Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2018-00120	7964580	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-25	—
IPR2018-00119	7964580	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-25	—
IPR2018-00121	8334270	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-26	—
IPR2018-00122	8334270	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-26	—
IPR2018-00125	8633309	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-30	—
IPR2018-00123	8735372	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-11-09	—
IPR2018-00390	8889159	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-12-26	—
IPR2018-00126	9284342	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-11-02	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

27 trials from ClinicalTrials.gov, 2 active, 20 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Lung Transplant HCV, Pilot Study NCT03112044	Early Phase 1	Active	University Health Network, Toronto	26	2017-09-19 → 2027-05-31
The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients NCT03809533	Phase 2	Active	Amit D Tevar, MD	30	2019-05-29 → 2026-04-01
Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia NCT02825212	Phase 2/3	Completed	Icahn School of Medicine at Mount Sinai	10	2016-02 → 2019-07-19
Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial NCT03032666	Phase 4	Completed	Ala'a Sharara	7	2017-05-01 → 2018-08-06
Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in PWID and People With HIV Coinfection.NCT02625909	Phase 3	Completed	Kirby Institute	222	2017-03-09 → 2020-03-23
A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams NCT03492112	N/A	Completed	Kirby Institute	101	2019-09-10 → 2021-11-30
Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant NCT03619837	Phase 4	Completed	University of California, San Francisco	122	2018-07-15 → 2020-08-13
Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication NCT03823911	Phase 4	Completed	University of Maryland, Baltimore	87	2018-11-18 → 2022-12-31
Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection NCT02836925	Phase 2	Completed	Fondazione Italiana Linfomi - ETS	40	2016-03 → 2022-11
The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients NCT03819322	Phase 2	Completed	Fernanda P Silveira, MD, MS	5	2019-08-15 → 2025-03-17

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$865.96

per ea

Lowest NADAC/Unit

$278.25

per ea

Brand NDCs

Generic NDCs

Avg Brand: $865.96

Avg Generic: $278.25

68% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61958220101EPCLUSA 400 MG-100 MG TABLET	$865.96	EA	Brand	$278.25	2026-06-17
72626270101SOFOSBUVIR-VELPATASVIR 400-100	$278.25	EA	Generic	—	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 | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$4781.37

Highest Price

$20036.18

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-2201-01EPCLUSA 400MG/100MG	$8064.56	FSS	Gilead Sciences, Inc.	09/29/2026
61958-2201-01EPCLUSA 400MG/100MG	$8064.56	Big4	Gilead Sciences, Inc.	09/29/2026
61958-2203-01EPCLUSA 200MG/50MG	$20036.18	FSS	Gilead Sciences, Inc.	09/29/2026
61958-2203-01EPCLUSA 200MG/50MG	$18478.72	Big4	Gilead Sciences, Inc.	09/29/2026
72626-2701-01VELPATASVIR 100MG/SOFOSBUVIR 400MG TAB	$7477.39	FSS	Asegua Therapeutics LLC	09/14/2030
72626-2701-01VELPATASVIR 100MG/SOFOSBUVIR 400MG TAB	$4781.37	Big4	Asegua Therapeutics LLC	09/14/2030

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

Medicare Part D Spending

CMS annual spending data for Epclusa (2024)

Total Spending

$758.0M

Total Claims

31,431

Beneficiaries

12,242

Avg Cost/Unit

$848.72

Spending Trend

$1.0B(2019)→$867.1M(2020)→$938.7M(2021)→$899.9M(2022)→$877.4M(2023)→$758.0M(2024)

YoY Change:-8.6%

5yr CAGR:-0.9%

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Feb 21, 2023	SUPPL -20	View Letter (PDF)
Apr 29, 2022	SUPPL -19	View Letter (PDF)
Jun 14, 2021	SUPPL -17	View Letter (PDF)
Jul 20, 2020	SUPPL -15	View Letter (PDF)
Mar 20, 2020	SUPPL -14	View Letter (PDF)
Nov 19, 2019	SUPPL -12	View Letter (PDF)
Sep 20, 2019	SUPPL -13	View Letter (PDF)
Nov 13, 2017	SUPPL -9	View Letter (PDF)
Sep 1, 2017	SUPPL -7	View Letter (PDF)
Aug 2, 2017	SUPPL -1	View Letter (PDF)
Feb 15, 2017	SUPPL -2	View Letter (PDF)
Jun 28, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 400MG;100MG

RLD

15 patents2 exclusivities▴

TABLET;ORAL | Approved: Jun 28, 2016

Patents (15) · 14 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7964580	Mar 26, 2029PED: Sep 26, 2029	PED	Yes	Yes		—
8334270	Mar 21, 2028PED: Sep 21, 2028	PED	Yes	Yes		—
8575135	Nov 16, 2032PED: May 16, 2033	PED	Yes	Yes		—
8580765	Mar 21, 2028PED: Sep 21, 2028	PED	Yes	Yes		—
8618076	Dec 11, 2030PED: Jun 11, 2031	PED	Yes	Yes		—
8633309	Mar 26, 2029PED: Sep 26, 2029	PED	Yes	Yes		—
8735372	Mar 21, 2028PED: Sep 21, 2028	PED	—	—		—
8889159	Mar 26, 2029PED: Sep 26, 2029	PED	—	Yes		—
8921341	Nov 16, 2032PED: May 16, 2033	PED	Yes	Yes		—
8940718	Nov 16, 2032PED: May 16, 2033	PED	Yes	Yes		—
9085573	Mar 21, 2028PED: Sep 21, 2028	PED	Yes	Yes		—
9284342	Sep 13, 2030PED: Mar 13, 2031	PED	Yes	Yes		—
9757406	Jan 30, 2034PED: Jul 30, 2034	PED	—	Yes	—	—
10086011	Jan 30, 2034PED: Jul 30, 2034	PED	—	—		—
11116783	Jan 30, 2034PED: Jul 30, 2034	PED	—	Yes		—

Exclusivities (2)

Code	Date	Status
ODE-293	Mar 19, 2027	< 1 year
PED	Sep 19, 2027	Active

#002 — 200MG;50MG

RLD

15 patents2 exclusivities▾

TABLET;ORAL | Approved: Mar 19, 2020