Viewing data from:

GENVOYA

NDA

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | N207561 | GILEAD SCIENCES INC

1 strength9 unique patents0 unique exclusivities

Patent Timeline

9 unique patents by expiration date

Expiring < 1yr (3)Active (6)TodayPED (+6 mo)

2027

2028

2029

2030

2031

2032

2033

Today

Feb. 27, 2027

Apr. 26, 2027

Mar. 3, 2030

Oct. 30, 2030

Feb. 15, 2033

Apr. 26, 2027

Feb. 15, 2033

Mar. 3, 2030

Apr. 6, 2033

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Gilead Sciences, Inc. v. Lupin Limited 1:2021cv01615	D. Del.	2021-11-15	Terminated 2023-03-15	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Analysis of Crushed and Whole Tablet Genvoya NCT03717129	Phase 4	Completed	Johns Hopkins University	12	2019-04-15 → 2021-11-01
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
Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy NCT03549312	Phase 4	UNKNOWN	Saskatchewan Health Authority - Regina Area	25	2018-02-01 → 2021-06-22

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$143.35

per ea

Lowest NADAC/Unit

$143.35

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61958190101GENVOYA TABLET	$143.35	EA	Brand	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$2919.78

Highest Price

$3050.79

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-1901-01GENVOYA	$3050.79	FSS	Gilead Sciences, Inc.	09/29/2026
61958-1901-01GENVOYA	$2919.78	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 Genvoya (2024)

Total Spending

$552.0M

Total Claims

131,432

Beneficiaries

14,573

Avg Cost/Unit

$131.85

Spending Trend

$797.2M(2019)→$755.8M(2020)→$701.9M(2021)→$667.7M(2022)→$626.1M(2023)→$552.0M(2024)

YoY Change:-1.0%

5yr CAGR:+4.6%

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

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Jan 11, 2022	SUPPL -29	View Letter (PDF)
Sep 15, 2021	SUPPL -27	View Letter (PDF)
Mar 8, 2021	SUPPL -25	View Letter (PDF)
Dec 3, 2020	SUPPL -24	View Letter (PDF)
Mar 19, 2019	SUPPL -23	View Letter (PDF)
Dec 20, 2018	SUPPL -18	View Letter (PDF)
Nov 15, 2018	SUPPL -20	View Letter (PDF)
Aug 3, 2018	SUPPL -17	View Letter (PDF)
Nov 27, 2017	SUPPL -13	View Letter (PDF)
Sep 28, 2017	SUPPL -14	View Letter (PDF)
Aug 21, 2017	SUPPL -11	View Letter (PDF)
Apr 12, 2017	SUPPL -10	View Letter (PDF)
Dec 8, 2016	SUPPL -2	View Letter (PDF)
Sep 19, 2016	SUPPL -7	View Letter (PDF)
Sep 9, 2016	SUPPL -1	View Letter (PDF)
Mar 10, 2016	SUPPL -3	View Letter (PDF)
Nov 9, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG;150MG;200MG;EQ 10MG BASE

RLD

9 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 5, 2015

Patents (9) · 7 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7176220	Aug 27, 2026PED: Feb 27, 2027	PED	Yes	Yes		—
7635704	Oct 26, 2026PED: Apr 26, 2027	PED	Yes	Yes		—
8148374	Sep 3, 2029PED: Mar 3, 2030	PED	Yes	Yes		—
8633219	Apr 30, 2030PED: Oct 30, 2030	PED	—	Yes		—
8754065	Aug 15, 2032PED: Feb 15, 2033	PED	Yes	Yes		—
8981103	Oct 26, 2026PED: Apr 26, 2027	PED	Yes	Yes	—	—
9296769	Aug 15, 2032PED: Feb 15, 2033	PED	Yes	Yes		—
9891239	Sep 3, 2029PED: Mar 3, 2030	PED	—	Yes		—
10039718	Oct 6, 2032PED: Apr 6, 2033	PED	—	Yes	—	—