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

AQNEURSA (FOR SUSPENSION) (ORAL) LEVACETYLLEUCINE
NDA Applicant: INTRABIO      NDA No.: 219132  Prod. No.: 001 RX (1GM/PACKET)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-498: Treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing greater than or equal to 15 kg	Sep 24, 2031	New exclusivity for this product

ARTESUNATE (POWDER) (INTRAVENOUS) ARTESUNATE
NDA Applicant: AMIVAS      NDA No.: 213036  Prod. No.: 001 RX (110MG/VIAL)

Patents	Expiration	Change
Pat. No. 12121506 DP* Artesunate powders, pharmaceutical compositions and methods of manufacture Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation claimed by its inherent performace characteristics; Process	Feb 16, 2044	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. 12109178 Bupropion as a modulator of drug activity Pat. Sub. Date(s): 001: Oct 15, 2024 Claim Types: Method of use Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder	Nov 5, 2034	New patent for this product

BYLVAY (CAPSULE, PELLETS) (ORAL) ODEVIXIBAT
Drug Classes: ileal bile acid transporter (IBAT) inhibitor
NDA Applicant: IPSEN      NDA No.: 215498  Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (1.2MG)

Patents	Expiration	Change
Pat. No. 12091394 DS* Crystal modifications of odevixibat Pat. Sub. Date(s): All strengths: Oct 17, 2024 Claim Types: Process; Product-by-process	Jun 20, 2039	New patent for this product

BYNFEZIA PEN (SOLUTION) (SUBCUTANEOUS) OCTREOTIDE ACETATE
Drug Classes: somatostatin analog
NDA Applicant: SUN PHARM      NDA No.: 213224  Prod. No.: 001 RX (7MG/2.8ML (2.5MG/ML))

Patents	Expiration	Change
Pat. No. 11052196 Method of injecting octreotide acetate into the body Pat. Sub. Date(s): 001: Oct 18, 2024 Claim Types: Method of use Use Code: U-4007: Method of treating acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses Use Code: U-4008: Method of treating profuse watery diarrhea associated with vasoactive intestinal peptide tumors (vipomas)-secreting tumors Use Code: U-4009: Method of treating severe diarrhea and flushing episodes associated with metastatic carcinoid tumors	Nov 3, 2040	New patent for this product
Pat. No. 11246991 Method of injecting octreotide acetate into the body Pat. Sub. Date(s): 001: Oct 18, 2024 Claim Types: Method of use; Method of administration Use Code: U-4007: Method of treating acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses Use Code: U-4008: Method of treating profuse watery diarrhea associated with vasoactive intestinal peptide tumors (vipomas)-secreting tumors Use Code: U-4009: Method of treating severe diarrhea and flushing episodes associated with metastatic carcinoid tumors	Nov 3, 2040	New patent for this product
Pat. No. 11534553 Method of injecting octreotide acetate into the body Pat. Sub. Date(s): 001: Oct 18, 2024 Claim Types: Method of use; Method of administration Use Code: U-4007: Method of treating acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses Use Code: U-4008: Method of treating profuse watery diarrhea associated with vasoactive intestinal peptide tumors (vipomas)-secreting tumors Use Code: U-4009: Method of treating severe diarrhea and flushing episodes associated with metastatic carcinoid tumors	Nov 3, 2040	New patent for this product

CAPLYTA (CAPSULE) (ORAL) LUMATEPERONE TOSYLATE
Drug Classes: atypical antipsychotic
NDA Applicant: INTRA-CELLULAR      NDA No.: 209500  Prod. No.: 001 RX (EQ 42MG BASE)

Patents	Expiration	Change
Pat. No. 12122792 DP* Pharmaceutical compositions comprising 4-((6bR,10aS)-3-methyl2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin8(7H)-yl)-1-(4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)phenyl)butan-1-one for treating conditions of the central nervous system and cardiac disorders Pat. Sub. Date(s): 001: Oct 28, 2024 Claim Types: Composition; Formulation; Method of use Use Code: U-4019: Treatment of bipolar depression by inhibiting the 5-HT2A receptor, inhibiting the serotonin transporter, and/or modulating dopamine D2 receptor function, or treatment of bipolar disorder Use Code: U-4020: Treatment of schizophrenia by inhibiting the 5-HT2A receptor, inhibiting the serotonin transporter, and/or modulating dopamine D2 receptor function, or treatment of schizophrenia	Dec 10, 2040	New patent for this product
Pat. No. 12128043 DP* Pharmaceutical capsules comprising lumateperone mono-tosylate Pat. Sub. Date(s): 001: Oct 30, 2024 Claim Types: Formulation; Method of use; Formulation claimed by its inherent performace characteristics Use Code: U-3362: Treatment of bipolar depression mediated by the 5-HT2A receptor, serotonin transporter, and/or dopamine d1/d2 signaling pathways Use Code: U-3363: Treatment of schizophrenia mediated by the 5-HT2A receptor, serotonin transporter, and/or dopamine D1/D2 signaling pathways	Aug 30, 2039	New patent for this product

CAPLYTA (CAPSULE) (ORAL) LUMATEPERONE TOSYLATE
Drug Classes: atypical antipsychotic
NDA Applicant: INTRA-CELLULAR      NDA No.: 209500  Prod. No.: 002 RX (EQ 10.5MG BASE); 003 RX (EQ 21MG BASE)

Patents	Expiration	Change
Pat. No. 12122792 DP* Pharmaceutical compositions comprising 4-((6bR,10aS)-3-methyl2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin8(7H)-yl)-1-(4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)phenyl)butan-1-one for treating conditions of the central nervous system and cardiac disorders Pat. Sub. Date(s): All strengths: Oct 28, 2024 Claim Types: Composition; Formulation; Method of use Use Code: U-4019: Treatment of bipolar depression by inhibiting the 5-HT2A receptor, inhibiting the serotonin transporter, and/or modulating dopamine D2 receptor function, or treatment of bipolar disorder Use Code: U-4020: Treatment of schizophrenia by inhibiting the 5-HT2A receptor, inhibiting the serotonin transporter, and/or modulating dopamine D2 receptor function, or treatment of schizophrenia	Dec 10, 2040	New patent for this product

COBENFY (CAPSULE) (ORAL) TROSPIUM CHLORIDE; XANOMELINE TARTRATE
Drug Classes: muscarinic antagonist
NDA Applicant: BRISTOL-MYERS      NDA No.: 216158  Prod. No.: 001 RX (20MG;EQ 50MG BASE); 002 RX (20MG;EQ 100MG BASE); 003 RX (30MG;EQ 125MG BASE)

Patents	Expiration	Change
Pat. No. 10238643 DP* Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Formulation	Jul 21, 2030	New patent for this product
Pat. No. 10265311 Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Method of use Use Code: U-3513: Treatment of schizophrenia in adults	Jul 21, 2030	New patent for this product
Pat. No. 10369143 Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Method of use Use Code: U-3513: Treatment of schizophrenia in adults	Jul 21, 2030	New patent for this product
Pat. No. 10369144 DP* Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Formulation; Method of use Use Code: U-3513: Treatment of schizophrenia in adults	Jul 21, 2030	New patent for this product
Pat. No. 10695339 Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Method of use Use Code: U-3513: Treatment of schizophrenia in adults	Jul 21, 2030	New patent for this product
Pat. No. 10925832 DP* Compositions and methods for treatment of disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Formulation	Sep 27, 2039	New patent for this product
Pat. No. 10933020 DP* Compositions and methods for treating disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Formulation; Method of use; Process Use Code: U-3513: Treatment of schizophrenia in adults	Sep 27, 2039	New patent for this product
Pat. No. 11452692 Compositions and methods for treating disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Method of use Use Code: U-3513: Treatment of schizophrenia in adults	Sep 27, 2039	New patent for this product
Pat. No. 11471413 Compositions and methods for treating disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Method of administration Use Code: U-3513: Treatment of schizophrenia in adults	Sep 27, 2039	New patent for this product
Pat. No. 11890378 DP* Compositions and methods for treating disorders ameliorated by muscarinic receptor activation Pat. Sub. Date(s): All strengths: Oct 25, 2024 Claim Types: Formulation; Method of use Use Code: U-3513: Treatment of schizophrenia in adults	Sep 27, 2039	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Sep 26, 2029	New exclusivity for this product

CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS      NDA No.: 207500  Prod. No.: 001 RX (186MG); 002 RX (74.5MG)

Patents	Expiration	Change
Pat. No. 6812238 DS* N-substituted carbamoyloxyalkyl-azolium derivatives Pat. Sub. Date(s): 001: Apr 1, 2015; 002: Jun 29, 2023 Claim Types: Composition; Method of use; Compound	Apr 30, 2026 *PED	New expiration date. Was previously May 1, 2026 *PED

CRESEMBA (POWDER) (INTRAVENOUS) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS      NDA No.: 207501  Prod. No.: 001 RX (372MG)

Patents	Expiration	Change
Pat. No. 6812238 DS* N-substituted carbamoyloxyalkyl-azolium derivatives Pat. Sub. Date(s): 001: Apr 1, 2015 Claim Types: Composition; Method of use; Compound	Apr 30, 2026 *PED	New expiration date. Was previously May 1, 2026 *PED

CREXONT (CAPSULE, EXTENDED RELEASE) (ORAL) CARBIDOPA; LEVODOPA
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: IMPAX      NDA No.: 217186  Prod. No.: 001 RX (35MG;140MG); 002 RX (52.5MG;210MG); 003 RX (70MG;280MG); 004 RX (87.5MG;350MG)

Patents	Expiration	Change
Pat. No. 12109185 Levodopa dosing regimen Pat. Sub. Date(s): All strengths: Oct 11, 2024 Claim Types: Method of use Use Code: U-1649: Treatment of post-encephalitic Parkinsonism Use Code: U-219: Treatment of Parkinson's disease Use Code: U-4004: Treatment of parkinsonism that may follow carbon monoxide intoxication Use Code: U-4005: Treatment of parkinsonism that may follow manganese intoxication	Dec 21, 2041	New patent for this product

CYCLOSET (TABLET) (ORAL) BROMOCRIPTINE MESYLATE
Drug Classes: ergot derivative
NDA Applicant: VEROSCIENCE      NDA No.: 020866  Prod. No.: 001 RX (EQ 0.8MG BASE)

Patents	Expiration	Change
Pat. No. 11666567 Bromocriptine formulations Pat. Sub. Date(s): 001: Oct 25, 2024 Claim Types: Formulation; Method of use Use Code: U-4015: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1 and 10 Use Code: U-4016: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 1, 10, and 11 Use Code: U-4017: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 12 and 21 Use Code: U-4018: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetis by orally administering a dosage form comprising bromocriptine and one or more excipients as recited in claims 12, 21, and 22	Apr 30, 2032	New patent for this product

DETECTNET (SOLUTION) (INTRAVENOUS) COPPER CU-64 DOTATATE
Drug Classes: copper-containing intrauterine device (IUD)
NDA Applicant: RADIOMEDIX      NDA No.: 213227  Prod. No.: 001 RX (4mL (1mCi/ML))

Patents	Expiration	Change
Pat. No. 12102696 DP* Radiolabeling and formulation for scale up of 64Cu-DOTATATE Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation	Sep 3, 2041	New patent for this product

EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
NDA Applicant: JAZZ PHARMS RES      NDA No.: 210365  Prod. No.: 001 RX (100MG/ML)

Patents	Expiration	Change
Pat. No. 12102619 Methods of treating tuberous sclerosis complex with cannabidiol and everolimus Pat. Sub. Date(s): 001: Oct 31, 2024 Claim Types: Method of use Use Code: U-3233: Use for the treatment of seizures associated with tuberous sclerosis complex in patients taking everolimus	Mar 1, 2041	New patent for this product

ERYTHROMYCIN (TABLET, DELAYED RELEASE) (ORAL) ERYTHROMYCIN [GENERIC AB]
Drug Classes: macrolide == macrolide antimicrobial
NDA Applicant: TORRENT      NDA No.: 211975  Prod. No.: 003 RX (333MG)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 22, 2025	New exclusivity 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. 12128049 Dosage regimen of paliperidone palmitate extended-release injectable suspension Pat. Sub. Date(s): All strengths: Oct 31, 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)	Oct 26, 2038	New patent for this product

FINTEPLA (SOLUTION) (ORAL) FENFLURAMINE HYDROCHLORIDE
NDA Applicant: UCB INC      NDA No.: 212102  Prod. No.: 001 RX (EQ 2.2MG BASE/ML)

Patents	Expiration	Change
Pat. No. 12097206 Method for the treatment of Dravet Syndrome Pat. Sub. Date(s): 001: Oct 11, 2024 Claim Types: Method of use Use Code: U-4013: A method of adjunctive treating, preventing and/or ameliorating seizures in a person with dravet syndrome comprising administering fenfluramine or a salt thereof in a dose of 0.2 mg/kg/day to 0.5/mg/kg/day and doses of stiripentol and clobazam	Nov 3, 2033 *PED	New patent for this product

FLYRCADO (SOLUTION) (INTRAVENOUS) FLURPIRIDAZ F-18
NDA Applicant: GE HLTHCARE      NDA No.: 215168  Prod. No.: 001 RX (5-55mCi/ML)

Patents	Expiration	Change
Pat. No. 7344702 DS* Contrast agents for myocardial perfusion imaging Pat. Sub. Date(s): 001: Oct 22, 2024 Claim Types: Compound	May 26, 2026	New patent for this product
Pat. No. 8226929 Contrast agents for myocardial perfusion imaging Pat. Sub. Date(s): 001: Oct 22, 2024 Claim Types: Diagnostic or surgical method Use Code: U-4011: Method of positron emission tomography (PET) for cardiac imaging	Jun 21, 2028	New patent for this product
Pat. No. 8936777 Methods and apparatus for synthesizing imaging agents, and intermediates thereof Pat. Sub. Date(s): 001: Oct 22, 2024 Claim Types: Process; Compound; Method of use; Device Use Code: U-4011: Method of positron emission tomography (PET) for cardiac imaging	Jun 30, 2031	New patent for this product
Pat. No. 9161997 DS* DP* Contrast agents for myocardial perfusion imaging Pat. Sub. Date(s): 001: Oct 22, 2024 Claim Types: Compound; Kit; Diagnostic or surgical method Use Code: U-4011: Method of positron emission tomography (PET) for cardiac imaging	Feb 4, 2026	New patent for this product
Pat. No. 9603951 Methods and apparatus for synthesizing imaging agents, and intermediates thereof Pat. Sub. Date(s): 001: Oct 22, 2024 Claim Types: Diagnostic or surgical method Use Code: U-4011: Method of positron emission tomography (PET) for cardiac imaging	May 2, 2031	New patent for this product
Pat. No. 9687571 DP* Stabilization of radiopharmaceutical compositions using ascorbic acid Pat. Sub. Date(s): 001: Oct 22, 2024 Claim Types: Formulation; Process; Diagnostic or surgical method Use Code: U-4011: Method of positron emission tomography (PET) for cardiac imaging	Nov 1, 2032	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Sep 27, 2029	New exclusivity for this product

GALAFOLD (CAPSULE) (ORAL) MIGALASTAT HYDROCHLORIDE
NDA Applicant: AMICUS THERAP US      NDA No.: 208623  Prod. No.: 001 RX (EQ 123MG BASE)

Patents	Expiration	Change
Pat. No. 12109205 DS* Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Oct 15, 2024 Claim Types: Method of use; Compound Use Code: U-2371: The treatment of Fabry patients	May 30, 2038	New patent for this product

HYDROMORPHONE HYDROCHLORIDE (INJECTABLE) (INJECTION) HYDROMORPHONE HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist
NDA Applicant: HIKMA      NDA No.: 216899  Prod. No.: 001 RX (0.2MG/ML)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Apr 12, 2025	New exclusivity 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. 12109196 Non-sedating dexmedetomidine treatment regimens Pat. Sub. Date(s): All strengths: Oct 11, 2024 Claim Types: Method of use 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 patent for this product

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)

Patents	Expiration	Change
Pat. No. 8476284 Inhibitors of Bruton's tyrosine kinase Pat. Sub. Date(s): All strengths: Mar 6, 2018 Claim Types: Method of use Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia Use Code: U-1946: Treatment of small lymphocytic lymphoma Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion	Jun 28, 2027 *PED	Deleted Use Code(s): U-1456
Pat. No. 8497277 Inhibitors of Bruton's tyrosine kinase Pat. Sub. Date(s): All strengths: Mar 6, 2018 Claim Types: Method of use Use Code: U-1491: Treatment of chronic lymphocytic leukemia Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia Use Code: U-1946: Treatment of small lymphocytic lymphoma Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion Use Code: U-3422: Treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy	Jun 28, 2027 *PED	Deleted Use Code(s): U-1456
Pat. No. 8952015 Inhibitors of Bruton's tyrosine kinase Pat. Sub. Date(s): All strengths: Mar 6, 2018 Claim Types: Method of use Use Code: U-1491: Treatment of chronic lymphocytic leukemia Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia Use Code: U-1946: Treatment of small lymphocytic lymphoma Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion	Jun 28, 2027 *PED	Deleted Use Code(s): U-1456
Pat. No. 8754090 DLR* Use of inhibitors of bruton's tyrosine kinase (Btk) Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1456: Treatment of mantle cell lymphoma	Dec 3, 2031 *PED	This patent is no longer listed for this product

JAYPIRCA (TABLET) (ORAL) PIRTOBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: LOXO ONCOL      NDA No.: 216059  Prod. No.: 001 RX (50MG); 002 RX (100MG)

Patents	Expiration	Change
Pat. No. 12109193 DP* Spray-dried dispersions, formulations, and polymorphs of (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1H-pyrazole-4-carboxamide Pat. Sub. Date(s): All strengths: Oct 31, 2024 Claim Types: Formulation	Sep 14, 2041	New patent for this product

LITFULO (CAPSULE) (ORAL) RITLECITINIB TOSYLATE
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER      NDA No.: 215830  Prod. No.: 001 RX (EQ 50MG BASE)

Patents	Expiration	Change
Pat. No. 12116368 DS* Pyrrolo[2,3-d]pyrimidine tosylate salt, crystalline form thereof and manufacturing process and intermediates thereto Pat. Sub. Date(s): 001: Oct 17, 2024 Claim Types: New polymorph, salt or hydrate; Method of use	Oct 17, 2041	New patent for this product

LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: AVADEL CNS      NDA No.: 214755  Prod. No.: 001 RX (4.5GM/PACKET); 002 RX (6GM/PACKET); 003 RX (7.5GM/PACKET); 004 RX (9GM/PACKET)

Patents	Expiration	Change
Pat. No. 12097175 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Oct 15, 2024 Claim Types: Formulation	Jul 21, 2037	New patent for this product
Pat. No. 12097176 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Oct 15, 2024 Claim Types: Method of use Use Code: U-4006: Treatment of a disorder treatable with ghb using a single dose of a ghb formulation in an amount equivalent to 3 g to 12 g of sodium oxybate where the formulation contains an immediate release portion and a modified release portion	Jul 21, 2037	New patent for this product
Pat. No. 12109186 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Oct 15, 2024 Claim Types: Formulation	Jul 21, 2037	New patent for this product
Pat. No. 12115142 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Oct 22, 2024 Claim Types: Formulation	Jul 21, 2037	New patent for this product
Pat. No. 12115143 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Oct 22, 2024 Claim Types: Formulation	Jul 21, 2037	New patent for this product
Pat. No. 12115144 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Oct 22, 2024 Claim Types: Formulation	Jul 21, 2037	New patent for this product
Pat. No. 12115145 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Oct 22, 2024 Claim Types: Method of use; Formulation	Jul 21, 2037	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-494: Treatment of cataplexy or excessive daytime sleepiness (EDS) in pediatric patients 7 years of age and older with narcolepsy	Oct 16, 2031	New exclusivity for this product

MEKINIST (TABLET) (ORAL) TRAMETINIB DIMETHYL SULFOXIDE
Drug Classes: kinase inhibitor
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. 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	Feb 28, 2034 *PED	New expiration date. Was previously Mar 2, 2034 *PED

MIPLYFFA (CAPSULE) (ORAL) ARIMOCLOMOL CITRATE
NDA Applicant: ZEVRA DENMARK      NDA No.: 214927  Prod. No.: 001 RX (EQ 47MG BASE); 002 RX (EQ 62MG BASE); 003 RX (EQ 93MG BASE); 004 RX (EQ 124MG BASE)

Patents	Expiration	Change
Pat. No. 9289472 Use of HSP70 as a regulator of enzymatic activity Pat. Sub. Date(s): All strengths: Oct 21, 2024 Claim Types: Method of use Use Code: U-4021: Use of arimoclomol, in combination with miglustat, for treatment of neurological manifestations of Niemann-Pick disease type C (NPC)	Aug 11, 2029	New patent for this product
Pat. No. 9884058 Use of Hsp70 as a regulator of enzymatic activity Pat. Sub. Date(s): All strengths: Oct 21, 2024 Claim Types: Method of use Use Code: U-4021: Use of arimoclomol, in combination with miglustat, for treatment of neurological manifestations of Niemann-Pick disease type C (NPC)	Jun 26, 2029	New patent for this product
Pat. No. 11045460 Use of Hsp70 as a regulator of enzymatic activity Pat. Sub. Date(s): All strengths: Oct 21, 2024 Claim Types: Method of use Use Code: U-4021: Use of arimoclomol, in combination with miglustat, for treatment of neurological manifestations of Niemann-Pick disease type C (NPC)	Aug 19, 2029	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-496: Treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older	Sep 20, 2031	New exclusivity for this product

MYRBETRIQ GRANULES (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI      NDA No.: 213801  Prod. No.: 001 RX (8MG/ML)

Patents	Expiration	Change
Pat. No. 10058536 DP* Pharmaceutical composition containing mirabegron Pat. Sub. Date(s): 001: Apr 22, 2021 Claim Types: Formulation; Method of administration Use Code: U-3108: Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older by administration of an extended-release suspension formulation of mirabegron	Sep 30, 2036 *PED	New expiration date. Was previously Oct 1, 2036 *PED

NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: ACERUS PHARMS      NDA No.: 201656  Prod. No.: 001 DISC (0.00083MG/SPRAY); 002 DISC (0.00166MG/SPRAY)

Patents	Expiration	Change
Pat. No. 12090190 DP* Safe desmopressin administration Pat. Sub. Date(s): All strengths: Oct 11, 2024 Claim Types: Device; Method of use Use Code: U-4003: Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void by intranasally administering a plume of droplets comprising a dose of 0.75 mcg or 1.5 mcg desmopressin	Jun 15, 2030	New patent for this product

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. 12110277 DP* Synthesis of nirogacestat Pat. Sub. Date(s): All strengths: Oct 17, 2024 Claim Types: Composition	Jul 8, 2042	New patent for this product
Pat. No. 12116347 DP* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof Pat. Sub. Date(s): All strengths: Oct 17, 2024 Claim Types: New polymorph, salt or hydrate	Aug 9, 2039	New patent for this product

ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 203496  Prod. No.: 002 RX (EQ 0.25MG BASE); 003 RX (EQ 1MG BASE); 004 RX (EQ 2.5MG BASE)

Patents	Expiration	Change
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): None Claim Types: Product-by-process	Dec 15, 2028	This patent is no longer listed for this product

ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 210450  Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 200MG BASE)

Patents	Expiration	Change
Pat. No. 12102637 DP* Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Pat. Sub. Date(s): All strengths: Oct 29, 2024 Claim Types: Formulation	Aug 20, 2038	New patent for this product

ORSERDU (TABLET) (ORAL) ELACESTRANT DIHYDROCHLORIDE
Drug Classes: estrogen receptor antagonist
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, 2025	New expiration date. Was previously Dec 25, 2024

PONVORY (TABLET) (ORAL) PONESIMOD
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: VANDA PHARMS INC      NDA No.: 213498  Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (4MG); 004 RX (5MG); 005 RX (6MG)

Patents	Expiration	Change
Pat. No. RE43728 DS* DP* Thiazolidin-4-one derivatives Pat. Sub. Date(s): All strengths: Apr 14, 2021 Claim Types: Composition; Compound; Process	Nov 16, 2025	New expiration date. Was previously Nov 16, 2024

PREDNISOLONE ACETATE (SUSPENSION/DROPS) (OPHTHALMIC) PREDNISOLONE ACETATE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: LUPIN LTD      NDA No.: 216935  Prod. No.: 001 RX (1%)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 9, 2025	New exclusivity for this product

PREVYMIS (TABLET) (ORAL) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 209939  Prod. No.: 001 RX (240MG); 002 RX (480MG)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-495: Prophylaxis of cytomegalovirus (CMV) disease in pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [d+/r-])	Aug 30, 2031	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-497: Prophylaxis of cytomegalovirus (CMV) infection and disease in pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [r+] of an allogeneic hematopoietic stem cell transplant (HSCT)	Aug 30, 2031	New exclusivity for this product

PREVYMIS (SOLUTION) (INTRAVENOUS) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 209940  Prod. No.: 001 RX (240MG/12ML (20MG/ML)); 002 RX (480MG/24ML (20MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-495: Prophylaxis of cytomegalovirus (CMV) disease in pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [d+/r-])	Aug 30, 2031	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-497: Prophylaxis of cytomegalovirus (CMV) infection and disease in pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [r+] of an allogeneic hematopoietic stem cell transplant (HSCT)	Aug 30, 2031	New exclusivity for this product

PREVYMIS (PELLETS) (ORAL) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MSD      NDA No.: 219104  Prod. No.: 001 RX (20MG/PACKET); 002 RX (120MG/PACKET)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-495: Prophylaxis of cytomegalovirus (CMV) disease in pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [d+/r-])	Aug 30, 2031	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-497: Prophylaxis of cytomegalovirus (CMV) infection and disease in pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [r+] of an allogeneic hematopoietic stem cell transplant (HSCT)	Aug 30, 2031	New exclusivity for this product

PYRIDOSTIGMINE BROMIDE (TABLET, EXTENDED RELEASE) (ORAL) PYRIDOSTIGMINE BROMIDE
Drug Classes: cholinesterase inhibitor
NDA Applicant: AMNEAL      NDA No.: 217604  Prod. No.: 001 DISC (105MG)

Patents	Expiration	Change
Pat. No. 10881617 DP* Extended release compositions comprising pyridostigmine Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation	Jun 18, 2038	New product in Orange Book
Pat. No. 10925833 DP* Extended release compositions comprising pyridostigmine Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation	Jun 18, 2038	New product in Orange Book
Pat. No. 10987311 DP* Extended release compositions comprising pyridostigmine Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation; Method of use	Jun 18, 2038	New product in Orange Book
Pat. No. 11229606 DP* Extended release compositions comprising pyridostigmine Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation; Method of use	Jun 18, 2038	New product in Orange Book
Pat. No. 11478425 DP* Extended release compositions comprising pyridostigmine Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation; Method of use Use Code: U-4012: Pretreatment against the lethal effects of soman nerve agent poisoning	Jun 18, 2038	New product in Orange Book
Pat. No. 11666536 DP* Extended release compositions comprising pyridostigmine Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation; Method of use	Jun 18, 2038	New product in Orange Book
Pat. No. 11911515 DP* Extended release compositions comprising pyridostigmine Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation	Jun 18, 2038	New product in Orange Book
Pat. No. 12042559 DP* Gastroretentive dosage forms for sustained drug delivery Pat. Sub. Date(s): 001: Oct 23, 2024 Claim Types: Formulation; Method of improving a treatment	Jun 18, 2038	New product in Orange Book

QSYMIA (CAPSULE, EXTENDED RELEASE) (ORAL) PHENTERMINE HYDROCHLORIDE; TOPIRAMATE [GENERIC AB]
Drug Classes: sympathomimetic amine anorectic
NDA Applicant: VIVUS LLC      NDA No.: 022580  Prod. No.: 001 RX (EQ 3.75MG BASE;23MG); 002 RX (EQ 7.5MG BASE;46MG); 003 RX (EQ 11.25MG BASE;69MG); 004 RX (EQ 15MG BASE;92MG)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-308: Information added to the labeling to describe a clinical study	Sep 13, 2027	New exclusivity for this product

QULIPTA (TABLET) (ORAL) ATOGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 215206  Prod. No.: 003 RX (60MG)

Patents	Expiration	Change
Pat. No. 12090148 Treatment of migraine Pat. Sub. Date(s): 003: Oct 16, 2024 Claim Types: Method of use Use Code: U-3534: Preventive treatment of migraine in adults	Jul 29, 2041	New patent for this product

QUVIVIQ (TABLET) (ORAL) DARIDOREXANT HYDROCHLORIDE
Drug Classes: orexin receptor antagonist
NDA Applicant: IDORSIA      NDA No.: 214985  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 50MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-310: Revisions to the clinical studies section to reflect the results of a clinical study to fulfill post-marketing requirement 4150-1	Sep 30, 2027	New exclusivity for this product

REMODULIN (INJECTABLE) (INTRAVENOUS, SUBCUTANEOUS; IV (INFUSION), SUBCUTANEOUS) TREPROSTINIL [GENERIC AP]
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 021272  Prod. No.: 001 RX (1MG/ML); 002 RX (2.5MG/ML); 003 RX (5MG/ML); 004 RX (10MG/ML); 005 RX (20MG/ML); 006 RX (0.1MG/ML); 007 RX (0.2MG/ML); 008 RX (0.4MG/ML)

Patents	Expiration	Change
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): None Claim Types: Product-by-process	Dec 15, 2028	This patent is no longer listed for this product

REMODULIN (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 208276  Prod. No.: 001 DISC (20MG/20ML (1MG/ML)); 002 DISC (50MG/20ML (2.5MG/ML)); 003 DISC (100MG/20ML (5MG/ML)); 004 DISC (200MG/20ML (10MG/ML))

Patents	Expiration	Change
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): None Claim Types: Product-by-process	Dec 15, 2028	This patent is no longer listed 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)

Patents	Expiration	Change
Pat. No. 10137124 Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): All strengths: Jun 5, 2020 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-2826, U-2827, U-2828, 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: Jun 5, 2020 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-2826, U-2827, U-2828, U-3451, U-3452, U-3453
Pat. No. 10584124 DS* Crystalline forms Pat. Sub. Date(s): All strengths: Jun 5, 2020 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-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, 2038	New Use Code; Deleted Use Code(s): U-2826, U-2827, U-2828, U-3451, U-3452, U-3453
Pat. No. 10786489 DP* 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): All strengths: Oct 26, 2020 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-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, 2038	New Use Code; Deleted Use Code(s): U-2971, U-2972, U-2973, U-2974, U-2975, U-2976, U-2977, U-3451, U-3452, U-3453

REZUROCK (TABLET) (ORAL) BELUMOSUDIL MESYLATE
NDA Applicant: KADMON PHARMS LLC      NDA No.: 214783  Prod. No.: 001 RX (EQ 200MG BASE)

Patents	Expiration	Change
Pat. No. 12097202 Methods of administering Belumosudil for treatment of chronic graft versus host disease Pat. Sub. Date(s): 001: Oct 24, 2024 Claim Types: Method of use Use Code: U-4014: Treatment of chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients 12 years and older with a grade 3 infection adverse reaction	Jul 14, 2042	New patent for this product
Pat. No. 9815820 Rho kinase inhibitors Pat. Sub. Date(s): None Claim Types: Compound; Method of use Use Code: U-3247: For the treatment of chronic graft versus hold disease	Oct 7, 2033	This patent is no longer listed 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)

Patents	Expiration	Change
Pat. No. 12103933 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: Oct 31, 2024 Claim Types: Formulation claimed by its inherent performace characteristics	Oct 17, 2036	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.: 002 RX (30MG)

Patents	Expiration	Change
Pat. No. 12091415 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 002: Oct 16, 2024 Claim Types: Formulation claimed by its inherent performace characteristics	Oct 17, 2036	New patent for this product

RINVOQ LQ (SOLUTION) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.: 218347  Prod. No.: 001 RX (1MG/ML)

Patents	Expiration	Change
Pat. No. 12110298 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: Nov 5, 2024 Claim Types: Compound; Process; New polymorph, salt or hydrate	Oct 17, 2036	New patent for this product

SILENOR (TABLET) (ORAL) DOXEPIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: tricyclic antidepressant (TCA)
NDA Applicant: CURRAX      NDA No.: 022036  Prod. No.: 001 RX (EQ 3MG BASE); 002 RX (EQ 6MG BASE)

Patents	Expiration	Change
Pat. No. 12083090 Methods of using low-dose doxepin for the improvement of sleep Pat. Sub. Date(s): All strengths: Oct 10, 2024 Claim Types: Method of use Use Code: U-620: Treatment of insomnia	May 18, 2027	New patent 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))

Patents	Expiration	Change
Pat. No. 8628759 Soft anticholinergic esters Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	Nov 13, 2026	New patent for this product
Pat. No. 9220707 Method of dosing and use of soft anticholinergic esters Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Method of use; Method of administration Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	Mar 14, 2034	New patent for this product
Pat. No. 9492429 DP* Method of dosing and use of soft anticholinergic esters Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	Mar 14, 2034	New patent for this product
Pat. No. 9895350 Method of dosing and use of soft anticholinergic esters Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	Mar 14, 2034	New patent for this product
Pat. No. 10383846 Method of dosing and use of soft anticholinergic esters Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Method of use; Method of administration Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	Mar 14, 2034	New patent for this product
Pat. No. 10947192 Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	May 22, 2034	New patent for this product
Pat. No. 10952990 Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	May 22, 2034	New patent for this product
Pat. No. 10959983 Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	May 22, 2034	New patent for this product
Pat. No. 10961191 Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	May 22, 2034	New patent for this product
Pat. No. 11026919 DP* Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Formulation Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	May 22, 2034	New patent for this product
Pat. No. 11034652 DP* Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Formulation; Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	May 22, 2034	New patent for this product
Pat. No. 11052067 DP* Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Formulation; Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	May 22, 2034	New patent for this product
Pat. No. 11084788 DP* Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Formulation; Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	May 22, 2034	New patent for this product
Pat. No. 11123325 DP* Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Formulation; Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	Jul 20, 2037	New patent for this product

SPIRIVA RESPIMAT (SPRAY, METERED) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021936  Prod. No.: 001 RX (EQ 0.0025MG BASE/INH); 002 RX (EQ 0.00125MG BASE/INH)

Patents	Expiration	Change
Pat. No. 9027967 DP* Device for clamping a fluidic component Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015 Claim Types: Device; Process	Sep 30, 2027 *PED	New expiration date. Was previously Oct 1, 2027 *PED

SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA      NDA No.: 211230  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 12102609 Methods of administering solriamfetol to lactating women Pat. Sub. Date(s): All strengths: Oct 15, 2024 Claim Types: Method of improving a treatment; Method of use Use Code: U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol	Dec 30, 2042	New patent for this product

SYMDEKO (COPACKAGED) (TABLET) (ORAL) IVACAFTOR; IVACAFTOR, TEZACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
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. 10058546 Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof Pat. Sub. Date(s): 001: Sep 21, 2018; 002: Jul 17, 2019 Claim Types: Method of use Use Code: U-3022: Treatment of CF in patients 12 years and older who have a F508DEL or G551D CFTR mutation and a 2nd mutation selected from R117H, A455E, 2789+5G->A, & 3849+10KBC->T, comprising concurrent coadministration of the compositions of claim 1 of US 10058546 Use Code: U-3023: Treatment of cf in patients 6 years and older who have a F508DEL OR G551D CFTR mutation and a 2nd mutation selected from R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, comprising concurrent coadministration of the compositions of claim 1 of US 10058546	Jul 15, 2033	Deleted Use Code(s): U-2399, U-2572
Pat. No. 10081621 DP* Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide Pat. Sub. Date(s): 001: Oct 25, 2018; 002: Jul 17, 2019 Claim Types: Formulation; Method of use Use Code: U-3024: Treatment of cystic fibrosis in patients age 12 and older, who have two copies of the F508DEL mutation or who have at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,081,621 Use Code: U-3025: Treatment of cystic fibrosis in patients age 6 and older, who have two copies of the F508DEL mutation or who have at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,081,621	Mar 25, 2031	Deleted Use Code(s): U-2420, U-2571
Pat. No. 10206877 DP* Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases Pat. Sub. Date(s): 001: Mar 20, 2019; 002: Jul 17, 2019 Claim Types: Formulation; Method of use Use Code: U-3026: Treatment of cystic fibrosis in patients age 12 and older, who have two copies of the F508DEL mutation or at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,206,877 Use Code: U-3027: Treatment of cystic fibrosis in patients age 6 and older, who have two copies of the F508DEL mutation or at least one CFTR mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of US 10,206,877	Apr 14, 2035	Deleted Use Code(s): U-2498, U-2570

TAFINLAR (CAPSULE) (ORAL) DABRAFENIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 202806  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE)

Patents	Expiration	Change
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	Feb 28, 2034 *PED	New expiration date. Was previously Mar 2, 2034 *PED

TAGRISSO (TABLET) (ORAL) OSIMERTINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 208065  Prod. No.: 001 RX (EQ 40MG BASE); 002 RX (EQ 80MG BASE)

Patents	Expiration	Change
Pat. No. 8946235 DS* DP* 2-(2,4,5-substituted-anilino) pyrimidine compounds Pat. Sub. Date(s): All strengths: Dec 11, 2015 Claim Types: Compound; Composition; Method of use Use Code: U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy Use Code: U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations Use Code: U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations Use Code: U-3823: Treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations in combination with pemetrexed and platinum-based chemotherapy Use Code: U-4010: Treatment of patients with locally advanced, unresectable (stage iii) nsclc whose disease has not progressed during or following platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations	Aug 8, 2032	New Use Code
Pat. No. 9732058 DS* DP* 2-(2,4,5-substituted-anilino)pyrimidine compounds Pat. Sub. Date(s): All strengths: Aug 29, 2017 Claim Types: Compound; Composition; Method of use Use Code: U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy Use Code: U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations Use Code: U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations Use Code: U-3823: Treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations in combination with pemetrexed and platinum-based chemotherapy Use Code: U-4010: Treatment of patients with locally advanced, unresectable (stage iii) nsclc whose disease has not progressed during or following platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations	Jul 25, 2032	New Use Code
Pat. No. 10183020 DP* Pharmaceutical compositions comprising AZD9291 Pat. Sub. Date(s): All strengths: Feb 12, 2019 Claim Types: Formulation; Method of use Use Code: U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy Use Code: U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations Use Code: U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations Use Code: U-3823: Treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations in combination with pemetrexed and platinum-based chemotherapy Use Code: U-4010: Treatment of patients with locally advanced, unresectable (stage iii) nsclc whose disease has not progressed during or following platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations	Jan 2, 2035	New Use Code

TOSYMRA (SPRAY) (NASAL) SUMATRIPTAN
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: TONIX MEDS      NDA No.: 210884  Prod. No.: 001 RX (10MG/SPRAY)

Patents	Expiration	Change
Pat. No. 12090139 DP* Formulations comprising triptan compounds Pat. Sub. Date(s): 001: Oct 17, 2024 Claim Types: Formulation; Method of use; Device	Jun 16, 2030	New patent for this product

TRIKAFTA (COPACKAGED) (TABLET) (ORAL) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
NDA Applicant: VERTEX PHARMS INC      NDA No.: 212273  Prod. No.: 001 RX (100MG,75MG,50MG; 150MG)

Patents	Expiration	Change
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Method of use Use Code: U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor Use Code: U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor	Aug 5, 2027	Deleted Use Code(s): U-2645
Pat. No. 8354427 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Method of use Use Code: U-3029: Treatment of cystic fibrosis in patients aged 12 years and older who have a R117H mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor Use Code: U-3145: Treatment of cystic fibrosis in patients aged 6 years and older who have a R117H mutation in the CFTR gene with elexacaftor, tezacaftor, and ivacaftor	Jul 6, 2026	Deleted Use Code(s): U-2646
Pat. No. 8415387 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Method of use Use Code: U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor Use Code: U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor	Nov 12, 2027	Deleted Use Code(s): U-2645
Pat. No. 8598181 Modulators of ATP-binding cassette transpor Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Method of use Use Code: U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor Use Code: U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor	May 1, 2027	Deleted Use Code(s): U-2645
Pat. No. 8629162 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Method of use Use Code: U-3030: Treatment of a moderate to mild clinical phenotype of CF in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elx, tez, and iva Use Code: U-3146: Treatment of a moderate to mild clinical phenotype of CF in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elx, tez, and iva	Jun 24, 2025	Deleted Use Code(s): U-2648
Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-3031: Treatment of CF in patients 12 years and older who have at least one F508DEL mutation or a mutation in the CFTR gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva Use Code: U-3155: Treatment of CF in patients 6 years and older who have at least one F508DEL mutation or a mutation in the CFTR gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva	Dec 28, 2026	Deleted Use Code(s): U-2650
Pat. No. 9931334 DP* Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Method of use; Formulation Use Code: U-3031: Treatment of CF in patients 12 years and older who have at least one F508DEL mutation or a mutation in the CFTR gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva Use Code: U-3155: Treatment of CF in patients 6 years and older who have at least one F508DEL mutation or a mutation in the CFTR gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva	Dec 28, 2026	Deleted Use Code(s): U-2650
Pat. No. 9974781 DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Method of use; Composition Use Code: U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor Use Code: U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor	Apr 9, 2027	Deleted Use Code(s): U-2645
Pat. No. 10081621 DP* Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Formulation; Method of use Use Code: U-3032: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with a composition according to claim 1 of US 10081621 Use Code: U-3157: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with a composition according to claim 1 of US 10081621	Mar 25, 2031	Deleted Use Code(s): U-2652
Pat. No. 10239867 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Nov 14, 2019 Claim Types: Compound; Composition; Method of use Use Code: U-3033: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva Use Code: U-3158: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva	Apr 9, 2027	Deleted Use Code(s): U-2653
Pat. No. 10758534 DS* DP* Modulators of cystic fibrosis transmembrane conductance regulator Pat. Sub. Date(s): 001: Sep 22, 2020 Claim Types: Compound; Composition; Method of use Use Code: U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor Use Code: U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor	Oct 6, 2035	Deleted Use Code(s): U-2645
Pat. No. 10793547 DS* DP* Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator Pat. Sub. Date(s): 001: Oct 29, 2020 Claim Types: Compound; Composition; Method of use Use Code: U-3028: Treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor Use Code: U-3144: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor	Dec 8, 2037	Deleted Use Code(s): U-2645

TYVASO (SOLUTION) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 022387  Prod. No.: 001 RX (0.6MG/ML)

Patents	Expiration	Change
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): None Claim Types: Product-by-process	Dec 15, 2028	This patent is no longer listed for this product
Pat. No. 10716793 Treprostinil administration by inhalation Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1849: Method of treating pulmonary hypertension by administering treprostinil or a salt thereof by inhalation using a device	May 14, 2027	This patent is no longer listed for this product

TYVASO DPI (POWDER) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 214324  Prod. No.: 001 RX (0.016MG/INH); 002 RX (0.032MG/INH); 003 RX (0.048MG/INH); 004 RX (0.064MG/INH)

Patents	Expiration	Change
Pat. No. 10716793 DLR* Treprostinil administration by inhalation Pat. Sub. Date(s): All strengths: Jun 17, 2022 Claim Types: Method of use Use Code: U-1849: Method of treating pulmonary hypertension by administering treprostinil or a salt thereof by inhalation using a device	May 14, 2027	New Delisting Request flag
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): None Claim Types: Product-by-process	Dec 15, 2028	This patent is no longer listed for this product

VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: mu-opioid receptor agonist
NDA Applicant: ABBVIE      NDA No.: 206940  Prod. No.: 001 RX (75MG)

Patents	Expiration	Change
Pat. No. 12097187 Opioid receptor modulator dosage formulations Pat. Sub. Date(s): 001: Oct 21, 2024 Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Use Code: U-3475: Reduction of the frequency of abdominal pain and diarrhea, in an inflammatory bowel disease with diarrhea (IBS-D) patient, with eluxadoline twice daily with food	Mar 14, 2033	New patent for this product

XOLREMDI (CAPSULE) (ORAL) MAVORIXAFOR
NDA Applicant: X4 PHARMS      NDA No.: 218709  Prod. No.: 001 RX (100MG)

Patents	Expiration	Change
Pat. No. 12115156 DP* Compositions of CXCR4 inhibitors and methods of preparation and use Pat. Sub. Date(s): 001: Oct 31, 2024 Claim Types: Formulation	Dec 11, 2038	New patent for this product

ZEMBRACE SYMTOUCH (SOLUTION) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: TONIX MEDS      NDA No.: 208223  Prod. No.: 001 RX (EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML))

Patents	Expiration	Change
Pat. No. 12097183 DP* Pharmaceutical composition for treating migraine Pat. Sub. Date(s): 001: Oct 24, 2024 Claim Types: Device	Jan 29, 2036	New patent for this product

ZEPBOUND (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TIRZEPATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist == glucose-dependent insulinotropic polypeptide (GIP) receptor agonist
NDA Applicant: ELI LILLY AND CO      NDA No.: 217806  Prod. No.: 001 RX (2.5MG/0.5ML (2.5MG/0.5ML)); 002 RX (5MG/0.5ML (5MG/0.5ML)); 003 RX (7.5MG/0.5ML (7.5MG/0.5ML)); 004 RX (10MG/0.5ML (10MG/0.5ML)); 005 RX (12.5MG/0.5ML (12.5MG/0.5ML)); 006 RX (15MG/0.5ML (15MG/0.5ML)); 007 RX (2.5MG/0.5ML (2.5MG/0.5ML)); 008 RX (5MG/0.5ML (5MG/0.5ML)); 009 RX (7.5MG/0.5ML (7.5MG/0.5ML)); 010 RX (10MG/0.5ML (10MG/0.5ML)); 011 RX (12.5MG/0.5ML (12.5MG/0.5ML)); 012 RX (15MG/0.5ML (15MG/0.5ML))

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-82: Labeling revisions related to clinical studies	Oct 18, 2027	New exclusivity for this product

ZEPOSIA (CAPSULE) (ORAL) OZANIMOD HYDROCHLORIDE
Drug Classes: sphingosine 1-phosphate (S1P) receptor modulator
NDA Applicant: BRISTOL      NDA No.: 209899  Prod. No.: 001 RX (EQ 0.23MG BASE); 002 RX (EQ 0.46MG BASE); 003 RX (EQ 0.92MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-309: Information added to the labeling to include results from a study to fulfill postmarketing requirement 3809-5	Aug 30, 2027	New exclusivity for this product

ZUNVEYL (TABLET, DELAYED RELEASE) (ORAL) BENZGALANTAMINE GLUCONATE
NDA Applicant: ALPHA COGNITION      NDA No.: 218549  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 15MG BASE)

Patents	Expiration	Change
Pat. No. 9763953 Cholinergic enhancers with improved blood-brain barrier permeability for the treatment of diseases accompanied by cognitive impairment Pat. Sub. Date(s): All strengths: Aug 22, 2024 Claim Types: Method of use Use Code: U-713: Treatment of mild to moderate dementia of the Alzheimer's type	Dec 1, 2026	New expiration date. Was previously May 16, 2027