Viewing data from:

DESCOVY

NDA

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | N208215 | GILEAD SCIENCES INC

2 strengths5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Feb. 15, 2033

Feb. 15, 2033

Jun. 29, 2036

Jun. 29, 2036

Jun. 29, 2036

M-316

Jun. 20, 2028

ODE-457

Jan. 7, 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

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Gilead Sciences, Inc. v. Cipla Ltd. 1:2026cv00149 7 patentsemtricitabine/tenofovir alafenamide (TAF/FTC)	D. Del.	2026-02-10	Active	—
Gilead Sciences, Inc. v. Apotex, Inc. et al 1:2020cv00189 4 patentsANDA 213867, 214053, 214095, 214226, 213926, 214227, 214030, 213989, 214072, 213845, 214173, 214059, 214058, 214216, 214179, 211850tenofovir alafenamide	D. Del.	2020-02-07	Terminated 2022-09-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

27 trials from ClinicalTrials.gov, 20 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)NCT04233879	Phase 3	Completed	Merck Sharp & Dohme LLC	599	2020-02-28 → 2025-01-29
B/F/TAF Switch Study for HIV-HBV Coinfection NCT03797014	Phase 4	Completed	University of Maryland, Baltimore	28	2019-04-30 → 2023-05-05
Effects of Biktarvy on CFR in Stable HIV Patients NCT03656783	Phase 3	Completed	Brigham and Women's Hospital	25	2018-09-14 → 2021-09-15
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals NCT02251236	N/A	Completed	University of California, San Diego	14	2016-01 → 2017-01-18
Early ART to Limit Infection and Establishment of Reservoir NCT02859558	Phase 2	Completed	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	195	2017-01-24 → 2025-04-16
Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens NCT03976752	Phase 1	Completed	Emory University	41	2019-03-13 → 2019-09-20
Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination NCT02475135	Phase 1	Completed	Janssen Sciences Ireland UC	72	2015-06-01 → 2015-08-14
The Cellular Pharmacology of F-TAF in Dried Blood Spots NCT02962739	Phase 1	Completed	University of Colorado, Denver	38	2016-03 → 2019-05-22
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE NCT03998176	Phase 4	Completed	University of Nebraska	43	2019-10-09 → 2022-04-01
Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1 NCT03502005	Phase 4	Completed	Midland Research Group, Inc.	100	2018-03-01 → 2019-12-30

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$74.94

per ea

Lowest NADAC/Unit

$74.85

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61958200201DESCOVY 200-25 MG TABLET	$74.94	EA	Brand	—	2026-06-29
61958200202DESCOVY 200-25 MG TABLET	$74.94	EA	Brand	—	2026-06-29
61958200501DESCOVY 120-15 MG TABLET	$74.85	EA	Brand	—	2026-06-29

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

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

Lowest Price

$1633.32

Highest Price

$1772.36

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-2002-01DESCOVY	$1675.48	FSS	Gilead Sciences, Inc.	09/29/2026
61958-2002-01DESCOVY	$1633.32	Big4	Gilead Sciences, Inc.	09/29/2026
61958-2002-02DESCOVY	$1737.50	FSS	Gilead Sciences, Inc.	09/29/2026
61958-2002-02DESCOVY	$1646.36	Big4	Gilead Sciences, Inc.	09/29/2026
61958-2005-01DESCOVY	$1772.36	FSS	Gilead Sciences, Inc.	09/29/2026
61958-2005-01DESCOVY	$1636.21	Big4	Gilead Sciences, Inc.	09/29/2026

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

Medicare Part D Spending

CMS annual spending data for Descovy (2024)

Total Spending

$544.7M

Total Claims

238,782

Beneficiaries

30,179

Avg Cost/Unit

$72.19

Spending Trend

$524.7M(2019)→$557.9M(2020)→$559.5M(2021)→$574.0M(2022)→$589.8M(2023)→$544.7M(2024)

YoY Change:-4.4%

5yr CAGR:+3.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jun 25, 2025	SUPPL -25	View Letter (PDF)
Jun 25, 2025	SUPPL -23	View Letter (PDF)
Jan 11, 2022	SUPPL -20	View Letter (PDF)
Sep 17, 2021	SUPPL -19	View Letter (PDF)
Apr 26, 2021	SUPPL -14	View Letter (PDF)
Mar 5, 2021	SUPPL -17	View Letter (PDF)
Dec 4, 2019	SUPPL -11	View Letter (PDF)
Oct 4, 2019	SUPPL -12	View Letter (PDF)
Oct 2, 2017	SUPPL -5	View Letter (PDF)
Apr 13, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG;EQ 25MG BASE

RLDAB

5 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 4, 2016

Patents (5) · 8 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8754065	Aug 15, 2032PED: Feb 15, 2033	PED	Yes	Yes		—
9296769	Aug 15, 2032PED: Feb 15, 2033	PED	Yes	Yes		—
12629338	Jun 29, 2036	—	—	Yes	—	—
12648911	Jun 29, 2036	—	—	—		—
12661323Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Jun 29, 2036	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
M-316	Jun 20, 2028	Active

#002 — 120MG;EQ 15MG BASE

RLD

3 patents2 exclusivities▾

TABLET;ORAL | Approved: Jan 7, 2022