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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Chubb
Cerilliant
Colorcon
Dow
Boehringer Ingelheim
Teva
Harvard Business School
McKesson

Generated: August 20, 2018

DrugPatentWatch Database Preview

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 esomeprazole magnesium; naproxen patent protection?

Esomeprazole magnesium; naproxen is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd and Horizon Pharma Usa, and is included in two NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium; naproxen has one hundred and twenty-eight patent family members in forty-six countries.

There are seventy drug master file entries for esomeprazole magnesium; naproxen. One supplier is listed for this compound.

Summary for esomeprazole magnesium; naproxen

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 Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes 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

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Expired US Patents for esomeprazole magnesium; naproxen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 ➤ Sign Up ➤ Sign Up
Horizon Pharma Usa 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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Non-Orange Book US Patents for esomeprazole magnesium; naproxen

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,206,741 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
8,865,190 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
9,364,439 Pharmaceutical compositions for the coordinated delivery of NSAIDs ➤ Sign Up
9,801,824 Method for delivering a pharmaceutical composition to patient in need thereof ➤ Sign Up
6,677,455 Potassium salt of S-omeprazole ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for esomeprazole magnesium; naproxen

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00483 Netherlands ➤ Sign Up PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
90006-4 Sweden ➤ Sign Up PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
2012 00008 Denmark ➤ Sign Up
C/GB11/015 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
00517 Netherlands ➤ Sign Up PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Cipla
Argus Health
Farmers Insurance
Deloitte
Mallinckrodt
Merck
UBS

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 verifification 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.