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	—
IPR2018-00123	8735372	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-11-09	—
IPR2018-00125	8633309	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-10-30	—
IPR2018-00126	9284342	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-11-02	—
IPR2018-00211	9393256	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-12-06	—
IPR2018-00390	8889159	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-12-26	—

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Harvoni (2023)

Total Spending

$55.0M

Total Claims

1,621

Beneficiaries

691

Avg Cost/Unit

$1177.72

Spending Trend

$744.7M(2019)→$243.2M(2020)→$143.2M(2021)→$77.8M(2022)→$55.0M(2023)

YoY Change:-0.1%

5yr CAGR:+0.6%

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

Approval Letters

20 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 90MG;400MG

RLD

17 patents1 exclusivity▴

TABLET;ORAL | Approved: Oct 10, 2014

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7964580	Mar 26, 2029PED: Sep 26, 2029	PED	Yes	Yes		—
8088368	May 12, 2030PED: Nov 12, 2030	PED	Yes	Yes	—	—
8273341	May 12, 2030PED: Nov 12, 2030	PED	—	—		—
8334270	Mar 21, 2028PED: Sep 21, 2028	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	—	—		—
8822430	May 12, 2030PED: Nov 12, 2030	PED	Yes	Yes		—
8841278	May 12, 2030PED: Nov 12, 2030	PED	—	Yes		—
8889159	Mar 26, 2029PED: Sep 26, 2029	PED	—	Yes		—
9085573	Mar 21, 2028PED: Sep 21, 2028	PED	Yes	Yes		—
9284342	Sep 13, 2030PED: Mar 13, 2031	PED	Yes	Yes		—
9393256	Sep 14, 2032PED: Mar 14, 2033	PED	—	—		—
9511056	May 12, 2030PED: Nov 12, 2030	PED	—	Yes		—
10039779	Jan 30, 2034PED: Jul 30, 2034	PED	Yes	Yes		—
10456414	Sep 14, 2032	—	—	Yes	—	—

Code	Date	Status
ODE*	Aug 28, 2026	< 1 year

#002 — 45MG;200MG

RLD

17 patents1 exclusivity▾

TABLET;ORAL | Approved: Aug 28, 2019