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 == Central Nervous System Agents:Central Nervous System, Other
NDA Applicant: AXSOME      NDA No.: 215430  Prod. No.: 001 RX (105MG;45MG)

Patents	Expiration	Change
Pat. No. 11617728 Bupropion as a modulator of drug activity Pat. Sub. Date(s): 001: May 3, 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
Pat. No. 11617747 Bupropion as a modulator of drug activity Pat. Sub. Date(s): 001: May 3, 2023 Claim Types: Method of use; Method of improving a treatment Use Code: U-3563: Dextromethorphan and bupropion in combination to increase dextromethorphan plasma levels	Nov 5, 2034	New patent for this product

BRIDION (SOLUTION) (INTRAVENOUS) SUGAMMADEX SODIUM
NDA Applicant: ORGANON SUB MERCK      NDA No.: 022225  Prod. No.: 001 RX (EQ 500MG BASE/5ML (EQ 100MG BASE/ML)); 002 RX (EQ 200MG BASE/2ML (EQ 100MG BASE/ML))

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-291: Revisions to the use in specific populations section of the package insert to include the result of study P145	Jan 22, 2024	New exclusivity for this product

BUDESONIDE (AEROSOL, FOAM) (RECTAL) BUDESONIDE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: PADAGIS ISRAEL      NDA No.: 215328  Prod. No.: 001 RX (2MG/ACTUATION)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Oct 24, 2023	New exclusivity for this product

DAYBUE (SOLUTION) (ORAL) TROFINETIDE
NDA Applicant: ACADIA PHARMS INC      NDA No.: 217026  Prod. No.: 001 RX (200MG/ML)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-425: Treatment of Rett syndrome in adults and pediatric patients 2 years of age and older	Mar 10, 2030	New exclusivity for this product

DHIVY (TABLET) (ORAL) CARBIDOPA; LEVODOPA [Has competitive generic]
Drug Classes: Antiparkinson Agents:Dopamine Precursors and/or L-Amino Acid Decarboxylase Inhibitors == Antiparkinson Agents:Antiparkinson Agents, Other
NDA Applicant: AVION PHARMS      NDA No.: 214869  Prod. No.: 001 RX (25MG;100MG)

Patents	Expiration	Change
Pat. No. 11439613 Levodopa fractionated dose composition and use Pat. Sub. Date(s): 001: Apr 18, 2023 Claim Types: Method of use Use Code: U-3557: Treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication	Mar 28, 2039	New patent for this product

EMERPHED (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
NDA Applicant: NEXUS PHARMS      NDA No.: 213407  Prod. No.: 002 RX (25MG/5ML (5MG/ML))

Patents	Expiration	Change
Pat. No. 11464752 DP* Compositions comprising ephedrine or an ephedrine salt and methods of making and using same Pat. Sub. Date(s): 002: Mar 2, 2023 Claim Types: Formulation claimed by its inherent performace characteristics; Product-by-process	May 16, 2040	New patent for this product
Pat. No. 11571398 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same Pat. Sub. Date(s): 002: Mar 2, 2023 Claim Types: Method of administration Use Code: U-3183: Use of ephedrine sulfate for treating hypotension	May 16, 2040	New patent for this product

EPINEPHRINE IN 0.9% SODIUM CHLORIDE (SOLUTION) (INTRAVENOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic
NDA Applicant: PAR STERILE PRODUCTS      NDA No.: 215875  Prod. No.: 001 RX (2MG/250ML (8MCG/ML)); 002 RX (4MG/250ML (16MCG/ML)); 003 RX (5MG/250ML (20MCG/ML)); 004 RX (8MG/250ML (32MCG/ML)); 005 RX (10MG/250ML (40MCG/ML))

Patents	Expiration	Change
Pat. No. 10653646 DP* Epinephrine compositions and containers Pat. Sub. Date(s): All strengths: May 10, 2023 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Mar 21, 2039	New product in Orange Book
Pat. No. 11083698 Epinephrine compositions and containers Pat. Sub. Date(s): All strengths: May 10, 2023 Claim Types: Method of administration; Method of use Use Code: U-3567: To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock	Mar 21, 2039	New product in Orange Book
Pat. No. 11207280 DP* Epinephrine compositions and containers Pat. Sub. Date(s): All strengths: May 10, 2023 Claim Types: Process; Formulation claimed by its inherent performace characteristics	Mar 21, 2039	New product in Orange Book

EPRONTIA (SOLUTION) (ORAL) TOPIRAMATE
Drug Classes: Anticonvulsants:Anticonvulsants, Other == Antimigraine Agents:Antimigraine Agents, Other
NDA Applicant: AZURITY      NDA No.: 214679  Prod. No.: 001 RX (25MG/ML)

Patents	Expiration	Change
Pat. No. 11633374 DP* Compositions and methods for treating epilepsy, seizures and other conditions Pat. Sub. Date(s): 001: Apr 27, 2023 Claim Types: Formulation	Aug 21, 2040	New patent for this product

FIRVANQ KIT (FOR SOLUTION) (ORAL) VANCOMYCIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antibacterials:Antibacterials, Other
NDA Applicant: AZURITY      NDA No.: 208910  Prod. No.: 001 RX (EQ 25MG BASE/ML); 002 RX (EQ 50MG BASE/ML)

Patents	Expiration	Change
Pat. No. 11638692 DP* Composition and method for vancomycin oral liquid Pat. Sub. Date(s): All strengths: May 2, 2023 Claim Types: Formulation	Mar 13, 2035	New patent for this product

GALAFOLD (CAPSULE) (ORAL) MIGALASTAT HYDROCHLORIDE
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: AMICUS THERAP US      NDA No.: 208623  Prod. No.: 001 RX (EQ 123MG BASE)

Patents	Expiration	Change
Pat. No. 11612593 DS* Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Apr 17, 2023 Claim Types: Formulation	May 30, 2038	New patent for this product
Pat. No. 11612594 DS* Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Apr 17, 2023 Claim Types: Formulation	May 30, 2038	New patent for this product
Pat. No. 11622962 DS* Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Apr 17, 2023 Claim Types: Composition	May 30, 2038	New patent for this product

GENOSYL (GAS) (INHALATION) NITRIC OXIDE [Has competitive generic]
NDA Applicant: VERO BIOTECH INC      NDA No.: 202860  Prod. No.: 001 RX (800PPM)

Patents	Expiration	Change
Pat. No. 11554241 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Pat. Sub. Date(s): 001: Apr 28, 2023 Claim Types: Method of use Use Code: U-3037: A method of delivering nitric oxide to a patient	Aug 18, 2025	New patent for this product

GIMOTI (SPRAY, METERED) (NASAL) METOCLOPRAMIDE HYDROCHLORIDE
Drug Classes: Antiemetics:Antiemetics, Other == Gastrointestinal Agents:Gastrointestinal Agents, Other
NDA Applicant: EVOKE PHARMA INC      NDA No.: 209388  Prod. No.: 001 RX (EQ 15MG BASE/SPRAY)

Patents	Expiration	Change
Pat. No. 11628150 DP* Nasal formulations of metoclopramide Pat. Sub. Date(s): 001: Apr 25, 2023 Claim Types: Formulation claimed by its inherent performace characteristics; Method of use Use Code: U-2843: Nasal administration of metoclopramide for treatment of diabetic gastroparesis	Dec 22, 2029	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11633377 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Apr 27, 2023 Claim Types: Method of improving a treatment Use Code: U-2149: Treatment of non-24 hour sleep-wake disorder by administering tasimelteon Use Code: U-3003: Treatment of nighttime sleep disturbances in Smith-Magenis syndrome by administering tasimelteon	Jan 25, 2033	New patent for this product

HETLIOZ LQ (SUSPENSION) (ORAL) TASIMELTEON
Drug Classes: Sleep Disorder Agents:Sleep Promoting Agents
NDA Applicant: VANDA PHARMS INC      NDA No.: 214517  Prod. No.: 001 RX (4MG/ML)

Patents	Expiration	Change
Pat. No. 11633377 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Apr 27, 2023 Claim Types: Method of improving a treatment Use Code: U-3003: Treatment of nighttime sleep disturbances in Smith-Magenis syndrome by administering tasimelteon	Jan 25, 2033	New patent for this product

JOENJA (TABLET) (ORAL) LENIOLISIB PHOSPHATE
NDA Applicant: PHARMING      NDA No.: 217759  Prod. No.: 001 RX (EQ 70MG BASE)

Patents	Expiration	Change
Pat. No. 8653092 DS* DP* Tetrahydro-pyrido-pyrimidine derivatives Pat. Sub. Date(s): 001: Apr 18, 2023 Claim Types: Compound; Composition	Feb 19, 2032	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Mar 24, 2028	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-430: Treatment of activated phosphoinositide 3-kinase delta (PI3K delta) syndrome (APDS) in adult and pediatric patients 12 years of age and older	Mar 24, 2030	New exclusivity for this product

KLOXXADO (SPRAY) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents
NDA Applicant: HIKMA      NDA No.: 212045  Prod. No.: 001 RX (8MG/SPRAY)

Patents	Expiration	Change
Pat. No. 11617713 DP* Liquid naloxone spray Pat. Sub. Date(s): 001: Apr 28, 2023 Claim Types: Formulation; Method of use Use Code: U-3110: Use of naloxone for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients	Aug 26, 2034	New patent for this product
Pat. No. 11628139 DP* Liquid naloxone spray Pat. Sub. Date(s): 001: Apr 28, 2023 Claim Types: Formulation; Method of use Use Code: U-3110: Use of naloxone for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients	Aug 26, 2034	New patent for this product

LIVMARLI (SOLUTION) (ORAL) MARALIXIBAT CHLORIDE
NDA Applicant: MIRUM      NDA No.: 214662  Prod. No.: 001 RX (EQ 9.5MG BASE/ML)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Mar 13, 2026	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-429: Treatment of cholestatic pruritus in patients 3 months of age to less than 1 year of age with alagille syndrome (ALGS)	Mar 13, 2030	New exclusivity 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. 11622991 Protocol for treatment of lupus nephritis Pat. Sub. Date(s): 001: May 5, 2023 Claim Types: Method of use Use Code: U-3056: Treatment of patients with active lupus nephritis	Dec 7, 2037	New patent for this product

MEKINIST (TABLET) (ORAL) TRAMETINIB DIMETHYL SULFOXIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: NOVARTIS      NDA No.: 204114  Prod. No.: 001 RX (EQ 0.5MG); 003 RX (EQ 2MG) NDA No.: 204114  Prod. No.: 002 DISC (EQ 1MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-908: Treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600 mutation who require systemic therapy	Mar 16, 2026	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-428: Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Mar 16, 2030	New exclusivity for this product

MEKINIST (SOLUTION) (ORAL) TRAMETINIB DIMETHYL SULFOXIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: NOVARTIS      NDA No.: 217513  Prod. No.: 001 RX (EQ 0.05MG BASE/ML)

Patents	Expiration	Change
Pat. No. 7378423 DS* DP* [Extended 718 days (2 years)] Pyrimidine compound and medical use thereof Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Compound; Composition; Formulation	May 29, 2027	New patent for this product
Pat. No. 8835443 Pyrimidine compound and medical use thereof Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Method of use Use Code: U-3564: MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Jun 10, 2025	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Mar 16, 2026	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-428: Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Mar 16, 2030	New exclusivity for this product

METHSUXIMIDE (CAPSULE) (ORAL) METHSUXIMIDE [GENERIC AB]
Drug Classes: Anticonvulsants:Calcium Channel Modifying Agents
NDA Applicant: NOVITIUM PHARMA      NDA No.: 217213  Prod. No.: 001 RX (300MG)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Oct 28, 2023	New product in Orange Book

NEXLETOL (TABLET) (ORAL) BEMPEDOIC ACID
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == adenosine triphosphate-citrate lyase (ACL) inhibitor
NDA Applicant: ESPERION THERAPS INC      NDA No.: 211616  Prod. No.: 001 RX (180MG)

Patents	Expiration	Change
Pat. No. 11613511 DS* Methods of making bempedoic acid and compositions of the same Pat. Sub. Date(s): 001: Apr 20, 2023 Claim Types: New polymorph, salt or hydrate	Jun 19, 2040	New patent for this product

NEXLIZET (TABLET) (ORAL) BEMPEDOIC ACID; EZETIMIBE
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == adenosine triphosphate-citrate lyase (ACL) inhibitor == Cardiovascular Agents:Cardiovascular Combinations
NDA Applicant: ESPERION THERAPS INC      NDA No.: 211617  Prod. No.: 001 RX (180MG;10MG)

Patents	Expiration	Change
Pat. No. 11613511 DS* Methods of making bempedoic acid and compositions of the same Pat. Sub. Date(s): 001: Apr 20, 2023 Claim Types: New polymorph, salt or hydrate	Jun 19, 2040	New patent for this product

OFEV (CAPSULE) (ORAL) NINTEDANIB ESYLATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Fibrosis Agents
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 205832  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE)

Patents	Expiration	Change
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)	Jan 8, 2026	New expiration date. Was previously Dec 20, 2025

ORLADEYO (CAPSULE) (ORAL) BEROTRALSTAT HYDROCHLORIDE
NDA Applicant: BIOCRYST      NDA No.: 214094  Prod. No.: 001 RX (EQ 110MG BASE); 002 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 11618733 Crystalline salts of a plasma kallikrein inhibitor Pat. Sub. Date(s): All strengths: May 4, 2023 Claim Types: Method of use Use Code: U-3300: Prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older	Nov 1, 2039	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. 11617793 DP* Anhydrous sodium thiosulfate and formulations thereof Pat. Sub. Date(s): 001: Apr 17, 2023 Claim Types: Formulation	Jul 1, 2039	New patent for this product

QUILLICHEW ER (TABLET, EXTENDED RELEASE, CHEWABLE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Non-amphetamines
NDA Applicant: NEXTWAVE PHARMS      NDA No.: 207960  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG)

Patents	Expiration	Change
Pat. No. 11633389 DP* Methylphenidate extended release chewable tablet Pat. Sub. Date(s): All strengths: May 9, 2023 Claim Types: Formulation	Aug 14, 2033	New patent for this product

REVATIO (SOLUTION) (INTRAVENOUS) SILDENAFIL CITRATE [GENERIC AP]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == Sexual Disorder Agents:Sexual Disorder Agents (Male)
NDA Applicant: VIATRIS      NDA No.: 022473  Prod. No.: 001 RX (EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML))

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-287: Labeling regarding new dosing regimen in adults with pulmonary arterial hypertension (PAH) and treatment of PAH in pediatric patients (ages 1-17)	Jan 31, 2026	New exclusivity for this product

REVATIO (FOR SUSPENSION) (ORAL) SILDENAFIL CITRATE [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == Sexual Disorder Agents:Sexual Disorder Agents (Male)
NDA Applicant: VIATRIS      NDA No.: 203109  Prod. No.: 001 RX (EQ 10MG BASE/ML)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-287: Labeling regarding new dosing regimen in adults with pulmonary arterial hypertension (PAH) and treatment of PAH in pediatric patients (ages 1-17)	Jan 31, 2026	New exclusivity for this product

REZZAYO (POWDER) (INTRAVENOUS) REZAFUNGIN ACETATE
NDA Applicant: CIDARA THERAPS      NDA No.: 217417  Prod. No.: 001 RX (EQ 200MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 8722619 DS* DP* Antifungal agents and uses thereof Pat. Sub. Date(s): 001: Apr 20, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-3566: Treatment of candidemia and invasive candidiasis with rezafungin by intravenous administration	Mar 2, 2032	New patent for this product
Pat. No. 9526835 DS* DP* Dosing regimens for echinocandin class compounds Pat. Sub. Date(s): 001: Apr 20, 2023 Claim Types: Formulation claimed by its inherent performace characteristics; Method of use; Method of Use claimed by its inherent performace characteristics Use Code: U-3566: Treatment of candidemia and invasive candidiasis with rezafungin by intravenous administration	Mar 14, 2033	New patent for this product
Pat. No. 10702573 DS* DP* Dosing regimens for echinocandin class compounds Pat. Sub. Date(s): 001: Apr 20, 2023 Claim Types: Method of use Use Code: U-3566: Treatment of candidemia and invasive candidiasis with rezafungin by intravenous administration	Mar 14, 2033	New patent for this product
Pat. No. 11197909 DS* DP* Compositions and methods for the treatment of fungal infections Pat. Sub. Date(s): 001: Apr 20, 2023 Claim Types: Formulation; Method of use Use Code: U-3566: Treatment of candidemia and invasive candidiasis with rezafungin by intravenous administration	Jul 14, 2038	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Mar 22, 2033 GAIN	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-426: For use in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis	Mar 22, 2035 GAIN	New exclusivity for this product

RHOPRESSA (SOLUTION/DROPS) (OPHTHALMIC) NETARSUDIL MESYLATE
Drug Classes: Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
NDA Applicant: AERIE PHARMS INC      NDA No.: 208254  Prod. No.: 001 RX (EQ 0.02% BASE)

Patents	Expiration	Change
Pat. No. 11618748 Dual mechanism inhibitors for the treatment of disease Pat. Sub. Date(s): 001: Apr 21, 2023 Claim Types: Method of use Use Code: U-1524: Reduction of elevated intraocular pressure	Jan 27, 2030	New patent for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: ABBVIE      NDA No.: 211675  Prod. No.: 001 RX (15MG); 003 RX (45MG)

Patents	Expiration	Change
Pat. No. 11607411 Methods of treating Crohn's disease and ulcerative colitis Pat. Sub. Date(s): All strengths: Apr 18, 2023 Claim Types: Method of use Use Code: U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers	Mar 9, 2038	New patent for this product

ROCKLATAN (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST; NETARSUDIL DIMESYLATE
Drug Classes: Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
NDA Applicant: AERIE PHARMS INC      NDA No.: 208259  Prod. No.: 001 RX (0.005%;EQ 0.02% BASE)

Patents	Expiration	Change
Pat. No. 11618748 Dual mechanism inhibitors for the treatment of disease Pat. Sub. Date(s): 001: Apr 21, 2023 Claim Types: Method of use Use Code: U-1524: Reduction of elevated intraocular pressure	Jan 27, 2030	New patent for this product

SKYCLARYS (CAPSULE) (ORAL) OMAVELOXOLONE
NDA Applicant: REATA PHARMS      NDA No.: 216718  Prod. No.: 001 RX (50MG)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-427: Treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older	Feb 28, 2030	New exclusivity for this product

SOLUPREP S (SOLUTION) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Drug Classes: Dental and Oral Agents
NDA Applicant: 3M HEALTH CARE      NDA No.: 208288  Prod. No.: 001 OTC (2%;70%)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-292: Revisions to the labeling to describe modified formulation based on results of studies EM-05-014624 and EM-05-014815	Jan 20, 2026	New exclusivity for this product

SUNLENCA (SOLUTION) (SUBCUTANEOUS) LENACAPAVIR SODIUM
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 215973  Prod. No.: 001 RX (EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML))

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Dec 22, 2027	New exclusivity for this product

SUNLENCA (TABLET) (ORAL) LENACAPAVIR SODIUM
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 215974  Prod. No.: 001 RX (EQ 300MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Dec 22, 2027	New exclusivity for this product

SYNJARDY (TABLET) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 206111  Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (12.5MG;500MG); 004 RX (12.5MG;1GM)

Patents	Expiration	Change
Pat. No. 9949997 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Mar 1, 2023 Claim Types: Method of use Use Code: U-3532: Method for reducing the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes mellitus by once daily administration of empagliflozin Use Code: U-3533: Method for reducing the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease by once daily administration of 10 mg or 25 mg of empagliflozin	May 17, 2034	New Use Code

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

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-908: Treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600 mutation who require systemic therapy	Mar 16, 2026	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-428: Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Mar 16, 2030	New exclusivity for this product

TAFINLAR (TABLET, FOR SUSPENSION) (ORAL) DABRAFENIB MESYLATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: NOVARTIS      NDA No.: 217514  Prod. No.: 001 RX (EQ 10MG BASE)

Patents	Expiration	Change
Pat. No. 8835443 Pyrimidine compound and medical use thereof Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Method of use Use Code: U-3565: TAFINLAR is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Jun 10, 2025	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Mar 16, 2026	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-428: Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Mar 16, 2030	New exclusivity for this product

TAVNEOS (CAPSULE) (ORAL) AVACOPAN
NDA Applicant: CHEMOCENTRYX      NDA No.: 214487  Prod. No.: 001 RX (10MG)

Patents	Expiration	Change
Pat. No. 11603356 DS* DP* Amorphous form of a complement component C5a receptor Pat. Sub. Date(s): 001: Apr 14, 2023 Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Use Code: U-3558: An adjunctive treatment of adult patients with TAVNEOS (avacopan) with severe active ANCA-associated vasculitis (GPA and MPA) in combination with standard therapy including glucocorticoids	May 29, 2041	New patent for this product

TERIFLUNOMIDE (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents
NDA Applicant: AUROBINDO PHARMA      NDA No.: 209638  Prod. No.: 001 RX (7MG); 002 RX (14MG)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Sep 8, 2023	New exclusivity for this product

TYMLOS (SOLUTION) (SUBCUTANEOUS) ABALOPARATIDE
Drug Classes: Metabolic Bone Disease Agents
NDA Applicant: RADIUS HEALTH INC      NDA No.: 208743  Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-907: To increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy	Dec 19, 2025	New exclusivity for this product

UZEDY (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) RISPERIDONE
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
NDA Applicant: TEVA      NDA No.: 213586  Prod. No.: 001 RX (50MG/0.14ML (50MG/0.14ML)); 002 RX (75MG/0.21ML (75MG/0.21ML)); 003 RX (100MG/0.28ML (100MG/0.28ML)); 004 RX (125MG/0.35ML (125MG/0.35ML)); 005 RX (150MG/0.42ML (150MG/0.42ML)); 006 RX (200MG/0.56ML (200MG/0.56ML)); 007 RX (250MG/0.7ML (250MG/0.7ML))

Patents	Expiration	Change
Pat. No. 8221778 DP* Drug-containing implants and methods of use thereof Pat. Sub. Date(s): All strengths: May 3, 2023 Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics Use Code: U-543: Treatment of schizophrenia	Nov 12, 2027	New product in Orange Book
Pat. No. 8741327 DP* Method of maintaining therapeutic risperidone levels in a PLA:PLGA implant Pat. Sub. Date(s): All strengths: May 3, 2023 Claim Types: Method of administration Use Code: U-543: Treatment of schizophrenia	Nov 12, 2027	New product in Orange Book
Pat. No. 8802127 DP* Risperidone-containing PLA:PGA implants and methods of use thereof Pat. Sub. Date(s): All strengths: May 3, 2023 Claim Types: Formulation; Method of administration	Jan 12, 2025	New product in Orange Book
Pat. No. 9439905 DP* Risperidone-containing implants and methods of use thereof Pat. Sub. Date(s): All strengths: May 3, 2023 Claim Types: Method of use Use Code: U-543: Treatment of schizophrenia	Jan 12, 2025	New product in Orange Book
Pat. No. 9717799 DP* Drug-containing implants and methods of use thereof Pat. Sub. Date(s): All strengths: May 3, 2023 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Jan 12, 2025	New product in Orange Book
Pat. No. 9895447 DP* Drug-containing PLA implants and methods of use thereof Pat. Sub. Date(s): All strengths: May 3, 2023 Claim Types: Formulation claimed by its inherent performace characteristics	Jan 12, 2025	New product in Orange Book
Pat. No. 9925268 DP* Drug-containing implants and methods of use thereof Pat. Sub. Date(s): All strengths: May 3, 2023 Claim Types: Formulation claimed by its inherent performace characteristics	Jan 12, 2025	New product in Orange Book
Pat. No. 10736965 DP* Risperidone biodegradable implant Pat. Sub. Date(s): All strengths: May 3, 2023 Claim Types: Formulation	Jan 12, 2025	New product in Orange Book

VANCOMYCIN HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) VANCOMYCIN HYDROCHLORIDE
Drug Classes: Antibacterials:Antibacterials, Other
NDA Applicant: XELLIA PHARMS APS      NDA No.: 211962  Prod. No.: 001 RX (EQ 500MG BASE/100ML (EQ 5MG BASE/ML)); 002 RX (EQ 1GM BASE/200ML (EQ 5MG BASE/ML)); 003 RX (EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)); 004 RX (EQ 2GM BASE/400ML (EQ 5MG BASE/ML)); 005 RX (EQ 750MG BASE/150ML (EQ 5MG BASE/ML)); 006 RX (EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)); 007 RX (EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML))

Patents	Expiration	Change
Pat. No. 11628200 DP* Glycopeptide compositions Pat. Sub. Date(s): All strengths: May 9, 2023 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Nov 6, 2035	New patent for this product

VAZALORE (CAPSULE) (ORAL) ASPIRIN
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents
NDA Applicant: PLX PHARMA      NDA No.: 203697  Prod. No.: 001 OTC (325MG); 002 OTC (81MG)

Patents	Expiration	Change
Pat. No. 10646431 DP* PH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same Pat. Sub. Date(s): All strengths: Apr 5, 2023 Claim Types: Formulation	Sep 29, 2032	New patent for this product
Pat. No. 10786444 PH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same Pat. Sub. Date(s): 001: Apr 5, 2023; 002: Apr 27, 2023 Claim Types: Method of administration Use Code: U-3559: A method of targeting release of a non-steroidal anti-inflammatory drug (NSAID) to the small intestine of the subject when administered orally	Sep 29, 2032	New patent for this product

VERKAZIA (EMULSION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: Immunological Agents:Immunosuppressants == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: SANTEN      NDA No.: 214965  Prod. No.: 001 RX (0.1%)

Patents	Expiration	Change
Pat. No. 11612658 Oil-in-water emulsions comprising cetalkonium chloride and methods of making and using the same Pat. Sub. Date(s): 001: Apr 25, 2023 Claim Types: Method of use; Process; Kit Use Code: U-3560: For the treatment of vernal keratoconjunctivitis in children and adults	Jan 27, 2026	New patent for this product

VTAMA (CREAM) (TOPICAL) TAPINAROF
NDA Applicant: DERMAVANT SCI      NDA No.: 215272  Prod. No.: 001 RX (1%)

Patents	Expiration	Change
Pat. No. 11612573 Topical pharmaceutical compositions Pat. Sub. Date(s): 001: Apr 20, 2023 Claim Types: Method of improving a treatment Use Code: U-2625: Topical treatment of plaque psoriasis in adults	May 19, 2036	New patent for this product
Pat. No. 11617724 DP* Topical pharmaceutical compositions Pat. Sub. Date(s): 001: Apr 20, 2023 Claim Types: Formulation	May 19, 2036	New patent for this product
Pat. No. 11622945 DP* Topical pharmaceutical compositions Pat. Sub. Date(s): 001: Apr 20, 2023 Claim Types: Formulation	May 19, 2036	New patent for this product

VUITY (SOLUTION) (OPHTHALMIC) PILOCARPINE HYDROCHLORIDE
Drug Classes: Dental and Oral Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents
NDA Applicant: ABBVIE      NDA No.: 214028  Prod. No.: 001 RX (1.25%)

Patents	Expiration	Change
Pat. No. 10610518 Presbyopia treatments Pat. Sub. Date(s): 001: Nov 24, 2021 Claim Types: Method of use Use Code: U-3252: Use of VUITY for the treatment of presbyopia in adults Use Code: U-3561: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation once daily Use Code: U-3562: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation twice daily	Apr 24, 2039	New Use Code
Pat. No. 11285134 Presbyopia treatments Pat. Sub. Date(s): 001: Apr 28, 2022 Claim Types: Method of use Use Code: U-3252: Use of VUITY for the treatment of presbyopia in adults Use Code: U-3561: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation once daily Use Code: U-3562: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation twice daily	Apr 24, 2039	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: D - New Dosing Schedule: D-187: Addition of second dose for treatment of presbyopia in adults	Mar 28, 2026	New exclusivity for this product

ZAVZPRET (SPRAY, METERED) (NASAL) ZAVEGEPANT HYDROCHLORIDE
NDA Applicant: PFIZER      NDA No.: 216386  Prod. No.: 001 RX (EQ 10MG BASE/SPRAY)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Mar 9, 2028	New exclusivity for this product