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	—
IPR2018-00126	9284342	IPR	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.	Institution Denied	2017-11-02	—
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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Gilead Sciences, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al 1:2018cv00466 17 patentsANDA 211353sofosbuvir	D. Del.	2018-03-27	Terminated 2018-09-21	—
GILEAD SCIENCES, INC. et al v. NATCO PHARMA LIMITED 3:2018cv03592 6 patentsANDA 211373sofosbuvir	D.N.J.	2018-03-14	Terminated 2019-05-15	—
Gilead Sciences Inc. et al v. Abbvie Inc. 1:2013cv02034 11 patentsSofosbuvir (PSI-7977, GS-7977) and Ledipasvir (GS-5885)	D. Del.	2013-12-18	Terminated 2016-08-24	—

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

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 Sovaldi (2023)

Total Spending

$2.0M

Total Claims

Beneficiaries

Avg Cost/Unit

$1056.93

Spending Trend

$2.9M(2019)→$4.2M(2020)→$2.5M(2021)→$2.2M(2022)→$2.0M(2023)

YoY Change:+2.8%

5yr CAGR:+1.0%

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

API Supply Chain9 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDSOFOSBUVIR

DMF 289192014

MATRIX PHARMACORP PRIVATE LTDSOFOSBUVIR

DMF 312722017

TAPI NL BVSOFOSBUVIR 1213

DMF 317362017

TAPI NL BVSOFOSBUVIR 1613

DMF 317372017

CHANGZHOU PHARMACEUTICAL FACTORYSOFOSBUVIR (AMORPHOUS)

DMF 320482017

LAURUS LABS LTDSOFOSBUVIR

DMF 320682017

ALEMBIC PHARMACEUTICALS LTDSOFOSBUVIR

DMF 320752017

FUXIN LONG RUI PHARMACEUTICAL CO LTDSOFOSBUVIR

DMF 334872019

SUZHOU RYWAY BIOTECH CO LTDSOFOSBUVIR

DMF 423892025

LUPIN LTDInactiveSOFOSBUVIR PREMIX

DMF 315112017

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2024	SUPPL -19	View Letter (PDF)
Aug 28, 2020	SUPPL -18	View Letter (PDF)
Mar 6, 2020	SUPPL -17	View Letter (PDF)
Sep 20, 2019	SUPPL -16	View Letter (PDF)
Aug 30, 2019	SUPPL -14	View Letter (PDF)
Oct 30, 2018	SUPPL -13	View Letter (PDF)
Nov 13, 2017	SUPPL -12	View Letter (PDF)
Apr 12, 2017	SUPPL -6	View Letter (PDF)
Aug 21, 2015	SUPPL -2	View Letter (PDF)
Mar 24, 2015	SUPPL -4	View Letter (PDF)
Nov 18, 2014	SUPPL -1	View Letter (PDF)
Dec 9, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 400MG

RLD

9 patents1 exclusivity▴

TABLET;ORAL | Approved: Dec 6, 2013

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7964580	Mar 26, 2029PED: Sep 26, 2029	PED	Yes	Yes	—
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	—
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	—
9549941	Mar 26, 2029PED: Sep 26, 2029	PED	—	—	—

Exclusivities (1)

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

#002 — 200MG

RLD

8 patents1 exclusivity▾

TABLET;ORAL | Approved: Aug 28, 2019