Sparsentan - Generic Drug Details
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What are the generic sources for sparsentan and what is the scope of patent protection?
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
Generic Entry Date for sparsentan*:
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.
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 |
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 | 216403-001 | Feb 17, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Travere | FILSPARI | sparsentan | TABLET;ORAL | 216403-001 | Feb 17, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Travere | FILSPARI | sparsentan | TABLET;ORAL | 216403-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Travere | FILSPARI | sparsentan | TABLET;ORAL | 216403-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 sparsentan
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 3222277 | ⤷ Try a Trial | |
| Slovenia | 3222277 | ⤷ Try a Trial | |
| 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) | ⤷ Try a Trial |
| Poland | 2732818 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
