mirtazapine · Organon Usa Organon · NDA 021208
Remeron Soltab
Earliest generic entry, as listed · earliest of 3 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021208 · 001 · RLD | tablet, orally disintegrating, oral | 15MG | open |
| 021208 · 002 · RLD | tablet, orally disintegrating, oral | 30MG | open |
| 021208 · 003 · RLD | tablet, orally disintegrating, oral | 45MG | open |