Esomeprazole magnesium; naproxen - Generic Drug Details
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What are the generic sources for esomeprazole magnesium; naproxen and what is the scope of patent protection?
Esomeprazole magnesium; naproxen
is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Mylan, Sciegen Pharms Inc, and Horizon, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.Four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for esomeprazole magnesium; naproxen
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 4 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for esomeprazole magnesium; naproxen |
| DailyMed Link: | esomeprazole magnesium; naproxen at DailyMed |
Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM; NAPROXEN
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 esomeprazole magnesium; naproxen
| Drug Class | Nonsteroidal Anti-inflammatory Drug Proton Pump Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for esomeprazole magnesium; naproxen
Paragraph IV (Patent) Challenges for ESOMEPRAZOLE MAGNESIUM; NAPROXEN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VIMOVO | Delayed-release Tablets | esomeprazole magnesium; naproxen | 375 mg/20 mg and 500 mg/20 mg | 022511 | 1 | 2010-11-05 |
US Patents and Regulatory Information for esomeprazole magnesium; naproxen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sciegen Pharms Inc | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 217738-001 | Oct 11, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 204920-002 | Jul 20, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Actavis Labs Fl Inc | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 204470-002 | Aug 24, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 204206-002 | Feb 18, 2020 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 204920-001 | Jul 20, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ajanta Pharma Ltd | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 213699-001 | Oct 6, 2022 | AB | RX | 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 esomeprazole magnesium; naproxen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | ⤷ 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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