Viewing data from:

BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)

NDA

BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM | N221443 | GILEAD SCIENCES INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 2, 2026	ORIG -1	View Letter (PDF)
Aug 28, 2026	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 75MG BASE, EQ 50MG BASE; EQ 300MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 27, 2026

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

ADDED10/20/2026

BIXLENVO SUNLENCA STARTER PACK (bictegravir sodium/lenacapavir sodium) acquired new product exclusivity expiring Aug 2029.

New: BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) (BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM ) — exclusivity NP exp 08/27/2029

ADDED10/19/2026

Gilead Sciences' bictegravir sodium/lenacapavir sodium copackaged product (BIXLENVO SUNLENCA STARTER PACK) gained new chemical entity exclusivity expiring Dec 2027.

New: BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) (BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM ) — exclusivity NCE exp 12/22/2027