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SOFOSBUVIR

ANDA

SOFOSBUVIR | A211353 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case 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	—

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Feb 4, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 400MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 27, 2022

No patent or exclusivity listings for this strength.