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Last Updated: September 21, 2021

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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 Dr Reddys Labs Ltd, Mylan, and Horizon, and is included in three NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium; naproxen has fifty-two patent family members in twenty-four countries.

There are seventy-four drug master file entries for esomeprazole magnesium; naproxen. Two 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
⤷  Try it Free⤷  Try it FreeEQ 20MG BASE;500MGTABLET, DELAYED RELEASE;ORAL
⤷  Try it Free⤷  Try it FreeEQ 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 NDA Submissiondate
VIMOVO TABLET, DELAYED RELEASE;ORAL esomeprazole magnesium; naproxen 022511 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
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Mylan NAPROXEN AND ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 204920-002 Jul 20, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 ⤷  Try it Free ⤷  Try it Free
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 ⤷  Try it Free ⤷  Try it Free
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 ⤷  Try it Free ⤷  Try it Free
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 ⤷  Try it Free ⤷  Try it Free
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for esomeprazole magnesium; naproxen

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 1190013-1 Sweden ⤷  Try it Free PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900 18/2011 Austria ⤷  Try it Free PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
0984957 2012/048 Ireland ⤷  Try it Free PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
0984957 SPC/GB11/013 United Kingdom ⤷  Try it Free PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 435 Finland ⤷  Try it Free
1411900 C300481 Netherlands ⤷  Try it Free PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
McKinsey
Johnson and Johnson
Merck
Baxter
Express Scripts

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.