Viewing data from:

SUNLENCA

NDA

LENACAPAVIR SODIUM | N215974 | GILEAD SCIENCES INC

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Feb. 28, 2034

Aug. 17, 2037

Aug. 17, 2037

Aug. 16, 2038

Aug. 28, 2041

NCE

Dec. 22, 2027

I-999

Aug. 27, 2029

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

3 trials from ClinicalTrials.gov — 1 recruiting, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)NCT06101342	Phase 2	Active	Gilead Sciences	181	2023-12-13 → 2028-01
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)NCT06101329	Phase 2	Active	Gilead Sciences	253	2023-11-17 → 2028-01
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy NCT07682961	Phase 3	Recruiting	Gilead Sciences	590	2026-07-14 → 2033-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$2482.41

Highest Price

$3878.77

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-3001-01SUNLENCA 300MG TAB,PKT,4	$2482.41	Big4	Gilead Sciences, Inc.	09/29/2026
61958-3001-01SUNLENCA 300MG TAB,PKT,4	$3103.02	FSS	Gilead Sciences, Inc.	09/29/2026
61958-3001-02SUNLENCA 300MG TAB,PKT,5	$3103.02	Big4	Gilead Sciences, Inc.	09/29/2026
61958-3001-02SUNLENCA 300MG TAB,PKT,5	$3878.77	FSS	Gilead Sciences, Inc.	09/29/2026
61958-3001-03SUNLENCA 300MG TAB,PKT,4	$2491.60	Big4	Gilead Sciences, Inc.	09/29/2026
61958-3001-03SUNLENCA 300MG TAB,PKT,4	$3105.62	FSS	Gilead Sciences, Inc.	09/29/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

LEE PHARMA LTDLENACAPAVIR SODIUM

DMF 423942025

HETERO LABS LTDLENACAPAVIR SODIUM

DMF 424552025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Aug 28, 2026	SUPPL -17	View Letter (PDF)
Mar 16, 2026	SUPPL -14	View Letter (PDF)
Nov 26, 2024	SUPPL -8	View Letter (PDF)
Nov 14, 2024	SUPPL -9	View Letter (PDF)
Jul 18, 2024	SUPPL -7	View Letter (PDF)
Feb 3, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 300MG BASE

RLD

5 patents2 exclusivities▴

TABLET;ORAL | Approved: Dec 22, 2022

Patents (5) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9951043Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Feb 28, 2034	—	Yes	Yes		—
10071985	Aug 17, 2037	—	Yes	Yes	—	—
10654827Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Aug 17, 2037	—	—	—		—
11267799	Aug 16, 2038	—	Yes	—	—	—
11944611	Aug 28, 2041	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Dec 22, 2027	Active
I-999Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Aug 27, 2029	Active

Change History (1)

Recent changes detected for this application.

ADDED10/19/2026

Gilead Sciences added an I-999 regulatory exclusivity (orphan drug designation) to SUNLENCA (lenacapavir sodium, NDA 215974) expiring Aug 2029.

New: SUNLENCA (LENACAPAVIR SODIUM) — exclusivity I-999 exp 08/27/2029