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Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
Cipla
McKesson
Argus Health
Accenture
Queensland Health
US Army
Deloitte
Johnson and Johnson

Generated: October 21, 2017

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 Horizon Pharma Usa and Dr Reddys Labs Ltd, and is included in two NDAs. There are fifteen 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 eighty-three patent family members in forty-eight countries and twenty-six supplementary protection certificates in ten countries.

There are sixty-nine drug master file entries for esomeprazole magnesium; naproxen. Two suppliers are listed for this compound.

Summary for Generic Name: esomeprazole magnesium; naproxen

US Patents:15
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: see list69
Suppliers / Packagers: see list2
Clinical Trials: see list899
Drug Prices:see low prices
DailyMed Link:esomeprazole magnesium; naproxen at DailyMed
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;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► SubscribeY► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► Subscribe ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► SubscribeY► Subscribe
Dr Reddys Labs Ltd
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL202461-001Sep 27, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: 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;ORAL022511-002Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,466,175Form of S-omeprazole► Subscribe
8,206,741Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
9,364,439Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
8,076,361Form of S-omeprazole► Subscribe
8,865,190Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
6,747,155 Process► Subscribe
6,677,455 Potassium salt of S-omeprazole► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: esomeprazole magnesium; naproxen

Country Document Number Estimated Expiration
Russian Federation2184115► Subscribe
New Zealand500991► Subscribe
Denmark0984957► Subscribe
Algeria2495► Subscribe
Eurasian Patent Organization201290026► Subscribe
Norway2012011► Subscribe
Australia7198194► Subscribe
Portugal1411900► Subscribe
Slovakia285137► Subscribe
Serbia20070459► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00481Netherlands► SubscribePRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
2011005Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
2012000017Germany► SubscribePRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
2012 00036Denmark► Subscribe
0984957/02Switzerland► SubscribePRODUCT NAME: ESOMEPRAZOL + ACETYLSALICYLSAEURE ; REGISTRATION NO/DATE: SWISSMEDIC 62119 26.06.2012
2012 00035Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
2011005,C0984957Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
11/016Ireland► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
5Finland► Subscribe
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
McKinsey
AstraZeneca
Accenture
Healthtrust
Dow
Merck
US Army
Daiichi Sankyo

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.

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