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FILSPARI Drug Patent Profile

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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 September 5, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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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

Drug patent expirations by year for FILSPARI

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

Generic Entry Date for FILSPARI^: ⤷ Sign Up* 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 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

Pharmacology for FILSPARI

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 FILSPARI

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FILSPARI is ⤷ Sign Up.

This potential generic entry date is based on 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.
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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK OF RAPID DISEASE PROGRESSION

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK FOR DISEASE PROGRESSION

FDA Regulatory Exclusivity protecting FILSPARI

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
Exclusivity Expiration: ⤷ Sign Up

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
Exclusivity Expiration: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

International Patents for FILSPARI

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

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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)	⤷ Sign Up
Spain	2811342		⤷ Sign Up
Lithuania	2732818		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration