eribulin mesylate · Eisai Inc · NDA 201532
Halaven
Earliest generic entry, as listed
8 Jul 2027
Blocked by patent: US RE46965.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US RE46965 | — | 8 Jul 2027 |
| US RE46965 | product | 8 Jan 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 · 201532-00119 Oct 2026
- 25 Oct 2026Generic approved · 201532-0011 Jun 2026
- 25 Oct 2026Generic approved · 201532-00116 Mar 2026
- 24 Oct 2026Enters 12-month window basis: patent · 201532-0018 Jul 2027
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 201532 · 001 · RLD | solution, intravenous | 1MG/2ML (0.5MG/ML) | 8 Jul 2027 |
Expired or delisted (2)
- PED · 13 Mar 2026
- M-280 · 13 Sep 2025