2035 | New patent for this product |
| Pat. No. 10736839 Topical antiviral compositions, delivery systems, and methods of using the same Pat. Sub. Date(s): 001: Feb 2, 2024 Claim Types: Method of use Use Code: U-3790: Method of treating and/or preventing molluscum contagiosum with a nitric oxide releasing topical composition Use Code: U-3791: Method of treating, preventing, or reducing lesions caused by molluscum contagiosum Use Code: U-3792: Method of treating and/or preventing viral infection with a topical nitric oxide releasing component | Jul 10, 2035 | New patent for this product |
| Pat. No. 11040006 DP* Topical antiviral compositions, delivery systems, and methods of using the same Pat. Sub. Date(s): 001: Feb 2, 2024 Claim Types: Formulation claimed by its inherent performace characteristics Use Code: U-3789: Method of treating and/or preventing viral infection using a nitric oxide releasing active ingredient | Jul 10, 2035 | New patent for this product |
| Pat. No. 11723858 DP* Topical antiviral compositions, delivery systems, and methods of using the same Pat. Sub. Date(s): 001: Feb 2, 2024 Claim Types: Formulation; Method of administration Use Code: U-3788: Method of administering a nitric oxide releasing active pharmaceutical ingredient to treat and/or prevent viral infection | Jul 10, 2035 | New patent for this product |
ZEPBOUND (SOLUTION) (SUBCUTANEOUS) TIRZEPATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist == glucose-dependent insulinotropic polypeptide (GIP) receptor agonist
NDA Applicant: ELI LILLY AND CO NDA No.: 217806 Prod. No.: 001 RX (2.5MG/0.5ML (2.5MG/0.5ML)); 002 RX (5MG/0.5ML (5MG/0.5ML)); 003 RX (7.5MG/0.5ML (7.5MG/0.5ML)); 004 RX (10MG/0.5ML (10MG/0.5ML)); 005 RX (12.5MG/0.5ML (12.5MG/0.5ML)); 006 RX (15MG/0.5ML (15MG/0.5ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8734394 DP* Automatic injection device with delay mechanism including dual functioning biasing member Pat. Sub. Date(s): None Claim Types: Device | Feb 24, 2031 | This patent is no longer listed for this product |
| Pat. No. 9402957 DP* Automatic injection device with delay mechanism including dual functioning biasing member Pat. Sub. Date(s): None Claim Types: Device (Jepson claims) | Jun 29, 2031 | This patent is no longer listed for this product |
ZURZUVAE (CAPSULE) (ORAL) ZURANOLONE
Drug Classes: neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive mod
NDA Applicant: BIOGEN INC NDA No.: 217369 Prod. No.: 001 RX (20MG); 002 RX (25MG); 003 RX (30MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11884696 Crystalline 19-nor C3,3-disubstituted C21-n-pyrazolyl steroid Pat. Sub. Date(s): All strengths: Feb 26, 2024 Claim Types: Method of use Use Code: U-2552: Method of treating postpartum depression | Dec 24, 2037 | New patent for this product |