Emtricitabine manufacturers

About bictegravir

Bictegravir manufacturers are led by the originator, Gilead Sciences, which sells it only in the single-tablet regimen Biktarvy, while Indian companies make generic versions under licence for low- and middle-income countries. Bictegravir is an HIV integrase inhibitor. Biktarvy combines bictegravir with emtricitabine and tenofovir alafenamide and is the most prescribed HIV treatment in the US. Pharmaceutical companies can source bictegravir combination tablets and API for licensed territories through supply or out-licensing.

Bictegravir key facts

Bictegravir manufacturers and licensing history

Gilead developed bictegravir and launched it only as part of Biktarvy, a once-daily single tablet with emtricitabine and tenofovir alafenamide. The FDA approved Biktarvy in February 2018, and the EU later that year. A lower-dose tablet for children followed.

Biktarvy became Gilead's flagship HIV product, with more than half of the US HIV treatment market. From March 2022, Lupin, Laurus and Cipla filed ANDAs challenging Biktarvy patents. In October 2025, Gilead settled with all three, and no US generic entry is expected before 1 April 2036, subject to standard acceleration provisions.

For low- and middle-income countries, Gilead licensed bictegravir through the Medicines Patent Pool, and Indian companies produce generic bictegravir combinations for those markets. Buyers should confirm GMP status, WHO prequalification and licence territory before choosing a supplier.

Bictegravir dosage forms and dossier types

Bictegravir is supplied only in fixed-dose combination tablets with emtricitabine and tenofovir alafenamide.

Bictegravir regulatory and patent status

The FDA approved Biktarvy in February 2018. Under October 2025 settlements with Lupin, Cipla and Laurus, no generic Biktarvy is expected in the US before 1 April 2036. Gilead reports EU patent expiry in 2033. In low- and middle-income countries, generic bictegravir combinations are available under the Medicines Patent Pool licence.

Bictegravir mechanism of action and therapeutic use

Bictegravir blocks HIV integrase, the enzyme that inserts viral DNA into the host cell's genome. It has a high barrier to resistance. In Biktarvy, it is combined with emtricitabine and tenofovir alafenamide, which block HIV reverse transcriptase. Biktarvy is taken once daily as a complete regimen for HIV-1 infection in adults and children.

Bictegravir licensing and sourcing

Bictegravir suppliers and licensing partners typically offer finished-product supply or dossier out-licensing for licensed territories. Buyers usually compare GMP status, WHO prequalification, licence territory and patent position. Current offers and supplier contacts are listed among the bictegravir manufacturers on Pipelinepharma.

Frequently asked questions about bictegravir

Who manufactures bictegravir? Gilead Sciences makes bictegravir and sells it in Biktarvy. Indian companies make generic versions under the Medicines Patent Pool licence for low- and middle-income countries.

When can generic Biktarvy launch in the US? Under October 2025 settlements, no generic Biktarvy is expected in the US before 1 April 2036, subject to standard acceleration provisions.

Is bictegravir available on its own? No. Bictegravir is sold only in Biktarvy, combined with emtricitabine and tenofovir alafenamide.

What forms and strengths of bictegravir are available? Biktarvy is available as 50/200/25 mg tablets for adults and 30/120/15 mg tablets for children.

What is bictegravir used for? Bictegravir, in Biktarvy, is used as a complete once-daily regimen for HIV-1 infection.