Drug facts
MoleculeMirtazapine (Remeron)
Generics already compete: 11 makers on the market. 42 A-rated products from 11 makers substitute at the counter.
Remeron was first approved by the FDA on 06/14/1996 under NDA 020415; the application holder is Organon USA LLC.
The latest NADAC for MIRTAZAPINE 30 MG TABLET is $0.09 per unit (as of 10/28/2026).
Holder Organon USA LLCApplication NDA 020415Approved 06/14/1996
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
- Latest patent
- No Remeron patent listed in the Orange Book Orange Book
02Competition
- Generics
- 11 generic makers Orange Book
- First generic approved
- 01/24/2003 Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Mirtazapine profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.09 per unitMIRTAZAPINE 30 MG TABLET, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Organon USA LLC Orange Book
- Application
- NDA 020415 Orange Book
- First approved
- 06/14/1996 Orange Book
- Dosage forms
- tablet; tablet, orally disintegrating
- Routes
- oral
- Other brand names
- Remeron Soltab
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.