Viewing data from:

OMEPRAZOLE MAGNESIUM

ANDA

OMEPRAZOLE MAGNESIUM | A206877 | AUROBINDO PHARMA LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AUROBINDO PHARMA LIMITED et al v. ASTRAZENECA AB et al 3:2016cv05079 2 patentsANDA 206877omeprazole magnesium	D.N.J.	2016-08-18	Terminated 2017-09-21	—

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

API Supply Chain11 active DMFs4 inactive

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

DR REDDYS LABORATORIES LTDOMEPRAZOLE MAGNESIUM

DMF 177062004

APITORIA PHARMA PRIVATE LTDOMEPRAZOLE MAGNESIUM USP (NON STERILE DRUG SUBSTANCE)

DMF 229702009

HETERO DRUGS LTDOMEPRAZOLE MAGNESIUM

DMF 249822011

WAVELENGTH ENTERPRISES LTDOMEPRAZOLE MAGNESIUM

DMF 252272011

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDOMEPRAZOLE MAGNESIUM

DMF 277342013

SUN PHARMACEUTICAL INDUSTRIES LTDOMEPRAZOLE MAGNESIUM USP

DMF 303352016

GRANULES INDIA LTDOMEPRAZOLE MAGNESIUM USP

DMF 318292017

METROCHEM API PRIVATE LTDOMEPRAZOLE MAGNESIUM

DMF 353902020

CHROMO LABORATORIES INDIA PRIVATE LTDOMEPRAZOLE MAGNESIUM USP

DMF 385852024

DR REDDYS LABORATORIES LTDOMEPRAZOLE MAGNESIUM (CRYSTALLINE)

DMF 388822023

EVEREST ORGANICS LTDOMEPRAZOLE MAGNESIUM USP

DMF 398122024

MERCK AND CO INCInactiveOMEPRAZOLE MAGNESIUM

DMF 146491999

MYLAN LABORATORIES LTDInactiveOMEPRAZOLE MAGNESIUM USP

DMF 193672006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveOMEPRAZOLE MAGNESIUM USP

DMF 211002007

LUPIN LTDInactiveOMEPRAZOLE MAGNESIUM

DMF 215212008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 8, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 20MG BASE

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Jun 6, 2018

No patent or exclusivity listings for this strength.