Drug facts
BrandTivicay (Dolutegravir)
No generic dolutegravir is approved; the latest Tivicay patent or exclusivity in the Orange Book runs to 06/08/2030. 7 staged generic applications passed FDA review and wait on patents or exclusivity.
Tivicay was first approved by the FDA on 08/12/2013 under NDA 204790; the application holder is Viiv Healthcare Co.
The latest NADAC for TIVICAY 50 MG TABLET is $77.64 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.
1,316days until the latest patent expires
- Latest patent
- 06/08/2030Tivicay Orange Book
02Competition
- Generics
- No generic approved Orange Book
- Staged generics
- 7 passed FDA review, awaiting market entry FDA
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $77.64 per unitTIVICAY 50 MG TABLET, as of 10/28/2026 CMS NADAC
- Latest recall
- 05/17/2024Class III, Tivicay Pd, Glaxosmithkline LLC FDA enforcement
04Product
- Application holder
- Viiv Healthcare Co Orange Book
- Application
- NDA 204790 Orange Book
- First approved
- 08/12/2013 Orange Book
- Dosage forms
- tablet
- Routes
- oral
- Other brand names
- Tivicay Pd
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.