Medicine
Bixlenvo Sunlenca Starter Pack kit
Bixlenvo Sunlenca Starter Pack kit is a prescription medicine containing Bictegravir/lenacapavir, 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 and SUNLENCA tablets at 20 °C to 25 °C (68 °F to 77…
Key facts
- Active ingredient (INN)
- Bictegravir/lenacapavir
- Brand
- Bixlenvo Sunlenca Starter Pack
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Gilead Sciences
- Manufacturer
- Gilead Sciences
- Origin register
- US FDA, United States
- Storage
- Store BIXLENVO tablets and SUNLENCA 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 bottles 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
- 31 October 2026
- Identifiers
- RxCUI 2625890, 2625896, 2625897 +3DailyMed set ID b2a3ef0e-3ded-45d7-9ba6-f33c4d372dc1NDC 61958-3701Application NDA221443
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 |
|---|---|---|---|
| 1 kit in 1 carton * 30 tablet, film coated in 1 bottle, plastic * 4 tablet, film coated in 1 bottle, plastic | 61958-3701-1 | Gilead Sciences | 31 October 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 |
| 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/lenacapavir is a prescription medicine indicated for the initiation of BIXLENVO, 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/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/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 Sunlenca Starter Pack prescribing information (Gilead Sciences) · U.S. National Library of Medicine, DailyMed
Need Bixlenvo Sunlenca Starter Pack kit 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.