Omeprazole magnesium - Generic Drug Details
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What are the generic drug sources for omeprazole magnesium and what is the scope of freedom to operate?
Omeprazole magnesium
is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Covis, Aurobindo Pharma, Hetero Labs Ltd Iii, P And L, Perrigo R And D, and Astrazeneca, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are seventy-three drug master file entries for omeprazole magnesium. Fifty-one suppliers are listed for this compound.
Summary for omeprazole magnesium
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 10 |
| NDAs: | 10 |
| Drug Master File Entries: | 73 |
| Finished Product Suppliers / Packagers: | 51 |
| Raw Ingredient (Bulk) Api Vendors: | 294 |
| Clinical Trials: | 14 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for omeprazole magnesium |
| What excipients (inactive ingredients) are in omeprazole magnesium? | omeprazole magnesium excipients list |
| DailyMed Link: | omeprazole magnesium at DailyMed |
Recent Clinical Trials for omeprazole magnesium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Amgen | Early Phase 1 |
| AnHeart Therapeutics Inc. | Phase 1 |
| Instituto Mexicano del Seguro Social | Phase 4 |
Pharmacology for omeprazole magnesium
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for omeprazole magnesium
Paragraph IV (Patent) Challenges for OMEPRAZOLE MAGNESIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PRILOSEC OTC | Delayed-release Tablets | omeprazole magnesium | 20 mg | 021229 | 1 | 2012-03-30 |
| PRILOSEC OTC | Delayed-release Capsules | omeprazole magnesium | 20 mg | 021229 | 1 | 2007-03-19 |
US Patents and Regulatory Information for omeprazole magnesium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 206877-001 | Jun 6, 2018 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma Ltd | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 213201-001 | Apr 28, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | ||||
| P And L | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 206582-001 | Jun 1, 2020 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| L Perrigo Co | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 216096-001 | May 24, 2022 | OTC | 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 |
Expired US Patents for omeprazole magnesium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-002 | Mar 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
ISSN: 2162-2639
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