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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Cipla
Fish and Richardson
Covington
US Army
Daiichi Sankyo
Healthtrust
Argus Health
Express Scripts
Novartis

Generated: January 21, 2018

DrugPatentWatch Database Preview

Esomeprazole magnesium - Generic Drug Details

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What are the generic drug sources for esomeprazole magnesium and what is the scope of esomeprazole magnesium patent protection?

Esomeprazole magnesium
is the generic ingredient in five branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Kremers Urban Pharms, Mylan Pharms Inc, Torrent Pharms Ltd, Astrazeneca Pharms, Perrigo R And D, Astrazeneca Lp, and Horizon Pharma Usa, and is included in seventeen NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium has one hundred and eighty-one patent family members in forty-six countries.

There are seventy drug master file entries for esomeprazole magnesium. Sixty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for esomeprazole magnesium
Pharmacology for esomeprazole magnesium
Tentative approvals for ESOMEPRAZOLE MAGNESIUM
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe22MGCAPSULE, DELAYED RELEASE;ORAL

US Patents and Regulatory Information for esomeprazole magnesium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Kremers Urban Pharms ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 205563-002 Sep 1, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Horizon Pharma Usa VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-003 Dec 15, 2011 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-004 Dec 15, 2011 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-004 Dec 15, 2011 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-003 Dec 15, 2011 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for esomeprazole magnesium

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
6,677,455 Potassium salt of S-omeprazole ➤ Subscribe
6,747,155 Process ➤ Subscribe
8,076,361 Form of S-omeprazole ➤ Subscribe
7,745,466 Form of S-omeprazole ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for esomeprazole magnesium

Supplementary Protection Certificates for esomeprazole magnesium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012000017 Germany ➤ Subscribe PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
C/GB11/013 United Kingdom ➤ Subscribe PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
017 Luxembourg ➤ Subscribe 92017, EXPIRES: 20230525
C/GB01/006 United Kingdom ➤ Subscribe PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0483 Netherlands ➤ Subscribe PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
0984957/02 Switzerland ➤ Subscribe PRODUCT NAME: ESOMEPRAZOL + ACETYLSALICYLSAEURE ; REGISTRATION NO/DATE: SWISSMEDIC 62119 26.06.2012
2012000051 Germany ➤ Subscribe PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
00517 Netherlands ➤ Subscribe PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
C/GB11/015 United Kingdom ➤ Subscribe PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
2011005,C0984957 Lithuania ➤ Subscribe PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Argus Health
Chinese Patent Office
UBS
Dow
Colorcon
Farmers Insurance
Federal Trade Commission

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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