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Last Updated: August 10, 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 patent protection?

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, P And L, 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-nine 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-two 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
King Chulalongkorn Memorial HospitalN/A
ViiV HealthcarePhase 1
Wake Forest University Health SciencesPhase 2

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
Apotex OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 076048-002 Oct 22, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204137-001 Jul 15, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Dexcel Pharma OMEPRAZOLE omeprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 209400-001 Jul 5, 2017 OTC Yes No   Start Trial   Start Trial Y   Start Trial
Lannett Co Inc OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075410-002 Nov 1, 2002 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 019810-003 Oct 5, 1995   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 019810-002 Jan 15, 1998   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
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 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
1411900 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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