Bixlenvo Sunlenca Starter Pack

Product NDC: 61958-3701
Requested package NDC: 61958-3701-1
11-digit product format: 619583701
Labeler code: 61958
Product ID: 61958-3701_20c2a9c1-f2ca-4977-be9d-5131d31df3df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bictegravir/lenacapavir, lenacapavir sodium
Dosage form: KIT
Labeler: Gilead Sciences, Inc.
Application: NDA221443
Marketing category: NDA
Marketing start: 2026-10-31
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 45.

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
N221443-001	BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)	BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM	EQ 75MG BASE, EQ 50MG BASE; EQ 300MG 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
N221443-001	9216996	2033-12-19		Drug substance, Drug product	2026-09-22
N221443-001	9732092	2033-12-19		Drug substance, Drug product	2026-09-22
N221443-001	9951043	2034-02-28	U-4602	Drug substance, Drug product	2026-09-22
N221443-001	10385067	2035-06-19	U-4602		2026-09-22
N221443-001	9708342	2035-06-19		Drug substance, Drug product	2026-09-22
N221443-001	10071985	2037-08-17		Drug substance, Drug product	2026-09-22
N221443-001	10654827	2037-08-17	U-4602		2026-09-22
N221443-001	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
N221443-001	NCE	2027-12-22
N221443-001	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	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	N221443-001	BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)	EQ 75MG BASE, EQ 50MG BASE; EQ 300MG BASE	TABLET / ORAL	RLD, RS	2026-08-27	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N221443-001	BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)	EQ 75MG BASE, EQ 50MG BASE; EQ 300MG BASE	TABLET / ORAL	RLD, RS	2026-08-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N221443-001	BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)	EQ 75MG BASE, EQ 50MG BASE; EQ 300MG 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
2026-11-14 07:37:17	2026-10	N221443-001	9216996	2033-12-19		Drug substance, Drug product	2026-09-22	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N221443-001	9732092	2033-12-19		Drug substance, Drug product	2026-09-22	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N221443-001	9951043	2034-02-28	U-4602	Drug substance, Drug product	2026-09-22	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N221443-001	10385067	2035-06-19	U-4602		2026-09-22	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N221443-001	9708342	2035-06-19		Drug substance, Drug product	2026-09-22	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N221443-001	10071985	2037-08-17		Drug substance, Drug product	2026-09-22	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N221443-001	10654827	2037-08-17	U-4602		2026-09-22	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N221443-001	11267799	2038-08-16		Drug substance	2026-09-22	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N221443-001	9216996	2033-12-19		Drug substance, Drug product	2026-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N221443-001	9732092	2033-12-19		Drug substance, Drug product	2026-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N221443-001	9951043	2034-02-28	U-4602	Drug substance, Drug product	2026-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N221443-001	10385067	2035-06-19	U-4602		2026-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N221443-001	9708342	2035-06-19		Drug substance, Drug product	2026-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N221443-001	10071985	2037-08-17		Drug substance, Drug product	2026-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N221443-001	10654827	2037-08-17	U-4602		2026-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N221443-001	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
2026-11-14 07:37:17	2026-10	N221443-001	NCE	2027-12-22	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N221443-001	NP	2029-08-27	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N221443-001	NCE	2027-12-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N221443-001	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 Sunlenca Starter Pack
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2625890	Internal RxNorm lookup
2625896	Internal RxNorm lookup
2625897	Internal RxNorm lookup
2625898	Internal RxNorm lookup
2625899	Internal RxNorm lookup
2625900	Internal RxNorm lookup
2750177	Internal RxNorm lookup
2750183	Internal RxNorm lookup
2755799	Internal RxNorm lookup
2755800	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b2a3ef0e-3ded-45d7-9ba6-f33c4d372dc1	Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61958-3701-1	61958370101	1 KIT in 1 CARTON (61958-3701-1) * 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3601-3) * 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-4)	1 kit	2026-10-31	No	No	Current