pomalidomide · Bristol · NDA 204026
Pomalyst
Earliest generic entry, as listed · earliest of 4 marketed strengths
21 Dec 2031
Blocked by patent: US 8828427.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8828427 | — | 21 Dec 2031 |
| US 8828427 | substance, product | 21 Jun 2031 |
| US 10555939 | — | 19 Nov 2030 |
| US 9993467 | — | 19 Nov 2030 |
| US 10555939 | product | 19 May 2030 |
| US 9993467 | product | 19 May 2030 |
Exclusivities · 3 unexpired
| PED | pediatric (6 months added) | 14 Nov 2027 |
| ODE-296 | orphan drug (7 years) | 14 May 2027 |
| ODE-297 | orphan drug (7 years) | 14 May 2027 |
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
- 25 Oct 2026Generic approved · 204026-0012 Sep 2026
- 25 Oct 2026Generic approved · 204026-00131 Aug 2026
- 25 Oct 2026Generic approved · 204026-00131 Aug 2026
- 25 Oct 2026Generic approved · 204026-00131 Aug 2026
- 25 Oct 2026Generic approved · 204026-00131 Aug 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204026 · 001 · RLD | capsule, oral | 1MG | 21 Dec 2031 |
| 204026 · 002 · RLD | capsule, oral | 2MG | 21 Dec 2031 |
| 204026 · 003 · RLD | capsule, oral | 3MG | 21 Dec 2031 |
| 204026 · 004 · RLD | capsule, oral | 4MG | 21 Dec 2031 |