omacetaxine mepesuccinate · Teva Pharms Intl · NDA 203585
Synribo
Earliest generic entry, as listed
26 Oct 2026
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 6987103. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 6987103 | use U-1300 | 26 Oct 2026 |
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
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 203585-00126 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203585 · 001 · RLD · discontinued | powder, subcutaneous | 3.5MG/VIAL | 26 Oct 2026 |