OMEPRAZOLE Drug Patent Profile

When do Omeprazole patents expire, and when can generic versions of Omeprazole launch?

Omeprazole is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Cumberland, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Perrigo R And D, Sciegen Pharms Inc, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, L Perrigo Co, Spil, and P And L. and is included in forty-six NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in eight countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Omeprazole

A generic version of OMEPRAZOLE was approved as omeprazole magnesium by DR REDDYS LABS LTD on June 5^th, 2009.

Summary for OMEPRAZOLE

International Patents:	13
US Patents:	3
Applicants:	33
NDAs:	46
Finished Product Suppliers / Packagers:	94
Raw Ingredient (Bulk) Api Vendors:	225
Clinical Trials:	433
Patent Applications:	3,825
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OMEPRAZOLE
Drug Sales Revenues:	Drug sales revenues for OMEPRAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMEPRAZOLE
What excipients (inactive ingredients) are in OMEPRAZOLE?	OMEPRAZOLE excipients list
DailyMed Link:	OMEPRAZOLE at DailyMed

See drug prices for OMEPRAZOLE

See drug sales revenues for OMEPRAZOLE

Recent Clinical Trials for OMEPRAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amgen	Early Phase 1
Boehringer Ingelheim	N/A
Aya Mohamed Sadek Elsaid	Phase 3

See all OMEPRAZOLE clinical trials

Pharmacology for OMEPRAZOLE

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for OMEPRAZOLE

Anti-Ulcer Agents

Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OMEPRAZOLE

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for OMEPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMEPRAZOLE	Delayed-release Tablets	omeprazole	20 mg	022032	1	2015-06-03

US Patents and Regulatory Information for OMEPRAZOLE

OMEPRAZOLE is protected by three US patents.

Patents protecting OMEPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203290-002	May 25, 2018	AB	RX	No	No
Teva Pharms Usa	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	204661-002	Jun 13, 2017		DISCN	No	No
Mylan	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	205070-002	Jun 29, 2018		DISCN	No	No
Dr Reddys	OMEPRAZOLE	omeprazole	TABLET, DELAYED RELEASE;ORAL	207740-001	Nov 5, 2018		OTC	No	No
Aurolife Pharma Llc	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204922-002	Aug 19, 2016	AB	RX	No	No
Zydus Pharms Usa Inc	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	091352-002	Nov 19, 2012	AB	RX	No	No
Sun Pharm	OMEPRAZOLE	omeprazole	TABLET, DELAYED RELEASE;ORAL	207891-001	Oct 12, 2018		OTC	No	No

International Patents for OMEPRAZOLE

See the table below for patents covering OMEPRAZOLE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017216789
European Patent Office	1187599	FORMULATION DE BENZIMIDAZOLE STABLE (STABLE BENZIMIDAZOLE FORMULATION)
Israel	147232	STABLE BENZIMIDAZOLE FORMULATION
European Patent Office	3471708	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)
Australia	5423200
World Intellectual Property Organization (WIPO)	0078284
Canada	2377605	FORMULATION DE BENZIMIDAZOLE STABLE (STABLE BENZIMIDAZOLE FORMULATION)

Supplementary Protection Certificates for OMEPRAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727