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. 11559523 DP* Compositions and methods for treating centrally mediated nausea and vomiting Pat. Sub. Date(s): 001: Feb 22, 2023 Claim Types: Method of use; Composition Use Code: U-3522: Method of treating emesis | Nov 18, 2030 | New patent for this product |
ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 004 RX (0.055MG/INH); 005 RX (0.113MG/INH); 006 RX (0.232MG/INH) NDA No.: 208798 Prod. No.: 008 DISC (0.03MG/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11357935 DP* Drug delivery device with electronics Pat. Sub. Date(s): All strengths: Jul 13, 2022 Claim Types: Device | Mar 24, 2039 *PED | New expiration date. Was previously Sep 24, 2038 |
| Pat. No. 11439777 DP* Drug delivery device with electronics Pat. Sub. Date(s): All strengths: Oct 6, 2022 Claim Types: Device | Nov 24, 2040 *PED | New expiration date. Was previously May 24, 2040 |
| Pat. No. 11464923 DP* Inhaler system Pat. Sub. Date(s): All strengths: Nov 10, 2022 Claim Types: Device; Method of improving a treatment | Dec 19, 2040 *PED | New expiration date. Was previously Jun 19, 2040 |
ATORVALIQ (SUSPENSION) (ORAL) ATORVASTATIN CALCIUM
Drug Classes: Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors
NDA Applicant: CMP DEV LLC NDA No.: 213260 Prod. No.: 001 RX (20MG/5ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11369567 DP* Aqueous suspension suitable for oral administration Pat. Sub. Date(s): 001: Feb 7, 2023 Claim Types: Formulation | Jun 7, 2037 | New product in Orange Book |
AUSTEDO (TABLET) (ORAL) DEUTETRABENAZINE
Drug Classes: Central Nervous System Agents:Central Nervous System, Other
NDA Applicant: TEVA BRANDED PHARM NDA No.: 208082 Prod. No.: 001 RX (6MG); 002 RX (9MG); 003 RX (12MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11564917 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Feb 15, 2023 Claim Types: Method of use Use Code: U-1995: Treatment of tardive dyskinesia | Mar 7, 2036 | New patent for this product |
AUSTEDO XR (TABLET, EXTENDED RELEASE) (ORAL) DEUTETRABENAZINE
Drug Classes: Central Nervous System Agents:Central Nervous System, Other
NDA Applicant: TEVA NDA No.: 216354 Prod. No.: 001 RX (6MG); 002 RX (12MG); 003 RX (24MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8524733 DS* DP* [Extended 562 days (1.5 years)] Benzoquinoline inhibitors of vesicular monoamine transporter 2 Pat. Sub. Date(s): All strengths: Feb 27, 2023 Claim Types: Compound; Composition | Apr 3, 2031 | New product in Orange Book |
| Pat. No. 9550780 DS* DP* Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Pat. Sub. Date(s): All strengths: Feb 27, 2023 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-1995: Treatment of tardive dyskinesia Use Code: U-3055: A method of treating Huntington's chorea | Sep 18, 2033 | New product in Orange Book |
| Pat. No. 10959996 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Feb 27, 2023 Claim Types: Method of improving a treatment Use Code: U-3055: A method of treating Huntington's chorea | Mar 7, 2036 | New product in Orange Book |
| Pat. No. 11179386 DP* Analogs of deutetrabenazine, their preparation and use Pat. Sub. Date(s): All strengths: Feb 27, 2023 Claim Types: Composition; Method of use Use Code: U-1995: Treatment of tardive dyskinesia Use Code: U-3055: A method of treating Huntington's chorea | Mar 15, 2038 | New product in Orange Book |
| Pat. No. 11311488 DP* Osmotic dosage forms comprising deutetrabenazine and methods of use thereof Pat. Sub. Date(s): All strengths: Feb 27, 2023 Claim Types: Formulation; Method of use Use Code: U-1995: Treatment of tardive dyskinesia Use Code: U-3055: A method of treating Huntington's chorea | Jun 10, 2041 | New product in Orange Book |
| Pat. No. 11357772 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Feb 27, 2023 Claim Types: Method of use Use Code: U-1995: Treatment of tardive dyskinesia Use Code: U-3055: A method of treating Huntington's chorea | Mar 7, 2036 | New product in Orange Book |
| Pat. No. 11446291 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Feb 27, 2023 Claim Types: Dosaage regimen Use Code: U-1995: Treatment of tardive dyskinesia | Mar 7, 2036 | New product in Orange Book |
| Pat. No. 11564917 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Feb 27, 2023 Claim Types: Method of use Use Code: U-1995: Treatment of tardive dyskinesia | Mar 7, 2036 | New product in Orange Book |
AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: Antibacterials:Beta-lactam, Cephalosporins
NDA Applicant: ALLERGAN NDA No.: 206494 Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Dec 20, 2025 | New exclusivity for this product |
BRENZAVVY (TABLET) (ORAL) BEXAGLIFLOZIN
NDA Applicant: THERACOSBIO NDA No.: 214373 Prod. No.: 001 RX (20MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7838499 DS* DP* Benzylbenzene derivatives and methods of use Pat. Sub. Date(s): 001: Feb 15, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes | Jan 30, 2029 | New patent for this product |
| Pat. No. 8106021 Benzylbenzene derivatives and methods of use Pat. Sub. Date(s): 001: Feb 15, 2023 Claim Types: Method of use Use Code: U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes | Aug 22, 2028 | New patent for this product |
| Pat. No. 8802637 DS* DP* Benzylbenzene derivatives and methods of use Pat. Sub. Date(s): 001: Feb 15, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes | Aug 22, 2028 | New patent for this product |
| Pat. No. 8987323 DS* DP* Crystalline form of benzylbenzene SGLT2 inhibitor Pat. Sub. Date(s): 001: Feb 15, 2023 Claim Types: New polymorph, salt or hydrate; Composition | May 14, 2032 | New patent for this product |
| Pat. No. 10533032 Crystalline form of benzylbenzene SGLT2 inhibitor Pat. Sub. Date(s): 001: Feb 15, 2023 Claim Types: Method of use Use Code: U-2214: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes | Jul 3, 2031 | New patent for this product |
| Pat. No. 10981942 DS* DP* Crystalline form of benzylbenzene SGLT2 inhibitor Pat. Sub. Date(s): 001: Feb 15, 2023 Claim Types: New polymorph, salt or hydrate | Jun 13, 2031 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NCE - New chemical entity | Jan 20, 2028 | New exclusivity for this product |
BRUKINSA (CAPSULE) (ORAL) ZANUBRUTINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: BEIGENE NDA No.: 213217 Prod. No.: 001 RX (80MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11591340 (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: Mar 8, 2023 Claim Types: New polymorph, salt or hydrate; Process; 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 |
| Exclusivity | Expiration | Change |
| Exclusivity Code: I - New Indication: I-817: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) | Jan 19, 2026 | New exclusivity for this product |
CAMZYOS (CAPSULE) (ORAL) MAVACAMTEN
NDA Applicant: BRISTOL NDA No.: 214998 Prod. No.: 001 RX (2.5MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-398: Treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms | Apr 28, 2029 | New exclusivity for this product |
CUVRIOR (TABLET) (ORAL) TRIENTINE TETRAHYDROCHLORIDE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral/Metal Modifiers
NDA Applicant: ORPHALAN NDA No.: 215760 Prod. No.: 001 RX (300MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-401: Treatment of adult patients with stable Wilson's Disease who are de-coppered and tolerant to penicillamine | Apr 28, 2029 | New exclusivity for this product |
DOXEPIN HYDROCHLORIDE (CREAM) (TOPICAL) DOXEPIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antidepressants:Tricyclics == Anxiolytics:Anxiolytics, Other == Dermatological Agents:Dermatitis and Pruritus Agents == Sleep Disorder Agents:Sleep Promoting Agents
NDA Applicant: TEVA PHARMS NDA No.: 215408 Prod. No.: 001 RX (5%)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Aug 16, 2023 | New product in Orange Book |
DYANAVEL XR (SUSPENSION, EXTENDED RELEASE) (ORAL) AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines
NDA Applicant: TRIS PHARMA INC NDA No.: 208147 Prod. No.: 001 RX (2MG/ML;EQ 0.5MG BASE/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11590228 DP* Extended Release amphetamine Compositions Pat. Sub. Date(s): 001: Mar 8, 2023 Claim Types: Formulation Use Code: U-3538: Method of treating attention deficit hyperactivity disorder | Sep 7, 2036 | New patent for this product |
DYANAVEL XR 5; DYANAVEL XR 10; DYANAVEL XR 15; DYANAVEL XR 20 (TABLET, EXTENDED RELEASE) (ORAL) AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines
NDA Applicant: TRIS PHARMA INC NDA No.: 210526 Prod. No.: 001 RX (4MG;EQ 1MG BASE); 002 RX (8MG;EQ 2MG BASE); 003 RX (12MG;EQ 3MG BASE); 004 RX (16MG;EQ 4MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11590081 DP* Extended Release amphetamine Tablets Pat. Sub. Date(s): All strengths: Mar 8, 2023 Claim Types: Formulation claimed by its inherent performace characteristics Use Code: U-3538: Method of treating attention deficit hyperactivity disorder | Sep 24, 2038 | New patent for this product |
EMERPHED (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
NDA Applicant: NEXUS PHARMS NDA No.: 213407 Prod. No.: 001 RX (50MG/10ML (5MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11571398 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same Pat. Sub. Date(s): 001: Mar 2, 2023 Claim Types: Method of administration Use Code: U-3183: Use of ephedrine sulfate for treating hypotension | May 16, 2040 | New patent for this product |
ERLEADA (TABLET) (ORAL) APALUTAMIDE
Drug Classes: Antineoplastics:Antiandrogens
NDA Applicant: JANSSEN BIOTECH NDA No.: 210951 Prod. No.: 001 RX (60MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9481663 DS* DP* Crystalline forms of an androgen receptor modulator Pat. Sub. Date(s): 001: Mar 5, 2018 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC) Use Code: U-2624: Treatment of metastatic castration-sensitive prostate cancer (MCSPC) | Jun 4, 2033 | New Use Code; New Drug Substance/Drug Product flag |
ERLEADA (TABLET) (ORAL) APALUTAMIDE
Drug Classes: Antineoplastics:Antiandrogens
NDA Applicant: JANSSEN BIOTECH NDA No.: 210951 Prod. No.: 002 RX (240MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE49353 Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer Pat. Sub. Date(s): 002: Feb 27, 2023 Claim Types: Method of use Use Code: U-2381: Treatment in combination with a GNRH agonist of non-metastatic, castration-resistant prostate cancer (NM-CRPC) | Sep 23, 2033 | New strength or variation of this product |
| Pat. No. 8445507 DS* DP* Androgen receptor modulator for the treatment of prostate Pat. Sub. Date(s): 002: Feb 27, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC) Use Code: U-2624: Treatment of metastatic castration-sensitive prostate cancer (MCSPC) | Sep 15, 2030 | New strength or variation of this product |
| Pat. No. 8802689 Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases Pat. Sub. Date(s): 002: Feb 27, 2023 Claim Types: Method of use Use Code: U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC) Use Code: U-2624: Treatment of metastatic castration-sensitive prostate cancer (MCSPC) | Mar 27, 2027 | New strength or variation of this product |
| Pat. No. 9388159 DS* DP* Substituted diazaspiroalkanes as androgen receptor modulators Pat. Sub. Date(s): 002: Feb 27, 2023 Claim Types: Compound; Composition | Mar 27, 2027 | New strength or variation of this product |
| Pat. No. 9481663 DS* DP* Crystalline forms of an androgen receptor modulator Pat. Sub. Date(s): 002: None Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC) Use Code: U-2624: Treatment of metastatic castration-sensitive prostate cancer (MCSPC) | Jun 4, 2033 | New strength or variation of this product |
| Pat. No. 9884054 Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer Pat. Sub. Date(s): 002: Feb 27, 2023 Claim Types: Method of use Use Code: U-2237: Treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC) | Sep 23, 2033 | New strength or variation of this product |
| Pat. No. 9987261 DP* Substituted diazaspiroalkanes as androgen receptor modulators Pat. Sub. Date(s): 002: Feb 27, 2023 Claim Types: Formulation | Mar 27, 2027 | New strength or variation of this product |
| Pat. No. 10702508 Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer Pat. Sub. Date(s): 002: Feb 27, 2023 Claim Types: Method of use Use Code: U-3012: Treatment in combination with androgen deprivation therapy of non-metastatic, castration-resistant prostate cancer (NMCRPC) that improves metastasis free survival | Apr 30, 2038 | New strength or variation of this product |
| Pat. No. 10849888 Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer Pat. Sub. Date(s): 002: Feb 27, 2023 Claim Types: Method of use Use Code: U-3013: Treatment in combination with orchiectomy of non-metastatic, castration-resistant prostate cancer (NMCRPC) | Sep 23, 2033 | New strength or variation of this product |
EVRYSDI (FOR SOLUTION) (ORAL) RISDIPLAM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: GENENTECH INC NDA No.: 213535 Prod. No.: 001 RX (0.75MG/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11534444 Treatment of SMA Pat. Sub. Date(s): 001: Jan 25, 2023 Claim Types: Method of use Use Code: U-1943: Treatment of spinal muscular atrophy | Oct 4, 2038 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-400: Treatment of spinal muscular atrophy (SMA) in pediatric patients between birth and 2 months of age | May 27, 2029 | New exclusivity for this product |
FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: AVEO PHARMS NDA No.: 212904 Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 6821987 DS* DP* Quinoline derivatives and quinazoline derivatives having azolyl group Pat. Sub. Date(s): All strengths: Apr 6, 2021 Claim Types: Compound; Method of use; Composition Use Code: U-3100: A method of treating adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies by inhibiting the angiogenesis of blood vessels with a vascular endothelial growth factor inhibitor | Apr 26, 2024 | New expiration date. Was previously Apr 26, 2023 |
HETLIOZ (CAPSULE) (ORAL) TASIMELTEON [GENERIC AB]
Drug Classes: Sleep Disorder Agents:Sleep Promoting Agents
NDA Applicant: VANDA PHARMS INC NDA No.: 205677 Prod. No.: 001 RX (20MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11566011 DS* DP* Highly purified pharmaceutical grade tasimelteon Pat. Sub. Date(s): 001: Feb 15, 2023 Claim Types: Composition | Feb 12, 2035 | New patent for this product |
HETLIOZ LQ (SUSPENSION) (ORAL) TASIMELTEON
Drug Classes: Sleep Disorder Agents:Sleep Promoting Agents
NDA Applicant: VANDA PHARMS INC NDA No.: 214517 Prod. No.: 001 RX (4MG/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11566011 DS* DP* Highly purified pharmaceutical grade tasimelteon Pat. Sub. Date(s): 001: Feb 13, 2023 Claim Types: Composition | Feb 12, 2035 | New patent for this product |
IMBRUVICA (CAPSULE) (ORAL) IBRUTINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: PHARMACYCLICS INC NDA No.: 205552 Prod. No.: 001 RX (140MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-128: Treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy | Jul 18, 2024 PED | New expiration date. Was previously Jan 18, 2024 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-152: Treatment of adult patients with chronic graft versus host disease (CGVHD) | Feb 2, 2025 PED | New expiration date. Was previously Aug 2, 2024 |
IMCIVREE (SOLUTION) (SUBCUTANEOUS) SETMELANOTIDE ACETATE
Drug Classes: melanocortin 4 (MC4) receptor agonist
NDA Applicant: RHYTHM NDA No.: 213793 Prod. No.: 001 RX (EQ 10MG/ML BASE (EQ 10MG/ML BASE))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-402: For chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS) | Jun 16, 2029 | New exclusivity for this product |
JATENZO (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: TOLMAR NDA No.: 206089 Prod. No.: 001 RX (158MG); 002 RX (198MG); 003 RX (237MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11564933 Methods of treating testosterone deficiency Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Method of use Use Code: U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone | Apr 12, 2039 | New patent for this product |
JAYPIRCA (TABLET) (ORAL) PIRTOBRUTINIB
NDA Applicant: LOXO ONCOL NDA No.: 216059 Prod. No.: 001 RX (50MG); 002 RX (100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10342780 DS* DP* Compounds useful as kinase inhibitors Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Compound; Composition | Dec 16, 2036 | New patent for this product |
| Pat. No. 10464905 Compounds useful as kinase inhibitors Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Method of use Use Code: U-3518: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after at least two lines of systemic therapy, including a BTK inhibitor | Dec 16, 2036 | New patent for this product |
| Pat. No. 10695323 DS* DP* Compounds useful as kinase inhibitors Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-3518: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after at least two lines of systemic therapy, including a BTK inhibitor | Dec 16, 2036 | New patent for this product |
| Pat. No. 10918622 Compounds useful as kinase inhibitors Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Method of use Use Code: U-3518: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after at least two lines of systemic therapy, including a BTK inhibitor | Dec 16, 2036 | New patent for this product |
JESDUVROQ (TABLET) (ORAL) DAPRODUSTAT
NDA Applicant: GLAXOSMITHKLINE NDA No.: 216951 Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (4MG); 004 RX (6MG); 005 RX (8MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8324208 DS* DP* Prolyl hydroxylase inhibitors Pat. Sub. Date(s): All strengths: Feb 21, 2023 Claim Types: Compound; Composition | Dec 11, 2028 | New product in Orange Book |
| Pat. No. 8557834 Prolyl hydroxylase inhibitors Pat. Sub. Date(s): All strengths: Feb 21, 2023 Claim Types: Method of use Use Code: U-1238: Treatment of anemia due to chronic kidney disease | Jun 22, 2027 | New product in Orange Book |
| Pat. No. 8815884 DP* Prolyl hydroxylase inhibitors Pat. Sub. Date(s): All strengths: Feb 21, 2023 Claim Types: Composition; Method of use Use Code: U-1238: Treatment of anemia due to chronic kidney disease | Jun 22, 2027 | New product in Orange Book |
| Pat. No. 11117871 DS* DP* Crystalline forms of GSK1278863, preparation method and pharmaceutical use thereof Pat. Sub. Date(s): All strengths: Feb 21, 2023 Claim Types: New polymorph, salt or hydrate; Process; Method of use Use Code: U-3535: A method of treating anemia | Mar 13, 2038 | New product in Orange Book |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NCE - New chemical entity | Feb 1, 2028 | New product in Orange Book |
KALYDECO (TABLET) (ORAL) IVACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents
NDA Applicant: VERTEX PHARMS NDA No.: 203188 Prod. No.: 001 RX (150MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 001: Feb 28, 2023 Claim Types: Method of use Use Code: U-3530: Treatment of CF in a patient age 6 years and older who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11564916 | Aug 13, 2029 | New patent for this product |
KALYDECO (GRANULE) (ORAL) IVACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents
NDA Applicant: VERTEX PHARMS INC NDA No.: 207925 Prod. No.: 001 RX (50MG/PACKET); 002 RX (75MG/PACKET); 003 RX (25MG/PACKET)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Feb 28, 2023 Claim Types: Method of use Use Code: U-3528: Treatment of CF in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11564916 | Aug 13, 2029 | New patent for this product |
LENVIMA (CAPSULE) (ORAL) LENVATINIB MESYLATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: EISAI INC NDA No.: 206947 Prod. No.: 001 RX (EQ 4MG BASE); 002 RX (EQ 10MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11090386 Method for suppressing bitterness of quinoline derivative Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Method of administration Use Code: U-3519: Treatment with LENVIMA by administering LENVIMA as a suspension | Feb 23, 2036 | New patent for this product |
LILETTA (INTRAUTERINE DEVICE) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Contraceptives:Contraceptives, Other == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins
NDA Applicant: MEDICINES360 NDA No.: 206229 Prod. No.: 001 RX (52MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11571328 DP* IUD insertion devices Pat. Sub. Date(s): 001: Feb 27, 2023 Claim Types: Device | Sep 7, 2040 | New patent for this product |
LUMAKRAS (TABLET) (ORAL) SOTORASIB
NDA Applicant: AMGEN INC NDA No.: 214665 Prod. No.: 002 RX (320MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10519146 DS* DP* KRAS G12C inhibitors and methods of using the same Pat. Sub. Date(s): 002: Feb 14, 2023 Claim Types: Compound; Composition | May 21, 2038 | New strength or variation of this product |
| Pat. No. 11236091 DS* DP* Solid state forms Pat. Sub. Date(s): 002: Feb 14, 2023 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-3306: 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 20, 2040 | New strength or variation of this product |
| Pat. No. 11426404 Dosing of KRAS inhibitor for treatment of cancers Pat. Sub. Date(s): 002: Feb 14, 2023 Claim Types: Method of use Use Code: U-3306: 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 | Aug 11, 2040 | New strength or variation of this product |
MEKINIST (TABLET) (ORAL) TRAMETINIB DIMETHYL SULFOXIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: NOVARTIS NDA No.: 204114 Prod. No.: 001 RX (EQ 0.5MG); 003 RX (EQ 2MG) NDA No.: 204114 Prod. No.: 002 DISC (EQ 1MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7378423 DS* DP* [Extended 718 days (2 years)] Pyrimidine compound and medical use thereof Pat. Sub. Date(s): 001: Jun 6, 2013; 002: None; 003: None Claim Types: Compound; Composition; Formulation | Nov 29, 2027 *PED | New expiration date. Was previously May 29, 2027 |
| Pat. No. 8580304 DP* Pharmaceutical composition Pat. Sub. Date(s): 001: None; 002: None; 003: Dec 10, 2013 Claim Types: Formulation; Process | Jul 28, 2032 *PED | New expiration date. Was previously Jan 28, 2032 |
| Pat. No. 8703781 DS* DP* Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors Pat. Sub. Date(s): All strengths: May 22, 2015 Claim Types: Formulation; Method of use Use Code: U-1712: MEKINIST in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma Use Code: U-2020: MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test Use Code: U-2037: MEKINIST is indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test Use Code: U-2302: MEKINIST is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection Use Code: U-2305: MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options | 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): All strengths: Oct 7, 2014 Claim Types: Method of use Use Code: U-1581: In combination with dabrafenib for the treatment of unresectable or metastatic melanoma. Use Code: U-1582: Treatment of unresectable or metastatic melanoma Use Code: U-2020: MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test Use Code: U-2037: MEKINIST is indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test Use Code: U-2302: MEKINIST is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection Use Code: U-2305: MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options | Dec 10, 2025 *PED | New expiration date. Was previously Jun 10, 2025 |
| Pat. No. 8952018 Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors Pat. Sub. Date(s): All strengths: Sep 22, 2016 Claim Types: Method of use Use Code: U-2020: MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test | Apr 15, 2031 *PED | New expiration date. Was previously Oct 15, 2030 |
| Pat. No. 9155706 DP* Pharmaceutical composition Pat. Sub. Date(s): 001: Dec 10, 2015; 002: Sep 22, 2016; 003: Dec 10, 2015 Claim Types: Formulation; Process | Jul 28, 2032 *PED | New expiration date. Was previously Jan 28, 2032 |
| Pat. No. 9271941 DP* Pharmaceutical composition Pat. Sub. Date(s): 001: Apr 8, 2016; 002: Sep 22, 2016; 003: Apr 8, 2016 Claim Types: Composition; Formulation | Jul 28, 2032 *PED | New expiration date. Was previously Jan 28, 2032 |
| Pat. No. 9399021 DP* Pharmaceutical composition Pat. Sub. Date(s): All strengths: Dec 19, 2019 Claim Types: Formulation; Process | Jul 28, 2032 *PED | New expiration date. Was previously Jan 28, 2032 |
| Pat. No. 10869869 Method of adjuvant cancer treatment Pat. Sub. Date(s): All strengths: Aug 18, 2021 Claim Types: Method of use Use Code: U-3184: Mekinist(R) is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection | Mar 2, 2034 *PED | New expiration date. Was previously Aug 30, 2033 |
| Exclusivity | Expiration | Change |
| Exclusivity Code: I - New Indication: I-895: Trametinib is indicated in combination with dabrafenib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options | Dec 22, 2025 PED | New expiration date. Was previously Jun 22, 2025 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-148: Trametinib in combination with dabrafenib, for the tx. of pts with metastatic non-small cell lung cancer with BRAF V600E mutation as detected by an FDA-approved test | Dec 22, 2024 PED | New expiration date. Was previously Jun 22, 2024 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-182: Trametinib is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection | Oct 30, 2025 PED | New expiration date. Was previously Apr 30, 2025 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-183: Trametinib and dabrafenib in combination, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options | Nov 4, 2025 PED | New expiration date. Was previously May 4, 2025 |
NULIBRY (POWDER) (INTRAVENOUS) FOSDENOPTERIN HYDROBROMIDE
Drug Classes: cyclic pyranopterin monophosphate (cPMP)
NDA Applicant: SENTYNL THERAPS INC NDA No.: 214018 Prod. No.: 001 RX (EQ 9.5MG BASE/VIAL)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: M - Miscellaneous: M-286: Information added to clinical pharmacology section to include results from study ORGN001-102 | Oct 27, 2025 | New exclusivity for this product |
ONUREG (TABLET) (ORAL) AZACITIDINE
Drug Classes: Antineoplastics:Antimetabolites
NDA Applicant: BRISTOL NDA No.: 214120 Prod. No.: 001 RX (200MG); 002 RX (300MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11571436 DP* Oral formulations of cytidine analogs and methods of use thereof Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Composition | May 14, 2029 | New patent for this product |
OPZELURA (CREAM) (TOPICAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: INCYTE CORP NDA No.: 215309 Prod. No.: 001 RX (EQ 1.5% BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11571425 DP* Topical formulation for a JAK inhibitor Pat. Sub. Date(s): 001: Feb 28, 2023 Claim Types: Composition | May 20, 2031 | New patent for this product |
ORKAMBI (TABLET) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents
NDA Applicant: VERTEX PHARMS INC NDA No.: 206038 Prod. No.: 001 RX (125MG;200MG); 002 RX (125MG;100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Feb 28, 2023 Claim Types: Method of use Use Code: U-3529: Treatment of CF in a patient age 6 years and older who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916 | Aug 13, 2029 | New patent for this product |
ORKAMBI (GRANULE) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents
NDA Applicant: VERTEX PHARMS INC NDA No.: 211358 Prod. No.: 001 RX (125MG/PACKET;100MG/PACKET); 002 RX (188MG/PACKET;150MG/PACKET); 003 RX (94MG/PACKET;75MG/PACKET)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Feb 28, 2023 Claim Types: Method of use Use Code: U-3526: Treatment of CF in a patient age 1 to <6 years and weighing 7 kg or more who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916 | Aug 13, 2029 | New patent for this product |
ORSERDU (TABLET) (ORAL) ELACESTRANT DIHYDROCHLORIDE
NDA Applicant: STEMLINE THERAP NDA No.: 217639 Prod. No.: 001 RX (EQ 86MG BASE); 002 RX (EQ 345MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8399520 DS* DP* Selective estrogen receptor modulator Pat. Sub. Date(s): All strengths: Feb 24, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-3523: Treatment of an ER-positive breast cancer | Dec 25, 2023 | New patent for this product |
| Pat. No. 10071066 Method of treating cancer using selective estrogen receptor modulators Pat. Sub. Date(s): All strengths: Feb 24, 2023 Claim Types: Method of use Use Code: U-3524: Treatment of an ER-positive breast cancer following at least one line of endocrine therapy | Oct 10, 2034 | New patent for this product |
| Pat. No. 10745343 Polymorphic forms of RAD1901-2HCl Pat. Sub. Date(s): All strengths: Feb 24, 2023 Claim Types: Method of use Use Code: U-3523: Treatment of an ER-positive breast cancer | Jan 5, 2038 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NCE - New chemical entity | Jan 27, 2028 | New exclusivity for this product |
PREVDUO (SOLUTION) (INTRAVENOUS) GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE
Drug Classes: Gastrointestinal Agents:Antispasmodics, Gastrointestinal == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: SLAYBACK PHARMA LLC NDA No.: 216903 Prod. No.: 001 RX (0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10456354 DP* Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate Pat. Sub. Date(s): 001: Feb 24, 2023 Claim Types: Formulation | Oct 25, 2038 | New product in Orange Book |
| Pat. No. 11110054 DP* Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate Pat. Sub. Date(s): 001: Feb 24, 2023 Claim Types: Formulation | Oct 25, 2038 | New product in Orange Book |
QINLOCK (TABLET) (ORAL) RIPRETINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: DECIPHERA PHARMS NDA No.: 213973 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11576903 DP* Amorphous kinase inhibitor formulations and methods of use thereof Pat. Sub. Date(s): 001: Mar 6, 2023 Claim Types: Formulation | Dec 30, 2040 | New patent for this product |
| Pat. No. 11576904 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: Mar 6, 2023 Claim Types: Method of use Use Code: U-3537: Treatment of gastrointestinal stromal tumors in patients suffering from grade 2 or grade 3 arthralgia while being administered ripretinib daily | Aug 12, 2040 | New patent for this product |
QVAR REDIHALER (AEROSOL, METERED) (INHALATION) BECLOMETHASONE DIPROPIONATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids
NDA Applicant: NORTON WATERFORD NDA No.: 207921 Prod. No.: 001 RX (0.04MG/INH); 002 RX (0.08MG/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11559637 DP* Inhalers and related methods Pat. Sub. Date(s): All strengths: Feb 22, 2023 Claim Types: Device; Method of use | Jul 21, 2039 | New patent for this product |
RELYVRIO (FOR SUSPENSION) (ORAL) SODIUM PHENYLBUTYRATE; TAURURSODIOL
NDA Applicant: AMYLYX NDA No.: 216660 Prod. No.: 001 RX (3GM/PACKET; 1GM/PACKET)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11583542 DP* Compositions of bile acids and phenylbutyrate compounds Pat. Sub. Date(s): 001: Mar 3, 2023 Claim Types: Formulation | Jul 27, 2040 | New patent for this product |
REVATIO (TABLET) (ORAL) SILDENAFIL CITRATE [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == Sexual Disorder Agents:Sexual Disorder Agents (Male)
NDA Applicant: VIATRIS NDA No.: 021845 Prod. No.: 001 RX (EQ 20MG BASE)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: M - Miscellaneous: M-287: Labeling regarding new dosing regimen in adults with pulmonary arterial | Jan 31, 2026 | New exclusivity for this product |
SPRAVATO (SPRAY) (NASAL) ESKETAMINE HYDROCHLORIDE
Drug Classes: Antidepressants:Antidepressants, Other
NDA Applicant: JANSSEN PHARMS NDA No.: 211243 Prod. No.: 001 RX (EQ 28MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11173134 Methods for the treatment of depression Pat. Sub. Date(s): 001: Dec 16, 2021 Claim Types: Method of use Use Code: U-3257: Treatment of TRD in conjunction with an oral antidepressant by nasally administering 56mg or 84mg of esketamine in a maintenance phase weekly or 1x every two weeks to adults who have been administered esketamine in a induction phase for about 4 weeks Use Code: U-3536: Treatment of depression in adults with mod and acute suicidal ideation or behavior in conjunction with an oral antidepressant by nasally administering 56mg or 84mg of esketamine in a maintenance phase weekly or lx every 2 weeks after induction phase | Sep 10, 2035 | New expiration date. Was previously Sep 14, 2035; New Use Code |
SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: Sleep Disorder Agents:Wakefulness Promoting Agents
NDA Applicant: AXSOME MALTA NDA No.: 211230 Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11160779 Methods of providing solriamfetol therapy to subjects with impaired renal function Pat. Sub. Date(s): All strengths: Feb 13, 2023 Claim Types: Method of use Use Code: U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment | Mar 19, 2040 | New patent for this product |
| Pat. No. 11560354 DP* Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof Pat. Sub. Date(s): All strengths: Feb 13, 2023 Claim Types: Composition Use Code: U-3520: Treatment of excessive daytime sleepiness by adminstering a composition comprising solriamfetol hydrochloride and 2-chloropropane, wherein the composition comprises less than about 5 ppm 2-chloropropane | Mar 6, 2039 | New patent for this product |
SYMDEKO (COPACKAGED) (TABLET) (ORAL) IVACAFTOR; IVACAFTOR, TEZACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents
NDA Applicant: VERTEX PHARMS INC NDA No.: 210491 Prod. No.: 001 RX (150MG;150MG, 100MG); 002 RX (75MG;75MG, 50MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Feb 28, 2023 Claim Types: Method of use Use Code: U-3527: Treatment of CF in a patient age 6 years and older who is homozygous for F508DEL or has at least one CFTR gene mutation responsive to TEZ/IVA based on in vitro data and/or clinical evidence using the composition recited in US 11564916 claim 1 | Aug 13, 2029 | New patent for this product |
SYNJARDY (TABLET) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 206111 Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (12.5MG;500MG); 004 RX (12.5MG;1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9949997 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Mar 1, 2023 Claim Types: Method of use Use Code: U-3532: Method for reducing the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes mellitus by once daily administration of empagliflozin Use Code: U-3534: Method for reducing the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease by once daily administration of io mg or 25 mg of empagliflozin | May 17, 2034 | New patent for this product |
SYNJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 208658 Prod. No.: 001 RX (5MG;1GM); 002 RX (10MG;1GM); 003 RX (12.5MG;1GM); 004 RX (25MG;1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9949997 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Mar 1, 2023 Claim Types: Method of use Use Code: U-3532: Method for reducing the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes mellitus by once daily administration of empagliflozin Use Code: U-3533: Method for reducing the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease by once daily administration of 10 mg or 25 mg of empagliflozin | May 17, 2034 | New patent for this product |
TAFINLAR (CAPSULE) (ORAL) DABRAFENIB MESYLATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: NOVARTIS NDA No.: 202806 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7994185 DS* DP* Benzene sulfonamide thiazole and oxazole compounds Pat. Sub. Date(s): All strengths: Jun 13, 2013 Claim Types: Compound; Composition; Formulation; Method of use Use Code: U-1406: Treatment of melanoma Use Code: U-2031: TAFINLAR is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test Use Code: U-2032: TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Use Code: U-2296: TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection | 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): All strengths: Jun 13, 2013 Claim Types: Compound; Composition; Method of use; Process Use Code: U-1406: Treatment of melanoma Use Code: U-2031: TAFINLAR is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test Use Code: U-2032: TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Use Code: U-2296: TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection | 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): All strengths: May 22, 2015 Claim Types: Formulation; Method of use Use Code: U-1713: TAFINLAR in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma Use Code: U-2032: TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Use Code: U-2296: TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection Use Code: U-2298: TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with BRAF V600E mutation and with no satisfactory locoregional treatment options | 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): All strengths: Jul 18, 2017 Claim Types: Method of use Use Code: U-2026: Tafinlar(R) is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Use Code: U-2027: Tafinlar(R) is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. Use Code: U-2296: TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection Use Code: U-2298: TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with BRAF V600E mutation and with no satisfactory locoregional treatment options | Dec 10, 2025 *PED | New expiration date. Was previously Jun 10, 2025 |
| Pat. No. 8952018 Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors Pat. Sub. Date(s): All strengths: Jul 18, 2017 Claim Types: Method of use Use Code: U-2027: Tafinlar(R) is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. | Apr 15, 2031 *PED | New expiration date. Was previously Oct 15, 2030 |
| Pat. No. 9233956 Benzene sulfonamide thiazole and oxazole compounds Pat. Sub. Date(s): All strengths: Feb 24, 2016 Claim Types: Method of use Use Code: U-1811: Treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutations after confirming the presence of BRAF V600E mutation Use Code: U-2031: TAFINLAR is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test Use Code: U-2032: TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Use Code: U-2296: TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection | Nov 4, 2029 *PED | New expiration date. Was previously May 4, 2029 |
| Pat. No. 10869869 Method of adjuvant cancer treatment Pat. Sub. Date(s): All strengths: Aug 18, 2021 Claim Types: Method of use Use Code: U-3185: Tafinlar(R) is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf V600E or V600K mutations as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection | Mar 2, 2034 *PED | New expiration date. Was previously Aug 30, 2033 |
| Exclusivity | Expiration | Change |
| Exclusivity Code: I - New Indication: I-894: Dabrafenib is indicated in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options | Dec 22, 2025 PED | New expiration date. Was previously Jun 22, 2025 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-147: Dabrafenib in combination with trametinib, for the tx. of pts with metastatic non-small cell lung cancer with BRAF V600E mutation as detected by an FDA-approved test | Dec 22, 2024 PED | New expiration date. Was previously Jun 22, 2024 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-182: Trametinib is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection | Oct 30, 2025 PED | New expiration date. Was previously Apr 30, 2025 |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-183: Trametinib and dabrafenib in combination, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options | Nov 4, 2025 PED | New expiration date. Was previously May 4, 2025 |
TLANDO (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ANTARES PHARMA INC NDA No.: 208088 Prod. No.: 001 RX (112.5MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11559530 Oral testosterone undecanoate therapy Pat. Sub. Date(s): 001: Feb 14, 2023 Claim Types: Method of use Use Code: U-1500: Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone; primary hypogonadism (congenital or acquired); hypogonadotropic hypogonadism (congenital or acquired). | Nov 28, 2037 | New patent for this product |
TRIJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 212614 Prod. No.: 001 RX (5MG;2.5MG;1GM); 002 RX (10MG;5MG;1GM); 003 RX (12.5MG;2.5MG;1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11564886 DP* Pharmaceutical compositions Pat. Sub. Date(s): All strengths: Mar 1, 2023 Claim Types: Formulation Use Code: U-3531: Treatment of a type 2 diabetes patient with insufficient glycemic control despite metformin therapy using a composition comprising and extended release core comprising metformin and an outer coating comprising empagliflozin and linagliptin | Mar 7, 2032 | New patent for this product |
TRIKAFTA (COPACKAGED) (TABLET) (ORAL) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents
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. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Feb 28, 2023 Claim Types: Method of use Use Code: U-3525: Treatment of cf 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 the composition recited in US 11564916 claim 1 | Aug 13, 2029 | New patent for this product |
TUKYSA (TABLET) (ORAL) TUCATINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: SEAGEN NDA No.: 213411 Prod. No.: 001 RX (50MG); 002 RX (150MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: I - New Indication: I-906: Tucatinib in combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy | Jan 19, 2026 | New exclusivity for this product |
VERKAZIA (EMULSION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: Immunological Agents:Immunosuppressants == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: SANTEN NDA No.: 214965 Prod. No.: 001 RX (0.1%)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NP - New product | Jun 23, 2024 | New expiration date. Was previously Jun 23, 2023 |
VIDAZA (POWDER) (INTRAVENOUS, SUBCUTANEOUS) AZACITIDINE [GENERIC AP]
Drug Classes: Antineoplastics:Antimetabolites
NDA Applicant: BRISTOL-MYERS NDA No.: 050794 Prod. No.: 001 RX (100MG/VIAL)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-399: Treatment of pediatric patients aged one month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML) | May 20, 2029 | New exclusivity for this product |
VONJO (CAPSULE) (ORAL) PACRITINIB CITRATE
NDA Applicant: CTI BIOPHARMA CORP NDA No.: 208712 Prod. No.: 001 RX (EQ 100MG BASE)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-397: Treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50x10^9/l | Feb 28, 2029 | New exclusivity for this product |
XELSTRYM (SYSTEM) (TRANSDERMAL) DEXTROAMPHETAMINE
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines
NDA Applicant: NOVEN PHARMS INC NDA No.: 215401 Prod. No.: 001 RX (4.5MG/9HR); 002 RX (9MG/9HR); 003 RX (13.5MG/9HR); 004 RX (18MG/9HR)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11559501 DP* Transdermal amphetamine compositions with low levels of carbamate Pat. Sub. Date(s): All strengths: Feb 17, 2023 Claim Types: Formulation | Jan 6, 2042 | New patent for this product |
XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: OPTINOSE US INC NDA No.: 209022 Prod. No.: 001 RX (0.093MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11554229 Nasal administration Pat. Sub. Date(s): 001: Feb 8, 2023 Claim Types: Method of use Use Code: U-2133: Method of delivering fluticasone propionate to a nasal airway | Feb 23, 2036 | New patent for this product |
XYREM (SOLUTION) (ORAL) SODIUM OXYBATE
Drug Classes: Sleep Disorder Agents:Wakefulness Promoting Agents
NDA Applicant: JAZZ PHARMS NDA No.: 021196 Prod. No.: 001 RX (0.5GM/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8731963 Sensitive drug distribution system and method Pat. Sub. Date(s): None Claim Types: Method of improving a treatment Use Code: U-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution | Jun 17, 2023 *PED | This patent is no longer listed for this product |
ZIMHI (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents
NDA Applicant: ADAMIS PHARMS CORP NDA No.: 212854 Prod. No.: 001 RX (5MG/0.5ML (5MG/0.5ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11571518 DP* Emergency devices Pat. Sub. Date(s): 001: Feb 10, 2023 Claim Types: Device; Method of administration Use Code: U-3515: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device Use Code: U-3516: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device including a needle guard Use Code: U-3517: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device including a window configured to allow the user to view the opioid antagonist in the syringe | Jun 14, 2041 | New patent for this product |
ZINC SULFATE (SOLUTION) (INTRAVENOUS) ZINC SULFATE MONOHYDRATE [GENERIC AP]
NDA Applicant: FRESENIUS KABI USA NDA No.: 216145 Prod. No.: 001 RX (EQ 10MG BASE/10ML (EQ 1MG BASE/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Aug 14, 2023 | New exclusivity for this product |