pegcetacoplan · Apellis Pharms · NDA 215014
Empaveli
Earliest generic entry, as listed
14 Dec 2038
Blocked by patent: US 12290566.
Listed patents · 11 unexpired
27 Orange Book listing rows for 11 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12290566 | drug product, use U-4174, U-4175, U-4238, U-4239, U-4240 | 14 Dec 2038 |
| US 12290566 listing row | drug product, use U-4174 · sets the listed date | 14 Dec 2038 |
| US 12290566 listing row | drug product, use U-4175 · sets the listed date | 14 Dec 2038 |
| US 12290566 listing row | drug product, use U-4238 · sets the listed date | 14 Dec 2038 |
| US 12290566 listing row | drug product, use U-4239 · sets the listed date | 14 Dec 2038 |
| US 12290566 listing row | drug product, use U-4240 · sets the listed date | 14 Dec 2038 |
| US 11844841 | drug product, use U-3172, U-3173, U-3174, U-4241 | 9 Dec 2038 |
| US 11844841 listing row | drug product, use U-3172 | 9 Dec 2038 |
| US 11844841 listing row | drug product, use U-3173 | 9 Dec 2038 |
| US 11844841 listing row | drug product, use U-3174 | 9 Dec 2038 |
| US 11844841 listing row | drug product, use U-4241 | 9 Dec 2038 |
| US 11040107 | drug product, use U-3172, U-3173, U-3174, U-4241 | 9 Apr 2038 |
| US 11040107 listing row | drug product, use U-3172 | 9 Apr 2038 |
| US 11040107 listing row | drug product, use U-3173 | 9 Apr 2038 |
| US 11040107 listing row | drug product, use U-3174 | 9 Apr 2038 |
| US 11040107 listing row | drug product, use U-4241 | 9 Apr 2038 |
| US 10035822 | drug substance | 15 Nov 2033 |
| US 10875893 | drug substance, use U-3124, U-4242 | 15 Nov 2033 |
| US 10875893 listing row | drug substance, use U-3124 | 15 Nov 2033 |
| US 10875893 listing row | drug substance, use U-4242 | 15 Nov 2033 |
| US 11292815 | drug substance, drug product, use U-3124, U-3354, U-4242, U-4243 | 15 Nov 2033 |
| US 11292815 listing row | drug substance, drug product, use U-3124 | 15 Nov 2033 |
| US 11292815 listing row | drug substance, drug product, use U-3354 | 15 Nov 2033 |
| US 11292815 listing row | drug substance, drug product, use U-4242 | 15 Nov 2033 |
| US 11292815 listing row | drug substance, drug product, use U-4243 | 15 Nov 2033 |
| US 10125171 | drug substance | 2 Aug 2033 |
| US 11661441 | drug substance, use U-3124, U-4242 | 13 Jan 2033 |
| US 11661441 listing row | drug substance, use U-3124 | 13 Jan 2033 |
| US 11661441 listing row | drug substance, use U-4242 | 13 Jan 2033 |
| US 7888323 | drug substance | 4 Dec 2027 |
| US 7989589 | drug substance | 4 Dec 2027 |
| US 9169307 | drug substance, use U-3123, U-4244 | 18 Nov 2027 |
| US 9169307 listing row | drug substance, use U-3123 | 18 Nov 2027 |
| US 9169307 listing row | drug substance, use U-4244 | 18 Nov 2027 |
Exclusivities · 4 unexpired
| ODE-533 | orphan drug (7 years) | 28 Jul 2032 |
| ODE-539 | orphan drug (7 years) | 28 Jul 2032 |
| I-972 | new indication (3 years) | 28 Jul 2028 |
| ODE-351 | orphan drug (7 years) | 14 May 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215014 · 001 · RLD | solution, subcutaneous | 1080MG/20ML (54MG/ML) | 14 Dec 2038 |
Expired or delisted (2)
- NCE · 14 May 2026
- M-288 · 8 Feb 2026