FDA Orange Book
Is there a generic for Empaveli?
Empaveli 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 Empaveli (pegcetacoplan). The Orange Book shows its last listed patent expires December 14, 2038 and its last listed exclusivity ends July 28, 2032.
Run it in Rivvi
Map Empaveli and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Empaveli products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 1080MG/20ML (54MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 215014, 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.
Empaveli patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9169307 | November 18, 2027 | Drug substance | U-4244 | 215014 |
| 9169307 | November 18, 2027 | Drug substance | U-3123 | 215014 |
| 7989589 | December 4, 2027 | Drug substance | None | 215014 |
| 7888323 | December 4, 2027 | Drug substance | None | 215014 |
| 11661441 | January 13, 2033 | Drug substance | U-4242 | 215014 |
| 11661441 | January 13, 2033 | Drug substance | U-3124 | 215014 |
| 10125171 | August 2, 2033 | Drug substance | None | 215014 |
| 11292815 | November 15, 2033 | Drug substance, Drug product | U-3124 | 215014 |
| 11292815 | November 15, 2033 | Drug substance, Drug product | U-3354 | 215014 |
| 11292815 | November 15, 2033 | Drug substance, Drug product | U-4242 | 215014 |
| 11292815 | November 15, 2033 | Drug substance, Drug product | U-4243 | 215014 |
| 10875893 | November 15, 2033 | Drug substance | U-4242 | 215014 |
| 10875893 | November 15, 2033 | Drug substance | U-3124 | 215014 |
| 10035822 | November 15, 2033 | Drug substance | None | 215014 |
| 11040107 | April 9, 2038 | Drug product | U-3172 | 215014 |
| 11040107 | April 9, 2038 | Drug product | U-3174 | 215014 |
| 11040107 | April 9, 2038 | Drug product | U-3173 | 215014 |
| 11040107 | April 9, 2038 | Drug product | U-4241 | 215014 |
| 11844841 | December 9, 2038 | Drug product | U-4241 | 215014 |
| 11844841 | December 9, 2038 | Drug product | U-3172 | 215014 |
| 11844841 | December 9, 2038 | Drug product | U-3174 | 215014 |
| 11844841 | December 9, 2038 | Drug product | U-3173 | 215014 |
| 12290566 | December 14, 2038 | Drug product | U-4174 | 215014 |
| 12290566 | December 14, 2038 | Drug product | U-4175 | 215014 |
| 12290566 | December 14, 2038 | Drug product | U-4239 | 215014 |
| 12290566 | December 14, 2038 | Drug product | U-4238 | 215014 |
| 12290566 | December 14, 2038 | Drug product | U-4240 | 215014 |
Empaveli exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-288 | Miscellaneous | February 8, 2026 | 215014 |
| NCE | New chemical entity | May 14, 2026 | 215014 |
| ODE-351 | Orphan drug exclusivity | May 14, 2028 | 215014 |
| I-972 | New indication | July 28, 2028 | 215014 |
| ODE-533 | Orphan drug exclusivity | July 28, 2032 | 215014 |
| ODE-539 | Orphan drug exclusivity | July 28, 2032 | 215014 |
Empaveli NDC codes
Questions
Is there a generic for Empaveli?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Empaveli (pegcetacoplan). The Orange Book shows its last listed patent expires December 14, 2038 and its last listed exclusivity ends July 28, 2032.
What is the generic name for Empaveli?
The active ingredient in Empaveli is pegcetacoplan, per the FDA Orange Book.
When does the Empaveli patent expire?
The last patent listed for Empaveli 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.