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FILSPARI Drug Patent Profile

When do Filspari patents expire, and when can generic versions of Filspari launch?

Filspari is a drug marketed by Travere and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-nine patent family members in fourteen countries.

The generic ingredient in FILSPARI is sparsentan. One supplier is listed for this compound. Additional details are available on the sparsentan profile page.

DrugPatentWatch^® Generic Entry Outlook for Filspari

Filspari will be eligible for patent challenges on February 17, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 17, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FILSPARI

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	1
Patent Applications:	59
Drug Prices:	Drug price information for FILSPARI
What excipients (inactive ingredients) are in FILSPARI?	FILSPARI excipients list
DailyMed Link:	FILSPARI at DailyMed

See drug prices for FILSPARI

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

Constraining patent/regulatory exclusivity:

TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G

NDA:

216403

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 FILSPARI

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

Sponsor	Phase
Travere Therapeutics, Inc.	Phase 2

See all FILSPARI clinical trials

US Patents and Regulatory Information for FILSPARI

FILSPARI is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FILSPARI

FDA Regulatory Exclusivity protecting FILSPARI

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
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
Travere	FILSPARI	sparsentan	TABLET;ORAL	216403-002	Feb 17, 2023		RX	Yes	Yes

International Patents for FILSPARI

See the table below for patents covering FILSPARI around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	3222277
Slovenia	3222277
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
Japan	2015052001	血圧上昇および糖尿病性腎症を処置するための、ジフェニルスルホンアミドエンドセリンおよびアンジオテンシンＩＩ受容体アゴニストの経口製剤 (ORAL FORMULATION OF DIPHENYL SULFONAMIDE ENDOTHELIN AND ANGIOTENSIN II RECEPTOR AGONIST FOR TREATING BLOOD PRESSURE ELEVATION AND DIABETIC NEPHROPATHY)
Hungary	E033494