Home NDC 61958-3601-1 BIXLENVO
Product NDC 61958-3601
Requested package NDC 61958-3601-1
11-digit product format 619583601
Labeler code 61958
Product ID 61958-3601_1da44bad-4470-4f3d-b7b2-bc3730f496d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bictegravir/lenacapavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA221104
Marketing category NDA
Marketing start 2026-08-27
Substance BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM
Active strength 75; 50 mg/1; mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Capsid Inhibitors [MoA], Human Immunodeficiency Virus 1 Capsid Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N221104-001 BIXLENVO BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM EQ 75MG BASE;EQ 50MG BASE TABLET / ORAL RLD, RS 2026-08-27
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N221104-001 9216996 2033-12-19 Drug substance, Drug product 2026-09-22 N221104-001 9732092 2033-12-19 Drug substance, Drug product 2026-09-22 N221104-001 9951043 2034-02-28 U-4602 Drug substance, Drug product 2026-09-22 N221104-001 10385067 2035-06-19 U-4602 2026-09-22 N221104-001 9708342 2035-06-19 Drug substance, Drug product 2026-09-22 N221104-001 10071985 2037-08-17 Drug substance, Drug product 2026-09-22 N221104-001 10654827 2037-08-17 U-4602 2026-09-22 N221104-001 11267799 2038-08-16 Drug substance 2026-09-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N221104-001 NCE 2027-12-22 N221104-001 NP 2029-08-27
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N221104-001 BIXLENVO EQ 75MG BASE;EQ 50MG BASE TABLET / ORAL RLD, RS 2026-08-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N221104-001 BIXLENVO EQ 75MG BASE;EQ 50MG BASE TABLET / ORAL RLD, RS 2026-08-27 84e616aacf4f…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N221104-001 9216996 2033-12-19 Drug substance, Drug product 2026-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N221104-001 9732092 2033-12-19 Drug substance, Drug product 2026-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N221104-001 9951043 2034-02-28 U-4602 Drug substance, Drug product 2026-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N221104-001 10385067 2035-06-19 U-4602 2026-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N221104-001 9708342 2035-06-19 Drug substance, Drug product 2026-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N221104-001 10071985 2037-08-17 Drug substance, Drug product 2026-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N221104-001 10654827 2037-08-17 U-4602 2026-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N221104-001 11267799 2038-08-16 Drug substance 2026-09-22 c2088c7a36db…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-10-15 13:18:30 2026-09 N221104-001 NCE 2027-12-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N221104-001 NP 2029-08-27 c2088c7a36db…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base BIXLENVO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BICTEGRAVIR SODIUM 75 mg/1 LENACAPAVIR SODIUM 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4L5MP1Y7W7 Internal UNII lookup BDT58WJ9WE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2750177 Internal RxNorm lookup 2750183 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 61958-3601-1 61958360101 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3601-1) 2026-08-27 No No Current