Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022032

« Back to Dashboard

NDA 022032 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Glenmark Generics, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Zydus Pharms Usa Inc, Dexcel Pharma, Gastroentero, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Par Pharm, Perrigo R And D, and Sciegen Pharms Inc, and is included in thirty-four NDAs. It is available from one hundred and nine suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the OMEPRAZOLE profile page.

The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for 022032

Tradename:	OMEPRAZOLE
Applicant:	Dexcel Pharma
Ingredient:	omeprazole
Patents:	1
Therapeutic Class:	Gastrointestinal Agents
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 022032

Anti-Ulcer Agents
Proton Pump Inhibitors

Suppliers and Packaging for NDA: 022032

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OMEPRAZOLE	omeprazole	TABLET, DELAYED RELEASE;ORAL	022032	NDA	L. Perrigo Company	0113-0915	N	0113-0915-03
OMEPRAZOLE	omeprazole	TABLET, DELAYED RELEASE;ORAL	022032	NDA	L. Perrigo Company	0113-0915	N	0113-0915-30

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	20MG
Approval Date:	Dec 4, 2007	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Aug 16, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca

McKesson

Federal Trade Commission

Fish and Richardson

Mallinckrodt

Queensland Health

Cantor Fitzgerald

Farmers Insurance

Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.