You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Esomeprazole magnesium; naproxen - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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.

Five suppliers are listed for this compound. There is one tentative approval for this compound.

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 20MG BASE;500MGTABLET, DELAYED RELEASE;ORAL
⤷  Sign Up⤷  Sign UpEQ 20MG BASE;375MGTABLET, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 217738-002 Oct 11, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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
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 204920-002 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
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 022511-001 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 022511-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.