Details for New Drug Application (NDA): 216403
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The generic ingredient in FILSPARI is sparsentan. One supplier is listed for this compound. Additional details are available on the sparsentan profile page.
Summary for 216403
Tradename: | FILSPARI |
Applicant: | Travere |
Ingredient: | sparsentan |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216403
Generic Entry Date for 216403*:
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 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.
Suppliers and Packaging for NDA: 216403
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FILSPARI | sparsentan | TABLET;ORAL | 216403 | NDA | Travere Therapeutics, Inc. | 68974-200 | 68974-200-30 | 30 TABLET, FILM COATED in 1 BOTTLE (68974-200-30) |
FILSPARI | sparsentan | TABLET;ORAL | 216403 | NDA | Travere Therapeutics, Inc. | 68974-400 | 68974-400-30 | 30 TABLET, FILM COATED in 1 BOTTLE (68974-400-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Feb 17, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Feb 17, 2028 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Regulatory Exclusivity Expiration: | Feb 17, 2030 | ||||||||
Regulatory Exclusivity Use: | 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 | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 29, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) IN ADULTS AT RISK OF RAPID DISEASE PROGRESSION |
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