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

ACTHAR GEL (AUTOINJECTOR) (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: MALLINCKRODT ARD      NDA No.: 008372  Prod. No.: 003 RX (40 UNITS/0.5ML); 004 RX (80 UNITS/ML); 008 RX (80 UNITS/ML)

Patents	Expiration	Change
Pat. No. 11752199 Methods of modulating pericytes Pat. Sub. Date(s): 003: Jul 31, 2024; 004: Jul 31, 2024; 008: Sep 21, 2023 Claim Types: Method of use Use Code: U-3686: Treatment of exacerbations of multiple sclerosis in adults with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering Use Code: U-3687: Treatment of infantile spasms with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering Use Code: U-3688: Treatment of ophthalmic diseases with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering	Feb 25, 2041	New patent for this product

AIRDUO RESPICLICK; AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH); 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH) NDA No.: 208799  Prod. No.: 004 DISC (0.055MG/INH;EQ 0.014MG BASE/INH); 005 DISC (0.113MG/INH;EQ 0.014MG BASE/INH); 006 DISC (0.232MG/INH;EQ 0.014MG BASE/INH)

Patents	Expiration	Change
Pat. No. 11969544 DP* Inhalers and airflow adaptors therefor Pat. Sub. Date(s): All strengths: May 29, 2024 Claim Types: Device	Feb 20, 2040 *PED	New expiration date. Was previously Aug 20, 2039

ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.: 207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)

Patents	Expiration	Change
Pat. No. 12016873 Methods for treating pulmonary non-tuberculous mycobacterial infections Pat. Sub. Date(s): 001: Jul 22, 2024 Claim Types: Method of use Use Code: U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen	May 15, 2035	New patent for this product

ARMONAIR RESPICLICK; ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 001 DISC (0.055MG/INH); 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH); 004 DISC (0.055MG/INH); 005 DISC (0.113MG/INH); 006 DISC (0.232MG/INH); 007 DISC (0.03MG/INH); 008 DISC (0.03MG/INH)

Patents	Expiration	Change
Pat. No. 11969544 DP* Inhalers and airflow adaptors therefor Pat. Sub. Date(s): All strengths: May 29, 2024 Claim Types: Device	Feb 20, 2040 *PED	New expiration date. Was previously Aug 20, 2039

AUGTYRO (CAPSULE) (ORAL) REPOTRECTINIB
Drug Classes: kinase inhibitor
NDA Applicant: BRISTOL      NDA No.: 218213  Prod. No.: 001 RX (40MG)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-483: Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy	Jun 13, 2031	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-488: Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotropic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy	Jun 13, 2031	New exclusivity for this product

AUGTYRO (CAPSULE) (ORAL) REPOTRECTINIB
Drug Classes: kinase inhibitor
NDA Applicant: BRISTOL      NDA No.: 218213  Prod. No.: 002 RX (160MG)

Patents	Expiration	Change
Pat. No. 9714258 DS* DP* Diaryl macrocycles as modulators of protein kinases Pat. Sub. Date(s): 002: Jul 10, 2024 Claim Types: Compound; New polymorph, salt or hydrate	Jan 23, 2035	New strength or variation of this product
Pat. No. 10294242 DS* Diaryl macrocycle polymorph Pat. Sub. Date(s): 002: Jul 10, 2024 Claim Types: New polymorph, salt or hydrate	Jul 5, 2036	New strength or variation of this product
Pat. No. 11452725 Chiral diaryl macrocycles and uses thereof Pat. Sub. Date(s): 002: Jul 10, 2024 Claim Types: Method of use Use Code: U-3755: Treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) Use Code: U-3961: Treatment of adult and pediatric patients >12 years with solid tumors and NTRK gene fusion that are locally advanced or metastatic or likely surgically unresectable, and have progressed following treatment or have no satisfactory alternative therapy	Jul 24, 2036	New strength or variation of this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Nov 15, 2028	New strength or variation of this product
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Nov 15, 2030	New strength or variation of this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-488: Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotropic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy	Jun 13, 2031	New strength or variation of this product

AUSTEDO (TABLET) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 208082  Prod. No.: 001 RX (6MG); 002 RX (9MG); 003 RX (12MG)

Patents	Expiration	Change
Pat. No. 12016858 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 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 patent for this product

AUSTEDO XR (TABLET, EXTENDED RELEASE) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA      NDA No.: 216354  Prod. No.: 001 RX (6MG); 002 RX (12MG); 003 RX (24MG)

Patents	Expiration	Change
Pat. No. 12016858 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 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 patent for this product

AUSTEDO XR (TABLET, EXTENDED RELEASE) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA      NDA No.: 216354  Prod. No.: 004 RX (30MG); 005 RX (36MG); 006 RX (42MG); 007 RX (48MG); 008 RX (18MG)

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: Jul 25, 2024 Claim Types: Compound; Composition	Apr 3, 2031	New patent for this product
Pat. No. 9550780 DS* DP* Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Pat. Sub. Date(s): All strengths: Jul 25, 2024 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 patent for this product
Pat. No. 10959996 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 Claim Types: Method of improving a treatment Use Code: U-3055: A method of treating Huntington's chorea	Mar 7, 2036	New patent for this product
Pat. No. 11179386 DP* Analogs of deutetrabenazine, their preparation and use Pat. Sub. Date(s): All strengths: Jul 25, 2024 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 patent for this product
Pat. No. 11311488 DP* Osmotic dosage forms comprising deutetrabenazine and methods of use thereof Pat. Sub. Date(s): All strengths: Jul 25, 2024 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 patent for this product
Pat. No. 11357772 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 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 patent for this product
Pat. No. 11446291 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 Claim Types: Dosaage regimen Use Code: U-1995: Treatment of tardive dyskinesia	Mar 7, 2036	New patent for this product
Pat. No. 11564917 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 Claim Types: Method of use Use Code: U-1995: Treatment of tardive dyskinesia	Mar 7, 2036	New patent for this product
Pat. No. 11648244 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 Claim Types: Method of use Use Code: U-1995: Treatment of tardive dyskinesia	Mar 7, 2036	New patent for this product
Pat. No. 11813232 DP* Analogs of deutetrabenazine, their preparation and use Pat. Sub. Date(s): All strengths: Jul 25, 2024 Claim Types: Process; Product-by-process	Mar 15, 2038	New patent for this product
Pat. No. 12016858 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 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 patent 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. 12036191 Treatment of poor metabolizers of dextromethorphan with a combination of bupropion and dextromethorphan Pat. Sub. Date(s): 001: Aug 5, 2024 Claim Types: Method of use Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder	Feb 15, 2043	New patent for this product
Pat. No. 12042473 Compounds and combinations thereof for treating neurological and psychiatric conditions Pat. Sub. Date(s): 001: Aug 5, 2024 Claim Types: Method of use Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder	Feb 23, 2043	New patent for this product

BAXDELA (POWDER) (INTRAVENOUS) DELAFLOXACIN MEGLUMINE
Drug Classes: fluoroquinolone antibacterial
NDA Applicant: MELINTA      NDA No.: 208611  Prod. No.: 001 RX (EQ 300MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 12036219 Methods of treating infections in overweight and obese patients using antibiotics Pat. Sub. Date(s): 001: Jul 30, 2024 Claim Types: Method of use Use Code: U-3967: Treating an acute bacterial skin and skin structure infection (ABSSSI) in an overweight or obese patient by intravenously (IV) administering 300mg of delafloxacin or a pharmaceutically acceptable salt, twice a day	Jun 2, 2034	New patent for this product

DSUVIA (TABLET) (SUBLINGUAL) SUFENTANIL CITRATE
Drug Classes: opioid agonist
NDA Applicant: VERTICAL PHARMS      NDA No.: 209128  Prod. No.: 001 RX (EQ 0.03MG BASE)

Patents	Expiration	Change
Pat. No. 12033733 DP* Storage and dispensing devices for administration of oral transmucosal dosage forms Pat. Sub. Date(s): 001: Jul 31, 2024 Claim Types: Device	Mar 16, 2030	New patent for this product

EPHEDRINE SULFATE (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: ENDO OPERATIONS      NDA No.: 213994  Prod. No.: 002 RX (25MG/5ML (5MG/ML))

Patents	Expiration	Change
Pat. No. 12029710 Ephedrine compositions and methods Pat. Sub. Date(s): 002: Jul 16, 2024 Claim Types: Method of use Use Code: U-3963: Treatment of clinically important hypotension occurring in the setting of anesthesia	Jan 22, 2040	New patent for this product

ERZOFRI (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) PALIPERIDONE PALMITATE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: LUYE INNOMIND PHARMA      NDA No.: 216352  Prod. No.: 001 RX (39MG/0.25ML (39MG/0.25ML)); 002 RX (78MG/0.5ML (78MG/0.5ML)); 003 RX (117MG/0.75ML (117MG/0.75ML)); 004 RX (156MG/ML (156MG/ML)); 005 RX (234MG/1.5ML (156MG/ML)); 006 RX (351MG/2.25ML (156MG/ML))

Patents	Expiration	Change
Pat. No. 11666573 Dosage regimen of paliperidone palmitate extended-release injectable suspension Pat. Sub. Date(s): All strengths: Jul 30, 2024 Claim Types: Dosaage regimen Use Code: U-3968: Dosing regimen for the treatment of schizophrenia in adults by administering an initial dose of paliperidone palmitate followed by monthly dose(s) Use Code: U-3969: Dosing regimen for the treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants by administering an initial dose of paliperidone palmitate followed by monthly dose(s)	Sep 24, 2039	New product in Orange Book

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. 12042488 DS* Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Jul 30, 2024 Claim Types: Composition	May 30, 2038	New patent for this product
Pat. No. 12042489 DS* Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Jul 30, 2024 Claim Types: Composition; Method of use Use Code: U-2371: The treatment of Fabry patients	May 30, 2038	New patent for this product
Pat. No. 12042490 Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Jul 30, 2024 Claim Types: Method of use Use Code: U-2371: The treatment of Fabry patients	May 30, 2038	New patent for this product

HETLIOZ (CAPSULE) (ORAL) TASIMELTEON [GENERIC AB]
Drug Classes: melatonin receptor agonist
NDA Applicant: VANDA PHARMS INC      NDA No.: 205677  Prod. No.: 001 RX (20MG)

Patents	Expiration	Change
Pat. No. 12049457 DS* DP* Highly purified pharmaceutical grade tasimelteon Pat. Sub. Date(s): 001: Aug 2, 2024 Claim Types: Product-by-process	Feb 12, 2035	New patent for this product

HETLIOZ LQ (SUSPENSION) (ORAL) TASIMELTEON
Drug Classes: melatonin receptor agonist
NDA Applicant: VANDA PHARMS INC      NDA No.: 214517  Prod. No.: 001 RX (4MG/ML)

Patents	Expiration	Change
Pat. No. 12049457 DS* DP* Highly purified pharmaceutical grade tasimelteon Pat. Sub. Date(s): 001: Aug 2, 2024 Claim Types: Product-by-process	Feb 12, 2035	New patent for this product

IBSRELA (TABLET) (ORAL) TENAPANOR HYDROCHLORIDE
Drug Classes: sodium/hydrogen exchanger 3 (NHE3) inhibitor
NDA Applicant: ARDELYX INC      NDA No.: 211801  Prod. No.: 001 RX (EQ 50MG BASE)

Patents	Expiration	Change
Pat. No. 12016856 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders Pat. Sub. Date(s): 001: Jul 24, 2024 Claim Types: Compound	Dec 30, 2029	New patent for this product

IGALMI (FILM) (BUCCAL, SUBLINGUAL) DEXMEDETOMIDINE HYDROCHLORIDE
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: BIOXCEL      NDA No.: 215390  Prod. No.: 001 RX (EQ 0.12MG BASE); 002 RX (EQ 0.18MG BASE)

Patents	Expiration	Change
Pat. No. 11890272 Non-sedating Dexmedetomidine Treatment Regimens Pat. Sub. Date(s): All strengths: Feb 6, 2024 Claim Types: Method of use Use Code: U-3756: Acute treatment of agitation associated with bipolar I or II disorder by sublingual or buccal administration Use Code: U-3935: Acute treatment of agitation associated with schizophrenia or bipolar I or II disorder by sublingual or buccal administration	Jul 17, 2040	New Use Code

IMBRUVICA (CAPSULE) (ORAL) IBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PHARMACYCLICS LLC      NDA No.: 205552  Prod. No.: 001 RX (140MG); 002 RX (70MG)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsection	Feb 24, 2026 PED	New expiration date. Was previously Aug 4, 2025

IMBRUVICA (TABLET) (ORAL) IBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PHARMACYCLICS LLC      NDA No.: 210563  Prod. No.: 001 RX (140MG); 002 RX (280MG); 003 RX (420MG) NDA No.: 210563  Prod. No.: 004 DISC (560MG)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsection	Feb 24, 2026 PED	New expiration date. Was previously Aug 4, 2025

INLYTA (TABLET) (ORAL) AXITINIB
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 202324  Prod. No.: 001 RX (1MG); 002 RX (5MG)

Patents	Expiration	Change
Pat. No. 6534524 DS* DP* [Extended 1764 days (4.8 years)] Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use Pat. Sub. Date(s): 001: Feb 16, 2012; 002: None Claim Types: Compound; Composition; Method of use	Oct 29, 2025 *PED	New expiration date. Was previously Apr 29, 2025
Pat. No. 8791140 DS* Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals Pat. Sub. Date(s): All strengths: None Claim Types: New polymorph, salt or hydrate	Jun 14, 2031 *PED	New expiration date. Was previously Dec 14, 2030
Pat. No. 10570202 Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer Pat. Sub. Date(s): All strengths: Jun 30, 2020 Claim Types: Method of use; Kit Use Code: U-2844: In combination with pembrolizumab for the first-line treatment of patients with advanced renal cell carcinoma	Aug 3, 2035 *PED	New expiration date. Was previously Feb 3, 2035
Pat. No. 10869924 PD-L1 antagonist combination treatments Pat. Sub. Date(s): All strengths: Jan 21, 2021 Claim Types: Method of use Use Code: U-3044: Axitinib in combination with avelumab for the first-line treatment of patients with advanced renal cell carcinoma	Jul 12, 2037 *PED	New expiration date. Was previously Jan 12, 2037

IQIRVO (TABLET) (ORAL) ELAFIBRANOR
NDA Applicant: IPSEN      NDA No.: 218860  Prod. No.: 001 RX (80MG)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-486: Treatment of primary biliary cholangitis (PBC) in adults who have had an inadequate response to ursodeoxycholic acid (UDCA), or in patients unable to tolerate UDCA	Jun 10, 2031	New exclusivity for this product

KLISYRI (OINTMENT) (TOPICAL) TIRBANIBULIN
Drug Classes: microtubule inhibitor
NDA Applicant: ALMIRALL      NDA No.: 213189  Prod. No.: 001 RX (1%)

Exclusivity	Expiration	Change
Exclusivity Code: D - New Dosing Schedule: D-192: Expansion of the treatment field on the face or scalp up to 100 cm^2	Jun 7, 2027	New exclusivity for this product

KONVOMEP (FOR SUSPENSION) (ORAL) OMEPRAZOLE; SODIUM BICARBONATE
Drug Classes: proton pump inhibitor
NDA Applicant: AZURITY      NDA No.: 213593  Prod. No.: 001 RX (2MG/ML;84MG/ML)

Patents	Expiration	Change
Pat. No. 12042539 DP* Compositions and kits for Omeprazole suspension Pat. Sub. Date(s): 001: Aug 2, 2024 Claim Types: Excipient	Jul 16, 2039	New patent for this product

LUMAKRAS (TABLET) (ORAL) SOTORASIB
NDA Applicant: AMGEN INC      NDA No.: 214665  Prod. No.: 003 RX (240MG)

Patents	Expiration	Change
Pat. No. 10519146 DS* DP* KRAS G12C inhibitors and methods of using the same Pat. Sub. Date(s): 003: Jul 18, 2024 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): 003: Jul 18, 2024 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): 003: Jul 18, 2024 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	Sep 15, 2040	New strength or variation of this product
Pat. No. 11827635 DS* DP* Solid state forms Pat. Sub. Date(s): 003: Jul 18, 2024 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
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	May 28, 2026	New strength or variation of this product
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	May 28, 2028	New strength or variation of this product

MONOFERRIC (SOLUTION) (INTRAVENOUS) FERRIC DERISOMALTOSE
NDA Applicant: PHARMACOSMOS AS      NDA No.: 208171  Prod. No.: 003 RX (1GM/10ML (100MG/ML)) NDA No.: 208171  Prod. No.: 001 DISC (100MG/ML (100MG/ML)); 002 DISC (500MG/5ML (100MG/ML))

Patents	Expiration	Change
Pat. No. 11851504 DS* DP* Stable iron oligosaccharide compound Pat. Sub. Date(s): All strengths: Jan 11, 2024 Claim Types: Compound	Mar 25, 2029	New patent for this product
Pat. No. 12030962 DS* DP* Stable iron oligosaccharide compound Pat. Sub. Date(s): All strengths: Aug 5, 2024 Claim Types: Compound; Process; Product-by-process	Mar 25, 2029	New patent for this product

NUCYNTA (TABLET) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC      NDA No.: 022304  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE); 003 RX (EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Use Code: U-931: Relief of moderate to severe acute pain	Dec 27, 2025 *PED	New expiration date. Was previously Jun 27, 2025
Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Jan 3, 2027 PED	New expiration date. Was previously Jul 3, 2026

NUCYNTA (SOLUTION) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC      NDA No.: 203794  Prod. No.: 001 DISC (EQ 20MG BASE/ML**)

Patents	Expiration	Change
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Pat. Sub. Date(s): 001: Oct 24, 2012 Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Use Code: U-1289: Management of moderate to severe acute pain	Dec 27, 2025 *PED	New expiration date. Was previously Jun 27, 2025
Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Jan 3, 2027 PED	New expiration date. Was previously Jul 3, 2026

NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: COLLEGIUM PHARM INC      NDA No.: 200533  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 200MG BASE); 005 RX (EQ 250MG BASE)

Patents	Expiration	Change
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None; 004: None; 005: None Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Use Code: U-1178: Relief of moderate to severe chronic pain Use Code: U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy	Dec 27, 2025 *PED	New expiration date. Was previously Jun 27, 2025
Pat. No. 8536130 Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain Pat. Sub. Date(s): All strengths: None Claim Types: Method of use Use Code: U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy	Mar 22, 2029 *PED	New expiration date. Was previously Sep 22, 2028
Pat. No. 11344512 Titration of tapentadol Pat. Sub. Date(s): All strengths: Jun 29, 2022 Claim Types: Method of use Use Code: U-3391: A method of titrating an opioid to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate Use Code: U-3392: A method of titrating an opioid to manage neuropathic pain associated with diabetic peripheral neuropathy severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate	Oct 21, 2028 *PED	New expiration date. Was previously Apr 21, 2028

OGSIVEO (TABLET) (ORAL) NIROGACESTAT HYDROBROMIDE
NDA Applicant: SPRINGWORKS      NDA No.: 217677  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 12036207 Treatments with nirogacestat Pat. Sub. Date(s): All strengths: Jul 25, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New patent for this product

OHTUVAYRE (SUSPENSION) (INHALATION) ENSIFENTRINE
NDA Applicant: VERONA PHARMA      NDA No.: 217389  Prod. No.: 001 RX (3MG/2.5ML)

Patents	Expiration	Change
Pat. No. 9062047 DS* Crystalline form of pyrimido[6,1-A] isoquinolin-4-one compound Pat. Sub. Date(s): 001: Jul 12, 2024 Claim Types: New polymorph, salt or hydrate; Composition; Process; Product-by-process Use Code: U-3962: For the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients	Aug 21, 2031	New patent for this product
Pat. No. 9956171 DP* Liquid inhalation formulation comprising RPL554 Pat. Sub. Date(s): 001: Jul 12, 2024 Claim Types: Formulation; Drug in a container; Method of use Use Code: U-3962: For the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients	Sep 15, 2035	New patent for this product
Pat. No. 10945950 DP* Liquid inhalation formulation comprising RPL554 Pat. Sub. Date(s): 001: Jul 12, 2024 Claim Types: Formulation; Drug in a container	Sep 15, 2035	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Jun 26, 2029	New exclusivity for this product

ONPATTRO (SOLUTION) (INTRAVENOUS) PATISIRAN SODIUM
Drug Classes: transthyretin-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC      NDA No.: 210922  Prod. No.: 001 RX (EQ 10MG BASE/5ML (EQ 2MG BASE/ML))

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-270: Information added to clinical pharmacology section	Jan 13, 2026	New exclusivity for this product

PARAGARD T 380A (SYSTEM) (INTRAUTERINE) COPPER
Drug Classes: copper-containing intrauterine device (IUD)
NDA Applicant: COOPERSURGICAL      NDA No.: 018680  Prod. No.: 001 RX (309MG/COPPER)

Exclusivity	Expiration	Change
Exclusivity Code: D - New Dosing Schedule: D-193: New inserter intended to facilitate single-hand placement	Jun 28, 2027	New exclusivity for this product

POSLUMA (SOLUTION) (INTRAVENOUS) FLOTUFOLASTAT F-18 GALLIUM
NDA Applicant: BLUE EARTH      NDA No.: 216023  Prod. No.: 001 RX (25ML (8-158mCi/ML))

Patents	Expiration	Change
Pat. No. 12036290 DP* Pharmaceutical formulations Pat. Sub. Date(s): 001: Aug 1, 2024 Claim Types: Formulation; Diagnostic or surgical method; Process Use Code: U-3614: Positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy Use Code: U-3615: Positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level	Nov 27, 2041	New patent for this product

QLOSI (SOLUTION) (OPHTHALMIC) PILOCARPINE HYDROCHLORIDE
Drug Classes: cholinergic agonist
NDA Applicant: ORASIS PHARMS      NDA No.: 217836  Prod. No.: 001 RX (0.4%)

Patents	Expiration	Change
Pat. No. 11974986 Ophthalmic pharmaceutical compositions and uses relating thereto Pat. Sub. Date(s): 001: Jul 17, 2024 Claim Types: Method of Use claimed by its inherent performace characteristics Use Code: U-3741: Treatment of presbyopia	Aug 18, 2037	New patent for this product

RETEVMO (CAPSULE) (ORAL) SELPERCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.: 213246  Prod. No.: 001 RX (40MG); 002 RX (80MG)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-487: Treatment of pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options	May 29, 2031	New exclusivity for this product

RETEVMO (TABLET) (ORAL) SELPERCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.: 218160  Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (120MG); 004 RX (160MG)

Patents	Expiration	Change
Pat. No. 10137124 Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): All strengths: May 9, 2024 Claim Types: Method of use Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2037	New Use Code; Deleted Use Code(s): U-3451, U-3452, U-3453
Pat. No. 10172851 Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): All strengths: May 9, 2024 Claim Types: Method of use Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2037	New Use Code; Deleted Use Code(s): U-3451, U-3452, U-3453
Pat. No. 10584124 DS* DLR* Crystalline forms Pat. Sub. Date(s): None Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options	Oct 10, 2038	This patent is no longer listed for this product
Pat. No. 10786489 DP* DLR* Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-- diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-A]pyridine-3-carb- onitrile Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options	Oct 10, 2038	This patent is no longer listed for this product

RHOPRESSA (SOLUTION/DROPS) (OPHTHALMIC) NETARSUDIL MESYLATE
Drug Classes: Rho kinase inhibitor
NDA Applicant: ALCON LABS INC      NDA No.: 208254  Prod. No.: 001 RX (EQ 0.02% BASE)

Patents	Expiration	Change
Pat. No. 11020385 Combination therapy Pat. Sub. Date(s): 001: Jul 12, 2024 Claim Types: Method of use Use Code: U-1524: Reduction of elevated intraocular pressure	Mar 14, 2034	New patent for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.: 211675  Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Apr 26, 2027	New expiration date. Was previously Apr 24, 2027

ROCKLATAN (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST; NETARSUDIL DIMESYLATE
Drug Classes: prostaglandin analog == Rho kinase inhibitor
NDA Applicant: ALCON LABS INC      NDA No.: 208259  Prod. No.: 001 RX (0.005%;EQ 0.02% BASE)

Patents	Expiration	Change
Pat. No. 11020385 Combination therapy Pat. Sub. Date(s): 001: Jul 12, 2024 Claim Types: Method of use Use Code: U-1524: Reduction of elevated intraocular pressure	Mar 14, 2034	New patent for this product

SIRTURO (TABLET) (ORAL) BEDAQUILINE FUMARATE
Drug Classes: diarylquinoline antimycobacterial
NDA Applicant: JANSSEN THERAP      NDA No.: 204384  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 20MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous M-306: (Code description not yet released by FDA)	Jun 21, 2027	New exclusivity for this product

SOFDRA (GEL, METERED) (TOPICAL) SOFPIRONIUM BROMIDE
NDA Applicant: BOTANIX SB      NDA No.: 217347  Prod. No.: 001 RX (EQ 12.45% BASE (EQ 72MG BASE/ACTUATION))

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Jun 20, 2029	New exclusivity for this product

SOHONOS (CAPSULE) (ORAL) PALOVAROTENE
Drug Classes: retinoid
NDA Applicant: IPSEN      NDA No.: 215559  Prod. No.: 001 RX (1MG); 002 RX (1.5MG); 003 RX (2.5MG); 004 RX (5MG); 005 RX (10MG)

Patents	Expiration	Change
Pat. No. 12023312 Composition and method for muscle repair and regeneration Pat. Sub. Date(s): All strengths: Jul 25, 2024 Claim Types: Method of use Use Code: U-3966: Reduction of heterotopic ossification in patients with fibrodysplasia ossificans (myositis) progressiva	Aug 31, 2031	New patent for this product

TEPYLUTE (SOLUTION) (INTRAVENOUS) THIOTEPA
Drug Classes: alkylating drug
NDA Applicant: SHORLA      NDA No.: 216984  Prod. No.: 001 RX (15MG/1.5ML (10MG/ML))

Patents	Expiration	Change
Pat. No. 11975013 DP* Stable formulations comprising thiotepa Pat. Sub. Date(s): 001: Jul 25, 2024 Claim Types: Formulation	Aug 16, 2041	New patent for this product

TLANDO (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: VERITY      NDA No.: 208088  Prod. No.: 001 RX (112.5MG)

Patents	Expiration	Change
Pat. No. 12011503 DP* Fixed dose oral testosterone undecanoate compositions and use thereof Pat. Sub. Date(s): 001: Jul 17, 2024 Claim Types: Formulation claimed by its inherent performace characteristics Use Code: U-3964: Methods of administering testosterone undecanoate for restoring testosterone concentration in a hypogonadal male subject Use Code: U-3965: Methods of continuing or discontinuing a dosage regimen of a testosterone undecanoate pharmaceutical composition to a hypogonadal male subject	Oct 16, 2040	New patent for this product

VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS      NDA No.: 202057  Prod. No.: 001 RX (1GM); 002 RX (500MG)

Patents	Expiration	Change
Pat. No. 8357677 Methods of treating hypertriglyceridemia Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia	Feb 9, 2030	This patent is no longer listed for this product

VELPHORO (TABLET, CHEWABLE) (ORAL) FERRIC OXYHYDROXIDE
NDA Applicant: VIFOR FRESENIUS      NDA No.: 205109  Prod. No.: 001 RX (EQ 500MG IRON)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Jan 1, 2028 PED	New exclusivity for this product

XPHOZAH (TABLET) (ORAL) TENAPANOR HYDROCHLORIDE
Drug Classes: sodium/hydrogen exchanger 3 (NHE3) inhibitor
NDA Applicant: ARDELYX INC      NDA No.: 213931  Prod. No.: 002 RX (EQ 20MG BASE); 003 RX (EQ 30MG BASE) NDA No.: 213931  Prod. No.: 001 DISC (EQ 10MG BASE)

Patents	Expiration	Change
Pat. No. 12016856 DS* DP* Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders Pat. Sub. Date(s): All strengths: Jul 24, 2024 Claim Types: Compound	Dec 30, 2029	New patent for this product

XROMI (SOLUTION) (ORAL) HYDROXYUREA
Drug Classes: antimetabolite
NDA Applicant: NOVA LABS LTD      NDA No.: 216593  Prod. No.: 001 RX (100MG/ML)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Apr 4, 2027	New exclusivity for this product

XYWAV (SOLUTION) (ORAL) CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: JAZZ      NDA No.: 212690  Prod. No.: 001 RX (0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-361: Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy	Jan 21, 2028 PED	New expiration date. Was previously Jul 21, 2027

YUPELRI (SOLUTION) (INHALATION) REVEFENACIN
Drug Classes: anticholinergic
NDA Applicant: MYLAN IRELAND LTD      NDA No.: 210598  Prod. No.: 001 RX (175MCG/3ML)

Patents	Expiration	Change
Pat. No. 12048692 Methods for treating chronic obstructive pulmonary disease Pat. Sub. Date(s): 001: Jul 30, 2024 Claim Types: Method of use Use Code: U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)	Aug 29, 2039	New patent for this product

ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS      NDA No.: 215985  Prod. No.: 002 RX (0.15%)

Exclusivity	Expiration	Change
Exclusivity Code: NS - New strength	Jul 9, 2027	New strength or variation of this product