lenalidomide · Bristol Myers Squibb · NDA 021880
Revlimid
Earliest generic entry, as listed · earliest of 6 marketed strengths
8 Mar 2028
Blocked by patent: US 8741929. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8741929 | use U-1983 | 8 Mar 2028 |
| US 7465800 | substance, product | 27 Apr 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 · 021880-00114 Nov 2025
- 25 Oct 2026Generic approved · 021880-0012 Feb 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021880 · 001 · RLD | capsule, oral | 5MG | 8 Mar 2028 |
| 021880 · 002 · RLD | capsule, oral | 10MG | 8 Mar 2028 |
| 021880 · 003 · RLD | capsule, oral | 15MG | 8 Mar 2028 |
| 021880 · 004 · RLD | capsule, oral | 25MG | 8 Mar 2028 |
| 021880 · 005 · RLD | capsule, oral | 2.5MG | 8 Mar 2028 |
| 021880 · 006 · RLD | capsule, oral | 20MG | 8 Mar 2028 |
Expired or delisted (2)
- ODE-241 · 28 May 2026
- ODE-245 · 28 May 2026