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

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. 11969421 Bupropion as a modulator of drug activity Pat. Sub. Date(s): 001: May 7, 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

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG); 004 RX (25MG); 005 RX (50MG)

Patents	Expiration	Change
Pat. No. 11964980 DS* DP* Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1- f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Pat. Sub. Date(s): All strengths: Apr 23, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Apr 10, 2040	New patent for this product

BIKTARVY (TABLET) (ORAL) BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 210251  Prod. No.: 001 RX (EQ 50MG BASE;200MG;EQ 25MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-942: Expansion of indication to use of bictegravir/emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in virologically suppressed adults and pediatric patients on a stable HIV-1 treatment regimen with no known resistance to bictegravir or tenofovir	Feb 23, 2027	New exclusivity for this product
Exclusivity Code: M - Miscellaneous: M-305: Revisions to the labeling to include information for pregnant individuals	Apr 24, 2027	New exclusivity for this product

BIKTARVY (TABLET) (ORAL) BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 210251  Prod. No.: 002 RX (EQ 30MG BASE;120MG;EQ 15MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-942: Expansion of indication to use of bictegravir/emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in virologically suppressed adults and pediatric patients on a stable HIV-1 treatment regimen with no known resistance to bictegravir or tenofovir	Feb 23, 2027	New exclusivity for this product

BRUKINSA (CAPSULE) (ORAL) ZANUBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: BEIGENE      NDA No.: 213217  Prod. No.: 001 RX (80MG)

Patents	Expiration	Change
Pat. No. 9447106 DS* DP* Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators Pat. Sub. Date(s): 001: Nov 20, 2019 Claim Types: Compound; Composition; Method of use; Formulation Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Apr 22, 2034	New Use Code
Pat. No. 10570139 Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators Pat. Sub. Date(s): 001: Jun 4, 2021 Claim Types: Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Apr 22, 2034	New Use Code; Deleted Use Code(s): U-3856, U-3857, U-3858, U-3859
Pat. No. 11142528 DP* Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators Pat. Sub. Date(s): 001: Nov 12, 2021 Claim Types: Composition; Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Apr 22, 2034	New Use Code; Deleted Use Code(s): U-3856, U-3857, U-3858
Pat. No. 11786531 Methods of treating B-cell proliferative disorder Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer Use Code: U-3875: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) receiving a moderate cyp3a inducer, in combination with obinutuzumab, after two or more lines of systemic therapy	Jan 19, 2043	New Use Code
Pat. No. 11896596 Methods of treating B-cell proliferative disorder Pat. Sub. Date(s): 001: Mar 12, 2024 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer Use Code: U-3875: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) receiving a moderate cyp3a inducer, in combination with obinutuzumab, after two or more lines of systemic therapy	Jan 19, 2043	New Use Code
Pat. No. 11911386 Methods Of Treating B-cell Proliferative Disorder Pat. Sub. Date(s): 001: Feb 28, 2024 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer Use Code: U-3875: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) receiving a moderate cyp3a inducer, in combination with obinutuzumab, after two or more lines of systemic therapy	Jan 19, 2043	New Use Code

CEQUA (SOLUTION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: SUN PHARM      NDA No.: 210913  Prod. No.: 001 RX (0.09%)

Patents	Expiration	Change
Pat. No. 11951153 Topical cyclosporine-containing formulations and uses thereof Pat. Sub. Date(s): 001: May 2, 2024 Claim Types: Method of use Use Code: U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye).	Feb 28, 2037	New patent for this product

DROSPIRENONE (TABLET, CHEWABLE) (ORAL) DROSPIRENONE
Drug Classes: progestin
NDA Applicant: EXELTIS USA INC      NDA No.: 216285  Prod. No.: 001 DISC (3.5MG)

Patents	Expiration	Change
Pat. No. 11951213 Synthetic progestogens and pharmaceutical compositions comprising the same Pat. Sub. Date(s): 001: Apr 25, 2024 Claim Types: Method of use Use Code: U-2553: Prevention of pregnancy in females of reproductive age	Jun 28, 2031	New patent for this product

DUVYZAT (SUSPENSION) (ORAL) GIVINOSTAT HYDROCHLORIDE
NDA Applicant: ITALFARMACO SPA      NDA No.: 217865  Prod. No.: 001 RX (EQ 8.86MG BASE/ML)

Patents	Expiration	Change
Pat. No. 7329689 DS* DP* Monohydrate hydrochloride of the 4-hydroxycarbamoyl-phenyl)-carbamic acid (6-diethylaminomethyl-naphtalen-2-yl) ester Pat. Sub. Date(s): 001: Apr 19, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Jan 15, 2025	New patent for this product
Pat. No. 9421184 Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy Pat. Sub. Date(s): 001: Apr 19, 2024 Claim Types: Method of use Use Code: U-3885: A method for the treatment of Duchenne muscular dystrophy (DMD) using givinostat	Feb 3, 2032	New patent for this product
Pat. No. 9867799 Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy Pat. Sub. Date(s): 001: Apr 19, 2024 Claim Types: Method of use Use Code: U-3885: A method for the treatment of Duchenne muscular dystrophy (DMD) using givinostat	Feb 3, 2032	New patent for this product
Pat. No. 10688047 DP* Physically and chemically stable oral suspensions of givinostat Pat. Sub. Date(s): 001: Apr 19, 2024 Claim Types: Formulation; Method of use; Process Use Code: U-3885: A method for the treatment of Duchenne muscular dystrophy (DMD) using givinostat	Oct 28, 2036	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Mar 21, 2029	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-473: Treatment of Duchenne Muscular Dystrophy (DMD) in patients 6 years of age and older	Mar 21, 2031	New exclusivity for this product

EDURANT (TABLET) (ORAL) RILPIVIRINE HYDROCHLORIDE
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: JANSSEN PRODS      NDA No.: 202022  Prod. No.: 001 RX (EQ 25MG BASE)

Patents	Expiration	Change
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)] HIV inhibiting pyrimidines derivatives Pat. Sub. Date(s): 001: Jun 16, 2011 Claim Types: Compound; Composition; Method of use; Formulation Use Code: U-1153: In combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients, as set forth in the labeling, including I&U section Use Code: U-1307: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naive adult patients with HIV-1 RNA less than or equal to 100,000 at the start of therapy Use Code: U-1740: In combination with other antiretroviral agents for the treatment of hiv-1 infection in treatment-naive patients with hiv-1 rna less than or equal to 100,000 at the start of therapy Use Code: U-3353: Treatment in combination with cabotegravir of HIV-1 infection in adults and adolescents 12 and older to replace current regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure Use Code: U-3874: In combination with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral treatment-naive patients 2 years of age and older, weighing at least 14kg, with HIV-1 RNA less than or equal to 100,000 at the start of therapy	Oct 21, 2025 *PED	New Use Code

EDURANT PED (TABLET, FOR SUSPENSION) (ORAL) RILPIVIRINE HYDROCHLORIDE
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: JANSSEN PRODS      NDA No.: 219016  Prod. No.: 001 RX (EQ 2.5MG BASE)

Patents	Expiration	Change
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)] HIV inhibiting pyrimidines derivatives Pat. Sub. Date(s): 001: Apr 11, 2024 Claim Types: Compound; Composition; Method of use; Formulation Use Code: U-3874: In combination with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral treatment-naive patients 2 years of age and older, weighing at least 14kg, with HIV-1 RNA less than or equal to 100,000 at the start of therapy	Apr 21, 2025	New patent for this product
Pat. No. 11065198 DP* Dispersible compositions Pat. Sub. Date(s): 001: May 2, 2024 Claim Types: Formulation	Oct 23, 2037	New patent for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 021343  Prod. No.: 001 RX (7.5MG)

Patents	Expiration	Change
Pat. No. 11931559 DS* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Apr 15, 2024 Claim Types: Process	Dec 22, 2041	New patent for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 021379  Prod. No.: 001 RX (22.5MG)

Patents	Expiration	Change
Pat. No. 11931559 DS* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Apr 15, 2024 Claim Types: Process	Dec 22, 2041	New patent for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 021488  Prod. No.: 001 RX (30MG)

Patents	Expiration	Change
Pat. No. 11931559 DS* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Apr 15, 2024 Claim Types: Process	Dec 22, 2041	New patent for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 021731  Prod. No.: 001 RX (45MG)

Patents	Expiration	Change
Pat. No. 11931559 DS* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Apr 15, 2024 Claim Types: Process	Dec 22, 2041	New patent for this product

ENTRESTO SPRINKLE (CAPSULE, PELLETS) (ORAL) SACUBITRIL; VALSARTAN
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS      NDA No.: 218591  Prod. No.: 001 RX (6MG;6MG); 002 RX (15MG;16MG)

Patents	Expiration	Change
Pat. No. 8101659 DP* [Extended 732 days (2 years)] Methods of treatment and pharmaceutical composition Pat. Sub. Date(s): All strengths: May 8, 2024 Claim Types: Formulation	Jan 15, 2025	New product in Orange Book
Pat. No. 8877938 DS* DP* Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Pat. Sub. Date(s): All strengths: May 8, 2024 Claim Types: Compound; Composition; Formulation	May 27, 2027	New product in Orange Book
Pat. No. 9388134 Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations Pat. Sub. Date(s): All strengths: May 8, 2024 Claim Types: Method of use Use Code: U-1723: Treatment of heart failure	Nov 8, 2026	New product in Orange Book
Pat. No. 10722471 DP* Galenic formulations of organic compounds Pat. Sub. Date(s): All strengths: May 8, 2024 Claim Types: Formulation Use Code: U-3896: Treatment of heart failure with oral pellets	Feb 2, 2037	New product in Orange Book

ERLEADA (TABLET) (ORAL) APALUTAMIDE
NDA Applicant: JANSSEN BIOTECH      NDA No.: 210951  Prod. No.: 001 RX (60MG); 002 RX (240MG)

Patents	Expiration	Change
Pat. No. 11963952 Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer Pat. Sub. Date(s): All strengths: Apr 26, 2024 Claim Types: Method of use Use Code: U-3888: Treatment of patients with metastatic castration sensitive prostate cancer	Jan 30, 2040	New patent for this product

ESTRADIOL (GEL, METERED) (TRANSDERMAL) ESTRADIOL [GENERIC AB]
Drug Classes: estrogen
NDA Applicant: SOLARIS PHARMA CORP      NDA No.: 216160  Prod. No.: 001 RX (0.06% (1.25GM/ACTIVATION))

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Oct 23, 2024	New product in Orange Book

EVRYSDI (FOR SOLUTION) (ORAL) RISDIPLAM
Drug Classes: survival of motor neuron 2 (SMN2) splicing modifier
NDA Applicant: GENENTECH INC      NDA No.: 213535  Prod. No.: 001 RX (0.75MG/ML)

Patents	Expiration	Change
Pat. No. 11938136 DP* Compositions for treating spinal muscular atrophy Pat. Sub. Date(s): 001: Apr 17, 2024 Claim Types: Formulation	Nov 8, 2036	New patent for this product

FABHALTA (CAPSULE) (ORAL) IPTACOPAN HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.: 218276  Prod. No.: 001 RX (EQ 200MG BASE)

Patents	Expiration	Change
Pat. No. 11951101 Methods of using factor B inhibitors Pat. Sub. Date(s): 001: May 7, 2024 Claim Types: Method of use Use Code: U-3895: Treatment of paroxysmal nocturnal hemoglobinuria (PNH) by administration of 200 mg of iptacopan twice daily	Jul 15, 2041	New patent for this product

FANAPT (TABLET) (ORAL) ILOPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: VANDA PHARMS INC      NDA No.: 022192  Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (4MG); 004 RX (6MG); 005 RX (8MG); 006 RX (10MG); 007 RX (12MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-939: Indicated for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults	Apr 2, 2027	New exclusivity for this product

FENSOLVI KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 213150  Prod. No.: 001 RX (45MG)

Patents	Expiration	Change
Pat. No. 11931559 DS* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Apr 15, 2024 Claim Types: Process	Dec 22, 2041	New patent for this product

FETZIMA (CAPSULE, EXTENDED RELEASE) (ORAL) LEVOMILNACIPRAN HYDROCHLORIDE [Has competitive generic]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ABBVIE      NDA No.: 204168  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 80MG BASE); 004 RX (EQ 120MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-304: Information added to section 8.4 of the labeling to describe the results from study LVM-MD-11 and LVM-MD-14	Mar 24, 2026	New exclusivity for this product

FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: AVEO PHARMS      NDA No.: 212904  Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)

Patents	Expiration	Change
Pat. No. 6821987 DS* DP* Quinoline derivatives and quinazoline derivatives having azolyl group Pat. Sub. Date(s): All strengths: Apr 6, 2021 Claim Types: Compound; Method of use; Composition Use Code: U-3100: A method of treating adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies by inhibiting the angiogenesis of blood vessels with a vascular endothelial growth factor inhibitor	Apr 26, 2025	New expiration date. Was previously Apr 26, 2024

GOCOVRI (CAPSULE, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: ADAMAS OPERATIONS      NDA No.: 208944  Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)

Patents	Expiration	Change
Pat. No. 11903908 Methods of administering amantadine Pat. Sub. Date(s): All strengths: Mar 8, 2024 Claim Types: Method of use Use Code: U-3822: As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing 'off' episodes	Jun 17, 2034	New expiration date. Was previously Dec 4, 2034

ICLUSIG (TABLET) (ORAL) PONATINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 203469  Prod. No.: 001 RX (EQ 15MG BASE); 002 RX (EQ 45MG BASE); 003 RX (EQ 30MG BASE); 004 RX (EQ 10MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-472: Treatment of adult patients with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia (PH+ ALL)	Mar 19, 2031	New exclusivity 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. 8754090 DLR* Use of inhibitors of bruton's tyrosine kinase (Btk) Pat. Sub. Date(s): All strengths: Mar 6, 2018 Claim Types: Method of use Use Code: U-1456: Treatment of mantle cell lymphoma	Dec 3, 2031 *PED	New Delisting Request flag
Pat. No. 9814721 Use of inhibitors of Bruton'S tyrosine kinase (BTK) Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1947: Treatment of marginal zone lymphoma	Dec 3, 2031 *PED	This patent is no longer listed for this product
Pat. No. 10653696 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

KLOXXADO (SPRAY) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: HIKMA      NDA No.: 212045  Prod. No.: 001 RX (8MG/SPRAY)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Apr 29, 2024	New exclusivity for this product

LIVMARLI (SOLUTION) (ORAL) MARALIXIBAT CHLORIDE
Drug Classes: ileal bile acid transporter (IBAT) inhibitor
NDA Applicant: MIRUM      NDA No.: 214662  Prod. No.: 001 RX (EQ 9.5MG BASE/ML)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-471: Treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC)	Mar 13, 2031	New exclusivity for this product

LODOCO (TABLET) (ORAL) COLCHICINE
Drug Classes: alkaloid
NDA Applicant: AGEPHA PHARMA FZ      NDA No.: 215727  Prod. No.: 001 RX (0.5MG)

Patents	Expiration	Change
Pat. No. 9744144 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent Pat. Sub. Date(s): 001: Jun 29, 2023 Claim Types: Method of use Use Code: U-3643: Method of treating and/or reducing the risk of a cardiovascular event	Nov 1, 2033	New expiration date. Was previously Jan 22, 2035
Pat. No. 10130585 Methods of treating and/or preventing cardiovascular disease Pat. Sub. Date(s): 001: Jun 29, 2023 Claim Types: Method of use Use Code: U-3642: A method of treating cardiovascular disease	May 9, 2034	New expiration date. Was previously Dec 31, 2034
Pat. No. 10206891 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent Pat. Sub. Date(s): 001: Jun 29, 2023 Claim Types: Method of use Use Code: U-3641: A method of treating and/or reducing the risk of a cardiovascular event; acute coronary syndrome, out-of-hospital cardiac arrest, and/or noncardioembolic ischemic stroke	Nov 1, 2033	New expiration date. Was previously Jan 22, 2035
Pat. No. 10265281 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Pat. Sub. Date(s): 001: Jun 29, 2023 Claim Types: Method of use Use Code: U-3639: A method for treating and/or reducing the risk of a cardiovascular event	Nov 1, 2033	New expiration date. Was previously Jan 22, 2035
Pat. No. 10842762 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent Pat. Sub. Date(s): 001: Jun 29, 2023 Claim Types: Method of use Use Code: U-3640: A method of treating and/or reducing the risk of inflammation, atherosclerotic vascular disease, and cholesterol crystal induced inflammation within atherosclerotic plaques	Nov 1, 2033	New expiration date. Was previously Jan 22, 2035
Pat. No. 11026899 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Pat. Sub. Date(s): 001: Jun 29, 2023 Claim Types: Method of use Use Code: U-3639: A method for treating and/or reducing the risk of a cardiovascular event	Nov 1, 2033	New expiration date. Was previously Jan 22, 2035
Pat. No. 11026900 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Pat. Sub. Date(s): 001: Jun 29, 2023 Claim Types: Method of use Use Code: U-3639: A method for treating and/or reducing the risk of a cardiovascular event	Nov 1, 2033	New expiration date. Was previously Jan 22, 2035
Pat. No. 11026901 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Pat. Sub. Date(s): 001: Jun 29, 2023 Claim Types: Method of use Use Code: U-3638: A method for treating and/or reducing the risk of acute myocardial infarction	Nov 1, 2033	New expiration date. Was previously Jan 22, 2035

LUMISIGHT (POWDER) (INTRAVENOUS) PEGULICIANINE ACETATE
NDA Applicant: LUMICELL      NDA No.: 214511  Prod. No.: 001 RX (EQ 40MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 9032965 Methods and system for image guided cell ablation with microscopic resolution Pat. Sub. Date(s): 001: May 1, 2024 Claim Types: Method of use Use Code: U-3890: A method comprising administering pegulicianine to a human and obtaining an image of a tumor bed after tumor resection to distinguish in situ cancer cells from healthy cells	Dec 8, 2031	New product in Orange Book
Pat. No. 9155471 Methods and systems for spatially identifying abnormal cells Pat. Sub. Date(s): 001: May 1, 2024 Claim Types: Diagnostic or surgical method Use Code: U-3890: A method comprising administering pegulicianine to a human and obtaining an image of a tumor bed after tumor resection to distinguish in situ cancer cells from healthy cells	Oct 12, 2031	New product in Orange Book
Pat. No. 9532835 Methods and system for image guided cell ablation with microscopic resolution Pat. Sub. Date(s): 001: May 1, 2024 Claim Types: Method of use Use Code: U-3890: A method comprising administering pegulicianine to a human and obtaining an image of a tumor bed after tumor resection to distinguish in situ cancer cells from healthy cells	Dec 8, 2031	New product in Orange Book
Pat. No. 9763577 DS* DP* Imaging agent for detection of diseased cells Pat. Sub. Date(s): 001: May 1, 2024 Claim Types: Composition; Diagnostic or surgical method Use Code: U-3890: A method comprising administering pegulicianine to a human and obtaining an image of a tumor bed after tumor resection to distinguish in situ cancer cells from healthy cells	Sep 14, 2034	New product in Orange Book
Pat. No. 10285759 Methods and system for image guided cell ablation with microscopic resolution Pat. Sub. Date(s): 001: May 1, 2024 Claim Types: Method of use Use Code: U-3890: A method comprising administering pegulicianine to a human and obtaining an image of a tumor bed after tumor resection to distinguish in situ cancer cells from healthy cells	Dec 8, 2031	New product in Orange Book

LUTATHERA (SOLUTION) (INTRAVENOUS) LUTETIUM LU 177 DOTATATE
NDA Applicant: AAA USA INC      NDA No.: 208700  Prod. No.: 001 RX (10mCi/ML)

Patents	Expiration	Change
Pat. No. 10596276 DP* Stable, concentrated radionuclide complex solutions Pat. Sub. Date(s): 001: Apr 13, 2020 Claim Types: Product-by-proces; Process	Jan 25, 2039 *PED	New expiration date. Was previously Jul 25, 2038
Pat. No. 10596278 DP* Stable, concentrated radionuclide complex solutions Pat. Sub. Date(s): 001: Apr 13, 2020 Claim Types: Formulation	Jan 25, 2039 *PED	New expiration date. Was previously Jul 25, 2038
Pat. No. 11904027 DP* Stable, concentrated radionuclide complex solutions Pat. Sub. Date(s): 001: Mar 15, 2024 Claim Types: Process; Product-by-process	Jan 25, 2039 *PED	New expiration date. Was previously Jul 25, 2038
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-166: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS) including foregut, midgut, and hindgut neuroendocrine tumors in adults	Jul 26, 2025 PED	New expiration date. Was previously Jan 26, 2025

LYBALVI (TABLET) (ORAL) OLANZAPINE; SAMIDORPHAN L-MALATE
Drug Classes: atypical antipsychotic == opioid antagonist
NDA Applicant: ALKERMES INC      NDA No.: 213378  Prod. No.: 001 RX (5MG;EQ 10MG BASE); 002 RX (10MG;EQ 10MG BASE); 003 RX (15MG;EQ 10MG BASE); 004 RX (20MG;EQ 10MG BASE)

Patents	Expiration	Change
Pat. No. 11951111 Immediate release multilayer tablet Pat. Sub. Date(s): All strengths: Apr 24, 2024 Claim Types: Method of use Use Code: U-3886: Method of treating bipolar disorder by administering a bilayer tablet comprising olanzapine and samidorphan Use Code: U-3887: Method of treating schizophrenia by administering a bilayer tablet comprising olanzapine and samidorphan	Nov 12, 2041	New patent for this product

MAYZENT (TABLET) (ORAL) SIPONIMOD
Drug Classes: sphingosine 1-phosphate (S1P) receptor modulator
NDA Applicant: NOVARTIS      NDA No.: 209884  Prod. No.: 001 RX (EQ 0.25MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 1MG BASE)

Patents	Expiration	Change
Pat. No. 11944602 Treatment of autoimmune disease in a patient receiving additionally a beta-blocker Pat. Sub. Date(s): All strengths: Apr 30, 2024 Claim Types: Method of use Use Code: U-3889: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults receiving or who may receive a beta-blocker treatment	Jul 24, 2036	New patent for this product

MULTRYS (SOLUTION) (INTRAVENOUS) CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
NDA Applicant: AM REGENT      NDA No.: 209376  Prod. No.: 003 RX (EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML))

Patents	Expiration	Change
Pat. No. 11975022 Pat. Sub. Date(s): 003: May 8, 2024 Claim Types: Use Code: U-3900: Neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated	Jul 1, 2041	New patent for this product

MYCAPSSA (CAPSULE, DELAYED RELEASE) (ORAL) OCTREOTIDE ACETATE
Drug Classes: somatostatin analog
NDA Applicant: CHIESI      NDA No.: 208232  Prod. No.: 001 RX (EQ 20MG BASE)

Patents	Expiration	Change
Pat. No. 11969471 DP* Pharmaceutical compositions and related methods of delivery Pat. Sub. Date(s): 001: Apr 30, 2024 Claim Types: Formulation	Sep 17, 2029	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-474: Long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide	Jun 26, 2027	New exclusivity for this product

MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Drug Classes: estrogen == progestin == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: MYOVANT SCIENCES      NDA No.: 214846  Prod. No.: 001 RX (1MG;0.5MG;40MG)

Patents	Expiration	Change
Pat. No. 11957684 Treatment of heavy menstrual bleeding associated with uterine fibroids Pat. Sub. Date(s): 001: Apr 17, 2024 Claim Types: Method of use Use Code: U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women	Sep 29, 2037	New patent for this product

NEXLETOL (TABLET) (ORAL) BEMPEDOIC ACID
NDA Applicant: ESPERION THERAPS INC      NDA No.: 211616  Prod. No.: 001 RX (180MG)

Patents	Expiration	Change
Pat. No. 11744816 Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease Pat. Sub. Date(s): 001: Apr 19, 2024 Claim Types: Method of use Use Code: U-3883: A method of lowering LDL-C or reducing the risk of cardiovascular disease in patients with familial hypercholesterolemia using 180 mg bempedoic acid and 10 mg ezetimibe	Mar 14, 2036	New patent for this product

NEXLIZET (TABLET) (ORAL) BEMPEDOIC ACID; EZETIMIBE
Drug Classes: dietary cholesterol absorption inhibitor
NDA Applicant: ESPERION THERAPS INC      NDA No.: 211617  Prod. No.: 001 RX (180MG;10MG)

Patents	Expiration	Change
Pat. No. 10912751 Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease Pat. Sub. Date(s): 001: Oct 14, 2021 Claim Types: Method of use Use Code: U-3224: A method of treating heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease by decreasing the level of LDL-C using a fixed dose combination of 180 mg bempedoic acid and 10 mg ezetimibe Use Code: U-3884: A method of lowering LDL-C or reducing the risk of cardiovascular disease in patients with familial hypercholesterolemia using a fixed-dose combination of 180 mg bempedoic acid and 10 mg ezetimibe	Mar 14, 2036	New Use Code
Pat. No. 11744816 Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease Pat. Sub. Date(s): 001: Oct 3, 2023 Claim Types: Method of use Use Code: U-3692: A method of treating heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease by decreasing the level of LDL-C using 180 mg bempedoic acid and 10 mg ezetimibe Use Code: U-3883: A method of lowering LDL-C or reducing the risk of cardiovascular disease in patients with familial hypercholesterolemia using 180 mg bempedoic acid and 10 mg ezetimibe	Mar 14, 2036	New Use Code

NEXTSTELLIS (TABLET) (ORAL) DROSPIRENONE; ESTETROL
Drug Classes: progestin
NDA Applicant: MAYNE PHARMA      NDA No.: 214154  Prod. No.: 001 RX (3MG;14.2MG)

Patents	Expiration	Change
Pat. No. 11957694 DP* Orodispersible dosage unit containing an estetrol component Pat. Sub. Date(s): 001: Apr 29, 2024 Claim Types: Formulation claimed by its inherent performace characteristics; Method of use; Process	Jun 17, 2036	New patent for this product
Pat. No. 11964055 DP* Orodispersible dosage unit containing an estetrol component Pat. Sub. Date(s): 001: Apr 29, 2024 Claim Types: Formulation; Method of use	Jun 17, 2036	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11951096 Treatments with nirogacestat Pat. Sub. Date(s): 001: Apr 24, 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
Pat. No. 11957662 Treatments with nirogacestat Pat. Sub. Date(s): 001: Apr 24, 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

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

Patents	Expiration	Change
Pat. No. 7342118 DS* Imidazole compounds for the treatment of neurodegenerative disorders Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Compound; Composition	Aug 18, 2025	New strength or variation of this product
Pat. No. 7795447 DS* Imidazole compounds for the treatment of neurodegenerative disorders Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Compound; Composition	Aug 18, 2025	New strength or variation of this product
Pat. No. 7951958 DS* Imidazole compounds for the treatment of neurodegenerative disorders Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Compound; Composition	Mar 11, 2025	New strength or variation of this product
Pat. No. 10590087 DS* 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: Apr 12, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Aug 9, 2039	New strength or variation of this product
Pat. No. 10710966 DS* 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: Apr 12, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	Aug 9, 2039	New strength or variation of this product
Pat. No. 10941118 DS* 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: Apr 12, 2024 Claim Types: New polymorph, salt or hydrate Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	Aug 9, 2039	New strength or variation of this product
Pat. No. 11504354 DP* Chlorinated tetralin compounds and pharmaceutical compositions Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Composition; Formulation	Jul 8, 2042	New strength or variation of this product
Pat. No. 11612588 DP* Chlorinated tetralin compounds and pharmaceutical compositions Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	Jul 8, 2042	New strength or variation of this product
Pat. No. 11807611 DP* Chlorinated tetralin compounds and pharmaceutical compositions Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	Sep 8, 2042	New strength or variation of this product
Pat. No. 11820748 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: Apr 12, 2024 Claim Types: Formulation	Aug 9, 2039	New strength or variation of this product
Pat. No. 11844780 DP* Chlorinated tetralin compounds and pharmaceutical compositions Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	Sep 8, 2042	New strength or variation of this product
Pat. No. 11845732 DS* 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: Apr 12, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	Aug 9, 2039	New strength or variation of this product
Pat. No. 11872211 Treatments with nirogacestat Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New strength or variation of this product
Pat. No. 11884634 DP* Compositions Of Solid 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 Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: New polymorph, salt or hydrate	Aug 9, 2039	New strength or variation of this product
Pat. No. 11884635 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: Apr 12, 2024 Claim Types: Formulation claimed by its inherent performace characteristics	Aug 9, 2039	New strength or variation of this product
Pat. No. 11905255 DP* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Composition	Aug 9, 2039	New strength or variation of this product
Pat. No. 11925619 Treatments with nirogacestat Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Dosaage regimen; Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New strength or variation of this product
Pat. No. 11925620 Treatments with nirogacestat Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New strength or variation of this product
Pat. No. 11938116 Treatments with nirogacestat Pat. Sub. Date(s): All strengths: Apr 12, 2024 Claim Types: Dosaage regimen Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New strength or variation of this product
Pat. No. 11951096 Treatments with nirogacestat Pat. Sub. Date(s): All strengths: Apr 24, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New strength or variation of this product
Pat. No. 11957662 Treatments with nirogacestat Pat. Sub. Date(s): All strengths: Apr 24, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New strength or variation of this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Nov 27, 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 27, 2030	New strength or variation of this product

OJEMDA (TABLET) (ORAL) TOVORAFENIB
NDA Applicant: DAY ONE BIOPHARMS      NDA No.: 217700  Prod. No.: 001 RX (100MG)

Patents	Expiration	Change
Pat. No. 8293752 DS* DP* Compounds useful as Raf kinase inhibitors Pat. Sub. Date(s): 001: May 8, 2024 Claim Types: Compound; Composition	Aug 4, 2031	New product in Orange Book
Pat. No. 10426782 DP* Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation Pat. Sub. Date(s): 001: May 8, 2024 Claim Types: Formulation; Process	Jun 23, 2035	New product in Orange Book

OJEMDA (FOR SUSPENSION) (ORAL) TOVORAFENIB
NDA Applicant: DAY ONE BIOPHARMS      NDA No.: 218033  Prod. No.: 001 RX (25MG/ML)

Patents	Expiration	Change
Pat. No. 8293752 DS* DP* Compounds useful as Raf kinase inhibitors Pat. Sub. Date(s): 001: May 8, 2024 Claim Types: Compound; Composition	Aug 4, 2031	New product in Orange Book
Pat. No. 10426782 DP* Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation Pat. Sub. Date(s): 001: May 8, 2024 Claim Types: Formulation; Process	Jun 23, 2035	New product in Orange Book

ONGENTYS (CAPSULE) (ORAL) OPICAPONE
Drug Classes: catechol-O-methyltransferase (COMT) inhibitor
NDA Applicant: AMNEAL      NDA No.: 212489  Prod. No.: 001 RX (25MG); 002 RX (50MG)

Patents	Expiration	Change
Pat. No. 10357468 DLR* Medicaments for slowing Parkinson's disease Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-2812: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease	May 27, 2035	This patent is no longer listed for this product

OPSYNVI (TABLET) (ORAL) MACITENTAN; TADALAFIL
Drug Classes: endothelin receptor antagonist == phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: ACTELION      NDA No.: 218490  Prod. No.: 001 RX (10MG;20MG); 002 RX (10MG;40MG)

Patents	Expiration	Change
Pat. No. 7094781 DS* DP* [Extended 1150 days (3.2 years)] Sulfamides and their use as endothelin receptor antagonists Pat. Sub. Date(s): All strengths: Apr 18, 2024 Claim Types: Compound	Dec 5, 2025	New patent for this product
Pat. No. 8268847 DP* Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor Pat. Sub. Date(s): All strengths: Apr 18, 2024 Claim Types: Formulation; Method of use Use Code: U-3882: Method of treating pulmonary arterial hypertension comprising administering a combination of macitentan and tadalafil	Apr 18, 2029	New patent for this product
Pat. No. 10946015 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Pat. Sub. Date(s): All strengths: Apr 18, 2024 Claim Types: Formulation; Method of use Use Code: U-3881: Use of the combination of macitentan and tadalafil for the chronic treatment of adults with pulmonary arterial hypertension	Sep 11, 2026	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Mar 22, 2027	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-475: Chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO functional class (FC) II-III)	Mar 22, 2031	New exclusivity for this product

OTEZLA (TABLET) (ORAL) APREMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: AMGEN INC      NDA No.: 205437  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)

Patents	Expiration	Change
Pat. No. 7427638 DS* DP* [Extended 1186 days (3.2 years)] (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminois- oindoline-1,3-dione:, and methods of synthesis and compositions thereof Pat. Sub. Date(s): All strengths: Apr 15, 2014 Claim Types: Composition; Formulation	Aug 16, 2028 *PED	New expiration date. Was previously Feb 16, 2028
Pat. No. 9872854 Methods for the treatment of psoriatic arthritis using apremilast Pat. Sub. Date(s): All strengths: Feb 21, 2018 Claim Types: Method of use Use Code: U-2232: Treatment of psoriatic arthritis using a dosage titration schedule Use Code: U-2233: Treatment of psoriatic arthritis with apremilast using a dosage titration schedule and a second active agent	Nov 29, 2034 *PED	New expiration date. Was previously May 29, 2034
Pat. No. 10092541 Methods for the treatment of diseases ameliorated by PDE4 inhibition using dosage titration of apremilast Pat. Sub. Date(s): All strengths: Oct 9, 2018 Claim Types: Method of use Use Code: U-2403: Treatment of psoriasis using a dosage titration schedule Use Code: U-2659: Treatment of adult patients with oral ulcers associated with Behcet's disease using a dosage titration schedule	Nov 29, 2034 *PED	New expiration date. Was previously May 29, 2034

OXBRYTA (TABLET) (ORAL) VOXELOTOR
Drug Classes: hemoglobin S polymerization inhibitor
NDA Applicant: GLOBAL BLOOD THERAPS      NDA No.: 213137  Prod. No.: 001 RX (500MG); 002 RX (300MG)

Patents	Expiration	Change
Pat. No. 11944612 Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde Pat. Sub. Date(s): All strengths: May 2, 2024 Claim Types: Formulation; Method of use Use Code: U-3893: Treatment of sickle cell disease by administering voxelotor, as recited in claim 10	Dec 2, 2036	New patent for this product

OXBRYTA (TABLET, FOR SUSPENSION) (ORAL) VOXELOTOR
Drug Classes: hemoglobin S polymerization inhibitor
NDA Applicant: GLOBAL BLOOD THERAPS      NDA No.: 216157  Prod. No.: 001 RX (300MG)

Patents	Expiration	Change
Pat. No. 11944612 Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde Pat. Sub. Date(s): 001: May 2, 2024 Claim Types: Formulation; Method of use Use Code: U-3893: Treatment of sickle cell disease by administering voxelotor, as recited in claim 10	Dec 2, 2036	New patent for this product

OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 022272  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)

Patents	Expiration	Change
Pat. No. 11964056 DP* Tamper resistant dosage forms Pat. Sub. Date(s): All strengths: Apr 25, 2024 Claim Types: Formulation	Aug 24, 2027	New patent for this product

PEDMARK (SOLUTION) (INTRAVENOUS) SODIUM THIOSULFATE
NDA Applicant: FENNEC PHARMS INC      NDA No.: 212937  Prod. No.: 001 RX (12.5GM/100ML (125MG/ML))

Patents	Expiration	Change
Pat. No. 11964018 Therapeutic uses for sodium thiosulfate formulations Pat. Sub. Date(s): 001: May 8, 2024 Claim Types: Method of use Use Code: U-3898: Use of a pharmaceutical composition of about 0.5m sodium thiosulfate, about 0.004m boric acid, and a pH of between about 6.5 and 8.9 for reducing ototoxicity in a pediatric patient receiving cisplatin for the treatment of localized cancer	Jul 1, 2039	New patent for this product

PONVORY (TABLET) (ORAL) PONESIMOD
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: JANSSEN PHARMS      NDA No.: 213498  Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (4MG); 004 RX (5MG); 005 RX (6MG); 006 RX (7MG); 007 RX (8MG); 008 RX (9MG); 009 RX (10MG); 010 RX (20MG)

Patents	Expiration	Change
Pat. No. 11951097 Methods of treating multiple sclerosis Pat. Sub. Date(s): All strengths: May 2, 2024 Claim Types: Method of improving a treatment; Method of use Use Code: U-3891: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults being treated with a beta-blocker or in adults reinitiating treatment	Oct 10, 2042	New patent for this product

QINLOCK (TABLET) (ORAL) RIPRETINIB
Drug Classes: kinase inhibitor
NDA Applicant: DECIPHERA PHARMS      NDA No.: 213973  Prod. No.: 001 RX (50MG)

Patents	Expiration	Change
Pat. No. 11969414 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: May 8, 2024 Claim Types: Method of use Use Code: U-3897: Treatment of gastrointestinal stromal tumors in patients being treated concurrently with itraconazole	Feb 8, 2041	New patent for this product
Pat. No. 11969415 (methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea Pat. Sub. Date(s): 001: May 8, 2024 Claim Types: Formulation Use Code: U-3219: Treatment of gastrointestinal stromal tumor	Dec 30, 2040	New patent for this product

RADICAVA ORS (SUSPENSION) (ORAL) EDARAVONE
NDA Applicant: MITSUBISHI TANABE      NDA No.: 215446  Prod. No.: 001 RX (105MG/5ML)

Patents	Expiration	Change
Pat. No. 11957660 DP* Edaravone suspension for oral administration Pat. Sub. Date(s): 001: May 9, 2024 Claim Types: Formulation	Nov 1, 2039	New patent for this product

RAVICTI (LIQUID) (ORAL) GLYCEROL PHENYLBUTYRATE
NDA Applicant: HORIZON THERAP US      NDA No.: 203284  Prod. No.: 001 RX (1.1GM/ML)

Patents	Expiration	Change
Pat. No. 9254278 Methods of therapeutic monitoring of nitrogen scavenging drugs Pat. Sub. Date(s): 001: Feb 29, 2016 Claim Types: Method of use; Method of administration Use Code: U-1816: Treatment of a urea cycle disorder	Sep 22, 2030	New expiration date. Was previously Mar 9, 2032
Pat. No. 9326966 Methods of therapeutic monitoring of nitrogen scavenging drugs Pat. Sub. Date(s): 001: May 25, 2016 Claim Types: Method of administration Use Code: U-1816: Treatment of a urea cycle disorder	Sep 22, 2030	New expiration date. Was previously Mar 9, 2032

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. 10112942 DS* DP* Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): All strengths: May 9, 2024 Claim Types: Compound; Composition	Oct 10, 2037	New product in Orange Book
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-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, 2037	New product in Orange Book
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-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, 2037	New product in Orange Book
Pat. No. 10584124 DS* Crystalline forms Pat. Sub. Date(s): All strengths: May 9, 2024 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	New product in Orange Book
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: May 9, 2024 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	New product in Orange Book

RISVAN (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) RISPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: LABS FARMS ROVI SA      NDA No.: 214835  Prod. No.: 001 RX (75MG); 002 RX (100MG)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Mar 29, 2027	New exclusivity for this product

SCEMBLIX (TABLET) (ORAL) ASCIMINIB HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.: 215358  Prod. No.: 003 RX (EQ 100MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Oct 29, 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)	Oct 29, 2028	New strength or variation of this product

SLYND (TABLET) (ORAL) DROSPIRENONE
Drug Classes: progestin
NDA Applicant: EXELTIS USA INC      NDA No.: 211367  Prod. No.: 001 RX (4MG)

Patents	Expiration	Change
Pat. No. 11951213 Synthetic progestogens and pharmaceutical compositions comprising the same Pat. Sub. Date(s): 001: Apr 25, 2024 Claim Types: Method of use Use Code: U-2553: Prevention of pregnancy in females of reproductive age	Jun 28, 2031	New patent for this product

SUNLENCA (SOLUTION) (SUBCUTANEOUS) LENACAPAVIR SODIUM
Drug Classes: human immunodeficiency virus type 1 (HIV-1) capsid inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 215973  Prod. No.: 001 RX (EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML))

Patents	Expiration	Change
Pat. No. 11944611 Capsid inhibitors for the treatment of HIV Pat. Sub. Date(s): 001: Apr 23, 2024 Claim Types: Method of use Use Code: U-3507: In combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily-treatment experienced adults with multidrug resistant HIV-1 infection	Jun 4, 2041	New patent for this product

SUNLENCA (TABLET) (ORAL) LENACAPAVIR SODIUM
Drug Classes: human immunodeficiency virus type 1 (HIV-1) capsid inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 215974  Prod. No.: 001 RX (EQ 300MG BASE)

Patents	Expiration	Change
Pat. No. 11944611 DS* DP* Capsid inhibitors for the treatment of HIV Pat. Sub. Date(s): 001: Apr 23, 2024 Claim Types: Method of use Use Code: U-3507: In combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily-treatment experienced adults with multidrug resistant HIV-1 infection	Jun 4, 2041	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11969404 Methods of providing solriamfetol therapy to subjects with impaired renal function Pat. Sub. Date(s): All strengths: May 2, 2024 Claim Types: Method of use Use Code: U-3892: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having a history of bipolar disorders and moderate or severe renal impairment	Mar 19, 2040	New patent for this product

SYMDEKO (COPACKAGED) (TABLET) (ORAL) IVACAFTOR; IVACAFTOR, TEZACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR) potentiat
NDA Applicant: VERTEX PHARMS INC      NDA No.: 210491  Prod. No.: 001 RX (150MG;150MG, 100MG)

Patents	Expiration	Change
Pat. No. 11951212 DP* Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases Pat. Sub. Date(s): 001: May 2, 2024 Claim Types: Formulation; Method of use Use Code: U-3894: Treatment of cystic fibrosis in patients age 6 and older who are homozygous for the F508DEL mutation or have at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor with a composition according to claim 1 of US 11951212	Apr 14, 2035	New patent for this product

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)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-941: In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test	Feb 16, 2027	New exclusivity for this product

TALZENNA (CAPSULE) (ORAL) TALAZOPARIB TOSYLATE
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: PFIZER      NDA No.: 217439  Prod. No.: 001 RX (EQ 0.1MG BASE); 002 RX (EQ 0.25MG BASE); 004 RX (EQ 0.5MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-920: Use of talazoparib in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (MCRPC).	Jun 20, 2026	New exclusivity for this product

TAVNEOS (CAPSULE) (ORAL) AVACOPAN
Drug Classes: complement 5a receptor (C5aR) antagonist
NDA Applicant: CHEMOCENTRYX      NDA No.: 214487  Prod. No.: 001 RX (10MG)

Patents	Expiration	Change
Pat. No. 11951214 DP* Capsule formulations Pat. Sub. Date(s): 001: Apr 26, 2024 Claim Types: Formulation	Nov 27, 2039	New patent for this product

TRALEMENT (SOLUTION) (INTRAVENOUS) CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
NDA Applicant: AM REGENT      NDA No.: 209376  Prod. No.: 001 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)); 002 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML))

Patents	Expiration	Change
Pat. No. 11975022 Pat. Sub. Date(s): All strengths: May 8, 2024 Claim Types: Use Code: U-3899: Adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated	Jul 1, 2041	New patent for this product

TRYVIO (TABLET) (ORAL) APROCITENTAN
NDA Applicant: IDORSIA      NDA No.: 217686  Prod. No.: 001 RX (12.5MG)

Patents	Expiration	Change
Pat. No. 8324232 DS* DP* 4-pyrimidinesulfamide derivative Pat. Sub. Date(s): 001: Apr 16, 2024 Claim Types: Compound; Composition; Method of use; Process Use Code: U-3878: Treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs	Sep 21, 2029	New patent for this product
Pat. No. 10919881 DS* DP* Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan Pat. Sub. Date(s): 001: Apr 16, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Feb 26, 2038	New patent for this product
Pat. No. 11174247 Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases Pat. Sub. Date(s): 001: Apr 16, 2024 Claim Types: Formulation; Method of use Use Code: U-3879: Treatment of hypertension in combination with other antihypertensive drugs, including an angiotensin receptor blocker, to lower blood pressure in adult patients who are not adequately controlled on other drugs	Nov 6, 2037	New patent for this product
Pat. No. 11680058 Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan Pat. Sub. Date(s): 001: Apr 16, 2024 Claim Types: Method of use Use Code: U-3878: Treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs	Jul 26, 2038	New patent for this product
Pat. No. 11787782 Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases Pat. Sub. Date(s): 001: Apr 16, 2024 Claim Types: Formulation; Method of use Use Code: U-3877: Treatment of hypertension in combination with other antihypertensive drugs, including an angiotensin converting enzyme inhibitor, to lower blood pressure in adult patients who are not adequately controlled on other drugs	Mar 2, 2038	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Mar 22, 2029	New exclusivity for this product

UBRELVY (TABLET) (ORAL) UBROGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 211765  Prod. No.: 001 RX (50MG); 002 RX (100MG)

Patents	Expiration	Change
Pat. No. 11925709 DP* Tablet formulation for CGRP active compounds Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Formulation	Jan 30, 2035	New patent for this product

VAFSEO (TABLET) (ORAL) VADADUSTAT
NDA Applicant: AKEBIA      NDA No.: 215192  Prod. No.: 001 RX (150MG); 002 RX (300MG); 003 RX (450MG)

Patents	Expiration	Change
Pat. No. RE47437 DS* DP* Prolyl hydroxylase inhibitors and methods of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Compound; Composition	Jun 26, 2027	New patent for this product
Pat. No. 8323671 Prolyl hydroxylase inhibitors and methods of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Method of use Use Code: U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months	Apr 3, 2028	New patent for this product
Pat. No. 8598210 DS* DP* Prolyl hydroxylase inhibitors and methods of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Compound; Composition	Jun 26, 2027	New patent for this product
Pat. No. 8940773 Prolyl hydroxylase inhibitors and methods of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Method of use Use Code: U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months	Jun 26, 2027	New patent for this product
Pat. No. 9701636 DS* DP* Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Nov 14, 2034	New patent for this product
Pat. No. 9987262 Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Method of use Use Code: U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months	Nov 14, 2034	New patent for this product
Pat. No. 10149842 DS* DP* Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Nov 14, 2034	New patent for this product
Pat. No. 11065237 DS* DP* Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months	Nov 14, 2034	New patent for this product
Pat. No. 11324734 DP* Compositions and methods for treating anemia Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Formulation	Mar 31, 2036	New patent for this product
Pat. No. 11844756 Compositions and methods for treating anemia Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Method of use Use Code: U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months	Mar 31, 2036	New patent for this product
Pat. No. 11857543 Compositions and methods for treating anemia Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Method of use Use Code: U-3876: Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months	Jun 9, 2034	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Mar 27, 2029	New exclusivity for this product

VEMLIDY (TABLET) (ORAL) TENOFOVIR ALAFENAMIDE FUMARATE [GENERIC AB]
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208464  Prod. No.: 001 RX (EQ 25MG BASE)

Patents	Expiration	Change
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Pat. Sub. Date(s): 001: Nov 28, 2016 Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process Use Code: U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older Use Code: U-3880: Treatment of chronic hepatitis b virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg Use Code: U-999: Treatment of chronic hepatitis B in adult patients	Feb 15, 2033 *PED	New Use Code
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Pat. Sub. Date(s): 001: Nov 28, 2016 Claim Types: Formulation; Method of use Use Code: U-1275: Treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older Use Code: U-3880: Treatment of chronic hepatitis b virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg Use Code: U-999: Treatment of chronic hepatitis B in adult patients	Feb 15, 2033 *PED	New Use Code

VOYDEYA (TABLET) (ORAL) DANICOPAN
NDA Applicant: ALEXION PHARMS INC      NDA No.: 218037  Prod. No.: 001 RX (50MG); 002 RX (100MG)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Mar 29, 2029	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-476: Treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH)	Mar 29, 2031	New exclusivity for this product

XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: OPTINOSE US INC      NDA No.: 209022  Prod. No.: 001 RX (0.093MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-940: Treatment of chronic rhinosinusitis without nasal polyps (CRSSNP) in adults	Mar 15, 2027	New exclusivity for this product

XOSPATA (TABLET) (ORAL) GILTERITINIB FUMARATE
NDA Applicant: ASTELLAS      NDA No.: 211349  Prod. No.: 001 RX (EQ 40MG BASE)

Patents	Expiration	Change
Pat. No. 11938130 DP* Stable pharmaceutical composition for oral administration Pat. Sub. Date(s): 001: Apr 25, 2024 Claim Types: Formulation	Jul 1, 2036	New patent for this product
Pat. No. 11938131 DP* Stable pharmaceutical composition for oral administration Pat. Sub. Date(s): 001: Apr 25, 2024 Claim Types: Formulation	Jul 1, 2036	New patent for this product
Pat. No. 11938132 DP* Stable pharmaceutical composition for oral administration Pat. Sub. Date(s): 001: Apr 25, 2024 Claim Types: Process; Product-by-process	Jul 1, 2036	New patent for this product
Pat. No. 11938133 DP* Stable pharmaceutical composition for oral administration Pat. Sub. Date(s): 001: Apr 25, 2024 Claim Types: Process; Product-by-process	Jul 1, 2036	New patent for this product
Pat. No. 11944620 DP* Stable pharmaceutical composition for oral administration Pat. Sub. Date(s): 001: Apr 25, 2024 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Jul 1, 2036	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: ODE - Orphan drug exclusivity: ODE-470: To reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years, with sickle cell anemia with recurrent moderate to severe painful crises	Apr 4, 2031	New product in Orange Book

XYREM (SOLUTION) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: JAZZ PHARMS      NDA No.: 021196  Prod. No.: 001 RX (0.5GM/ML)

Patents	Expiration	Change
Pat. No. 7668730 DLR* Sensitive drug distribution system and method Pat. Sub. Date(s): None Claim Types: Method of distribution Use Code: U-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution	Dec 16, 2024 *PED	This patent is no longer listed for this product

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

Patents	Expiration	Change
Pat. No. 9474780 DS* DP* GIP and GLP-1 co-agonist compounds Pat. Sub. Date(s): All strengths: Apr 18, 2024 Claim Types: Compound; Composition; Method of use	Jan 5, 2036	New patent for this product
Pat. No. 11357820 DP* GIP/GLP1 agonist compositions Pat. Sub. Date(s): All strengths: Apr 18, 2024 Claim Types: Formulation; Method of use	Jun 14, 2039	New patent for this product
Pat. No. 11918623 GIP/GLP1 agonist compositions Pat. Sub. Date(s): All strengths: Apr 18, 2024 Claim Types: Method of use Use Code: U-3855: For chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obesity), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition	Jun 14, 2039	New patent for this product

ZEVTERA (POWDER) (INTRAVENOUS) CEFTOBIPROLE MEDOCARIL SODIUM
NDA Applicant: BASILEA PHARM ALLSCH      NDA No.: 218275  Prod. No.: 001 RX (667MG/VIAL)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Apr 3, 2034 GAIN	New product in Orange Book