Details for New Drug Application (NDA): 216403
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NDA 216403 describes FILSPARI, which is a drug marketed by Travere and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the FILSPARI profile page.
The generic ingredient in FILSPARI is sparsentan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sparsentan profile page.
The generic ingredient in FILSPARI is sparsentan. There is one drug master file entry for this compound. 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: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216403
Generic Entry Date for 216403*:
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.
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: | Apr 13, 2029 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE PROTEINURIA IN ADULT AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) WITHOUT NEPHROTIC SYNDROME | ||||||||
| 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 | ||||||||
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