mirtazapine · Organon · NDA 020415
Remeron
Earliest generic entry, as listed · earliest of 2 marketed strengths
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 220104, Micro Labs · 020415-001Approved 19 May 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219919, Novitium Pharma · 020415-001Approved 2 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219721, Annora Pharma · 020415-001Approved 2 Oct 2025Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020415 · 001 · RLD | tablet, oral | 15MG | open |
| 020415 · 002 · RLD | tablet, oral | 30MG | open |
| 020415 · 003 · RLD · discontinued | tablet, oral | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |