OMEPRAZOLE - Generic Drug Details

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What are the generic drug sources for omeprazole and what is the scope of freedom to operate?

Omeprazole is the generic ingredient in eight branded drugs 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, Astrazeneca, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Aurobindo Pharma Ltd, L Perrigo Co, Spil, Covis, P And L, Perrigo R And D, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Sciegen Pharms Inc, Zydus, Zydus Pharms, Salix, Riley Consumer, and Azurity, and is included in fifty-three NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has thirteen patent family members in eight countries.

There are one hundred and thirty-one drug master file entries for omeprazole. Ninety-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for OMEPRAZOLE

International Patents:	13
US Patents:	8
Tradenames:	8
Applicants:	37
NDAs:	53
Drug Master File Entries:	131
Finished Product Suppliers / Packagers:	96
Raw Ingredient (Bulk) Api Vendors:	225
Clinical Trials:	439
Patent Applications:	6,179
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends 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

Drug Sales Revenue Trends for OMEPRAZOLE

See drug sales revenues for OMEPRAZOLE

Recent Clinical Trials for OMEPRAZOLE

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

Sponsor	Phase
Hospital Clinico Universitario de Santiago	Phase 4
Complejo Hospitalario de Navarra	Phase 4
San Raffaele University Hospital, Italy	Phase 4

See all OMEPRAZOLE clinical trials

Generic filers with tentative approvals for OMEPRAZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	40MG	CAPSULE, DELAYED REL PELLETS;ORAL
⤷ Sign Up	⤷ Sign Up	20MG	CAPSULE, DELAYED REL PELLETS;ORAL
⤷ Sign Up	⤷ Sign Up	10MG	CAPSULE, DELAYED REL PELLETS;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd Iii	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	204012-001	Sep 26, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dexcel	OMEPRAZOLE	omeprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	209400-001	Jul 5, 2017		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Spil	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	210593-001	Jul 20, 2018		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	205070-001	Jun 29, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	076515-001	Jan 21, 2009	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurolife Pharma Llc	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204922-002	Aug 19, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	075757-002	Jan 28, 2003	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OMEPRAZOLE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OMEPRAZOLE

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Country	Patent Number	Title	Estimated Expiration
Spain	2304349		⤷ Sign Up
Israel	147232	STABLE BENZIMIDAZOLE FORMULATION	⤷ Sign Up
World Intellectual Property Organization (WIPO)	0078284		⤷ Sign Up
Israel	130602		⤷ Sign Up
European Patent Office	3471708	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)	⤷ Sign Up
Canada	2377605	FORMULATION DE BENZIMIDAZOLE STABLE (STABLE BENZIMIDAZOLE FORMULATION)	⤷ Sign Up
Germany	60038447		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OMEPRAZOLE

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

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