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Last Updated: December 5, 2019

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ESOMEPRAZOLE MAGNESIUM; NAPROXEN - Generic Drug Details

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What are the generic drug sources for esomeprazole magnesium; naproxen and what is the scope of freedom to operate?

Esomeprazole magnesium; naproxen is the generic ingredient in one branded drug marketed by Horizon and is included in one NDA. 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-one patent family members in twenty-three countries.

There are seventy-four drug master file entries for esomeprazole magnesium; naproxen. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Recent Litigation for ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Aralez Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2017-01-23
ASTRAZENECA AB v. CIPLA LIMITED2016-12-29
AUROBINDO PHARMA LIMITED v. ASTRAZENECA AB2016-08-18

See all ESOMEPRAZOLE MAGNESIUM; NAPROXEN litigation

PTAB Litigation
PetitionerDate
Dr. Reddy's Lab., Inc.2018-07-02
Dr. Reddy's Laboratories, Inc.2018-04-06
Mylan Pharmaceuticals Inc.2017-12-04

See all ESOMEPRAZOLE MAGNESIUM; NAPROXEN litigation

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 20MG BASE;500MGTABLET, DELAYED RELEASE;ORAL
  Start Trial  Start TrialEQ 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 022511-002 Apr 30, 2010 RX Yes No   Start Trial   Start Trial Y   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010   Start Trial   Start Trial
>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 435 Finland   Start Trial
0984957 2012/048 Ireland   Start Trial 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
1411900 2011/016 Ireland   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900 1190013-1 Sweden   Start Trial PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900 18/2011 Austria   Start Trial 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
1411900 C300481 Netherlands   Start Trial PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900 122012000052 Germany   Start Trial PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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