FDA Orange Book
Is there a generic for Fintepla?
Fintepla contains fenfluramine. 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 Fintepla (fenfluramine). The Orange Book shows its last listed patent expires December 29, 2038 and its last listed exclusivity ends September 25, 2029.
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Fintepla products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 2.2MG BASE/ML | Marketed (Rx) | None | 0 | None |
NDA 212102, held by UCB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Fintepla patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9603815 | May 3, 2033 | Method of use | U-2858 | 212102 |
| 9549909 | May 3, 2033 | Method of use | U-2858 | 212102 |
| 9610260 | May 3, 2033 | Method of use | U-2858 | 212102 |
| 9603814 | May 3, 2033 | Method of use | U-2858 | 212102 |
| 10478442 | May 3, 2033 | Method of use | U-2860 | 212102 |
| 10478441 | May 3, 2033 | Method of use | U-2860 | 212102 |
| 12097206 | May 3, 2033 | Method of use | U-4013 | 212102 |
| 9603815*PED | November 3, 2033 | Method of use | None | 212102 |
| 9549909*PED | November 3, 2033 | Method of use | None | 212102 |
| 9610260*PED | November 3, 2033 | Method of use | None | 212102 |
| 9603814*PED | November 3, 2033 | Method of use | None | 212102 |
| 10478442*PED | November 3, 2033 | Method of use | None | 212102 |
| 10478441*PED | November 3, 2033 | Method of use | None | 212102 |
| 12097206*PED | November 3, 2033 | Method of use | None | 212102 |
| 10947183 | December 20, 2036 | Drug substance, Drug product | None | 212102 |
| 10947183*PED | June 20, 2037 | Method of use | None | 212102 |
| 10603290 | August 2, 2037 | Method of use | U-2861 | 212102 |
| 11759440 | August 2, 2037 | Method of use | U-3694 | 212102 |
| 11040018 | August 2, 2037 | Method of use | U-2861 | 212102 |
| 11406606 | August 2, 2037 | Method of use | U-3406 | 212102 |
| 11406606 | August 2, 2037 | Method of use | U-3407 | 212102 |
| 11786487 | August 2, 2037 | Method of use | U-3733 | 212102 |
| 10603290 | August 2, 2037 | Method of use | U-3347 | 212102 |
| 11040018 | August 2, 2037 | Method of use | U-3347 | 212102 |
| 11759440*PED | February 2, 2038 | Method of use | None | 212102 |
| 11406606*PED | February 2, 2038 | Method of use | None | 212102 |
| 10603290*PED | February 2, 2038 | Method of use | None | 212102 |
| 11040018*PED | February 2, 2038 | Method of use | None | 212102 |
| 11786487*PED | February 2, 2038 | Method of use | None | 212102 |
| 10452815 | June 29, 2038 | Method of use | U-2859 | 212102 |
| 10452815*PED | December 29, 2038 | Method of use | None | 212102 |
Fintepla exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-312 | Orphan drug exclusivity | June 25, 2027 | 212102 |
| PED | Pediatric exclusivity | December 25, 2027 | 212102 |
| ODE-393 | Orphan drug exclusivity | March 25, 2029 | 212102 |
| PED | Pediatric exclusivity | September 25, 2029 | 212102 |
Fintepla NDC codes
Questions
Is there a generic for Fintepla?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Fintepla (fenfluramine). The Orange Book shows its last listed patent expires December 29, 2038 and its last listed exclusivity ends September 25, 2029.
What is the generic name for Fintepla?
The active ingredient in Fintepla is fenfluramine, per the FDA Orange Book.
When does the Fintepla patent expire?
The last patent listed for Fintepla in the Orange Book expires December 29, 2038. 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.