FDA Orange Book
Is there a generic for Filspari?
Filspari contains sparsentan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Filspari (sparsentan). The Orange Book shows its last listed patent expires October 13, 2037 and its last listed exclusivity ends September 5, 2031.
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Filspari products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 400MG | Marketed (Rx) | None | 0 | None |
NDA 216403, held by TRAVERE THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Filspari patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9993461 | March 29, 2030 | Method of use | U-3269 | 216403 |
| 9993461 | March 29, 2030 | Method of use | U-3993 | 216403 |
| 9662312 | March 29, 2030 | Method of use | U-4495 | 216403 |
| 9993461 | March 29, 2030 | Method of use | U-4495 | 216403 |
| 12714697 | October 13, 2037 | Method of use | U-3993 | 216403 |
Filspari exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 17, 2028 | 216403 |
| I-989 | New indication | April 13, 2029 | 216403 |
| ODE-389 | Orphan drug exclusivity | February 17, 2030 | 216403 |
| ODE-493 | Orphan drug exclusivity | September 5, 2031 | 216403 |
Filspari NDC codes
Questions
Is there a generic for Filspari?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Filspari (sparsentan). The Orange Book shows its last listed patent expires October 13, 2037 and its last listed exclusivity ends September 5, 2031.
What is the generic name for Filspari?
The active ingredient in Filspari is sparsentan, per the FDA Orange Book.
When does the Filspari patent expire?
The last patent listed for Filspari in the Orange Book expires October 13, 2037. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.