Sparsentan - Generic Drug Details

What are the generic sources for sparsentan and what is the scope of freedom to operate?

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

Sparsentan has twenty-nine patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for sparsentan

International Patents:	29
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	8
Patent Applications:	139
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
University of Edinburgh	Phase 2
University of Leicester	Phase 2
Travere Therapeutics, Inc.	Phase 1

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

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	216403-002	Feb 17, 2023		RX	Yes	Yes
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
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-001	Feb 17, 2023		RX	Yes	No
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

International Patents for sparsentan

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3708163	UTILISATION DE SPARSENTAN POUR LE TRAITEMENT DES MALADIES INFLAMMATOIRES CHRONIQUES (USE OF SPARSENTAN FOR THE TREATMENT OF CHRONIC INFLAMMATORY DISEASES)
Spain	2811342
Lithuania	2732818
European Patent Office	3222277	ANTAGONISTE DES RÉCEPTEURS DE L'ENDOTHÉLINE ET DE L'ANGIOTENSINE II À BASE DE BIPHÉNYLSULFONAMIDE POUR TRAITER LA GLOMÉRULOSCLÉROSE ET LA NEPHROPATHIE INDUITE PAR L'IGA (A BIPHENYLSULFONAMIDE ENDOTHELIN AND ANGIOTENSIN II RECEPTOR ANTAGONIST TO TREAT GLOMERULOSCLEROSIS AND IGA-INDUCED NEPHROPATHY)
Poland	2732818
China	102421434	Oral formulations of diphenylsulfonamide endothelin and angiotensin ii receptor agonists to treat elevated blood pressure and diabetic nephropathy