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

ADVAIR HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 021254  Prod. No.: 002 RX (0.115MG/INH;EQ 0.021MG BASE/INH)

Patents	Expiration	Change
Pat. No. 7500444 DP* Actuation indicator for a dispensing device Pat. Sub. Date(s): None Claim Types: Device	Aug 26, 2026 *PED	This patent is no longer listed for this product

AGAMREE (SUSPENSION) (ORAL) VAMOROLONE
Drug Classes: corticosteroid
NDA Applicant: CATALYST PHARMS      NDA No.: 215239  Prod. No.: 001 RX (40MG/ML)

Patents	Expiration	Change
Pat. No. 11833159 DP* Non-hormonal steroid modulators of NF-kB for treatment of disease Pat. Sub. Date(s): 001: Dec 18, 2023 Claim Types: Formulation	May 28, 2029	New patent for this product

AMPICILLIN TRIHYDRATE (CAPSULE) (ORAL) AMPICILLIN/AMPICILLIN TRIHYDRATE [Has competitive generic]
NDA Applicant: AUROBINDO PHARMA      NDA No.: 216554  Prod. No.: 001 RX (EQ 250MG BASE); 002 RX (EQ 500MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Jun 3, 2024	New exclusivity for this product

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 001 RX (0.1MG/INH)

Patents	Expiration	Change
Pat. No. 8113199 DP* Counter for use with a medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Apr 23, 2028 *PED	This patent is no longer listed for this product
Pat. No. 8161968 DP* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Aug 5, 2028 *PED	This patent is no longer listed for this product
Pat. No. 8534281 DP* Manifold for use in medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Sep 8, 2030 *PED	This patent is no longer listed for this product

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

Patents	Expiration	Change
Pat. No. 9714258 DS* DP* Diaryl macrocycles as modulators of protein kinases Pat. Sub. Date(s): 001: Dec 12, 2023 Claim Types: Compound; New polymorph, salt or hydrate	Jan 23, 2035	New patent for this product
Pat. No. 10294242 DS* Diaryl macrocycle polymorph Pat. Sub. Date(s): 001: Dec 12, 2023 Claim Types: New polymorph, salt or hydrate	Jul 5, 2036	New patent for this product
Pat. No. 11452725 Chiral diaryl macrocycles and uses thereof Pat. Sub. Date(s): 001: Dec 12, 2023 Claim Types: Method of use Use Code: U-3755: Treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)	Jul 24, 2036	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-455: Treatment of adult patients with locally advanced or metastatic ros1-positive non-small cell lung cancer (NSCLC) with adenocarcinoma histology	Nov 15, 2030	New exclusivity for this product

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

Patents	Expiration	Change
Pat. No. 11666566 DP* Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 Pat. Sub. Date(s): All strengths: Jun 16, 2023 Claim Types: Formulation	Mar 18, 2034 *PED	New expiration date. Was previously Sep 18, 2033
Pat. No. 11813232 DP* Analogs of deutetrabenazine, their preparation and use Pat. Sub. Date(s): All strengths: Dec 7, 2023 Claim Types: Process; Product-by-process	Sep 15, 2038 *PED	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11813232 DP* Analogs of deutetrabenazine, their preparation and use Pat. Sub. Date(s): All strengths: Dec 7, 2023 Claim Types: Process; Product-by-process	Sep 15, 2038 *PED	New patent for this product

AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME      NDA No.: 215430  Prod. No.: 001 RX (105MG;45MG)

Patents	Expiration	Change
Pat. No. 11839612 Compounds and combinations thereof for treating neurological and psychiatric conditions Pat. Sub. Date(s): 001: Jan 5, 2024 Claim Types: Method of use Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder	Mar 2, 2043	New patent for this product
Pat. No. 11844797 Combination of dextromethorphan and bupropion for treating depression Pat. Sub. Date(s): 001: Jan 5, 2024 Claim Types: Method of use Use Code: U-3778: Treatment of major depressive disorder by administering dextromethorphan and bupropion to a subject having moderate hepatic impairment	Apr 20, 2043	New patent for this product

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY)

Patents	Expiration	Change
Pat. No. 7731686 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Jun 1, 2026	This patent is no longer listed for this product
Pat. No. 7731690 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Jan 15, 2025	This patent is no longer listed for this product
Pat. No. 7749194 DP* DLR* Devices, systems, and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Oct 30, 2028	This patent is no longer listed for this product
Pat. No. 8016788 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Mar 21, 2025	This patent is no longer listed for this product
Pat. No. 8920377 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 8926594 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Mar 31, 2026	This patent is no longer listed for this product
Pat. No. 9238108 DP* DLR* Medicament delivery device having an electronic circuit system Pat. Sub. Date(s): None Claim Types: Device	Feb 20, 2027	This patent is no longer listed for this product
Pat. No. 10960155 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Jun 25, 2026	This patent is no longer listed for this product

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 002 RX (EQ 0.15MG/DELIVERY); 003 RX (EQ 0.1MG/DELIVERY)

Patents	Expiration	Change
Pat. No. 11771830 DP* Medicament delivery device and methods for delivering drugs to infants and children Pat. Sub. Date(s): All strengths: Dec 20, 2023 Claim Types: Method of administration; Device Use Code: U-2980: Method of treating an allergic reaction using an auto-injector	Dec 21, 2037	New patent for this product
Pat. No. 7731686 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Jun 1, 2026	This patent is no longer listed for this product
Pat. No. 7731690 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Jan 15, 2025	This patent is no longer listed for this product
Pat. No. 7749194 DP* DLR* Devices, systems, and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Oct 30, 2028	This patent is no longer listed for this product
Pat. No. 8016788 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Mar 21, 2025	This patent is no longer listed for this product
Pat. No. 8920377 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 8926594 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Mar 31, 2026	This patent is no longer listed for this product
Pat. No. 9238108 DP* DLR* Medicament delivery device having an electronic circuit system Pat. Sub. Date(s): None Claim Types: Device	Feb 20, 2027	This patent is no longer listed for this product
Pat. No. 10960155 DP* DLR* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Jun 25, 2026	This patent is no longer listed for this product

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 004 RX (25MG)

Patents	Expiration	Change
Pat. No. 11827642 DS* DP* Compositions useful for treating disorders related to KIT Pat. Sub. Date(s): 004: Dec 21, 2023 Claim Types: Method of use Use Code: U-3506: Treatment of indolent systemic mastocytosis (ISM)	Oct 15, 2034	New patent for this product

BELRAPZO (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.: 205580  Prod. No.: 001 RX (100MG/4ML (25MG/ML))

Patents	Expiration	Change
Pat. No. 11844783 Formulations of bendamustine Pat. Sub. Date(s): 001: Dec 19, 2023 Claim Types: Method of use Use Code: U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma Use Code: U-1971: For the treatment of patients with chronic lymphocytic leukemia Use Code: U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma	Jan 28, 2031	New patent for this product

BENDEKA (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.: 208194  Prod. No.: 001 RX (100MG/4ML (25MG/ML))

Patents	Expiration	Change
Pat. No. 11844783 Formulations of bendamustine Pat. Sub. Date(s): 001: Dec 19, 2023 Claim Types: Method of use Use Code: U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma Use Code: U-1971: For the treatment of patients with chronic lymphocytic leukemia Use Code: U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma	Jan 28, 2031	New patent for this product

BLUDIGO (SOLUTION) (INTRAVENOUS) INDIGOTINDISULFONATE SODIUM
NDA Applicant: PROVEPHARM SAS      NDA No.: 216264  Prod. No.: 001 RX (40MG/5ML (8MG/ML))

Patents	Expiration	Change
Pat. No. 11845867 DS* Process for the preparation of indigotindisulfonate sodium (indigo carmine) Pat. Sub. Date(s): 001: Jan 11, 2024 Claim Types: New polymorph, salt or hydrate	Nov 25, 2036	New patent for this product

BRAFTOVI (CAPSULE) (ORAL) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.: 210496  Prod. No.: 002 RX (75MG) NDA No.: 210496  Prod. No.: 001 DISC (50MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-928: Encorafenib in combination with binimetinib, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test	Oct 11, 2026	New exclusivity for this product

BREZTRI AEROSPHERE (AEROSOL, METERED) (INHALATION) BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist == anticholinergic == antimuscarinic agent
NDA Applicant: ASTRAZENECA AB      NDA No.: 212122  Prod. No.: 001 RX (0.16MG/INH;0.0048MG/INH;0.009MG/INH)

Patents	Expiration	Change
Pat. No. 11833292 DP* Drug delivery systems and related methods Pat. Sub. Date(s): 001: Dec 21, 2023 Claim Types: Device	Oct 5, 2038	New patent for this product

BRYHALI (LOTION) (TOPICAL) HALOBETASOL PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: BAUSCH      NDA No.: 209355  Prod. No.: 001 RX (0.01%)

Patents	Expiration	Change
Pat. No. 11839656 Pharmaceutical formulations containing corticosteroids for topical administration Pat. Sub. Date(s): 001: Jan 5, 2024 Claim Types: Method of use Use Code: U-2625: Topical treatment of plaque psoriasis in adults	Nov 2, 2031	New patent for this product

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

Patents	Expiration	Change
Pat. No. 9168258 DP* Methods and compositions for sleep disorders and other disorders Pat. Sub. Date(s): 002: Dec 12, 2023 Claim Types: Formulation	May 27, 2029	New patent for this product

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

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-454: treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater	Dec 8, 2030	New exclusivity for this product

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

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-453: Treatment of invasive mucormycosis in pediatric patients 1 year of age and older	Dec 8, 2030	New exclusivity for this product

DEFENCATH (SOLUTION) (N/A) HEPARIN SODIUM; TAUROLIDINE
Drug Classes: anticoagulant == unfractionated heparin
NDA Applicant: CORMEDIX      NDA No.: 214520  Prod. No.: 001 RX (3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)); 002 RX (5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML))

Patents	Expiration	Change
Pat. No. 7696182 DS* DP* Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin Pat. Sub. Date(s): All strengths: Dec 14, 2023 Claim Types: Formulation; Process Use Code: U-3774: A catheter lock solution to reduce catheter-related bloodstream infections in adult patients receiving hemodialysis through a central venous catheter	May 16, 2025	New patent for this product
Pat. No. 8541393 DS* DP* Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin Pat. Sub. Date(s): All strengths: Dec 14, 2023 Claim Types: Formulation; Process Use Code: U-3774: A catheter lock solution to reduce catheter-related bloodstream infections in adult patients receiving hemodialysis through a central venous catheter	Nov 2, 2024	New patent for this product
Pat. No. 9339036 DS* DP* Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin Pat. Sub. Date(s): All strengths: Dec 14, 2023 Claim Types: Formulation	Nov 2, 2024	New patent for this product
Pat. No. 11738120 DS* DP* Synthesis of taurolidine, purity profiles and polymorphs Pat. Sub. Date(s): All strengths: Dec 14, 2023 Claim Types: Formulation	Apr 15, 2042	New patent for this product

DHIVY (TABLET) (ORAL) CARBIDOPA; LEVODOPA [Has competitive generic]
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: AVION PHARMS      NDA No.: 214869  Prod. No.: 001 RX (25MG;100MG)

Patents	Expiration	Change
Pat. No. 11819485 Levodopa fractionated dose composition and use Pat. Sub. Date(s): 001: Dec 7, 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

DUOBRII (LOTION) (TOPICAL) HALOBETASOL PROPIONATE; TAZAROTENE
Drug Classes: corticosteroid == retinoid
NDA Applicant: BAUSCH      NDA No.: 209354  Prod. No.: 001 RX (0.01%;0.045%)

Patents	Expiration	Change
Pat. No. 11839656 Pharmaceutical formulations containing corticosteroids for topical administration Pat. Sub. Date(s): 001: Jan 5, 2024 Claim Types: Method of use Use Code: U-2625: Topical treatment of plaque psoriasis in adults	Nov 2, 2031	New patent for this product

EPRONTIA (SOLUTION) (ORAL) TOPIRAMATE
NDA Applicant: AZURITY      NDA No.: 214679  Prod. No.: 001 RX (25MG/ML)

Patents	Expiration	Change
Pat. No. 11826343 DP* Compositions and methods for treating epilepsy, seizures and other conditions Pat. Sub. Date(s): 001: Dec 11, 2023 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Aug 21, 2040	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11827646 Compounds for treating spinal muscular atrophy Pat. Sub. Date(s): 001: Dec 14, 2023 Claim Types: Method of use Use Code: U-1943: Treatment of spinal muscular atrophy	Jan 25, 2036	New patent for this product

EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.: 022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))

Patents	Expiration	Change
Pat. No. 11819574 DP* Manufacturing of bupivacaine multivesicular liposomes Pat. Sub. Date(s): All strengths: Dec 6, 2023 Claim Types: Product-by-process; Method of use Use Code: U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia	Jan 22, 2041	New patent for this product

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

Patents	Expiration	Change
Pat. No. 9682968 DS* DP* Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof Pat. Sub. Date(s): 001: Dec 18, 2023 Claim Types: Compound; Composition	Jul 14, 2034	New product in Orange Book
Pat. No. 11603363 DS* DP* Crystalline form of LNP023 Pat. Sub. Date(s): 001: Dec 18, 2023 Claim Types: New polymorph, salt or hydrate; Composition; Process	May 25, 2041	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-456: Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)	Dec 5, 2030	New product in Orange Book

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 202293  Prod. No.: 002 RX (10MG)

Patents	Expiration	Change
Pat. No. 11826376 Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same Pat. Sub. Date(s): 002: Dec 19, 2023 Claim Types: Method of use Use Code: U-3766: Reduce the risk of cardiovascular death and hospitalization for heart failure and urgent heart failure visits in adults with heart failure with preserved ejection fraction and without Type II diabetes	Jul 18, 2039	New patent for this product

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

Patents	Expiration	Change
Pat. No. 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 thereby modulating down the formation of norfenfluramine and resulting in higher levels of fenfluramine	Feb 2, 2038 *PED	New expiration date. Was previously Aug 2, 2037
Pat. No. 11786487 Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Pat. Sub. Date(s): 001: Nov 9, 2023 Claim Types: Method of use Use Code: U-3733: Method of treating seizures in a patient by administering a liquid formulation of fenfluramine or its salts plus stiripentol thereby reducing norfenfluramine formation while increasing the fenfluramine level. patients can have e.g. dravet or LGS	Feb 2, 2038 *PED	New expiration date. Was previously Aug 2, 2037

FIRMAGON (POWDER) (SUBCUTANEOUS) DEGARELIX ACETATE
Drug Classes: GnRH receptor antagonist
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. 11826397 Method of treating prostate cancer with GnRH antagonist Pat. Sub. Date(s): All strengths: Dec 15, 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

FLOVENT HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: GLAXO GRP LTD      NDA No.: 021433  Prod. No.: 003 RX (0.044MG/INH)

Patents	Expiration	Change
Pat. No. 7500444 DP* Actuation indicator for a dispensing device Pat. Sub. Date(s): None Claim Types: Device	Aug 26, 2026 *PED	This patent is no longer listed 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. 11813255 Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Dec 8, 2023 Claim Types: Method of use Use Code: U-2371: The treatment of Fabry patients	May 30, 2038	New patent for this product
Pat. No. 11826360 DS* Methods of treating Fabry patients having renal impairment Pat. Sub. Date(s): 001: Dec 8, 2023 Claim Types: Formulation	Feb 16, 2039	New patent for this product
Pat. No. 11833164 Methods of treating Fabry disease in patients having a mutation in the GLA gene Pat. Sub. Date(s): 001: Dec 8, 2023 Claim Types: Method of use Use Code: U-2371: The treatment of Fabry patients	Jan 11, 2042	New patent for this product

GLYXAMBI (TABLET) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 206073  Prod. No.: 001 RX (10MG;5MG); 002 RX (25MG;5MG)

Patents	Expiration	Change
Pat. No. 11833166 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3776: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr is >=30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control Use Code: U-3777: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr>=45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control	Apr 3, 2034	New patent for this product

HALOBETASOL PROPIONATE (AEROSOL, FOAM) (TOPICAL) HALOBETASOL PROPIONATE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: PADAGIS ISRAEL      NDA No.: 215266  Prod. No.: 001 RX (0.05%)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Jun 24, 2024	New exclusivity for this product

HEPZATO (POWDER) (INTRA-ARTERIAL) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: DELCATH SYSTEMS INC      NDA No.: 201848  Prod. No.: 001 RX (EQ 50MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 11833286 DP* Filter and frame apparatus and method of use Pat. Sub. Date(s): 001: Dec 27, 2023 Claim Types: Kit	Dec 30, 2032	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11833130 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Jan 3, 2024 Claim Types: Method of use 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
Pat. No. 11850229 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3342: Treatment of nighttime sleep disturbances in smith-magenis syndrome by avoiding the administration of tasimelteon with beta-adrenergic receptor antagonists Use Code: U-3343: Treatment of non-24-hour sleep-wake disorder by avoiding the administration of tasimelteon with beta-adrenergic receptor antagonists	Jan 25, 2033	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11833130 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Jan 3, 2024 Claim Types: Method of use Use Code: U-3003: Treatment of nighttime sleep disturbances in Smith-Magenis syndrome by administering tasimelteon	Jan 25, 2033	New patent for this product
Pat. No. 11850229 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3342: Treatment of nighttime sleep disturbances in smith-magenis syndrome by avoiding the administration of tasimelteon with beta-adrenergic receptor antagonists	Jan 25, 2033	New patent for this product

HYSINGLA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [GENERIC AB]
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 206627  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG); 004 RX (60MG); 005 RX (80MG); 006 RX (100MG); 007 RX (120MG)

Patents	Expiration	Change
Pat. No. 11844865 DP* Abuse-proofed oral dosage form Pat. Sub. Date(s): All strengths: Dec 22, 2023 Claim Types: Formulation; Process Use Code: U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.	Feb 13, 2025	New patent for this product

IDOSE TR (IMPLANT) (INTRACAMERAL) TRAVOPROST
Drug Classes: prostaglandin analog
NDA Applicant: GLAUKOS      NDA No.: 218010  Prod. No.: 001 RX (75MCG)

Patents	Expiration	Change
Pat. No. 10206813 DP* Implants with controlled drug delivery features and methods of using same Pat. Sub. Date(s): 001: Dec 22, 2023 Claim Types: Device	Oct 17, 2030	New product in Orange Book
Pat. No. 11426306 DP* Implants with controlled drug delivery features and methods of using same Pat. Sub. Date(s): 001: Dec 22, 2023 Claim Types: Device	Oct 17, 2030	New product in Orange Book

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

Patents	Expiration	Change
Pat. No. 11839604 Use of sublingual dexmedetomidine for the treatment of agitation Pat. Sub. Date(s): All strengths: Dec 12, 2023 Claim Types: Method of use Use Code: U-3756: Acute treatment of agitation associated with bipolar I or II disorder by sublingual or buccal administration	Dec 29, 2037	New patent for this product

JARDIANCE (TABLET) (ORAL) EMPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 204629  Prod. No.: 001 RX (10MG)

Patents	Expiration	Change
Pat. No. 11813275 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): 001: Dec 13, 2023 Claim Types: Method of use Use Code: U-3759: Method for reducing the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure and Type 2 diabetes mellitus by administration of empagliflozin Use Code: U-3760: Method for reducing the risk of cardiovascular death and hospitalization in patients with heart failure by administration of empagliflozin	Apr 3, 2034	New patent for this product
Pat. No. 11833166 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): 001: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3776: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr is >=30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control Use Code: U-3777: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr>=45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control	Apr 3, 2034	New patent for this product

JARDIANCE (TABLET) (ORAL) EMPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 204629  Prod. No.: 002 RX (25MG)

Patents	Expiration	Change
Pat. No. 11833166 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): 002: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3776: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr is >=30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control Use Code: U-3777: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr>=45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control	Apr 3, 2034	New patent for this product

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

Patents	Expiration	Change
Pat. No. 10464905 Compounds useful as kinase inhibitors Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Method of use Use Code: U-3518: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after at least two lines of systemic therapy, including a BTK inhibitor Use Code: U-3761: Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor	Dec 16, 2036	New Use Code
Pat. No. 10695323 DS* DP* Compounds useful as kinase inhibitors Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Compound; Composition; Method of use Use Code: U-3518: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after at least two lines of systemic therapy, including a BTK inhibitor Use Code: U-3761: Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor	Dec 16, 2036	New Use Code
Pat. No. 10918622 Compounds useful as kinase inhibitors Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Method of use Use Code: U-3518: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after at least two lines of systemic therapy, including a BTK inhibitor Use Code: U-3761: Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor	Dec 16, 2036	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-451: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor	Dec 1, 2030	New exclusivity for this product

KOSELUGO (CAPSULE) (ORAL) SELUMETINIB SULFATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 213756  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 25MG BASE)

Patents	Expiration	Change
Pat. No. 11813246 DP* Pharmaceutical composition Pat. Sub. Date(s): All strengths: Dec 7, 2023 Claim Types: Formulation	Mar 26, 2029	New patent for this product

LUMAKRAS (TABLET) (ORAL) SOTORASIB
NDA Applicant: AMGEN INC      NDA No.: 214665  Prod. No.: 001 RX (120MG); 002 RX (320MG)

Patents	Expiration	Change
Pat. No. 11827635 DS* DP* Solid state forms Pat. Sub. Date(s): All strengths: Dec 18, 2023 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-3306: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy	May 20, 2040	New patent for this product

LUMIFY (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: BAUSCH AND LOMB INC      NDA No.: 208144  Prod. No.: 001 OTC (0.025%)

Patents	Expiration	Change
Pat. No. 11833245 Vasoconstriction compositions and methods of use Pat. Sub. Date(s): 001: Dec 12, 2023 Claim Types: Method of use Use Code: U-2222: Relieves redness of the eye due to minor eye irritations	Jul 27, 2029	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11839597 DP* Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics Pat. Sub. Date(s): All strengths: Jan 4, 2024 Claim Types: Formulation claimed by its inherent performace characteristics	Jul 21, 2037	New patent for this product

LYTGOBI (TABLET) (ORAL) FUTIBATINIB
Drug Classes: kinase inhibitor
NDA Applicant: TAIHO ONCOLOGY      NDA No.: 214801  Prod. No.: 001 RX (4MG)

Patents	Expiration	Change
Pat. No. 11833151 DP* Pharmaceutical composition including sodium alkyl sulfate Pat. Sub. Date(s): 001: Jan 3, 2024 Claim Types: Formulation; Process	Nov 5, 2039	New patent for this product

MEKTOVI (TABLET) (ORAL) BINIMETINIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.: 210498  Prod. No.: 001 RX (15MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-928: Encorafenib in combination with binimetinib, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test	Oct 11, 2026	New exclusivity for this product

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

Patents	Expiration	Change
Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Pat. Sub. Date(s): 001: Jun 21, 2021 Claim Types: Compound	Jan 28, 2025	New expiration date. Was previously Jan 28, 2024
Pat. No. 8058280 DS* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof Pat. Sub. Date(s): 001: Jun 21, 2021 Claim Types: Compound; Composition; Process	Jan 28, 2025	New expiration date. Was previously Jan 28, 2024

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

Patents	Expiration	Change
Pat. No. 11844780 DP* Chlorinated tetralin compounds and pharmaceutical compositions Pat. Sub. Date(s): 001: Dec 20, 2023 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	Sep 8, 2042	New patent for this product
Pat. No. 11845732 DS* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof Pat. Sub. Date(s): 001: Dec 20, 2023 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	Aug 9, 2039	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-452: For adult patients with progressing desmoid tumors who require systemic treatment	Nov 27, 2030	New exclusivity for this product

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

Patents	Expiration	Change
Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Pat. Sub. Date(s): 001: Jan 14, 2021 Claim Types: Compound	Jan 28, 2025	New expiration date. Was previously Jan 28, 2024
Pat. No. 8058280 DS* DP* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof Pat. Sub. Date(s): 001: Jan 14, 2021 Claim Types: Compound; Composition; Process	Jan 28, 2025	New expiration date. Was previously Jan 28, 2024

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

Patents	Expiration	Change
Pat. No. 11819480 Methods for treating cancer Pat. Sub. Date(s): All strengths: Dec 21, 2023 Claim Types: Method of use Use Code: U-3523: Treatment of an ER-positive breast cancer	Nov 29, 2036	New patent for this product

PHYRAGO (TABLET) (ORAL) DASATINIB
Drug Classes: kinase inhibitor
NDA Applicant: NANOCOPOEIA      NDA No.: 216099  Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (70MG); 004 RX (80MG); 005 RX (100MG); 006 RX (140MG)

Patents	Expiration	Change
Pat. No. 11202778 Amorphous solid dispersions of dasatinib and uses thereof Pat. Sub. Date(s): All strengths: Dec 22, 2023 Claim Types: Method of use Use Code: U-3770: Use of dasatinib for treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase PH+ cml with resistance or intolerance to prior therapy including imatinib, when coadministered with a gastric acid reducing agent Use Code: U-3771: Use of dasatinib for treatment of adults with pH+ all with resistance or intolerance to prior therapy, when coadministered with a gastric acid reducing agent Use Code: U-3772: Use of dasatinib for treatment of newly diagnosed adults with pH+ CML in chronic phase, when coadministered with a gastric acid reducing agent	Jan 22, 2041	New product in Orange Book
Pat. No. 11298356 DP* Amorphous solid dispersions of dasatinib and uses thereof Pat. Sub. Date(s): All strengths: Dec 22, 2023 Claim Types: Formulation; Kit	Jan 22, 2041	New product in Orange Book
Pat. No. 11324745 Amorphous solid dispersions of dasatinib and uses thereof Pat. Sub. Date(s): All strengths: Dec 22, 2023 Claim Types: Method of use; Method of administration Use Code: U-3767: Use of dasatinib for treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase PH+ CML with resistance or intolerance to prior therapy including imatinib, when administered at elevated gastric pH Use Code: U-3768: Use of dasatinib for treatment of newly diagnosed adults with PH+ CML in chronic phase, when administered at elevated gastric pH Use Code: U-3769: Use of dasatinib for treatment of adults with pH+ all with resistance or intolerance to prior therapy, when administered at elevated gastric pH	Jan 22, 2041	New product in Orange Book

PODOFILOX (GEL) (TOPICAL) PODOFILOX [GENERIC AB]
NDA Applicant: PADAGIS US      NDA No.: 211871  Prod. No.: 001 RX (0.5%)

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

PRADAXA (CAPSULE) (ORAL) DABIGATRAN ETEXILATE MESYLATE [GENERIC AB]
Drug Classes: direct thrombin inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 022512  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 7866474 DP* DLR* Film container Pat. Sub. Date(s): None Claim Types: Device	Mar 2, 2028 *PED	This patent is no longer listed for this product

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

Patents	Expiration	Change
Pat. No. 11844788 DP* Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea Pat. Sub. Date(s): 001: Jan 8, 2024 Claim Types: Formulation	Dec 30, 2040	New patent for this product
Pat. No. 11850240 DP* Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea Pat. Sub. Date(s): 001: Jan 8, 2024 Claim Types: Formulation	Dec 30, 2040	New patent for this product
Pat. No. 11850241 DP* Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea Pat. Sub. Date(s): 001: Jan 8, 2024 Claim Types: Formulation	Dec 30, 2040	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11819533 DS* DP* Compositions and methods for the treatment of fungal infections Pat. Sub. Date(s): 001: Dec 20, 2023 Claim Types: Formulation; Method of use Use Code: U-3566: Treatment of candidemia and invasive candidiasis with rezafungin by intravenous administration	Jul 11, 2038	New patent for this product

ROZLYTREK (CAPSULE) (ORAL) ENTRECTINIB
NDA Applicant: GENENTECH INC      NDA No.: 212725  Prod. No.: 001 RX (100MG); 002 RX (200MG)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Oct 20, 2026	New exclusivity for this product

SECUADO (SYSTEM) (TRANSDERMAL) ASENAPINE
Drug Classes: atypical antipsychotic
NDA Applicant: HISAMITSU      NDA No.: 212268  Prod. No.: 001 RX (3.8MG/24HR); 002 RX (5.7MG/24HR); 003 RX (7.6MG/24HR)

Patents	Expiration	Change
Pat. No. 11813364 DP* Patch Pat. Sub. Date(s): All strengths: Dec 11, 2023 Claim Types: Device	Sep 22, 2033	New patent for this product

SEZABY (POWDER) (INTRAVENOUS) PHENOBARBITAL SODIUM
NDA Applicant: SUN PHARM INDS INC      NDA No.: 215910  Prod. No.: 001 RX (100MG/VIAL)

Patents	Expiration	Change
Pat. No. 11857683 DP* Stabilization of phenobarbital sodium for injection Pat. Sub. Date(s): 001: Jan 10, 2024 Claim Types: Formulation claimed by its inherent performace characteristics; Method of use Use Code: U-3779: Method of treating neonatal seizures	Apr 7, 2042	New patent for this product

SOTYLIZE (SOLUTION) (ORAL) SOTALOL HYDROCHLORIDE
Drug Classes: antiarrhythmic
NDA Applicant: AZURITY      NDA No.: 205108  Prod. No.: 001 RX (5MG/ML (5MG/ML))

Patents	Expiration	Change
Pat. No. 11850222 Sotalol compositions and uses of the same Pat. Sub. Date(s): 001: Jan 5, 2024 Claim Types: Method of use Use Code: U-2096: SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (Afib/AFL)] in patients with symptomatic Afib/AFL who are currently in sinus rhythm Use Code: U-2494: Indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgement of the physician are life-threatening	Nov 19, 2034	New patent for this product

SUBLOCADE (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: partial opioid agonist
NDA Applicant: INDIVIOR      NDA No.: 209819  Prod. No.: 001 RX (100MG/0.5ML (100MG/0.5ML)); 002 RX (300MG/1.5ML (200MG/ML))

Patents	Expiration	Change
Pat. No. 11839611 Buprenorphine dosing regimens Pat. Sub. Date(s): All strengths: Jan 8, 2024 Claim Types: Method of use Use Code: U-3111: Treating opioid use disorder	Nov 6, 2035	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11839598 Methods of providing solriamfetol therapy to subjects with impaired renal function Pat. Sub. Date(s): All strengths: Dec 15, 2023 Claim Types: Dosaage regimen Use Code: U-3765: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having moderate or severe renal impairment	Mar 19, 2040	New patent for this product
Pat. No. 11839599 Methods of providing solriamfetol therapy to subjects with impaired renal function Pat. Sub. Date(s): All strengths: Dec 15, 2023 Claim Types: Dosaage regimen Use Code: U-3764: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having obstructive sleep apnea (OSA) and no, mild, moderate, or severe renal impairment	Mar 19, 2040	New patent for this product
Pat. No. 11850226 Methods of providing solriamfetol therapy to subjects with impaired renal function Pat. Sub. Date(s): All strengths: Dec 29, 2023 Claim Types: Method of use Use Code: U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment	Mar 19, 2040	New patent for this product
Pat. No. 11850227 Methods of providing solriamfetol therapy to subjects with impaired renal function Pat. Sub. Date(s): All strengths: Dec 29, 2023 Claim Types: Method of use Use Code: U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment	Mar 19, 2040	New patent for this product
Pat. No. 11850228 Methods of providing solriamfetol therapy to subjects with impaired renal function Pat. Sub. Date(s): All strengths: Dec 29, 2023 Claim Types: Method of use Use Code: U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment	Mar 19, 2040	New patent for this product

SYNJARDY (TABLET) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 206111  Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM)

Patents	Expiration	Change
Pat. No. 11813275 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: Method of use Use Code: U-3759: Method for reducing the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure and Type 2 diabetes mellitus by administration of empagliflozin	Apr 3, 2034	New patent for this product
Pat. No. 11833166 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3776: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr is >=30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control Use Code: U-3777: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr>=45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control	Apr 3, 2034	New patent for this product

SYNJARDY (TABLET) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 206111  Prod. No.: 003 RX (12.5MG;500MG); 004 RX (12.5MG;1GM)

Patents	Expiration	Change
Pat. No. 11833166 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3776: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr is >=30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control Use Code: U-3777: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr>=45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control	Apr 3, 2034	New patent for this product

SYNJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 208658  Prod. No.: 001 RX (5MG;1GM); 002 RX (10MG;1GM)

Patents	Expiration	Change
Pat. No. 11813275 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: Method of use Use Code: U-3759: Method for reducing the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure and Type 2 diabetes mellitus by administration of empagliflozin	Apr 3, 2034	New patent for this product
Pat. No. 11833166 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3776: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr is >=30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control Use Code: U-3777: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr>=45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control	Apr 3, 2034	New patent for this product

SYNJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 208658  Prod. No.: 003 RX (12.5MG;1GM); 004 RX (25MG;1GM)

Patents	Expiration	Change
Pat. No. 11833166 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3776: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr is >=30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control Use Code: U-3777: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr>=45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control	Apr 3, 2034	New patent for this product

TAVALISSE (TABLET) (ORAL) FOSTAMATINIB DISODIUM
NDA Applicant: RIGEL PHARMS INC      NDA No.: 209299  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 7449458 DS* Prodrugs of 2,4-pyrimidinediamine compounds and their uses Pat. Sub. Date(s): All strengths: May 16, 2018 Claim Types: Compound	Sep 4, 2031	New expiration date. Was previously Sep 4, 2026

TECHNETIUM TC-99M SULFUR COLLOID KIT (SOLUTION) (INJECTION, ORAL) TECHNETIUM TC-99M SULFUR COLLOID KIT [GENERIC AP]
NDA Applicant: JUBILANT      NDA No.: 213516  Prod. No.: 001 RX (N/A)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Jun 1, 2024	New exclusivity for this product

TIROSINT-SOL (SOLUTION) (ORAL) LEVOTHYROXINE SODIUM
Drug Classes: L-thyroxine (T4)
NDA Applicant: IBSA      NDA No.: 206977  Prod. No.: 001 RX (13MCG/ML); 002 RX (25MCG/ML); 003 RX (50MCG/ML); 004 RX (75MCG/ML); 005 RX (88MCG/ML); 006 RX (100MCG/ML); 007 RX (112MCG/ML); 008 RX (125MCG/ML); 009 RX (137MCG/ML); 010 RX (150MCG/ML); 011 RX (175MCG/ML); 012 RX (200MCG/ML); 013 RX (37.5MCG/ML); 014 RX (44MCG/ML); 015 RX (62.5MCG/ML)

Patents	Expiration	Change
Pat. No. 11241382 Administration regimen of compositions of T4 thyroid hormone with high oral absorption Pat. Sub. Date(s): All strengths: Dec 14, 2023 Claim Types: Method of use Use Code: U-3757: Treatment of hypothyroidism by oral administration of L-thyroxine to a patient on an empty stomach 15 minutes before breakfast Use Code: U-3758: Treatment of pituitary thyrotropin suppression by oral administration of L-thyroxine to a patient on an empty stomach 15 minutes before breakfast	Sep 17, 2039	New patent for this product

TRIJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 212614  Prod. No.: 001 RX (5MG;2.5MG;1GM); 002 RX (10MG;5MG;1GM); 003 RX (12.5MG;2.5MG;1GM); 004 RX (25MG;5MG;1GM)

Patents	Expiration	Change
Pat. No. 11833166 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Jan 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3776: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr is >=30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control Use Code: U-3777: Treating type 2 diabetes mellitus by assessing renal function and orally administering empagliflozin in a daily amount of 10 mg or 25 mg if the egfr>=45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein the treatment improves glycemic control	Apr 3, 2034	New patent for this product

TRULANCE (TABLET) (ORAL) PLECANATIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: SALIX      NDA No.: 208745  Prod. No.: 001 RX (3MG)

Patents	Expiration	Change
Pat. No. 11834521 DP* Ultra-pure agonists of guanylate cyclase C, method of making and using same Pat. Sub. Date(s): 001: Dec 14, 2023 Claim Types: Formulation	Jun 5, 2034	New patent for this product

TRUQAP (TABLET) (ORAL) CAPIVASERTIB
NDA Applicant: ASTRAZENECA      NDA No.: 218197  Prod. No.: 001 RX (160MG); 002 RX (200MG)

Patents	Expiration	Change
Pat. No. 8101623 DS* DP* Substituted pyrrolo[2,3-d]pyrimidine as a protein kinase B inhibitor Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: Compound; Composition; Method of use; Process Use Code: U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy	Mar 10, 2030	New patent for this product
Pat. No. 8809336 Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein kinases inhibitors Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: Method of use Use Code: U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy	Oct 25, 2025	New patent for this product
Pat. No. 9006430 DP* Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: Composition	Oct 25, 2025	New patent for this product
Pat. No. 9487525 DS* DP* Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl) piperidine-4-carboxamide Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: New polymorph, salt or hydrate; Composition; Formulation	Apr 16, 2033	New patent for this product
Pat. No. 10039766 Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d] pyrimidin-4-y1) piperidine-4-carboxamide Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: Method of use Use Code: U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy	Apr 16, 2033	New patent for this product
Pat. No. 10059714 DS* DP* Protein kinase B inhibitors Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: Compound; Composition	Oct 10, 2028	New patent for this product
Pat. No. 10654855 Protein kinase B inhibitors Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: Method of use Use Code: U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy	Oct 10, 2028	New patent for this product
Pat. No. 11760760 Protein kinase B inhibitors Pat. Sub. Date(s): All strengths: Dec 13, 2023 Claim Types: Method of use Use Code: U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy	Oct 10, 2028	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Nov 16, 2028	New exclusivity for this product

VENTOLIN HFA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE [Has competitive generic]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020983  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)

Patents	Expiration	Change
Pat. No. 7500444 DP* Actuation indicator for a dispensing device Pat. Sub. Date(s): None Claim Types: Device	Aug 26, 2026 *PED	This patent is no longer listed for this product

VIVIMUSTA (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: SLAYBACK PHARMA LLC      NDA No.: 212209  Prod. No.: 001 RX (100MG/4ML (25MG/ML))

Patents	Expiration	Change
Pat. No. 11844784 DP* Stable pharmaceutical compositions of bendamustine Pat. Sub. Date(s): 001: Dec 19, 2023 Claim Types: Method of use	Jul 29, 2042	New patent for this product

VOQUEZNA (TABLET) (ORAL) VONOPRAZAN FUMARATE
NDA Applicant: PHATHOM      NDA No.: 215151  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 20MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	May 3, 2027	New exclusivity for this product
Exclusivity Code: NP - New product	Nov 1, 2026	New exclusivity for this product

WELIREG (TABLET) (ORAL) BELZUTIFAN
Drug Classes: hypoxia-inducible factor inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 215383  Prod. No.: 001 RX (40MG)

Patents	Expiration	Change
Pat. No. 9908845 DS* DP* Aryl ethers and uses thereof Pat. Sub. Date(s): 001: Sep 9, 2021 Claim Types: Compound; Composition; Method of use Use Code: U-3201: Treatment of adult patients with Von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery Use Code: U-3780: Treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-ligand inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor	Sep 5, 2034	New Use Code
Pat. No. 9969689 DS* DP* Aryl ethers and uses thereof Pat. Sub. Date(s): 001: Sep 9, 2021 Claim Types: Compound; Composition; Method of use Use Code: U-3201: Treatment of adult patients with Von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery Use Code: U-3780: Treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-ligand inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor	Sep 5, 2034	New Use Code

WINLEVI (CREAM) (TOPICAL) CLASCOTERONE
Drug Classes: androgen receptor inhibitor
NDA Applicant: SUN PHARM      NDA No.: 213433  Prod. No.: 001 RX (1%)

Patents	Expiration	Change
Pat. No. 8143240 17.alpha., 21-dihydroxypregnene esters as antiandrogenic agents Pat. Sub. Date(s): 001: Sep 4, 2020 Claim Types: Method of use Use Code: U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate	Jan 12, 2025	New expiration date. Was previously Jan 12, 2024

XTANDI (CAPSULE) (ORAL) ENZALUTAMIDE
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS      NDA No.: 203415  Prod. No.: 001 RX (40MG)

Patents	Expiration	Change
Pat. No. 8183274 [Extended 101 days (0.3 years)] Treatment of hyperproliferative disorders with diarylhydantoin compounds Pat. Sub. Date(s): 001: Sep 27, 2012 Claim Types: Method of use Use Code: U-1281: The treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel Use Code: U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC). Use Code: U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) Use Code: U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer Use Code: U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis	Aug 24, 2026	New Use Code
Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds Pat. Sub. Date(s): 001: Oct 7, 2015 Claim Types: Method of use Use Code: U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC). Use Code: U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) Use Code: U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer Use Code: U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis	May 15, 2026	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis	Nov 17, 2026	New exclusivity for this product

XTANDI (TABLET) (ORAL) ENZALUTAMIDE
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS      NDA No.: 213674  Prod. No.: 001 RX (40MG); 002 RX (80MG)

Patents	Expiration	Change
Pat. No. 8183274 [Extended 101 days (0.3 years)] Treatment of hyperproliferative disorders with diarylhydantoin compounds Pat. Sub. Date(s): All strengths: Sep 3, 2020 Claim Types: Method of use Use Code: U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) Use Code: U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer Use Code: U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis	Aug 24, 2026	New Use Code
Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds Pat. Sub. Date(s): All strengths: Sep 3, 2020 Claim Types: Method of use Use Code: U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) Use Code: U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer Use Code: U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis	May 15, 2026	New Use Code
Pat. No. 11839689 DP* Formulations of enzalutamide Pat. Sub. Date(s): All strengths: Dec 19, 2023 Claim Types: Formulation	Sep 11, 2033	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis	Nov 17, 2026	New exclusivity for this product

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

Patents	Expiration	Change
Pat. No. 11858898 DS* DP* Crystalline freebase forms of a biphenyl compound Pat. Sub. Date(s): 001: Jan 2, 2024 Claim Types: Method of use; New polymorph, salt or hydrate Use Code: U-2440: For the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)	Jul 14, 2030	New patent for this product

ZITUVIO (TABLET) (ORAL) SITAGLIPTIN
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: ZYDUS      NDA No.: 211566  Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (100MG)

Patents	Expiration	Change
Pat. No. 10925871 DP* Pharmaceutical compositions of sitagliptin Pat. Sub. Date(s): All strengths: Dec 18, 2023 Claim Types: Formulation	Feb 25, 2035	New patent for this product

ZORYVE (FOAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS      NDA No.: 217242  Prod. No.: 001 RX (0.3%)

Patents	Expiration	Change
Pat. No. 9884050 DP* Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Composition; Formulation	Jun 7, 2037	New product in Orange Book
Pat. No. 9907788 Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Method of use Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older	Jun 7, 2037	New product in Orange Book
Pat. No. 10940142 DP* Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Formulation	Jun 7, 2037	New product in Orange Book
Pat. No. 11129818 Topical roflumilast formulation having improved delivery and plasma half life Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Method of improving a treatment Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older	Aug 25, 2037	New product in Orange Book
Pat. No. 11707454 Topical roflumilast formulation having antifungal properties Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Method of use Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older	Dec 3, 2041	New product in Orange Book
Pat. No. 11793796 DP* Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Formulation	Jun 7, 2037	New product in Orange Book
Pat. No. 11819496 Topical roflumilast formulation having improved delivery and plasma half-life Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Method of use Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older	Jun 7, 2037	New product in Orange Book

ZYNRELEF KIT (SOLUTION, EXTENDED RELEASE) (PERIARTICULAR) BUPIVACAINE; MELOXICAM
Drug Classes: amide local anesthetic == nonsteroidal anti-inflammatory drug
NDA Applicant: HERON THERAPS INC      NDA No.: 211988  Prod. No.: 002 RX (200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)); 004 RX (400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)) NDA No.: 211988  Prod. No.: 001 DISC (60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)); 003 DISC (300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML))

Patents	Expiration	Change
Pat. No. 11844837 Compositions of a polyorthoester and an organic acid excipient Pat. Sub. Date(s): All strengths: Jan 3, 2024 Claim Types: Method of use Use Code: U-3417: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures via instillation	Apr 21, 2036	New patent for this product