FDA Orange Book
Is there a generic for Forzinity?
Forzinity contains elamipretide. 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 Forzinity (elamipretide). The Orange Book shows its last listed patent expires February 28, 2034 and its last listed exclusivity ends September 19, 2032.
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Forzinity products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 215244, held by STEALTH BIOTHERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Forzinity patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7576061 | January 20, 2027 | Drug substance, Drug product | None | 215244 |
| 12268724 | February 28, 2034 | Method of use | U-4277 | 215244 |
| 11771734 | February 28, 2034 | Method of use | U-4277 | 215244 |
| 11083772 | February 28, 2034 | Method of use | U-4277 | 215244 |
| 11083771 | February 28, 2034 | Method of use | U-4277 | 215244 |
| 9687519 | February 28, 2034 | Method of use | U-4277 | 215244 |
Forzinity exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 19, 2030 | 215244 |
| ODE-551 | Orphan drug exclusivity | September 19, 2032 | 215244 |
Forzinity NDC codes
Questions
Is there a generic for Forzinity?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Forzinity (elamipretide). The Orange Book shows its last listed patent expires February 28, 2034 and its last listed exclusivity ends September 19, 2032.
What is the generic name for Forzinity?
The active ingredient in Forzinity is elamipretide, per the FDA Orange Book.
When does the Forzinity patent expire?
The last patent listed for Forzinity in the Orange Book expires February 28, 2034. 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.