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

AMONDYS 45 (SOLUTION) (INTRAVENOUS) CASIMERSEN
NDA Applicant: SAREPTA THERAPS INC      NDA No.: 213026  Prod. No.: 001 RX (100MG/2ML (50MG/ML))

Patents	Expiration	Change
Pat. No. RE48960 DS* DP* Antisense oligonucleotides for inducing exon skipping and methods of use thereof Pat. Sub. Date(s): 001: Mar 31, 2022 Claim Types: Compound; Method of use; Formulation Use Code: U-3087: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by inducing exon-skipping of exon 45 Use Code: U-3088: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping	Feb 16, 2029	New expiration date. Was previously Jun 28, 2025

ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 203975  Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)

Patents	Expiration	Change
Pat. No. 8161968 DP* DLR* 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* DLR* 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
Pat. No. 8746242 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Apr 11, 2031 *PED	This patent is no longer listed for this product
Pat. No. 9333310 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device; Drug in a container	Apr 2, 2028 *PED	This patent is no longer listed for this product

APONVIE (EMULSION) (INTRAVENOUS) APREPITANT
NDA Applicant: HERON THERAPS INC      NDA No.: 216457  Prod. No.: 001 RX (32MG/4.4ML (7.2MG/ML))

Patents	Expiration	Change
Pat. No. 12290520 DP* Methods of use of emulsion formulations of aprepitant Pat. Sub. Date(s): 001: May 12, 2025 Claim Types: Formulation	Sep 18, 2035	New patent for this product

ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 008 DISC (0.03MG/INH)

Patents	Expiration	Change
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Pat. Sub. Date(s): 008: May 5, 2022 Claim Types: Device	Aug 25, 2032 *PED	New expiration date. Was previously May 8, 2031 *PED

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 003 RX (0.05MG/INH)

Patents	Expiration	Change
Pat. No. 8201556 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Feb 5, 2029	This patent is no longer listed for this product
Pat. No. 8746242 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Apr 11, 2031 *PED	This patent is no longer listed for this product
Pat. No. 9333310 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device; Drug in a container	Apr 2, 2028 *PED	This patent is no longer listed for this product

ATZUMI (POWDER) (NASAL) DIHYDROERGOTAMINE MESYLATE
NDA Applicant: SATSUMA PHARMS      NDA No.: 217901  Prod. No.: 001 RX (EQ 5.2MG BASE)

Patents	Expiration	Change
Pat. No. 10758532 DP* Compositions, devices, and methods for treating or preventing headaches Pat. Sub. Date(s): 001: May 23, 2025 Claim Types: Method of use	Dec 11, 2039	New patent for this product
Pat. No. 10792253 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: May 23, 2025 Claim Types: Formulation	Aug 4, 2037	New patent for this product
Pat. No. 11744967 DP* Intranasal delivery devices Pat. Sub. Date(s): 001: May 23, 2025 Claim Types: Device; Process	Oct 12, 2041	New patent for this product
Pat. No. 11872314 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: May 23, 2025 Claim Types: Formulation claimed by its inherent performace characteristics	Aug 4, 2037	New patent for this product
Pat. No. 12102754 DP* Intranasal delivery devices Pat. Sub. Date(s): 001: May 23, 2025 Claim Types: Device	Oct 12, 2041	New patent for this product
Pat. No. 12263162 DP* Compositions, devices, and methods for treating or preventing headaches Pat. Sub. Date(s): 001: May 23, 2025 Claim Types: Method of use	Dec 11, 2039	New patent for this product

AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
NDA Applicant: AXSOME      NDA No.: 215430  Prod. No.: 001 RX (105MG;45MG)

Patents	Expiration	Change
Pat. No. 12310961 Bupropion dosage forms with reduced food and alcohol dosing effects Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: Method of use Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder	Jan 20, 2043	New patent for this product

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) (CAPSULE, TABLET) (ORAL) AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
NDA Applicant: VERASTEM INC      NDA No.: 219616  Prod. No.: 001 RX (EQ 0.8MG BASE;EQ 200MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	May 8, 2030	New product in Orange Book

BREKIYA (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) DIHYDROERGOTAMINE MESYLATE
NDA Applicant: AMNEAL      NDA No.: 215400  Prod. No.: 001 RX (1MG/ML)

Patents	Expiration	Change
Pat. No. 10532049 DP* Parenteral unit dosage form of dihydroergotamine Pat. Sub. Date(s): 001: May 28, 2025 Claim Types: Formulation claimed by its inherent performace characteristics	Feb 26, 2039	New product in Orange Book
Pat. No. 11304942 DP* Parenteral unit dosage form of dihydroergotamine Pat. Sub. Date(s): 001: May 28, 2025 Claim Types: Formulation claimed by its inherent performace characteristics	Feb 26, 2039	New product in Orange Book
Pat. No. 11819501 Parenteral unit dosage form of dihydroergotamine Pat. Sub. Date(s): 001: May 28, 2025 Claim Types: Method of use Use Code: U-4188: Acute treatment of cluster headaches Use Code: U-848: Acute treatment of migraine with or without aura	Feb 26, 2039	New product in Orange Book

BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
NDA Applicant: GLAXO GRP LTD      NDA No.: 204275  Prod. No.: 001 RX (0.1MG/INH;EQ 0.025MG BASE/INH); 002 RX (0.2MG/INH;EQ 0.025MG BASE/INH); 003 RX (0.05MG/INH;EQ 0.025MG BASE/INH)

Patents	Expiration	Change
Pat. No. 8161968 DP* DLR* 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. 9333310 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device; Drug in a container	Apr 2, 2028 *PED	This patent is no longer listed for this product

BRYNOVIN (SOLUTION) (ORAL) SITAGLIPTIN HYDROCHLORIDE
NDA Applicant: AZURITY      NDA No.: 219122  Prod. No.: 001 RX (EQ 25MG BASE/ML)

Patents	Expiration	Change
Pat. No. 12295953 DP* Oral gliptin compositions and method for preparation thereof Pat. Sub. Date(s): 001: Jun 5, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Oct 23, 2040	New patent for this product

BYLVAY (CAPSULE, PELLETS) (ORAL) ODEVIXIBAT
NDA Applicant: IPSEN      NDA No.: 215498  Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (1.2MG)

Patents	Expiration	Change
Pat. No. 9694018 IBAT inhibitors for the treatment of liver disease Pat. Sub. Date(s): All strengths: Aug 18, 2021 Claim Types: Method of use Use Code: U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) Use Code: U-3648: Method of treating cholestatic pruritus in patients 12 months or older suffering from alagille syndrome (ALGS)	Nov 8, 2031	New Use Code; Deleted Use Code(s): U-3187, U-3649
Pat. No. 10011633 IBAT inhibitors for the treatment of liver diseases Pat. Sub. Date(s): All strengths: Aug 18, 2021 Claim Types: Method of use Use Code: U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) Use Code: U-3648: Method of treating cholestatic pruritus in patients 12 months or older suffering from alagille syndrome (ALGS)	Nov 8, 2031	New Use Code; Deleted Use Code(s): U-3187, U-3649
Pat. No. 10093697 IBAT inhibitors for the treatment of liver diseases Pat. Sub. Date(s): All strengths: Aug 18, 2021 Claim Types: Method of use Use Code: U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) Use Code: U-3648: Method of treating cholestatic pruritus in patients 12 months or older suffering from alagille syndrome (ALGS)	Nov 8, 2031	New Use Code; Deleted Use Code(s): U-3187, U-3649
Pat. No. 10487111 IBAT inhibitors for the treatment of liver diseases Pat. Sub. Date(s): All strengths: Aug 18, 2021 Claim Types: Method of use Use Code: U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) Use Code: U-3648: Method of treating cholestatic pruritus in patients 12 months or older suffering from alagille syndrome (ALGS)	Nov 8, 2031	New Use Code; Deleted Use Code(s): U-3187, U-3649
Pat. No. 11365182 Crystal modifications of odevixibat Pat. Sub. Date(s): All strengths: Jul 12, 2022 Claim Types: Method of use Use Code: U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) Use Code: U-3648: Method of treating cholestatic pruritus in patients 12 months or older suffering from alagille syndrome (ALGS)	Jun 20, 2039	New Use Code; Deleted Use Code(s): U-3187, U-3649
Pat. No. 11732006 IBAT inhibitors for the treatment of liver diseases Pat. Sub. Date(s): All strengths: Sep 21, 2023 Claim Types: Method of use Use Code: U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) Use Code: U-3648: Method of treating cholestatic pruritus in patients 12 months or older suffering from alagille syndrome (ALGS)	Nov 8, 2031	New Use Code; Deleted Use Code(s): U-3187, U-3649

CINVANTI (EMULSION) (INTRAVENOUS) APREPITANT
NDA Applicant: HERON THERAPS INC      NDA No.: 209296  Prod. No.: 001 RX (130MG/18ML (7.2MG/ML))

Patents	Expiration	Change
Pat. No. 12290520 DP* Methods of use of emulsion formulations of aprepitant Pat. Sub. Date(s): 001: May 12, 2025 Claim Types: Formulation	Sep 18, 2035	New patent for this product

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

Patents	Expiration	Change
Pat. No. 12295931 Levodopa dosing regimen Pat. Sub. Date(s): All strengths: Jun 12, 2025 Claim Types: Dosage regimen Use Code: U-1649: Treatment of post-encephalitic Parkinsonism Use Code: U-219: Treatment of Parkinson's disease Use Code: U-4004: Treatment of parkinsonism that may follow carbon monoxide intoxication Use Code: U-4005: Treatment of parkinsonism that may follow manganese intoxication	Dec 21, 2041	New patent for this product
Pat. No. 12303482 Levodopa dosing regimen Pat. Sub. Date(s): All strengths: Jun 12, 2025 Claim Types: Method of use; Dosage regimen Use Code: U-1649: Treatment of post-encephalitic Parkinsonism Use Code: U-219: Treatment of Parkinson's disease Use Code: U-4004: Treatment of parkinsonism that may follow carbon monoxide intoxication Use Code: U-4005: Treatment of parkinsonism that may follow manganese intoxication	Dec 21, 2041	New patent for this product
Pat. No. 12303605 DP* Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Jun 12, 2025 Claim Types: Formulation	Oct 7, 2034	New patent for this product

DEFENCATH (SOLUTION) (N/A) HEPARIN SODIUM; TAUROLIDINE
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, 2026	New expiration date. Was previously May 16, 2025

DEXTENZA (INSERT) (OPHTHALMIC) DEXAMETHASONE
NDA Applicant: OCULAR THERAPEUTIX      NDA No.: 208742  Prod. No.: 001 RX (0.4MG)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Apr 7, 2028	New exclusivity for this product

DUAKLIR PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
NDA Applicant: COVIS      NDA No.: 210595  Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)

Patents	Expiration	Change
Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)] Quinuclidine derivatives and their use as muscarinic M3 receptor ligands Pat. Sub. Date(s): None Claim Types: Compound; Process; Method of use Use Code: U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)	Feb 10, 2025	This patent is no longer listed for this product
Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler Pat. Sub. Date(s): None Claim Types: Device	Apr 22, 2027	This patent is no longer listed for this product

ELIQUIS (TABLET) (ORAL) APIXABAN [GENERIC AB]
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 202155  Prod. No.: 001 RX (2.5MG)

Patents	Expiration	Change
Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)] Lactam-containing compounds and derivatives thereof as factor Xa inhibitors Pat. Sub. Date(s): 001: Jan 25, 2013 Claim Types: Composition; Method of use; Compound Use Code: U-1167: Prophylaxis of deep vein thrombosis (DVT) Use Code: U-1200: Reducing the risk of stroke and systemic embolism Use Code: U-1301: Treatment of deep vein thrombosis (DVT) Use Code: U-1302: Treatment of pulmonary embolism (PE) Use Code: U-1323: Reducing the risk of stroke Use Code: U-1501: Prophylaxis of deep vein thrombosis and pulmonary embolism Use Code: U-1502: Prophylaxis of pulmonary embolism Use Code: U-1729: Reduce the risk of recurrent deep vein thrombosis (DVT) Use Code: U-1730: Reduce the risk of recurrent pulmonary embolism Use Code: U-4178: Treatment of venous thromboembolism (vte) and reduction in the risk of recurrent vte in pediatric patients with body weight greater than or equal to 35 kg	May 21, 2027 *PED	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Oct 17, 2028 PED	New exclusivity for this product

ELIQUIS (TABLET) (ORAL) APIXABAN [GENERIC AB]
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 202155  Prod. No.: 002 RX (5MG)

Patents	Expiration	Change
Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)] Lactam-containing compounds and derivatives thereof as factor Xa inhibitors Pat. Sub. Date(s): 002: Jan 25, 2013 Claim Types: Composition; Method of use; Compound Use Code: U-1200: Reducing the risk of stroke and systemic embolism Use Code: U-1301: Treatment of deep vein thrombosis (DVT) Use Code: U-1302: Treatment of pulmonary embolism (PE) Use Code: U-1323: Reducing the risk of stroke Use Code: U-4178: Treatment of venous thromboembolism (vte) and reduction in the risk of recurrent vte in pediatric patients with body weight greater than or equal to 35 kg	May 21, 2027 *PED	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Oct 17, 2028 PED	New exclusivity for this product

ELIQUIS (TABLET, FOR SUSPENSION) (ORAL) APIXABAN
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 202155  Prod. No.: 003 RX (0.5MG)

Patents	Expiration	Change
Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)] Lactam-containing compounds and derivatives thereof as factor Xa inhibitors Pat. Sub. Date(s): 003: May 16, 2025 Claim Types: Composition; Method of use; Compound Use Code: U-4179: Treatment of venous thromboembolism (vte) and reduction in the risk of recurrent vte in pediatric patients with body weight from 4 to less than 35 kg	May 21, 2027 *PED	New patent for this product
Pat. No. 9326945 DP* Apixaban formulations Pat. Sub. Date(s): 003: May 16, 2025 Claim Types: Formulation	Aug 24, 2031 *PED	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NS - New strength	Oct 17, 2028 PED	New exclusivity for this product

ELIQUIS SPRINKLE (FOR SUSPENSION) (ORAL) APIXABAN
NDA Applicant: BRISTOL      NDA No.: 220073  Prod. No.: 001 RX (0.15MG)

Patents	Expiration	Change
Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)] Lactam-containing compounds and derivatives thereof as factor Xa inhibitors Pat. Sub. Date(s): 001: May 16, 2025 Claim Types: Composition; Method of use; Compound Use Code: U-4180: Treatment of venous thromboembolism (vte) and reduction in the risk of recurrent vte in pediatric patients with body weight from 2.6 to less than 4 kg	May 21, 2027 *PED	New patent for this product
Pat. No. 11896586 DP* Apixaban formulations Pat. Sub. Date(s): 001: May 16, 2025 Claim Types: Part of a dosage form Use Code: U-4180: Treatment of venous thromboembolism (vte) and reduction in the risk of recurrent vte in pediatric patients with body weight from 2.6 to less than 4 kg	May 22, 2041 *PED	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Oct 17, 2028 PED	New exclusivity for this product

ELTROMBOPAG OLAMINE (TABLET) (ORAL) ELTROMBOPAG OLAMINE [GENERIC AB]
NDA Applicant: HETERO LABS LTD V      NDA No.: 206788  Prod. No.: 001 RX (EQ 12.5MG ACID); 002 RX (EQ 25MG ACID); 003 RX (EQ 50MG ACID); 004 RX (EQ 75MG ACID)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Nov 9, 2025	New exclusivity for this product

ELTROMBOPAG OLAMINE (FOR SUSPENSION) (ORAL) ELTROMBOPAG OLAMINE [GENERIC AB]
NDA Applicant: ANNORA PHARMA      NDA No.: 216620  Prod. No.: 001 RX (EQ 12.5MG ACID/PACKET); 002 RX (EQ 25MG ACID/PACKET)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Nov 9, 2025	New exclusivity for this product

EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
NDA Applicant: MYLAN      NDA No.: 208452  Prod. No.: 001 RX (200MG;EQ 25MG BASE;300MG)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Nov 23, 2025	New product in Orange Book

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

Patents	Expiration	Change
Pat. No. 12290503 DP* Compositions and methods for treating epilepsy, seizures and other conditions Pat. Sub. Date(s): 001: May 16, 2025 Claim Types: Method of use Use Code: U-3413: Indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older Use Code: U-3414: Indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older Use Code: U-3415: Indicated for the preventive treatment of migraine in patients 12 years and older	Aug 21, 2040	New patent for this product

EPSOLAY (CREAM) (TOPICAL) BENZOYL PEROXIDE
NDA Applicant: MAYNE PHARMA      NDA No.: 214510  Prod. No.: 001 RX (5%)

Patents	Expiration	Change
Pat. No. 12295935 Method for therapeutic treatment of rosacea Pat. Sub. Date(s): 001: May 23, 2025 Claim Types: Dosage regimen Use Code: U-3356: Topical treatment of inflammatory lesions of rosacea in adults 18 years of age and older	Dec 27, 2040	New patent for this product

ESLICARBAZEPINE ACETATE (TABLET) (ORAL) ESLICARBAZEPINE ACETATE [GENERIC AB]
NDA Applicant: ALKEM LABS LTD      NDA No.: 211199  Prod. No.: 001 RX (200MG); 002 RX (400MG); 003 RX (600MG); 004 RX (800MG)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Nov 2, 2025	New exclusivity for this product

EXONDYS 51 (SOLUTION) (INTRAVENOUS) ETEPLIRSEN
NDA Applicant: SAREPTA THERAPS INC      NDA No.: 206488  Prod. No.: 001 RX (100MG/2ML (50MG/ML)); 002 RX (500MG/10ML (50MG/ML))

Patents	Expiration	Change
Pat. No. 9243245 DS* Means and methods for counteracting muscle disorders Pat. Sub. Date(s): None Claim Types: Formulation; Method of use; Kit Use Code: U-2097: Treatment of DMD in patients having a mutation of the DMD gene that is amenable to exon 51 skipping Use Code: U-2098: Increasing production of functional dystrophin protein in DMD patients having a mutation of the DMD gene that is amenable to exon 51 skipping	Oct 27, 2028	This patent is no longer listed for this product

EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE [GENERIC AP]
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. 12296047 DP* Manufacturing of bupivacaine multivesicular liposomes Pat. Sub. Date(s): All strengths: May 20, 2025 Claim Types: Product-by-process; Method of use Use Code: U-4184: Method of treating pain, for example, via infiltration to provide local analgesia or via a nerve block to provide regional analgesia	Jan 22, 2041	New patent for this product
Pat. No. 12318483 Manufacturing of bupivacaine multivesicular liposomes Pat. Sub. Date(s): All strengths: Jun 11, 2025 Claim Types: Method of use; Part of a dosage form Use Code: U-4152: Method of treating pain, for example, via infiltration for local analgesia; or via interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, or adductor canal block for regional analgesia	Jul 2, 2044	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. 12285422 Uses of piperidinyl-indole derivatives Pat. Sub. Date(s): 001: May 19, 2025 Claim Types: Method of use Use Code: U-4181: Treatment of complement 3 glomerulopathy (c3g) by administration of 200 mg of iptacopan twice daily	Aug 30, 2038	New patent for this product

GOMEKLI (TABLET, FOR SUSPENSION) (ORAL) MIRDAMETINIB
NDA Applicant: SPRINGWORKS      NDA No.: 219379  Prod. No.: 001 RX (1MG)

Patents	Expiration	Change
Pat. No. 12295925 Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib Pat. Sub. Date(s): 001: May 15, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New patent for this product

GOMEKLI (CAPSULE) (ORAL) MIRDAMETINIB
NDA Applicant: SPRINGWORKS      NDA No.: 219389  Prod. No.: 001 RX (1MG); 002 RX (2MG)

Patents	Expiration	Change
Pat. No. 12295925 Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib Pat. Sub. Date(s): All strengths: May 15, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New patent for this product

GRAFAPEX (POWDER) (INTRAVENOUS) TREOSULFAN
NDA Applicant: MEDEXUS      NDA No.: 214759  Prod. No.: 001 RX (1GM/VIAL); 002 RX (5GM/VIAL)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-513: As a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML)	Jan 21, 2032	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-514: As a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS)	Jan 21, 2032	New exclusivity for this product

INCRUSE ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE
NDA Applicant: GLAXO GRP ENGLAND      NDA No.: 205382  Prod. No.: 001 RX (EQ 0.0625MG BASE/INH)

Patents	Expiration	Change
Pat. No. 8201556 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Feb 5, 2029	This patent is no longer listed for this product
Pat. No. 8746242 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Oct 11, 2030	This patent is no longer listed for this product
Pat. No. 9333310 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device; Drug in a container	Oct 2, 2027	This patent is no longer listed for this product

IQIRVO (TABLET) (ORAL) ELAFIBRANOR
NDA Applicant: IPSEN      NDA No.: 218860  Prod. No.: 001 RX (80MG)

Patents	Expiration	Change
Pat. No. 12295927 Methods of treatment of cholestatic diseases Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 30, 2037	New patent for this product
Pat. No. 12295928 Methods of treatment of cholestatic diseases Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 30, 2037	New patent for this product
Pat. No. 12310935 Methods of treatment of cholestatic diseases Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 30, 2037	New patent for this product

ISTURISA (TABLET) (ORAL) OSILODROSTAT PHOSPHATE
NDA Applicant: RECORDATI RARE      NDA No.: 212801  Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 5MG BASE)

Patents	Expiration	Change
Pat. No. 8609862 Use of an adrenal hormone-modifying agent Pat. Sub. Date(s): All strengths: Apr 3, 2020 Claim Types: Method of use Use Code: U-2770: Cushing's disease Use Code: U-4177: Cushing's syndrome, including cushing's disease	Jan 13, 2031	New Use Code
Pat. No. 10709691 Pharmaceutical dosage forms Pat. Sub. Date(s): All strengths: Aug 6, 2020 Claim Types: Method of use Use Code: U-2770: Cushing's disease Use Code: U-4177: Cushing's syndrome, including cushing's disease	Oct 12, 2035	New Use Code

KRAZATI (TABLET) (ORAL) ADAGRASIB
NDA Applicant: BRISTOL      NDA No.: 216340  Prod. No.: 001 RX (200MG)

Patents	Expiration	Change
Pat. No. 12281113 DS* DP* Crystalline forms of a KRas G12C inhibitor Pat. Sub. Date(s): 001: May 21, 2025 Claim Types: New polymorph, salt or hydrate; Formulation; Formulation claimed by its inherent performace characteristics	Sep 10, 2041	New patent for this product

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

Patents	Expiration	Change
Pat. No. RE47954 Combination therapy with peptide epoxyketones Pat. Sub. Date(s): All strengths: Oct 18, 2022 Claim Types: Method of use Use Code: U-3449: Use in combination with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy	Apr 21, 2030 *PED	New expiration date. Was previously Oct 21, 2029
Pat. No. 7417042 DS* DP* [Extended 462 days (1.3 years)] Compounds for enzyme inhibition Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016; 003: Jun 20, 2018 Claim Types: Compound; Composition	Jan 20, 2027 *PED	New expiration date. Was previously Jul 20, 2026
Pat. No. 7737112 DP* Composition for enzyme inhibition Pat. Sub. Date(s): 001: Aug 9, 2012; 002: Aug 15, 2016; 003: Jun 20, 2018 Claim Types: Formulation	Jun 7, 2028 *PED	New expiration date. Was previously Dec 7, 2027
Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Pat. Sub. Date(s): 001: Mar 9, 2017; 002: Mar 9, 2017; 003: Jun 20, 2018 Claim Types: Formulation; Product-by-process; Process	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033

LEQSELVI (TABLET) (ORAL) DEURUXOLITINIB PHOSPHATE
NDA Applicant: SUN PHARM INDS INC      NDA No.: 217900  Prod. No.: 001 RX (EQ 8MG BASE)

Patents	Expiration	Change
Pat. No. 12285432 Treatment of hair loss disorders with deuterated JAK inhibitors Pat. Sub. Date(s): 001: May 29, 2025 Claim Types: Method of use Use Code: U-3976: Treatment of adult patients with alopecia areata	Aug 11, 2042	New patent for this product

LEVULAN (SOLUTION) (TOPICAL) AMINOLEVULINIC ACID HYDROCHLORIDE
NDA Applicant: SUN PHARM INDS INC      NDA No.: 020965  Prod. No.: 001 RX (20%)

Patents	Expiration	Change
Pat. No. 11179574 Method of administering 5-aminolevulinic acid (ALA) to a patient Pat. Sub. Date(s): 001: May 30, 2025 Claim Types: Method of administration Use Code: U-804: Treatment of actinic keratoses by photodynamic therapy	Oct 13, 2036	New patent for this product
Pat. No. 11446512 Adjustable illuminator for photodynamic therapy and diagnosis Pat. Sub. Date(s): 001: May 30, 2025 Claim Types: Device Use Code: U-804: Treatment of actinic keratoses by photodynamic therapy	Jan 17, 2037	New patent for this product
Pat. No. 11697028 Adjustable illuminator for photodynamic therapy and diagnosis Pat. Sub. Date(s): 001: May 30, 2025 Claim Types: Device Use Code: U-804: Treatment of actinic keratoses by photodynamic therapy	Oct 13, 2036	New patent for this product
Pat. No. 12290700 Adjustable illuminator for photodynamic therapy and diagnosis Pat. Sub. Date(s): 001: May 30, 2025 Claim Types: Method of use; Device Use Code: U-804: Treatment of actinic keratoses by photodynamic therapy	Oct 13, 2036	New patent for this product
Pat. No. 12296011 Methods for photodynamic therapy Pat. Sub. Date(s): 001: Jun 6, 2025 Claim Types: Method of use Use Code: U-3163: Treatment of actinic keratosis of upper extremities by photodynamic therapy	Jan 12, 2038	New patent for this product

LIVMARLI (TABLET) (ORAL) MARALIXIBAT CHLORIDE
NDA Applicant: MIRUM      NDA No.: 219485  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 15MG BASE); 003 RX (EQ 20MG BASE); 004 RX (EQ 30MG BASE)

Patents	Expiration	Change
Pat. No. 12296050 DP* Pharmaceutical compositions comprising maralixibat and uses thereof Pat. Sub. Date(s): All strengths: May 29, 2025 Claim Types: Formulation; Process; Method of use Use Code: U-4186: Treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (pfic) who weigh 25 kilograms and above Use Code: U-4187: Treatment of cholestatic pruritus in patients 3 months of age and older with alagille syndrome (algs) who weigh 25 kilograms and above	Oct 5, 2043	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-938: Treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC)	Mar 13, 2027	New exclusivity for this product
Exclusivity Code: NCE - New chemical entity	Sep 29, 2026	New exclusivity for this product

LIVTENCITY (TABLET) (ORAL) MARIBAVIR
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 215596  Prod. No.: 001 RX (200MG)

Patents	Expiration	Change
Pat. No. 12295940 DS* DP* Viral inhibitors, the synthesis thereof, and intermediates thereto Pat. Sub. Date(s): 001: May 29, 2025 Claim Types: Formulation	Oct 11, 2043	New patent for this product

LUMAKRAS (TABLET) (ORAL) SOTORASIB
NDA Applicant: AMGEN INC      NDA No.: 214665  Prod. No.: 001 RX (120MG); 002 RX (320MG); 003 RX (240MG)

Patents	Expiration	Change
Pat. No. 12280056 Combination therapy including a KRASG12C inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers Pat. Sub. Date(s): All strengths: May 12, 2025 Claim Types: Method of use Use Code: U-4107: In combination with panitumumab for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (MCRC), as determined by an FDA-approved test, who have received prior chemotherapy	Nov 18, 2039	New patent for this product

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

Patents	Expiration	Change
Pat. No. 12303478 Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state Pat. Sub. Date(s): All strengths: Jun 2, 2025 Claim Types: Method of use Use Code: U-4189: Method of decreasing excessive daytime sleepiness by orally administering a dose proportional, pharmaceutical composition comprising immediate release and modified release gamma-hydroxybutyrate portions once daily at bedtime	Jul 21, 2037	New patent for this product

MEZOFY (FILM) (ORAL) ARIPIPRAZOLE
NDA Applicant: CMG PHARM CO LTD      NDA No.: 211448  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG)

Patents	Expiration	Change
Pat. No. 9694008 DP* Fast-dissolving oral film preparation comprising aripiprazole Pat. Sub. Date(s): All strengths: May 12, 2025 Claim Types: Formulation	Aug 7, 2033	New patent for this product

MOUNJARO (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TIRZEPATIDE
NDA Applicant: ELI LILLY AND CO      NDA No.: 215866  Prod. No.: 001 RX (2.5MG/0.5ML (2.5MG/0.5ML)); 002 RX (5MG/0.5ML (5MG/0.5ML)); 003 RX (7.5MG/0.5ML (7.5MG/0.5ML)); 004 RX (10MG/0.5ML (10MG/0.5ML)); 005 RX (12.5MG/0.5ML (12.5MG/0.5ML)); 006 RX (15MG/0.5ML (15MG/0.5ML)); 007 RX (2.5MG/0.5ML (2.5MG/0.5ML)); 008 RX (5MG/0.5ML (5MG/0.5ML)); 009 RX (7.5MG/0.5ML (7.5MG/0.5ML)); 010 RX (10MG/0.5ML (10MG/0.5ML)); 011 RX (12.5MG/0.5ML (12.5MG/0.5ML)); 012 RX (15MG/0.5ML (15MG/0.5ML))

Patents	Expiration	Change
Pat. No. 12295987 Method of using a GIP/GLP1 co-agonist for diabetes Pat. Sub. Date(s): All strengths: Jun 11, 2025 Claim Types: Method of use Use Code: U-4192: Treatment of type 2 diabetes by administering in 4 doses, at least 2 weeks apart, a gip:glp-1 peptide having a gip:glp-1 receptor agonist potency ratio in a range determined by a casein camp assay, where doses are 25%, 50% and 75% of 4th dose Use Code: U-4193: Treatment of type 2 diabetes by administering in 4 doses, at least 4 weeks apart, a gip:glp-1 peptide having a gip:glp-1 receptor agonist potency ratio in a range determined by a casein camp assay, where doses are 25%, 50% and 75% of 4th dose	Dec 30, 2041	New patent for this product

MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON [GENERIC AB]
NDA Applicant: APGDI      NDA No.: 202611  Prod. No.: 001 RX (25MG); 002 RX (50MG)

Patents	Expiration	Change
Pat. No. 12059409 DP* Pat. Sub. Date(s): All strengths: Aug 28, 2024 Claim Types:	Mar 28, 2030 *PED	New expiration date. Was previously Sep 28, 2029
Pat. No. 12097189 Pharmaceutical composition for modified release Pat. Sub. Date(s): All strengths: Oct 2, 2024 Claim Types: Method of use Use Code: U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency Use Code: U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more	Mar 28, 2030 *PED	New expiration date. Was previously Sep 28, 2029

NILOTINIB HYDROCHLORIDE (CAPSULE) (ORAL) NILOTINIB HYDROCHLORIDE [GENERIC AB]
NDA Applicant: APOTEX      NDA No.: 203640  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 200MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Nov 19, 2025	New exclusivity for this product

NITHIODOTE (SOLUTION, SOLUTION) (INTRAVENOUS, INTRAVENOUS) SODIUM NITRITE; SODIUM THIOSULFATE
NDA Applicant: HOPE PHARMS      NDA No.: 201444  Prod. No.: 001 RX (300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML))

Patents	Expiration	Change
Pat. No. 12304813 DP* Sodium thiosulfate-containing pharmaceutical compositions Pat. Sub. Date(s): 001: May 22, 2025 Claim Types: Formulation claimed by its inherent performace characteristics	Feb 10, 2030	New patent for this product

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (SOLUTION) (INTRAVENOUS) NOREPINEPHRINE BITARTRATE
NDA Applicant: BAXTER HLTHCARE CORP      NDA No.: 214313  Prod. No.: 001 RX (EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)); 002 RX (EQ 8MG BASE/250ML (EQ 32MCG BASE/ML))

Patents	Expiration	Change
Pat. No. 12290494 DP* Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation Pat. Sub. Date(s): All strengths: May 16, 2025 Claim Types: Drug in a container	Mar 8, 2041	New patent for this product

NUZYRA (POWDER) (INTRAVENOUS) OMADACYCLINE TOSYLATE
NDA Applicant: PARATEK PHARMS INC      NDA No.: 209817  Prod. No.: 001 RX (EQ 100MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 9265740 DP* Minocycline compounds and methods of use thereof Pat. Sub. Date(s): 001: Jul 23, 2019 Claim Types: Method of use; Composition	Mar 5, 2029	New expiration date. Was previously Oct 24, 2030

OGSIVEO (TABLET) (ORAL) NIROGACESTAT HYDROBROMIDE
NDA Applicant: SPRINGWORKS      NDA No.: 217677  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 12297177 DP* Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof Pat. Sub. Date(s): All strengths: May 19, 2025 Claim Types: New polymorph, salt or hydrate; Formulation claimed by its inherent performace characteristics	Aug 9, 2039	New patent for this product

OPTISON (INJECTABLE) (INJECTION) ALBUMIN HUMAN
NDA Applicant: GE HEALTHCARE      NDA No.: 020899  Prod. No.: 001 RX (10MG/ML)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	May 9, 2028	New exclusivity for this product

OPVEE (SPRAY) (NASAL) NALMEFENE HYDROCHLORIDE
NDA Applicant: INDIVIOR      NDA No.: 217470  Prod. No.: 001 RX (EQ 2.7MG BASE/SPRAY)

Patents	Expiration	Change
Pat. No. 12290596 Compositions and methods for the treatment of opioid overdose Pat. Sub. Date(s): 001: May 20, 2025 Claim Types: Method of use Use Code: U-4182: Emergency treatment of a known or suspected opioid overdose/symptom thereof in a human caused by natural or synthetic opioids, such as remifentanil-induced respiratory depression, with 2.7mg nalmefene, administered as 3mg nalmefene hydrochloride	Aug 4, 2042	New patent for this product

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

Patents	Expiration	Change
Pat. No. 12280152 DP* Tamper resistant dosage forms Pat. Sub. Date(s): All strengths: May 22, 2025 Claim Types: Formulation; Product-by-process	Aug 24, 2027	New patent for this product

OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
NDA Applicant: NOVO      NDA No.: 209637  Prod. No.: 003 RX (8MG/3ML (2.68MG/ML))

Patents	Expiration	Change
Pat. No. 12295988 Semaglutide in medical therapy Pat. Sub. Date(s): 003: May 29, 2025 Claim Types: Method of use Use Code: U-2628: Method of treating Type 2 diabetes mellitus	Oct 10, 2038	New patent for this product

PERAMPANEL (TABLET) (ORAL) PERAMPANEL [GENERIC AB]
NDA Applicant: TEVA PHARMS USA INC      NDA No.: 209801  Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (6MG); 004 RX (8MG); 005 RX (10MG); 006 RX (12MG)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Nov 25, 2025	New product in Orange Book

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE (SOLUTION) (INTRAVENOUS) POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
NDA Applicant: FRESENIUS KABI USA      NDA No.: 212832  Prod. No.: 004 RX (1.18GM/100ML(11.8MG/ML); 1.12GM/100ML(11.2MG/ML)); 005 RX (1.18GM/250ML(4.72MG/ML); 1.12GM/250ML(4.48MG/ML))

Patents	Expiration	Change
Pat. No. 11813291 DP* Ready-to-use potassium phosphates in sodium chloride solutions Pat. Sub. Date(s): All strengths: May 22, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Use Code: U-4185: Method to provide phosphorus replacement by administering without prior dilution an isotonic, sterile, and ready-to-use solution comprising about 15 mmol phosphorus and about 22 meq potassium from a flexible container	Oct 12, 2041	New strength or variation of this product
Pat. No. 11925661 DP* Ready-to-use potassium phosphates in sodium chloride solutions Pat. Sub. Date(s): All strengths: May 22, 2025 Claim Types: Formulation Use Code: U-4185: Method to provide phosphorus replacement by administering without prior dilution an isotonic, sterile, and ready-to-use solution comprising about 15 mmol phosphorus and about 22 meq potassium from a flexible container	Oct 12, 2041	New strength or variation of this product

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

Patents	Expiration	Change
Pat. No. 12295944 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: May 20, 2025 Claim Types: Dosage regimen Use Code: U-4183: Treatment of gastrointestinal stromal tumors in a patient suffering from grade 3 arthralgia while being administered ripretinib daily	Aug 12, 2040	New patent for this product
Pat. No. 12318373 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: Jun 10, 2025 Claim Types: Method of use Use Code: U-4191: Treatment of gastrointestinal stromal tumors in a patient suffering from grade 3 palmar-plantar erythrodysesthesia while being administered ripetrinib daily	Aug 12, 2040	New patent for this product
Pat. No. 12318374 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: Jun 10, 2025 Claim Types: Formulation	Dec 30, 2040	New patent for this product

QVAR REDIHALER (AEROSOL, METERED) (INHALATION) BECLOMETHASONE DIPROPIONATE
NDA Applicant: NORTON WATERFORD      NDA No.: 207921  Prod. No.: 001 RX (0.04MG/INH); 002 RX (0.08MG/INH)

Patents	Expiration	Change
Pat. No. 12296089 DP* Inhalers and related methods Pat. Sub. Date(s): All strengths: Jun 2, 2025 Claim Types: Device	Jan 26, 2038	New patent for this product

RETEVMO (TABLET) (ORAL) SELPERCATINIB
NDA Applicant: ELI LILLY AND CO      NDA No.: 218160  Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (120MG); 004 RX (160MG)

Exclusivity	Expiration	Change
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	May 29, 2031	New exclusivity for this product
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	May 8, 2027	New exclusivity for this product
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Sep 21, 2029	New exclusivity for this product

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

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication I-966: (Code description not yet released by FDA)	Apr 28, 2028	New exclusivity for this product

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

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Mar 27, 2028	New exclusivity for this product

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

Patents	Expiration	Change
Pat. No. 12280151 DP* Synthetic progestogens and pharmaceutical compositions comprising the same Pat. Sub. Date(s): 001: May 8, 2025 Claim Types: Formulation claimed by its inherent performace characteristics	Jun 28, 2031	New patent for this product
Pat. No. 11439598 DP* Synthetic progestogens and pharmaceutical compositions comprising the same Pat. Sub. Date(s): None Claim Types: Formulation claimed by its inherent performace characteristics	Jun 28, 2031	This patent is no longer listed for this product

SODIUM THIOSULFATE (SOLUTION) (INTRAVENOUS) SODIUM THIOSULFATE
NDA Applicant: HOPE PHARMS      NDA No.: 203923  Prod. No.: 001 RX (12.5GM/50ML (250MG/ML))

Patents	Expiration	Change
Pat. No. 12304813 DP* Sodium thiosulfate-containing pharmaceutical compositions Pat. Sub. Date(s): 001: May 22, 2025 Claim Types: Formulation claimed by its inherent performace characteristics	Feb 10, 2030	New patent for this product

SOFDRA (GEL, METERED) (TOPICAL) SOFPIRONIUM BROMIDE
NDA Applicant: BOTANIX SB      NDA No.: 217347  Prod. No.: 001 RX (EQ 12.45% BASE (EQ 72MG BASE/ACTUATION))

Patents	Expiration	Change
Pat. No. 12156865 DP* Formulation for soft anticholinergic analogs Pat. Sub. Date(s): 001: Jun 10, 2025 Claim Types: Formulation; Method of use Use Code: U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older	May 22, 2034	New patent for this product

SOLOSEC (GRANULE) (ORAL) SECNIDAZOLE
NDA Applicant: EVOFEM INC      NDA No.: 209363  Prod. No.: 001 RX (2GM/PACKET)

Patents	Expiration	Change
Pat. No. 12280037 Method and pharmaceutical composition for treating or preventing trichomoniasis and uses thereof Pat. Sub. Date(s): 001: May 19, 2025 Claim Types: Method of use Use Code: U-3302: Treatment of trichomoniasis in patients 12 years of age and older	Dec 11, 2041	New patent for this product

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

Patents	Expiration	Change
Pat. No. 12290495 Sotalol compositions and uses of the same Pat. Sub. Date(s): 001: May 22, 2025 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	Apr 1, 2034	New patent for this product

SUCCINYLCHOLINE CHLORIDE (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS) SUCCINYLCHOLINE CHLORIDE [GENERIC AP]
NDA Applicant: HIKMA      NDA No.: 215143  Prod. No.: 001 RX (100MG/5ML (20MG/ML))

Patents	Expiration	Change
Pat. No. 12295932 DP* Succinylcholine chloride prefilled syringe Pat. Sub. Date(s): 001: Jun 10, 2025 Claim Types: Drug in a container; Kit	Nov 2, 2041	New patent for this product

SUFLAVE (FOR SOLUTION) (ORAL) MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE
NDA Applicant: BRAINTREE LABS      NDA No.: 215344  Prod. No.: 001 RX (0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT)

Patents	Expiration	Change
Pat. No. 12290529 DP* Methods of administering safe colon cleansing compositions Pat. Sub. Date(s): 001: May 9, 2025 Claim Types: Kit	Aug 2, 2044	New patent for this product

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

Patents	Expiration	Change
Pat. No. 12318362 Methods of providing solriamfetol therapy to subjects with impaired renal function Pat. Sub. Date(s): 001: Jun 10, 2025 Claim Types: Dosage regimen; Method of use 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

TEPADINA AND SODIUM CHLORIDE (POWDER) (INTRAVENOUS) THIOTEPA
NDA Applicant: ADIENNE SA      NDA No.: 208264  Prod. No.: 003 RX (200MG)

Patents	Expiration	Change
Pat. No. 9931458 DP* Multi chamber flexible bag and methods of using same Pat. Sub. Date(s): 003: May 9, 2025 Claim Types: Device	May 31, 2037	New strength or variation of this product

TICAGRELOR (TABLET) (ORAL) TICAGRELOR [GENERIC AB]
NDA Applicant: WATSON LABS INC      NDA No.: 208390  Prod. No.: 001 RX (60MG)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Oct 28, 2025	New exclusivity for this product

TICAGRELOR (TABLET) (ORAL) TICAGRELOR [Has competitive generic]
NDA Applicant: AMNEAL      NDA No.: 208531  Prod. No.: 001 DISC (90MG)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Oct 28, 2025	New exclusivity for this product

TLANDO (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
NDA Applicant: VERITY      NDA No.: 208088  Prod. No.: 001 RX (112.5MG)

Patents	Expiration	Change
Pat. No. 12310978 Composition and method for oral delivery of androgen prodrugs Pat. Sub. Date(s): 001: Jun 11, 2025 Claim Types: Method of use; Formulation claimed by its inherent performace characteristics Use Code: U-4194: Methods of restoring testosterone concentration for conditions associated with deficiency or absence of endogenous testosterone in a male subject	Feb 21, 2039	New patent for this product

TOLVAPTAN (TABLET) (ORAL) TOLVAPTAN [GENERIC AB2]
NDA Applicant: LUPIN LTD      NDA No.: 216063  Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG); 004 RX (60MG); 005 RX (90MG)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Nov 8, 2025	New exclusivity for this product

TRELEGY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 209482  Prod. No.: 001 RX (0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH); 002 RX (0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)

Patents	Expiration	Change
Pat. No. 8161968 DP* DLR* 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. 8511304 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device; Method of use Use Code: U-2954: Method of dispensing a combination medicament product from claimed delivery device, for example for the treatment of asthma or COPD	Dec 14, 2027 *PED	This patent is no longer listed for this product
Pat. No. 9333310 DP* DLR* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device; Drug in a container	Apr 2, 2028 *PED	This patent is no longer listed for this product

TUDORZA PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE
NDA Applicant: COVIS      NDA No.: 202450  Prod. No.: 001 RX (0.4MG/INH)

Patents	Expiration	Change
Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)] Quinuclidine derivatives and their use as muscarinic M3 receptor ligands Pat. Sub. Date(s): None Claim Types: Compound; Process; Method of use Use Code: U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)	Feb 10, 2025	This patent is no longer listed for this product
Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler Pat. Sub. Date(s): None Claim Types: Device	Apr 22, 2027	This patent is no longer listed for this product

TWYNEO (CREAM) (TOPICAL) BENZOYL PEROXIDE; TRETINOIN
NDA Applicant: MAYNE PHARMA      NDA No.: 214902  Prod. No.: 001 RX (3%;0.1%)

Patents	Expiration	Change
Pat. No. 12295935 Method for therapeutic treatment of rosacea Pat. Sub. Date(s): 001: May 23, 2025 Claim Types: Dosage regimen Use Code: U-3987: Topical treatment of acne	Dec 27, 2040	New patent for this product

VALTOCO (SPRAY) (NASAL) DIAZEPAM
NDA Applicant: NEURELIS INC      NDA No.: 211635  Prod. No.: 001 RX (5MG/SPRAY); 002 RX (7.5MG/SPRAY); 003 RX (10MG/SPRAY)

Patents	Expiration	Change
Pat. No. 8927497 DP* Absorption enhancers for intranasal administration Pat. Sub. Date(s): All strengths: Feb 6, 2020 Claim Types: Method of improving a treatment Use Code: U-4173: Nasal administration of diazepam for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older	Jul 21, 2025	Deleted Use Code(s): U-2727

VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS      NDA No.: 202057  Prod. No.: 001 RX (1GM); 002 RX (500MG)

Patents	Expiration	Change
Pat. No. 8440650 Methods of treating hypertriglyceridemia Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia	Feb 9, 2030	This patent is no longer listed for this product

VIGAFYDE (SOLUTION) (ORAL) VIGABATRIN
NDA Applicant: PYROS PHARMS      NDA No.: 217684  Prod. No.: 001 RX (100MG/ML)

Patents	Expiration	Change
Pat. No. 12290499 DP* Vigabatrin liquid pharmaceutical composition Pat. Sub. Date(s): 001: May 13, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Oct 17, 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, 2032 GAIN	New expiration date. Was previously May 3, 2027

VYALEV (SOLUTION) (SUBCUTANEOUS) FOSCARBIDOPA; FOSLEVODOPA
NDA Applicant: ABBVIE      NDA No.: 216962  Prod. No.: 001 RX (120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML))

Patents	Expiration	Change
Pat. No. 12251365 Pharmaceutical formulations for subcutaneous administration Pat. Sub. Date(s): 001: Apr 10, 2025 Claim Types: Method of use Use Code: U-4030: Treatment of motor fluctuations in adults with advanced parkinson's disease	Jun 10, 2040	New expiration date. Was previously Jun 11, 2040

VYKAT XR (TABLET, EXTENDED RELEASE) (ORAL) DIAZOXIDE CHOLINE
NDA Applicant: SOLENO THERAP      NDA No.: 216665  Prod. No.: 001 RX (25MG); 002 RX (75MG); 003 RX (150MG)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Mar 26, 2028	New exclusivity for this product

WELIREG (TABLET) (ORAL) BELZUTIFAN
NDA Applicant: MERCK SHARP DOHME      NDA No.: 215383  Prod. No.: 001 RX (40MG)

Patents	Expiration	Change
Pat. No. RE49948 DS* DP* Aryl ethers and uses thereof Pat. Sub. Date(s): 001: May 28, 2024 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 Use Code: U-4176: Treatment of adult patients with advanced renal cell carcinoma with a clear cell component following a programmed death receptor-i or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor	Sep 5, 2034	New Use Code
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 Use Code: U-4176: Treatment of adult patients with advanced renal cell carcinoma with a clear cell component following a programmed death receptor-i or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor	Sep 5, 2034	New Use Code

XENLETA (SOLUTION) (INTRAVENOUS) LEFAMULIN ACETATE
NDA Applicant: HONG KONG      NDA No.: 211673  Prod. No.: 001 RX (EQ 150MG BASE/15ML (EQ 10MG BASE/ML))

Patents	Expiration	Change
Pat. No. 12121582 DP* Injectable pharmaceutical formulations of lefamulin Pat. Sub. Date(s): 001: May 13, 2025 Claim Types: Formulation	Jun 14, 2036	New patent for this product

XPOVIO (TABLET) (ORAL) SELINEXOR
NDA Applicant: KARYOPHARM THERAPS      NDA No.: 212306  Prod. No.: 001 RX (20MG); 002 RX (40MG); 003 RX (50MG); 004 RX (60MG)

Patents	Expiration	Change
Pat. No. 12291508 Hydrazide containing nuclear transport modulators and uses thereof Pat. Sub. Date(s): All strengths: Jun 4, 2025 Claim Types: Method of use Use Code: U-2584: XPOVIO is indicated in combination with dexamethasone to treat relapsed or refractory multiple myeloma (refractory to at least an anti-CD38 mab, 2 proteasome inhibitors and 2 immunomodulatory agents) in adults who received at least 4 prior therapies Use Code: U-2855: XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy Use Code: U-3018: XPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy	Jul 26, 2032	New patent for this product

XPOVIO (TABLET) (ORAL) SELINEXOR
NDA Applicant: KARYOPHARM THERAPS      NDA No.: 212306  Prod. No.: 005 RX (10MG)

Patents	Expiration	Change
Pat. No. 12291508 Hydrazide containing nuclear transport modulators and uses thereof Pat. Sub. Date(s): 005: Jun 4, 2025 Claim Types: Method of use Use Code: U-2584: XPOVIO is indicated in combination with dexamethasone to treat relapsed or refractory multiple myeloma (refractory to at least an anti-CD38 mab, 2 proteasome inhibitors and 2 immunomodulatory agents) in adults who received at least 4 prior therapies Use Code: U-2855: XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy Use Code: U-3018: XPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy	Jul 26, 2032	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Dec 18, 2027	New exclusivity for this product
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Jul 3, 2026	New exclusivity for this product
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Jun 22, 2027	New exclusivity for this product

YCANTH (SOLUTION) (TOPICAL) CANTHARIDIN
NDA Applicant: VERRICA PHARMS      NDA No.: 212905  Prod. No.: 001 RX (0.7%)

Patents	Expiration	Change
Pat. No. 12290651 DP* Devices and methods for the treatment of body surface disorders Pat. Sub. Date(s): 001: May 16, 2025 Claim Types: Device	Feb 19, 2041	New patent for this product

YORVIPATH (SOLUTION) (SUBCUTANEOUS) PALOPEGTERIPARATIDE
NDA Applicant: ASCENDIS PHARMA BONE      NDA No.: 216490  Prod. No.: 001 RX (EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)); 002 RX (EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)); 003 RX (EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML))

Patents	Expiration	Change
Pat. No. 12295989 Controlled-release PTH compound Pat. Sub. Date(s): All strengths: May 29, 2025 Claim Types: Method of use Use Code: U-3982: Treatment of hypoparathyroidism in adults	Sep 28, 2037	New patent for this product

ZOKINVY (CAPSULE) (ORAL) LONAFARNIB
NDA Applicant: SENTYNL THERAPS INC      NDA No.: 213969  Prod. No.: 001 RX (50MG); 002 RX (75MG)

Patents	Expiration	Change
Pat. No. 7838531 Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis Pat. Sub. Date(s): All strengths: Feb 24, 2021 Claim Types: Method of use Use Code: U-3070: Reducing the risk of mortality in Hutchinson-Gilford progeria syndrome (HGPS)	Jul 26, 2029	New expiration date. Was previously Jul 26, 2025