Sparsentan - Generic Drug Details

What are the generic sources for sparsentan and what is the scope of patent protection?

Sparsentan is the generic ingredient in one branded drug marketed by Travere and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for sparsentan

International Patents:	39
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	10
What excipients (inactive ingredients) are in sparsentan?	sparsentan excipients list
DailyMed Link:	sparsentan at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sparsentan

Constraining patent/regulatory exclusivity:

TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) WHO ARE AT RISK FOR DISEASE PROGRESSION, EXCLUDING THE USE PROVIDED FOR IN THE INDICATION APPROVED ON FEBRUARY 17, 2023

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for sparsentan

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Travere Therapeutics, Inc.	PHASE1
Brigham and Women's Hospital	PHASE1
Travere Therapeutics, Inc.	PHASE4

See all sparsentan clinical trials

Pharmacology for sparsentan

Drug Class	Angiotensin 2 Receptor Blocker Endothelin Receptor Antagonist
Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Endothelin Receptor Antagonists P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sparsentan

C09XX	Other agents acting on the renin-angiotensin system
C09X	OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for sparsentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-002	Feb 17, 2023		RX	Yes	Yes	9,662,312
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-002	Feb 17, 2023		RX	Yes	Yes	9,993,461
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No	9,993,461

International Patents for sparsentan

Country	Patent Number	Title	Estimated Expiration
China	102421434	Oral formulations of diphenylsulfonamide endothelin and angiotensin ii receptor agonists to treat elevated blood pressure and diabetic nephropathy
China	104107176	Oral formulations of diphenylsulfonamide endothelin and angiotensin II receptor agonists to treat elevated blood pressure and diabetic nephropathy
Cyprus	1119232
Cyprus	1123017
Cyprus	2024028

Supplementary Protection Certificates for sparsentan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3222277	LUC00357	Luxembourg		PRODUCT NAME: SPARSENTAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1788 20240423
3222277	122024000053	Germany		PRODUCT NAME: SPARSENTAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; AUTHORISATION NO/DATE: EU/1/23/1788 20240419
3222277	24C1038	France		PRODUCT NAME: SPARSENTAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/23/1788 20240423
3222277	202440030	Slovenia		PRODUCT NAME: SPARSENTAN OR ITS PHARMACEUTICALLY ACCEPTABLE SALT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1788; DATE OF NATIONAL AUTHORISATION: 20240419; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3222277	2024C/537	Belgium		PRODUCT NAME: SPARSENTAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1788 20240423