PEGCETACOPLAN | N215014 | APELLIS PHARMACEUTICALS INC
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7888323 | Dec 4, 2027 | — | Yes | — | — | — |
| 7989589 | Dec 4, 2027 | — | Yes | — | — | — |
| 9169307 | Nov 18, 2027 | — | Yes | — | — | |
| 10035822 | Nov 15, 2033 | — | Yes | — | — | — |
| 10125171 | Aug 2, 2033 | — | Yes | — | — | — |
| 10875893 | Nov 15, 2033 | — | Yes | — | — | |
| 11040107 | Apr 9, 2038 | — | — | Yes | — | |
| 11292815 | Nov 15, 2033 | — | Yes | Yes | — | |
| 11661441 | Jan 13, 2033 | — | Yes | — | — | |
| 11844841 | Dec 9, 2038 | — | — | Yes | — | |
| 12290566 | Dec 14, 2038 | — | — | Yes | — |
| Code | Date | Status |
|---|---|---|
| I-972 | Jul 28, 2028 | Active |
| M-288 | Feb 8, 2026 | Expired |
| NCE | May 14, 2026 | Expired |
| ODE-351 | May 14, 2028 | Active |
| ODE-533 | Jul 28, 2032 | Active |
| ODE-539 | Jul 28, 2032 | Active |
Apellis Pharmaceuticals received orphan drug exclusivity for pegcetacoplan (Empaveli), preventing FDA approval of competing applications for this indication through Jan 2028.
New: New record
Orphan drug exclusivity designated for pegcetacoplan (EMPAVELI) under code ODE-539 in NDA 215014.
New: New record