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Serving leading biopharmaceutical companies globally:

McKinsey
Cantor Fitzgerald
Express Scripts
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Deloitte
Accenture
US Army
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Generated: December 12, 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 Dr Reddys Labs Ltd and Horizon Pharma Usa, 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-two 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 esomeprazole magnesium; naproxen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdNAPROXEN AND ESOMEPRAZOLE MAGNESIUMesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL202461-002Sep 27, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► Subscribe► SubscribeY► 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 UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010► Subscribe► Subscribe
Horizon Pharma UsaVIMOVOesomeprazole magnesium; naproxenTABLET, DELAYED RELEASE;ORAL022511-002Apr 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
9,801,824Method for delivering a pharmaceutical composition to patient in need thereof► Subscribe
6,677,455 Potassium salt of S-omeprazole► Subscribe
8,206,741Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
8,076,361Form of S-omeprazole► Subscribe
8,466,175Form of S-omeprazole► Subscribe
9,364,439Pharmaceutical compositions for the coordinated delivery of NSAIDs► Subscribe
6,747,155 Process► Subscribe
8,865,190Pharmaceutical compositions for the coordinated delivery of NSAIDs► 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
Saudi Arabia1996► Subscribe
Sweden9302396► Subscribe
Hong Kong1025962► Subscribe
Slovakia285137► Subscribe
Serbia50067► Subscribe
China1064680► Subscribe
Iceland2774► Subscribe
Malaysia120745► Subscribe
Finland114154► Subscribe
New Zealand268693► 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
2012 00036Denmark► Subscribe
0483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
2011005Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
1411900/01Switzerland► SubscribePRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
00481Netherlands► SubscribePRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
2012 00008Denmark► Subscribe
12/048Ireland► SubscribePRODUCT 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
00517Netherlands► SubscribePRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
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
2012 00035Denmark► Subscribe
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Serving leading biopharmaceutical companies globally:

Julphar
McKinsey
Teva
Argus Health
Deloitte
Baxter
Chinese Patent Office
Cipla
Cantor Fitzgerald
Covington

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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