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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Genvoya (2023)

Total Spending

$626.1M

Total Claims

148,487

Beneficiaries

16,335

Avg Cost/Unit

$133.22

Spending Trend

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

YoY Change:+6.8%

5yr CAGR:+6.4%

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

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	—	—