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

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

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

5 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2024	SUPPL -4	View Letter (PDF)
Mar 6, 2020	SUPPL -2	View Letter (PDF)
Dec 5, 2019	SUPPL -3	View Letter (PDF)
Sep 20, 2019	SUPPL -1	View Letter (PDF)
Aug 30, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 150MG/PACKET

RLD

8 patents1 exclusivity▴

PELLETS;ORAL | Approved: Aug 28, 2019

Patents (8)

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	—

Exclusivities (1)

Code	Date	Status
ODE-258	Aug 28, 2026	< 1 year

#002 — 200MG/PACKET

RLD

8 patents1 exclusivity▾

PELLETS;ORAL | Approved: Aug 28, 2019