Medicine
Bixlenvo 75 mg/50 mg tablet
Bixlenvo 75 mg/50 mg tablet is a prescription medicine containing Bictegravir and Lenacapavir 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store BIXLENVO tablets at 20 °C to 25 °C (68 °F to 77 °F), excursions…
Key facts
- Active ingredient (INN)
- Bictegravir and Lenacapavir
- Brand
- Bixlenvo
- Strength
- 75 mg/50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Gilead Sciences
- Manufacturer
- Gilead Sciences
- Origin register
- US FDA, United States
- Storage
- Store BIXLENVO tablets at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). Dispense and store only in the original container to protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 August 2026
- Identifiers
- RxCUI 2750177, 2750183DailyMed set ID 072a3c7e-33fb-4a87-ba21-3d8dad3f5c48NDC 61958-3601Application NDA221104
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle, plastic | 61958-3601-1 | Gilead Sciences | 27 August 2026 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 27 August 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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
Clinical summary
Bictegravir and Lenacapavir is a fixed-dose combination medicine indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those. MedsAcross supplies Bictegravir and Lenacapavir 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 and LenacapavirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BIXLENVO prescribing information (Gilead Sciences) · U.S. National Library of Medicine, DailyMed
Need Bixlenvo 75 mg/50 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.