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Medicine

Biktarvy 50 mg/200 mg/25 mg tablet

Available on requestPrescription onlyUS FDA

Biktarvy 50 mg/200 mg/25 mg tablet is a prescription medicine containing Bictegravir, Emtricitabine and Tenofovir alafenamide for oral use, marketed by Gilead Sciences, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store bottle below 30 °C (86 °F). Store blister pack at 25 °C (77 °F)…

Key facts

Active ingredient (INN)
Bictegravir, Emtricitabine and Tenofovir alafenamide
Brand
Biktarvy
Strength
50 mg/200 mg/25 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 7 tablets and 2 more
Marketing authorisation holder
Gilead Sciences
Manufacturers
Gilead SciencesA-S Medication Solutions
Origin register
US FDA, United States
Storage
Store bottle below 30 °C (86 °F). Store blister pack at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J05AR20 Bictegravir, Emtricitabine and Tenofovir alafenamide
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
7 February 2018
Identifiers
RxCUI 1999667, 1999673, 2584354 +1DailyMed set ID 0476d7eb-1024-4821-bbe7-abaacfda32a2, 664cb8f0-1f65-441b-b0d9-ba3d798be309NDC 50090-6247, 61958-2501Application NDA210251

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

PackCodeLabelerMarketed since
30 tablet in 1 bottle, plastic61958-2501-1Gilead Sciences7 February 2018
7 tablet in 1 bottle, plastic61958-2501-2Gilead Sciences26 July 2018
30 tablet in 1 blister pack61958-2501-3Gilead Sciences24 August 2021
30 tablet in 1 blister pack61958-2501-5Gilead Sciences30 March 2026
30 tablet in 1 bottle, plastic50090-6247-0A-S Medication Solutions28 November 2022

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 7 February 2018Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Other strengths and forms of Bictegravir, Emtricitabine and Tenofovir alafenamide

Clinical summary

Bictegravir, Emtricitabine and Tenofovir alafenamide is a fixed-dose combination of a human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor and a hepatitis B virus nucleoside analog reverse transcriptase inhibitor. MedsAcross supplies Bictegravir, Emtricitabine and Tenofovir alafenamide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Bictegravir, Emtricitabine and Tenofovir alafenamide

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Biktarvy 50 mg/200 mg/25 mg tablet for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.