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Last Updated: July 4, 2020

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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 seven branded drugs marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge, Dr Reddys Labs Ltd, Glenmark Generics, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Zydus Pharms Usa Inc, Astrazeneca Pharms, Dexcel Pharma, Dr Reddys, Sun Pharm, Spil, Covis Pharma Bv, Perrigo R And D, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Guardian Drug, Par Pharm, Sciegen Pharms Inc, Zydus Pharms, Salix, and Bayer Healthcare Llc, and is included in forty-eight NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has twelve patent family members in eight countries.

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

Drug Prices for OMEPRAZOLE

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Drug Sales Revenue Trends for OMEPRAZOLE

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Recent Clinical Trials for OMEPRAZOLE

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

SponsorPhase
Wake Forest University Health SciencesPhase 2
Spero TherapeuticsPhase 1
R-PharmPhase 1

See all OMEPRAZOLE clinical trials

Generic filers with tentative approvals for OMEPRAZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial40MGCAPSULE, DELAYED REL PELLETS;ORAL
  Start Trial  Start Trial20MGCAPSULE, DELAYED REL PELLETS;ORAL
  Start Trial  Start Trial10MGCAPSULE, 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
Medical Subject Heading (MeSH) Categories for OMEPRAZOLE
Paragraph IV (Patent) Challenges for OMEPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
PRILOSEC CAPSULE, DELAYED REL PELLETS;ORAL omeprazole 019810
OMEPRAZOLE TABLET, DELAYED RELEASE;ORAL omeprazole 022032

US Patents and Regulatory Information for OMEPRAZOLE

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 204012-002 Sep 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075347-002 May 30, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 078966-002 May 25, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Breckenridge OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 203481-002 Jul 3, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 204661-002 Jun 13, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>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

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

Supplementary Protection Certificates for OMEPRAZOLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011/016 Ireland   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0124495 SPC/GB01/006 United Kingdom   Start Trial PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0984957 SPC/GB11/013 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 2012/048 Ireland   Start Trial 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 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Medtronic
AstraZeneca
Baxter
Dow

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