Drug facts
BrandBiktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide)
No generic bictegravir, emtricitabine and tenofovir alafenamide is approved; the latest Biktarvy patent or exclusivity in the Orange Book runs to 11/08/2036. 2 staged generic applications passed FDA review and wait on patents or exclusivity.
Biktarvy was first approved by the FDA on 02/07/2018 under NDA 210251; the application holder is Gilead Sciences Inc.
The latest NADAC for BIKTARVY 30-120-15 MG TABLET is $136.63 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.
3,661days until the latest patent expires
- Latest patent
- 11/08/2036Biktarvy Orange Book
- Exclusivity
- 07/30/2032Biktarvy Orange Book
02Competition
- Generics
- No generic approved Orange Book
- Staged generics
- 2 passed FDA review, awaiting market entry FDA
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $136.63 per unitBIKTARVY 30-120-15 MG TABLET, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Gilead Sciences Inc Orange Book
- Application
- NDA 210251 Orange Book
- First approved
- 02/07/2018 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.