OMEPRAZOLE Drug Patent Profile
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Which patents cover Omeprazole, and what generic alternatives are available?
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, Norvium Bioscience, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, 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. Fifty 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 5th, 2009.
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Summary for OMEPRAZOLE
| International Patents: | 13 |
| US Patents: | 3 |
| Applicants: | 32 |
| NDAs: | 46 |
| Finished Product Suppliers / Packagers: | 99 |
| Raw Ingredient (Bulk) Api Vendors: | 225 |
| Clinical Trials: | 445 |
| Patent Applications: | 3,958 |
| 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
Recent Clinical Trials for OMEPRAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jacobio Pharmaceuticals Co., Ltd. | Phase 1 |
| Karolinska Institutet | Phase 4 |
| Nationwide Children's Hospital | N/A |
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
OMEPRAZOLE is protected by three US patents.
Patents protecting OMEPRAZOLE
Stable orally disintegrating pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable orally disintegrating pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable benzimidazole formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | OMEPRAZOLE AND SODIUM BICARBONATE | omeprazole; sodium bicarbonate | FOR SUSPENSION;ORAL | 205545-001 | Jul 27, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 204661-002 | Jun 13, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 205070-002 | Jun 29, 2018 | DISCN | No | No | ⤷ 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 |
International Patents for OMEPRAZOLE
See the table below for patents covering OMEPRAZOLE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2304349 | ⤷ Sign Up | |
| Australia | 5423200 | ⤷ Sign Up | |
| European Patent Office | 3932396 | COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OMEPRAZOLE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | 2011C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
| 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 |
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Sign Up | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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