ramelteon · Takeda Pharms Usa · NDA 021782
Rozerem
Earliest generic entry, as listed
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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
- Generic approved · ANDA 215485, Adaptis · 021782-001Approved 4 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021782 · 001 · RLD | tablet, oral | 8MG | open |