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: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other
NDA Applicant: AXSOME      NDA No.: 215430  Prod. No.: 001 RX (105MG;45MG)

Patents	Expiration	Change
Pat. No. 11779579 Bupropion as a modulator of drug activity Pat. Sub. Date(s): 001: Oct 12, 2023 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

BOSULIF (TABLET) (ORAL) BOSUTINIB MONOHYDRATE
NDA Applicant: PF PRISM CV      NDA No.: 203341  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 500MG BASE); 003 RX (EQ 400MG BASE)

Patents	Expiration	Change
Pat. No. 7417148 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017 Claim Types: Method of use Use Code: U-1283: A method of treating chronic myelogenous leukemia Use Code: U-3707: A method of treating patients 1 year of age and older with chronic phase ph+ CML, newly-diagnosed or resistant or intolerant to prior therapy Use Code: U-3708: A method of treating patients with accelerated, or blast phase ph+ CML with resistance or intolerance to prior therapy	Jun 11, 2026 *PED	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-923: For the treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML), newly-diagnosed or resistant or intolerant to prior therapy	Mar 26, 2027 PED	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-444: Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML), newly-diagnosed or resistant or intolerant to prior therapy	Mar 26, 2031 PED	New exclusivity for this product

BOSULIF (CAPSULE) (ORAL) BOSUTINIB MONOHYDRATE
NDA Applicant: PF PRISM CV      NDA No.: 217729  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. RE42376 DS* DP* [Extended 1663 days (4.6 years)] Substituted 3-cyanoquinolines Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Compound; Composition	Oct 13, 2024 *PED	New patent for this product
Pat. No. 7417148 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Method of use Use Code: U-3707: A method of treating patients 1 year of age and older with chronic phase ph+ CML, newly-diagnosed or resistant or intolerant to prior therapy Use Code: U-3708: A method of treating patients with accelerated, or blast phase ph+ CML with resistance or intolerance to prior therapy	Jun 11, 2026 *PED	New patent for this product
Pat. No. 7767678 DS* DP* Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: New polymorph, salt or hydrate; Process; Composition	May 23, 2027 *PED	New patent for this product
Pat. No. 7919625 DP* 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Formulation	Jun 11, 2026 *PED	New patent for this product
Pat. No. 11103497 Treatment of imatinib resistant leukemia Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Method of use Use Code: U-3216: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the BCRABL protein at 949T>C Use Code: U-3217: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the bcrabl protein at F317L	Aug 28, 2034 *PED	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Mar 26, 2027 PED	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-444: Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML), newly-diagnosed or resistant or intolerant to prior therapy	Mar 26, 2031 PED	New exclusivity for this product

BRINZOLAMIDE (SUSPENSION/DROPS) (OPHTHALMIC) BRINZOLAMIDE [GENERIC AB]
NDA Applicant: PADAGIS US      NDA No.: 211914  Prod. No.: 001 RX (1%)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 7, 2024	New exclusivity for this product

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

Patents	Expiration	Change
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	Jan 19, 2043	New patent for this product

CABTREO (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Drug Classes: Antibacterials:Antibacterials, Other
NDA Applicant: BAUSCH      NDA No.: 216632  Prod. No.: 001 RX (0.15%;3.1%;1.2%)

Patents	Expiration	Change
Pat. No. 8288434 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Formulation; Method of use Use Code: U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older	Aug 5, 2029	New product in Orange Book
Pat. No. 9561208 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Formulation; Method of use Use Code: U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older	Jun 3, 2029	New product in Orange Book
Pat. No. 10220049 DP* Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Formulation; Method of use Use Code: U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older	Jun 3, 2029	New product in Orange Book
Pat. No. 10624918 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Method of use Use Code: U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older	Jun 3, 2029	New product in Orange Book
Pat. No. 11389467 DP* Topical compositions Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Formulation; Method of use; Drug in a container; Process Use Code: U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older	Dec 28, 2040	New product in Orange Book

CALCIUM GLUCONATE (SOLUTION) (INTRAVENOUS) CALCIUM GLUCONATE [GENERIC AP]
NDA Applicant: B BRAUN MEDICAL INC      NDA No.: 216541  Prod. No.: 001 RX (10GM/100ML (100MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 30, 2024	New exclusivity for this product

CALCIUM GLUCONATE (SOLUTION) (INTRAVENOUS) CALCIUM GLUCONATE [GENERIC AP]
NDA Applicant: SOMERSET      NDA No.: 217689  Prod. No.: 001 RX (5GM/50ML (100MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 17, 2024	New product in Orange Book

CALQUENCE (CAPSULE) (ORAL) ACALABRUTINIB
NDA Applicant: ASTRAZENECA      NDA No.: 210259  Prod. No.: 001 RX (100MG)

Patents	Expiration	Change
Pat. No. 11771696 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Pat. Sub. Date(s): 001: Oct 30, 2023 Claim Types: Method of use Use Code: U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab	Jan 21, 2035	New patent for this product

CALQUENCE (TABLET) (ORAL) ACALABRUTINIB MALEATE
NDA Applicant: ASTRAZENECA      NDA No.: 216387  Prod. No.: 001 RX (EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. 11771696 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Pat. Sub. Date(s): 001: Oct 30, 2023 Claim Types: Method of use Use Code: U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab	Jan 21, 2035	New patent for this product

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (GEL) (TOPICAL) BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE [GENERIC AB]
Drug Classes: Antibacterials:Antibacterials, Other
NDA Applicant: TARO      NDA No.: 208683  Prod. No.: 001 RX (3.75%;EQ 1.2% BASE)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Mar 30, 2024	New exclusivity for this product

COLCHICINE (CAPSULE) (ORAL) COLCHICINE [GENERIC AB]
NDA Applicant: PAR PHARM INC      NDA No.: 208678  Prod. No.: 001 RX (0.6MG)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Apr 29, 2024	New exclusivity for this product

COMBOGESIC IV (SOLUTION) (INTRAVENOUS) ACETAMINOPHEN; IBUPROFEN SODIUM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HIKMA      NDA No.: 215320  Prod. No.: 001 RX (1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML))

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Oct 17, 2026	New product in Orange Book

DOJOLVI (LIQUID) (ORAL) TRIHEPTANOIN
NDA Applicant: ULTRAGENYX PHARM INC      NDA No.: 213687  Prod. No.: 001 RX (100% w/w)

Patents	Expiration	Change
Pat. No. 8697748 DP* Glycogen or polysaccharide storage disease treatment method Pat. Sub. Date(s): 001: Oct 2, 2020 Claim Types: Formulation	Apr 28, 2029	New expiration date. Was previously Oct 3, 2025

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
NDA Applicant: TOLMAR      NDA No.: 021343  Prod. No.: 001 RX (7.5MG)

Patents	Expiration	Change
Pat. No. 11771841 DS* DP* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Oct 27, 2023 Claim Types: Device	Dec 22, 2041	New patent for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
NDA Applicant: TOLMAR      NDA No.: 021379  Prod. No.: 001 RX (22.5MG)

Patents	Expiration	Change
Pat. No. 11771841 DS* DP* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Oct 27, 2023 Claim Types: Device	Dec 22, 2041	New patent for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
NDA Applicant: TOLMAR      NDA No.: 021488  Prod. No.: 001 RX (30MG)

Patents	Expiration	Change
Pat. No. 11771841 DS* DP* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Oct 27, 2023 Claim Types: Device	Dec 22, 2041	New patent for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
NDA Applicant: TOLMAR      NDA No.: 021731  Prod. No.: 001 RX (45MG)

Patents	Expiration	Change
Pat. No. 11771841 DS* DP* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Oct 27, 2023 Claim Types: Device	Dec 22, 2041	New patent for this product

EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
Drug Classes: Anticonvulsants:Anticonvulsants, Other
NDA Applicant: GW RES LTD      NDA No.: 210365  Prod. No.: 001 RX (100MG/ML)

Patents	Expiration	Change
Pat. No. 11766411 Use of cannabinoids in the treatment of epilepsy Pat. Sub. Date(s): 001: Oct 19, 2023 Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Use Code: U-2781: Use for the treatment of seizures in patients with Dravet syndrome	Jun 17, 2035	New patent for this product

EUCRISA (OINTMENT) (TOPICAL) CRISABOROLE
NDA Applicant: ANACOR PHARMS INC      NDA No.: 207695  Prod. No.: 001 RX (2%)

Exclusivity	Expiration	Change
Exclusivity Code: D - New Dosing Schedule: D-191: Addition of a once daily dosing regimen	Apr 3, 2026	New exclusivity for this product

EVRYSDI (FOR SOLUTION) (ORAL) RISDIPLAM
NDA Applicant: GENENTECH INC      NDA No.: 213535  Prod. No.: 001 RX (0.75MG/ML)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-270: Information added to clinical pharmacology section	Oct 3, 2026	New exclusivity for this product

EXXUA (TABLET, EXTENDED RELEASE) (ORAL) GEPIRONE HYDROCHLORIDE
NDA Applicant: FABRE KRAMER      NDA No.: 021164  Prod. No.: 001 RX (EQ 18.2MG BASE); 002 RX (EQ 36.3MG BASE); 003 RX (EQ 54.5MG BASE ); 004 RX (EQ 72.6MG BASE)

Patents	Expiration	Change
Pat. No. 7538116 Treatment of sexual disorders Pat. Sub. Date(s): All strengths: Oct 18, 2023 Claim Types: Method of use Use Code: U-3699: Treatment of subjects with major depression with sexual dysfunction caused by either major depression or prior treatments, or treatment of subjects with major depression without the risk of sexual dysfunction adverse reactions	Sep 2, 2025	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Sep 22, 2028	New exclusivity for this product

FENSOLVI KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
NDA Applicant: TOLMAR      NDA No.: 213150  Prod. No.: 001 RX (45MG)

Patents	Expiration	Change
Pat. No. 11771841 DS* DP* Systems and methods for mixing syringe valve assemblies Pat. Sub. Date(s): 001: Oct 27, 2023 Claim Types: Device	Dec 22, 2041	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11759440 Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Pat. Sub. Date(s): 001: Oct 16, 2023 Claim Types: Method of use Use Code: U-3694: Method of reducing or ameliorating seizures in a patient by administering a liquid formulation of fenfluramine with stiripentol therapy modulating down the formation of norfenfluramine and resulting in higher levels of fenfluramine	Aug 2, 2037	New patent for this product

FIRMAGON (POWDER) (SUBCUTANEOUS) DEGARELIX ACETATE
NDA Applicant: FERRING      NDA No.: 022201  Prod. No.: 001 RX (EQ 80MG BASE/VIAL); 002 RX (EQ 120MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 11766468 Method of treating prostate cancer with GnRH antagonist Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Method of use Use Code: U-1978: Treatment of advanced prostate cancer with a reduced likelihood of causing a gonadotrophin releasing hormone agonist side-effect	Apr 27, 2032	New patent for this product

FLUORESCEIN SODIUM (INJECTABLE) (INTRAVENOUS) FLUORESCEIN SODIUM [GENERIC AP]
NDA Applicant: NEXUS PHARMS      NDA No.: 215709  Prod. No.: 001 RX (EQ 500MG BASE/5ML (EQ 100MG BASE/ML))

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 21, 2024	New exclusivity for this product

FOCINVEZ (SOLUTION) (INTRAVENOUS) FOSAPREPITANT DIMEGLUMINE
NDA Applicant: STERISCIENCE      NDA No.: 216686  Prod. No.: 001 RX (EQ 150MG BASE/50ML (EQ 3MG BASE/ML))

Patents	Expiration	Change
Pat. No. 11065265 DP* Compositions of fosaprepitant and methods of preparation Pat. Sub. Date(s): 001: Sep 13, 2023 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Jan 11, 2039	New patent for this product
Pat. No. 11065256 DP* Administration and dosage of diaminophenothiazines Pat. Sub. Date(s): None Claim Types: Method of use	Jan 11, 2039	This patent is no longer listed for this product

FORTEO (SOLUTION) (SUBCUTANEOUS) TERIPARATIDE
NDA Applicant: LILLY      NDA No.: 021318  Prod. No.: 002 RX (0.6MG/2.4ML (0.25MG/ML)) NDA No.: 021318  Prod. No.: 001 DISC (0.75MG/3ML (0.25MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-302: Information added to labeling regarding osteosarcoma	Nov 16, 2023	New exclusivity for this product

GADOBUTROL (SOLUTION) (INTRAVENOUS) GADOBUTROL [GENERIC AP]
NDA Applicant: HENGRUI PHARMA      NDA No.: 216081  Prod. No.: 001 RX (18.1416GM/30ML (604.72MG/ML)); 002 RX (39.3068GM/65ML (604.72MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 29, 2024	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. 11786516 DS* Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Oct 25, 2023 Claim Types: Formulation	May 30, 2038	New patent for this product

GLIPIZIDE (TABLET) (ORAL) GLIPIZIDE [Has competitive generic]
NDA Applicant: RUBICON      NDA No.: 214874  Prod. No.: 001 RX (2.5MG)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 15, 2024	New exclusivity for this product

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

Patents	Expiration	Change
Pat. No. 11759446 Liquid tasimelteon formulations and methods of use thereof Pat. Sub. Date(s): 001: Oct 13, 2023 Claim Types: Method of use Use Code: U-3003: Treatment of nighttime sleep disturbances in Smith-Magenis syndrome by administering tasimelteon	Feb 21, 2041	New patent for this product
Pat. No. 11760740 DS* DP* Highly purified pharmaceutical grade tasimelteon Pat. Sub. Date(s): 001: Oct 13, 2023 Claim Types: Product-by-process; Composition	Feb 12, 2035	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11759446 Liquid tasimelteon formulations and methods of use thereof Pat. Sub. Date(s): 001: Oct 13, 2023 Claim Types: Method of use Use Code: U-3003: Treatment of nighttime sleep disturbances in Smith-Magenis syndrome by administering tasimelteon	Feb 21, 2041	New patent for this product
Pat. No. 11760740 DS* DP* Highly purified pharmaceutical grade tasimelteon Pat. Sub. Date(s): 001: Oct 13, 2023 Claim Types: Product-by-process; Composition	Feb 12, 2035	New patent for this product

IGALMI (FILM) (BUCCAL, SUBLINGUAL) DEXMEDETOMIDINE HYDROCHLORIDE
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. 11786508 Use of sublingual dexmedetomidine for the treatment of agitation Pat. Sub. Date(s): All strengths: Oct 17, 2023 Claim Types: Method of use Use Code: U-3698: Acute treatment of agitation associated with schizophrenia by sublingual or buccal administration	Dec 29, 2037	New patent for this product
Pat. No. 11806334 Non-sedating dexmedetomidine treatment regimens Pat. Sub. Date(s): All strengths: Nov 7, 2023 Claim Types: Method of use Use Code: U-3725: Acute treatment of agitation associated with schizophrenia or bipolar i or ii disorder by sublingual or buccal administration in patients with severe hepatic impairment	Jan 12, 2043	New patent for this product

JARDIANCE (TABLET) (ORAL) EMPAGLIFLOZIN
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 204629  Prod. No.: 001 RX (10MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-922: Use of empagliflozin to reduce the risk of sustained decline in EGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression	Sep 21, 2026	New exclusivity for this product

JYLAMVO (SOLUTION) (ORAL) METHOTREXATE
NDA Applicant: SHORLA      NDA No.: 212479  Prod. No.: 001 RX (2MG/ML)

Patents	Expiration	Change
Pat. No. 11771701 DP* Methotrexate formulation Pat. Sub. Date(s): 001: Oct 20, 2023 Claim Types: Method of administration Use Code: U-3700: Treatment of adults with acute lymphoblastic leukemia with an oral solution of methotrexate Use Code: U-3701: Treatment of adults with mycosis fungoides with an oral solution of methotrexate Use Code: U-3702: Treatment of adults with relapsed or refractory non-hodgkin lymphomas with an oral solution of methotrexate Use Code: U-3703: Treatment of adults with rheumatoid arthritis with an oral solution of methotrexate Use Code: U-3704: Treatment of adults with severe psoriasis with an oral solution of methotrexate	Oct 29, 2034	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11771686 Compositions and kits for omeprazole suspension Pat. Sub. Date(s): 001: Oct 30, 2023 Claim Types: Method of use Use Code: U-623: Short term treatment of active benign gastric ulcer	Mar 1, 2040	New patent for this product

KYPROLIS (POWDER) (INTRAVENOUS) CARFILZOMIB [GENERIC AP]
NDA Applicant: ONYX PHARMS AMGEN      NDA No.: 202714  Prod. No.: 001 RX (60MG/VIAL); 002 RX (30MG/VIAL); 003 RX (10MG/VIAL)

Patents	Expiration	Change
Pat. No. 9511109 Combination therapy with peptide epoxyketones Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1924: KYPROLIS is indicated in combination with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy	Oct 21, 2029	This patent is no longer listed for this product

LIKMEZ (SUSPENSION) (ORAL) METRONIDAZOLE
Drug Classes: Antibacterials:Antibacterials, Other
NDA Applicant: SAPTALIS PHARMS      NDA No.: 216755  Prod. No.: 001 RX (500MG/5ML)

Patents	Expiration	Change
Pat. No. 11541035 DP* Oral formulations of metronidazole and methods of treating an infection using same Pat. Sub. Date(s): 001: Oct 18, 2023 Claim Types: Formulation; Method of use	Oct 4, 2039	New patent for this product

LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
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. 11779557 Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Oct 24, 2023 Claim Types: Method of use Use Code: U-3705: Treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy who have an apnea/hypopnea index ≤15 with a once-nightly formulation of gamma-hydroxybutyrate	Mar 16, 2042	New patent for this product

LUPKYNIS (CAPSULE) (ORAL) VOCLOSPORIN
Drug Classes: calcineurin-inhibitor immunosuppressant
NDA Applicant: AURINIA      NDA No.: 213716  Prod. No.: 001 RX (7.9MG)

Patents	Expiration	Change
Pat. No. 7332472 DS* DP* Cyclosporine analogue mixtures and their use as immunomodulating agents Pat. Sub. Date(s): 001: Feb 11, 2021 Claim Types: Formulation; Method of use Use Code: U-3056: Treatment of patients with active lupus nephritis	Oct 17, 2024	New expiration date. Was previously Oct 17, 2023

LYNPARZA (TABLET) (ORAL) OLAPARIB
NDA Applicant: ASTRAZENECA      NDA No.: 208558  Prod. No.: 001 RX (100MG); 002 RX (150MG)

Patents	Expiration	Change
Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer Pat. Sub. Date(s): All strengths: Jun 18, 2020 Claim Types: Method of use Use Code: U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy Use Code: U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting Use Code: U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy Use Code: U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen Use Code: U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation Use Code: U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability Use Code: U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation Use Code: U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability Use Code: U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation Use Code: U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability Use Code: U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone Use Code: U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone Use Code: U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy Use Code: U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone Use Code: U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy	Aug 12, 2027	Deleted Use Code(s): U-2101, U-2103
Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Pat. Sub. Date(s): All strengths: Sep 15, 2017 Claim Types: Method of use Use Code: U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy Use Code: U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting Use Code: U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy Use Code: U-2716: Maintenance treatment of deleterious or suspected deleterious gbrca-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen Use Code: U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation Use Code: U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability Use Code: U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation Use Code: U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability Use Code: U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation Use Code: U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability Use Code: U-2832: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone Use Code: U-2833: Treatment of deleterious or suspected deleterious germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer, which has progressed following prior treatment with enzalutamide or abiraterone Use Code: U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy Use Code: U-3631: Treatment of deleterious or suspected deleterious brca-mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone Use Code: U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy	Aug 12, 2027	Deleted Use Code(s): U-2101, U-2103
Pat. No. 8912187 Phthalazinone derivatives Pat. Sub. Date(s): All strengths: Sep 15, 2017 Claim Types: Method of use Use Code: U-2480: Maintenance treatment of GBRCA- or SBRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy Use Code: U-2482: Treatment of HR-negative, HER-2 negative, GBRCA-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting Use Code: U-2483: Treatment of HR-positive, HER-2 negative, gbrca-mutated metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting, and with endocrine therapy or are inappropriate for endocrine therapy Use Code: U-2819: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation Use Code: U-2820: Maintenance treatment with bevacizumab of adv. epithelial ovarian cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability Use Code: U-2821: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation Use Code: U-2822: Maintenance treatment with bevacizumab of fallopian tube cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability Use Code: U-2823: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with a deleterious or suspected deleterious BRCA mutation Use Code: U-2824: Maintenance treatment with bevacizumab of primary peritoneal cancer in complete or partial response to first-line platinum chemotherapy and homologous recombination deficiency-positive with genomic instability Use Code: U-3333: Adjuvant treatment of patients with GBRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy Use Code: U-3695: Maintenance treatment of deleterious or suspected deleterious germline or somatic BRCA-muted recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy	Mar 12, 2024	Deleted Use Code(s): U-2101

MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Drug Classes: 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. 11793812 Methods of treating endometriosis Pat. Sub. Date(s): 001: Oct 25, 2023 Claim Types: Method of use Use Code: U-2360: Management of moderate to severe pain associated with endometriosis	May 3, 2038	New patent for this product
Pat. No. 11795178 DS* DP* Compositions of thienopyrimidine derivatives Pat. Sub. Date(s): 001: Oct 25, 2023 Claim Types: Composition; Formulation	Sep 27, 2033	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11793760 DP* Orodispersible dosage unit containing an estetrol component Pat. Sub. Date(s): 001: Oct 31, 2023 Claim Types: Formulation	Jun 17, 2036	New patent for this product

OFEV (CAPSULE) (ORAL) NINTEDANIB ESYLATE
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 205832  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 6762180 DS* DP* [Extended 1824 days (5 years)] Substituted indolines which inhibit receptor tyrosine kinases Pat. Sub. Date(s): All strengths: Oct 22, 2014 Claim Types: Compound; Composition	Apr 1, 2026 *PED	New expiration date. Was previously Oct 1, 2025
Pat. No. 9907756 DP* Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative Pat. Sub. Date(s): All strengths: Apr 4, 2018 Claim Types: Formulation	Dec 7, 2029 *PED	New expiration date. Was previously Jun 7, 2029
Pat. No. 10105323 DP* Pharmaceutical dosage form for immediate release of an indolinone derivative Pat. Sub. Date(s): All strengths: Nov 6, 2018 Claim Types: Formulation	Dec 4, 2029 *PED	New expiration date. Was previously Jun 4, 2029
Pat. No. 10154990 Medicaments for the treatment or prevention of fibrotic diseases Pat. Sub. Date(s): All strengths: Sep 18, 2019 Claim Types: Method of use Use Code: U-2620: Use of nintedanib for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD)	Jul 8, 2026 *PED	New expiration date. Was previously Jan 8, 2026
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-261: Indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD)	Mar 6, 2027 PED	New expiration date. Was previously Sep 6, 2026

OPFOLDA (CAPSULE) (ORAL) MIGLUSTAT
NDA Applicant: AMICUS THERAP US      NDA No.: 215211  Prod. No.: 001 RX (65MG)

Patents	Expiration	Change
Pat. No. 10208299 DS* DP* Highly potent acid alpha-glucosidase with enhanced carbohydrates Pat. Sub. Date(s): 001: Oct 26, 2023 Claim Types: Composition; Method of use Use Code: U-3726: The treatment of pompe patients	Sep 30, 2035	New patent for this product
Pat. No. 10512677 High concentration alpha-glucosidase compositions for the treatment of pompe disease Pat. Sub. Date(s): 001: Oct 26, 2023 Claim Types: Method of use Use Code: U-3726: The treatment of pompe patients	Mar 7, 2033	New patent for this product
Pat. No. 10857212 Augmented acid alpha-glucosidase for the treatment of Pompe disease Pat. Sub. Date(s): 001: Oct 26, 2023 Claim Types: Method of use; Composition Use Code: U-3726: The treatment of pompe patients	Aug 12, 2037	New patent for this product
Pat. No. 10961522 Highly potent acid alpha-glucosidase with enhanced carbohydrates Pat. Sub. Date(s): 001: Oct 26, 2023 Claim Types: Method of use Use Code: U-3726: The treatment of pompe patients	Sep 30, 2035	New patent for this product
Pat. No. 11278599 High concentration alpha-glucosidase compositions for the treatment of Pompe disease Pat. Sub. Date(s): 001: Oct 26, 2023 Claim Types: Method of use Use Code: U-3726: The treatment of pompe patients	Mar 7, 2033	New patent for this product
Pat. No. 11278601 DP* Augmented acid alpha-glucosidase for the treatment of Pompe disease Pat. Sub. Date(s): 001: Oct 26, 2023 Claim Types: Method of use; Kit Use Code: U-3726: The treatment of pompe patients	Dec 29, 2036	New patent for this product
Pat. No. 11753632 Highly potent acid alpha-glucosidase with enhanced carbohydrates Pat. Sub. Date(s): 001: Oct 26, 2023 Claim Types: Method of use Use Code: U-3726: The treatment of pompe patients	Sep 30, 2035	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Sep 28, 2026	New exclusivity for this product

ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: MYOVANT SCIENCES      NDA No.: 214621  Prod. No.: 001 RX (120MG)

Patents	Expiration	Change
Pat. No. 11795178 DS* DP* Compositions of thienopyrimidine derivatives Pat. Sub. Date(s): 001: Oct 25, 2023 Claim Types: Composition; Formulation	Sep 27, 2033	New patent for this product

ORSERDU (TABLET) (ORAL) ELACESTRANT DIHYDROCHLORIDE
NDA Applicant: STEMLINE THERAP      NDA No.: 217639  Prod. No.: 001 RX (EQ 86MG BASE); 002 RX (EQ 345MG BASE)

Patents	Expiration	Change
Pat. No. 8399520 DS* DP* Selective estrogen receptor modulator Pat. Sub. Date(s): All strengths: Feb 24, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-3523: Treatment of an ER-positive breast cancer	Dec 25, 2024	New expiration date. Was previously Dec 25, 2023
Pat. No. 11779552 Method of treating cancer using selective estrogen receptor modulators Pat. Sub. Date(s): All strengths: Nov 6, 2023 Claim Types: Method of use Use Code: U-3524: Treatment of an ER-positive breast cancer following at least one line of endocrine therapy	Oct 10, 2034	New patent for this product

PEMFEXY (SOLUTION) (INTRAVENOUS) PEMETREXED
NDA Applicant: EAGLE PHARMS      NDA No.: 209472  Prod. No.: 001 RX (500MG/20ML (25MG/ML))

Patents	Expiration	Change
Pat. No. 11793813 DP* Pemetrexed formulations Pat. Sub. Date(s): 001: Oct 24, 2023 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Drug in a container	Feb 19, 2036	New patent for this product

POSIMIR (SOLUTION, EXTENDED RELEASE) (INFILTRATION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: INNOCOLL      NDA No.: 204803  Prod. No.: 001 RX (660MG/5ML (132MG/ML))

Patents	Expiration	Change
Pat. No. 11771624 Sustained release drug delivery systems with reduced impurities and related methods Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Method of use Use Code: U-3724: To produce post-surgical analgesia	Jan 12, 2041	New patent for this product

POTASSIUM PHOSPHATES (SOLUTION) (INTRAVENOUS) POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC [GENERIC AP]
NDA Applicant: AM REGENT      NDA No.: 216274  Prod. No.: 001 RX (1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 13, 2024	New exclusivity for this product

POTASSIUM PHOSPHATES (SOLUTION) (INTRAVENOUS) POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC [GENERIC AP]
NDA Applicant: AM REGENT      NDA No.: 216274  Prod. No.: 002 RX (3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)); 003 RX (11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 10, 2024	New exclusivity for this product

PYRUKYND (TABLET) (ORAL) MITAPIVAT SULFATE
NDA Applicant: AGIOS PHARMS INC      NDA No.: 216196  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 20MG BASE); 003 RX (EQ 50MG BASE)

Patents	Expiration	Change
Pat. No. 11793806 Pyruvate kinase activators for use in therapy Pat. Sub. Date(s): All strengths: Oct 31, 2023 Claim Types: Method of use Use Code: U-3320: Method for increasing the lifetime of red blood cells (RBCS) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency	Apr 12, 2033	New patent for this product

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

Patents	Expiration	Change
Pat. No. 8461179 DS* DP* Dihydronaphthyridines and related compounds useful as kinase inhibitors for the treatment of proliferative diseases Pat. Sub. Date(s): 001: Jun 11, 2020 Claim Types: Compound; Composition	May 15, 2034	New expiration date. Was previously Jun 7, 2032
Pat. No. 11779572 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Method of use Use Code: U-3714: Treatment of gastrointestinal stromal tumors in patients having pre-existing severe hepatic impairment and suffering from an adverse event while being administered ripretinib daily	Oct 6, 2042	New patent for this product
Pat. No. 11793795 DP* Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Formulation	Dec 30, 2040	New patent for this product

RAYALDEE (CAPSULE, EXTENDED RELEASE) (ORAL) CALCIFEDIOL
NDA Applicant: EIRGEN      NDA No.: 208010  Prod. No.: 001 RX (0.03MG)

Patents	Expiration	Change
Pat. No. 11801253 DP* Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Method of use Use Code: U-3721: Treatment of secondary hyperparathyroidism with sustained release 25-hydroxyvitamin D in chronic kidney disease patients receiving cholestyramine Use Code: U-3722: Treatment of secondary hyperparathyroidism with sustained release 25-hydroxyvitamin D in chronic kidney disease patients receiving phenobarbital or other anticonvulsants Use Code: U-3723: Treatment of secondary hyperparathyroidism with sustained release 25-hydroxyvitamin d in chronic kidney disease patients receiving CYP3A inhibitors	Sep 7, 2030	New patent for this product

REMODULIN (INJECTABLE) (IV (INFUSION), SUBCUTANEOUS) TREPROSTINIL
NDA Applicant: UNITED THERAP      NDA No.: 021272  Prod. No.: 006 RX (0.1MG/ML); 007 RX (0.2MG/ML); 008 RX (0.4MG/ML)

Patents	Expiration	Change
Pat. No. 7999007 DP* Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same Pat. Sub. Date(s): All strengths: Oct 20, 2023 Claim Types: Method of use; Formulation Use Code: U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration	Mar 29, 2029	New strength or variation of this product
Pat. No. 8653137 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same Pat. Sub. Date(s): All strengths: Oct 20, 2023 Claim Types: Method of use Use Code: U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration	Sep 5, 2028	New strength or variation of this product
Pat. No. 8658694 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same Pat. Sub. Date(s): All strengths: Oct 20, 2023 Claim Types: Method of use Use Code: U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration	Sep 5, 2028	New strength or variation of this product
Pat. No. 9199908 Compounds and methods for delivery of prostacyclin analogs Pat. Sub. Date(s): All strengths: Oct 20, 2023 Claim Types: Method of use Use Code: U-1771: Administration of REMODULIN diluted for intravenous infusion with sterile water for injection or 0.9% sodium chloride injection prior to administration	May 24, 2024	New strength or variation of this product
Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM. Pat. Sub. Date(s): All strengths: Oct 20, 2023 Claim Types: Composition; New polymorph, salt or hydrate	Dec 15, 2028	New strength or variation of this product
Pat. No. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): All strengths: Oct 20, 2023 Claim Types: Product-by-process	Dec 15, 2028	New strength or variation of this product
Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin® Pat. Sub. Date(s): All strengths: Oct 20, 2023 Claim Types: Product-by-process; Process	Dec 15, 2028	New strength or variation of this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
NDA Applicant: ABBVIE      NDA No.: 211675  Prod. No.: 001 RX (15MG)

Patents	Expiration	Change
Pat. No. 11767326 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 23, 2023 Claim Types: Method of use Use Code: U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable	Oct 17, 2036	New patent for this product
Pat. No. 11773105 DS* 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: Nov 2, 2023 Claim Types: New polymorph, salt or hydrate	Oct 17, 2036	New patent for this product
Pat. No. 11773106 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 2, 2023 Claim Types: Method of use Use Code: U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers Use Code: U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers Use Code: U-3487: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to one or more tnf blockers	Oct 17, 2036	New patent for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
NDA Applicant: ABBVIE      NDA No.: 211675  Prod. No.: 002 RX (30MG)

Patents	Expiration	Change
Pat. No. 11767326 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 23, 2023 Claim Types: Method of use Use Code: U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable	Oct 17, 2036	New patent for this product
Pat. No. 11773105 DS* 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: Nov 2, 2023 Claim Types: New polymorph, salt or hydrate	Oct 17, 2036	New patent for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
NDA Applicant: ABBVIE      NDA No.: 211675  Prod. No.: 003 RX (45MG)

Patents	Expiration	Change
Pat. No. 11773105 DS* 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): 003: Nov 2, 2023 Claim Types: New polymorph, salt or hydrate	Oct 17, 2036	New patent for this product

RIVFLOZA (SOLUTION) (INJECTION) NEDOSIRAN SODIUM
NDA Applicant: NOVO      NDA No.: 215842  Prod. No.: 001 RX (EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)); 002 RX (EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)); 003 RX (EQ 160MG BASE/ML (EQ 160MG BASE/ML))

Patents	Expiration	Change
Pat. No. 10351854 DS* DP* Therapeutic inhibition of lactate dehydrogenase and agents therefor Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Compound; Composition; Cell	Oct 9, 2035	New patent for this product
Pat. No. 10738311 DS* DP* Therapeutic inhibition of lactate dehydrogenase and agents therefor Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Method of use Use Code: U-3709: Method of treating primary hyperoxaluria type 1 (PH1)	Oct 9, 2035	New patent for this product
Pat. No. 11053502 DS* DP* Therapeutic inhibition of lactate dehydrogenase and agents therefor Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Compound; Composition; Cell	Oct 29, 2035	New patent for this product
Pat. No. 11286488 DS* DP* Methods and compositions for inhibiting expression of LDHA Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-3709: Method of treating primary hyperoxaluria type 1 (PH1)	Oct 12, 2038	New patent for this product
Pat. No. 11359203 DS* DP* Therapeutic inhibition of lactate dehydrogenase and agents therefor Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-3709: Method of treating primary hyperoxaluria type 1 (PH1)	Oct 9, 2035	New patent for this product
Pat. No. 11661604 DS* DP* Methods and compositions for inhibiting expression of LDHA Pat. Sub. Date(s): All strengths: Oct 26, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-3709: Method of treating primary hyperoxaluria type 1 (PH1)	Oct 12, 2038	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Sep 29, 2028	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-443: To lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., EGFR greater than or equal to 30 ml/min/1.73 m^2	Sep 29, 2030	New exclusivity for this product

RYZUMVI (SOLUTION) (OPHTHALMIC) PHENTOLAMINE MESYLATE
NDA Applicant: OCUPHIRE      NDA No.: 217064  Prod. No.: 001 RX (EQ 0.75% BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Sep 25, 2026	New exclusivity for this product

SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
NDA Applicant: AXSOME MALTA      NDA No.: 211230  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 11779554 Methods of administering solriamfetol to lactating women Pat. Sub. Date(s): All strengths: Oct 12, 2023 Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics 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
Pat. No. 11793776 Methods of administering solriamfetol to lactating women Pat. Sub. Date(s): All strengths: Oct 27, 2023 Claim Types: 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

TALICIA (CAPSULE, DELAYED RELEASE) (ORAL) AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
Drug Classes: Antibacterials:Beta-lactam, Penicillins
NDA Applicant: REDHILL      NDA No.: 213004  Prod. No.: 001 RX (250MG;EQ 10MG BASE;12.5MG)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Nov 1, 2027 GAIN	New exclusivity for this product

TERLIVAZ (POWDER) (INTRAVENOUS) TERLIPRESSIN ACETATE
NDA Applicant: MALLINCKRODT IRELAND      NDA No.: 022231  Prod. No.: 001 RX (EQ 0.85MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 10335452 Method of treating patients with hepatorenal syndrome type 1 Pat. Sub. Date(s): 001: Oct 25, 2023 Claim Types: Method of use Use Code: U-3711: A method to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function	Apr 5, 2037	New patent for this product

TRANEXAMIC ACID (SOLUTION) (INTRAVENOUS) TRANEXAMIC ACID [GENERIC AP]
NDA Applicant: AMNEAL      NDA No.: 217155  Prod. No.: 001 RX (1GM/100ML (10MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Apr 16, 2024	New product in Orange Book

TYMLOS (SOLUTION) (SUBCUTANEOUS) ABALOPARATIDE
NDA Applicant: RADIUS      NDA No.: 208743  Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))

Patents	Expiration	Change
Pat. No. 11782041 DP* Abaloparatide formulations and methods of testing, storing, modifying, and using same Pat. Sub. Date(s): 001: Oct 23, 2023 Claim Types: Formulation; Method of use Use Code: U-2009: Method of treating postmenopausal women with osteoporosis at high risk for fracture. Use Code: U-3543: Treatment to increase bone density in men with osteoporosis at high risk for fracture	Apr 30, 2038	New patent for this product

UPNEEQ (SOLUTION/DROPS) (OPHTHALMIC) OXYMETAZOLINE HYDROCHLORIDE
NDA Applicant: RVL PHARMS      NDA No.: 212520  Prod. No.: 001 RX (0.1%)

Patents	Expiration	Change
Pat. No. 11701343 Compositions and methods for treating ocular disorders Pat. Sub. Date(s): 001: Nov 7, 2023 Claim Types: Method of use Use Code: U-2849: Method of treating blepharoptosis	Dec 16, 2039	New patent for this product

VALTOCO (SPRAY) (NASAL) DIAZEPAM
Drug Classes: Anticonvulsants:Gamma-aminobutyric Acid (GABA) Augmenting Agents
NDA Applicant: NEURELIS INC      NDA No.: 211635  Prod. No.: 001 RX (5MG/SPRAY); 002 RX (7.5MG/SPRAY); 003 RX (10MG/SPRAY)

Patents	Expiration	Change
Pat. No. 11793786 DP* Administration of benzodiazepine compositions Pat. Sub. Date(s): All strengths: Oct 31, 2023 Claim Types: Formulation	Mar 27, 2029	New patent for this product

VELSIPITY (TABLET) (ORAL) ETRASIMOD ARGININE
NDA Applicant: PFIZER      NDA No.: 216956  Prod. No.: 001 RX (EQ 2MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Oct 12, 2028	New product in Orange Book

XIFAXAN (TABLET) (ORAL) RIFAXIMIN
Drug Classes: Antibacterials:Antibacterials, Other
NDA Applicant: SALIX PHARMS      NDA No.: 021361  Prod. No.: 002 RX (550MG)

Patents	Expiration	Change
Pat. No. 11779571 Methods for treating irritable bowel syndrome (IBS) Pat. Sub. Date(s): 002: Oct 23, 2023 Claim Types: Method of use Use Code: U-3706: Treatment of bloating associated with diarrhea-predominant irritable bowel syndrome (IBS-D) in adult female subjects	Feb 26, 2029	New patent for this product

XYOSTED (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TESTOSTERONE ENANTHATE
NDA Applicant: ANTARES PHARMA INC      NDA No.: 209863  Prod. No.: 001 RX (50MG/0.5ML (50MG/0.5ML)); 002 RX (75MG/0.5ML (75MG/0.5ML)); 003 RX (100MG/0.5ML (100MG/0.5ML))

Patents	Expiration	Change
Pat. No. 11771646 DP* Needle assisted jet injection administration of testosterone compositions Pat. Sub. Date(s): All strengths: Oct 12, 2023 Claim Types: Device	Apr 10, 2034	New patent for this product

ZOKINVY (CAPSULE) (ORAL) LONAFARNIB
Drug Classes: farnesyltransferase inhibitor
NDA Applicant: EIGER BIOPHARMS      NDA No.: 213969  Prod. No.: 001 RX (50MG); 002 RX (75MG)

Patents	Expiration	Change
Pat. No. 8828356 Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis Pat. Sub. Date(s): All strengths: Feb 24, 2021 Claim Types: Method of use Use Code: U-3070: Reducing the risk of mortality in Hutchinson-Gilford progeria syndrome (HGPS)	Oct 17, 2024	New expiration date. Was previously Oct 17, 2023

ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
NDA Applicant: ARCUTIS      NDA No.: 215985  Prod. No.: 001 RX (0.3%)

Patents	Expiration	Change
Pat. No. 9907788 Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 001: Aug 19, 2022 Claim Types: Method of use Use Code: U-3408: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1) Use Code: U-3712: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age or older	Jun 7, 2037	New Use Code
Pat. No. 11129818 Topical roflumilast formulation having improved delivery and plasma half life Pat. Sub. Date(s): 001: Aug 19, 2022 Claim Types: Method of improving a treatment Use Code: U-3408: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1) Use Code: U-3712: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age or older	Aug 25, 2037	New Use Code
Pat. No. 11793796 DP* Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 001: Oct 24, 2023 Claim Types: Formulation	Jun 7, 2037	New patent for this product

ZTLIDO (PATCH) (TOPICAL) LIDOCAINE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: SCILEX PHARMS      NDA No.: 207962  Prod. No.: 001 RX (1.8%)

Patents	Expiration	Change
Pat. No. 11786455 DP* Non-aqueous patch Pat. Sub. Date(s): 001: Oct 23, 2023 Claim Types: Formulation; Method of use Use Code: U-2267: Method for relieving the pain associated with post-herpetic neuralgia	May 10, 2031	New patent for this product
Pat. No. 11793766 Non-aqueous patch for the relief of pain Pat. Sub. Date(s): 001: Nov 6, 2023 Claim Types: Method of use Use Code: U-2267: Method for relieving the pain associated with post-herpetic neuralgia	May 10, 2031	New patent for this product

ZURZUVAE (CAPSULE) (ORAL) ZURANOLONE
NDA Applicant: BIOGEN INC      NDA No.: 217369  Prod. No.: 001 RX (20MG); 002 RX (25MG); 003 RX (30MG)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Oct 31, 2028	New product in Orange Book