Drug facts
BrandDovato (Dolutegravir and Lamivudine)
No generic dolutegravir and lamivudine is approved; the latest Dovato patent or exclusivity in the Orange Book runs to 01/24/2031. 1 staged generic application passed FDA review and waits on patents or exclusivity.
Dovato was first approved by the FDA on 04/08/2019 under NDA 211994; the application holder is Viiv Healthcare Co.
The latest NADAC for DOVATO 50-300 MG TABLET is $105.22 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.
1,546days until the latest patent expires
- Latest patent
- 01/24/2031Dovato Orange Book
- Exclusivity
- 04/05/2027Dovato 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
- $105.22 per unitDOVATO 50-300 MG TABLET, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Viiv Healthcare Co Orange Book
- Application
- NDA 211994 Orange Book
- First approved
- 04/08/2019 Orange Book
- Dosage forms
- tablet
- Routes
- oral
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.