OMEPRAZOLE MAGNESIUM Drug Patent Profile
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Which patents cover Omeprazole Magnesium, and what generic alternatives are available?
Omeprazole Magnesium is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Aurobindo Pharma, Hetero Labs Ltd Iii, P And L, and Perrigo R And D. and is included in eight NDAs.
The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Omeprazole Magnesium
A generic version of OMEPRAZOLE MAGNESIUM was approved as omeprazole magnesium by DR REDDYS LABS LTD on June 5th, 2009.
Summary for OMEPRAZOLE MAGNESIUM
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 47 |
| Raw Ingredient (Bulk) Api Vendors: | 294 |
| Clinical Trials: | 13 |
| Formulation / Manufacturing: | see details |
| 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 Ltd | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 213201-001 | Apr 28, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| P And L | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 206582-001 | Jun 1, 2020 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Spil | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 210593-001 | Jul 20, 2018 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Perrigo R And D | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 204152-001 | Jul 30, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Dr Reddys Labs Ltd | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 078878-001 | Jun 5, 2009 | OTC | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| L Perrigo Co | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 216096-001 | May 24, 2022 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hetero Labs Ltd Iii | OMEPRAZOLE MAGNESIUM | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 211732-001 | Mar 25, 2020 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
