Drug facts
BrandOtezla (Apremilast)
No generic apremilast has an active Orange Book listing (a generic was first approved 02/17/2021); the latest Otezla patent or exclusivity in the Orange Book runs to 11/29/2034. 1 staged generic application passed FDA review and waits on patents or exclusivity.
Otezla was first approved by the FDA on 03/21/2014 under NDA 205437; the application holder is Amgen Inc.
The latest NADAC for OTEZLA 30 MG TABLET is $90.59 per unit (as of 10/28/2026).
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.
2,951days until the latest Otezla patent expires
- Latest patent
- 11/29/2034Otezla Orange Book
- Exclusivity
- 10/25/2027Otezla Orange Book
- Later patents, other products
- Otezla XR 05/27/2042 Orange Book
02Competition
- Generics
- No active generic listing in the Orange Book Orange Book
- Staged generics
- 1 passed FDA review, awaiting market entry FDA
- First generic approved
- 02/17/2021 Orange Book
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $90.59 per unitOTEZLA 30 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Amgen Inc Orange Book
- Application
- NDA 205437 Orange Book
- First approved
- 03/21/2014 Orange Book
- Dosage forms
- tablet
- Routes
- oral
- Other brand names
- Otezla XR
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.