FDA Orange Book
Is there a generic for Syfovre?
Syfovre contains pegcetacoplan. 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 Syfovre (pegcetacoplan). The Orange Book shows its last listed patent expires December 14, 2038 and its last listed exclusivity ends May 14, 2026.
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Syfovre products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravitreal | 15MG/0.1ML (15MG/0.1ML) | Marketed (Rx) | None | 0 | None |
NDA 217171, held by APELLIS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Syfovre patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9056076 | October 25, 2026 | Method of use | U-3540 | 217171 |
| 8168584 | April 7, 2027 | Method of use | U-3540 | 217171 |
| 8168584 | April 7, 2027 | Method of use | U-3542 | 217171 |
| 9169307 | November 18, 2027 | Drug substance | U-3541 | 217171 |
| 7989589 | December 4, 2027 | Drug substance | None | 217171 |
| 7888323 | December 4, 2027 | Drug substance | None | 217171 |
| 11661441 | January 13, 2033 | Drug substance | U-3540 | 217171 |
| 10125171 | August 2, 2033 | Drug substance | None | 217171 |
| 11292815 | November 15, 2033 | Drug substance, Drug product | U-3540 | 217171 |
| 10875893 | November 15, 2033 | Drug substance | U-3540 | 217171 |
| 10035822 | November 15, 2033 | Drug substance | None | 217171 |
| 12528836 | October 7, 2036 | Method of use | U-4394 | 217171 |
| 11903994 | February 22, 2037 | Method of use | U-3826 | 217171 |
| 11903994 | February 22, 2037 | Method of use | U-3827 | 217171 |
| 11903994 | February 22, 2037 | Method of use | U-3828 | 217171 |
| 12458695 | December 14, 2038 | Drug product | None | 217171 |
Syfovre exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | February 22, 2026 | 217171 |
| NCE | New chemical entity | May 14, 2026 | 217171 |
Syfovre NDC codes
Questions
Is there a generic for Syfovre?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Syfovre (pegcetacoplan). The Orange Book shows its last listed patent expires December 14, 2038 and its last listed exclusivity ends May 14, 2026.
What is the generic name for Syfovre?
The active ingredient in Syfovre is pegcetacoplan, per the FDA Orange Book.
When does the Syfovre patent expire?
The last patent listed for Syfovre in the Orange Book expires December 14, 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.