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DESCOVY

NDA

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | N208215 | GILEAD SCIENCES INC

2 strengths4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Active (4)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

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Descovy (2023)

Total Spending

$589.8M

Total Claims

249,185

Beneficiaries

29,514

Avg Cost/Unit

$75.49

Spending Trend

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

YoY Change:+6.7%

5yr CAGR:+6.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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

4 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 4, 2016

Patents (4)

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	—	—	—		—

Exclusivities (1)

Code	Date	Status
M-316	Jun 20, 2028	Active

#002 — 120MG;EQ 15MG BASE

RLD

2 patents2 exclusivities▾

TABLET;ORAL | Approved: Jan 7, 2022

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

Gilead Sciences added U.S. Patent 12,648,911 to the Orange Book for DESCOVY (emtricitabine; tenofovir alafenamide fumarate), application N-208215-001.

New: New record

ADDED7/1/2026

Gilead Sciences added U.S. Patent 12,629,338 to the Orange Book for DESCOVY (emtricitabine; tenofovir alafenamide fumarate), NDA 208215.

New: New record