Drug facts
BrandOzempic (Semaglutide)
No generic semaglutide is approved; the latest Ozempic patent or exclusivity in the Orange Book runs to 02/17/2041. 1 staged generic application passed FDA review and waits on patents or exclusivity.
Ozempic was first approved by the FDA on 12/05/2017 under NDA 209637; the application holder is Novo Nordisk Inc.
The latest NADAC for OZEMPIC 2 MG/DOSE (8 MG/3 ML) PEN is $332.00 per mL (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.
5,223days until the latest patent expires
- Latest patent
- 02/17/2041Ozempic Orange Book
- Exclusivity
- 01/28/2028Ozempic Orange Book
02Competition
- Generics
- No generic approved Orange Book
- Staged generics
- 1 passed FDA review, awaiting market entry FDA
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $332.00 per mLOZEMPIC 2 MG/DOSE (8 MG/3 ML) PEN, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Novo Nordisk Inc Orange Book
- Application
- NDA 209637 Orange Book
- First approved
- 12/05/2017 Orange Book
- Dosage forms
- solution
- Routes
- subcutaneous
- Other brand names
- RybelsusWegovy
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.