Viewing data from:

VEKLURY

NDA

REMDESIVIR | N214787 | GILEAD SCIENCES INC

2 strengths16 unique patents3 unique exclusivities

Patent Timeline

16 unique patents, 2 exclusivities by expiration date

Active (16)TodayPED (+6 mo)Exclusivity

2025

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Oct. 22, 2029

Mar. 6, 2030

Oct. 22, 2029

Apr. 29, 2036

Apr. 29, 2036

Mar. 16, 2032

Jan. 10, 2039

Mar. 16, 2037

Mar. 16, 2037

Jan. 10, 2039

Mar. 16, 2037

Nov. 28, 2041

Jun. 8, 2032

Nov. 28, 2041

Nov. 28, 2041

Jan. 10, 2039

NCE

Apr. 22, 2026

M-301

Apr. 22, 2026

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
GILEAD SCIENCES, INC. v. ASPIRO PHARMA LTD. et al 2:2025cv13936 6 patentsANDA 220566remdesivir	D.N.J.	2025-07-30	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised NCT07013474	Phase 3	Recruiting	Pfizer	300	2025-07-14 → 2028-02-25

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

Medicare Part D Spending

CMS annual spending data for Veklury (2023)

Total Spending

$583K

Total Claims

446

Beneficiaries

263

Avg Cost/Unit

$138.51

Spending Trend

$254K(2022)→$583K(2023)

YoY Change:+45.7%

5yr CAGR:+45.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Veklury (2023)

Total Spending

$22.7M

Total Claims

23,566

Beneficiaries

11,848

ASP Price

—

HCPCS: J0248 — Injection, remdesivir, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain2 active DMFs

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

MSN LIFE SCIENCES PRIVATE LTDREMDESIVIR

DMF 357752021

HONOUR LAB LTDREMDESIVIR

DMF 359702021

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

Approval Letters

23 letters from Drugs@FDA

Date	Submission	Document
Oct 10, 2025	SUPPL -32	View Letter (PDF)
Aug 26, 2025	SUPPL -31	View Letter (PDF)
Jan 13, 2025	SUPPL -30	View Letter (PDF)
Dec 20, 2024	SUPPL -29	View Letter (PDF)
Jun 28, 2024	SUPPL -27	View Letter (PDF)
Feb 29, 2024	SUPPL -26	View Letter (PDF)
Aug 24, 2023	SUPPL -24	View Letter (PDF)
Aug 18, 2023	SUPPL -25	View Letter (PDF)
Jul 14, 2023	SUPPL -19	View Letter (PDF)
Jun 13, 2023	SUPPL -21	View Letter (PDF)
Jun 8, 2023	SUPPL -23	View Letter (PDF)
May 1, 2023	SUPPL -22	View Letter (PDF)
Mar 30, 2023	SUPPL -18	View Letter (PDF)
Dec 15, 2022	SUPPL -20	View Letter (PDF)
Oct 25, 2022	SUPPL -16	View Letter (PDF)
Sep 30, 2022	SUPPL -14	View Letter (PDF)
Jun 24, 2022	SUPPL -15	View Letter (PDF)
Apr 26, 2022	SUPPL -11	View Letter (PDF)
Mar 25, 2022	SUPPL -13	View Letter (PDF)
Jan 24, 2022	SUPPL -10	View Letter (PDF)
Jan 20, 2022	SUPPL -9	View Letter (PDF)
Feb 24, 2021	SUPPL -5	View Letter (PDF)
Oct 22, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/VIAL

RLD

16 patents3 exclusivities▴

POWDER;INTRAVENOUS | Approved: Oct 22, 2020

Patents (16)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE46762	Apr 22, 2029PED: Oct 22, 2029	PED	Yes	Yes	—	—
8008264	Sep 6, 2029PED: Mar 6, 2030	PED	Yes	Yes	—	—
8318682	Apr 22, 2029PED: Oct 22, 2029	PED	Yes	Yes	—	—
9724360	Oct 29, 2035PED: Apr 29, 2036	PED	Yes	Yes	—	—
9949994	Oct 29, 2035PED: Apr 29, 2036	PED	Yes	—	—	—
10065958	Sep 16, 2031PED: Mar 16, 2032	PED	Yes	—	—	—
10675296	Jul 10, 2038PED: Jan 10, 2039	PED	—	Yes	—	—
10695361	Sep 16, 2036PED: Mar 16, 2037	PED	—	—		—
11007208	Sep 16, 2036PED: Mar 16, 2037	PED	—	—		—
11266681	Jul 10, 2038PED: Jan 10, 2039	PED	—	—		—
11382926	Sep 16, 2036PED: Mar 16, 2037	PED	—	—		—
11491169	May 28, 2041PED: Nov 28, 2041	PED	—	—		—
11492353	Dec 8, 2031PED: Jun 8, 2032	PED	Yes	—	—	—
11903953	May 28, 2041PED: Nov 28, 2041	PED	—	—		—
11975012	May 28, 2041PED: Nov 28, 2041	PED	—	—		—
11975017	Jul 10, 2038PED: Jan 10, 2039	PED	—	Yes	—	—

Exclusivities (3)

Code	Date	Status
M-301	Jul 13, 2026	< 1 year
NCE	Oct 22, 2025	Expired
PED	Apr 22, 2026	Expired

#002 — 100MG/20ML (5MG/ML)

RLD

13 patents3 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Oct 22, 2020