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 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, Norvium Bioscience, 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-four NDAs. There are nine 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-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for omeprazole
International Patents: | 13 |
US Patents: | 9 |
Tradenames: | 8 |
Applicants: | 37 |
NDAs: | 54 |
Drug Master File Entries: | 131 |
Finished Product Suppliers / Packagers: | 98 |
Raw Ingredient (Bulk) Api Vendors: | 225 |
Clinical Trials: | 445 |
Patent Applications: | 6,785 |
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 |
Recent Clinical Trials for omeprazole
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jacobio Pharmaceuticals Co., Ltd. | Phase 1 |
Hospital Clinico Universitario de Santiago | Phase 4 |
Complejo Hospitalario de Navarra | Phase 4 |
Generic filers with tentative approvals for OMEPRAZOLE
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL |
⤷ Subscribe | ⤷ Subscribe | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL |
⤷ Subscribe | ⤷ Subscribe | 20MG | 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
Anatomical Therapeutic Chemical (ATC) Classes for omeprazole
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 075757-001 | Jan 28, 2003 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Azurity | KONVOMEP | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 213593-001 | Aug 30, 2022 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Xiromed | OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 212977-001 | Dec 10, 2020 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Breckenridge | OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 203481-003 | Jul 3, 2017 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Zydus Pharms Usa Inc | OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 091352-001 | Nov 19, 2012 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Norvium Bioscience | OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 205070-001 | Jun 29, 2018 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Lannett Co Inc | OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 075410-003 | Jan 23, 2009 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-002 | Jan 15, 1998 | ⤷ Subscribe | ⤷ Subscribe |
Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-002 | Jan 15, 1998 | ⤷ Subscribe | ⤷ Subscribe |
Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-003 | Oct 5, 1995 | ⤷ Subscribe | ⤷ Subscribe |
Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-001 | Sep 14, 1989 | ⤷ Subscribe | ⤷ Subscribe |
Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-002 | Jan 15, 1998 | ⤷ Subscribe | ⤷ Subscribe |
Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-001 | Sep 14, 1989 | ⤷ Subscribe | ⤷ Subscribe |
Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-003 | Oct 5, 1995 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for omeprazole
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3932396 | COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS) | ⤷ Subscribe |
Australia | 5423200 | ⤷ Subscribe | |
Canada | 2377605 | FORMULATION DE BENZIMIDAZOLE STABLE (STABLE BENZIMIDAZOLE FORMULATION) | ⤷ Subscribe |
European Patent Office | 3471708 | COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS) | ⤷ Subscribe |
Germany | 60038447 | ⤷ Subscribe | |
World Intellectual Property Organization (WIPO) | 0078284 | ⤷ Subscribe | |
Spain | 2304349 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for omeprazole
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0984957 | 2012/048 | Ireland | ⤷ Subscribe | 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 | ⤷ Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
0984957 | SPC/GB11/013 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
1411900 | 2011C/016 | Belgium | ⤷ Subscribe | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
1411900 | 2011/016 | Ireland | ⤷ Subscribe | 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 | ⤷ Subscribe | 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 |
Omeprazole Market Analysis and Financial Projection Experimental
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