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Esomeprazole magnesium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for esomeprazole magnesium?

Esomeprazole magnesium is the generic ingredient in five branded drugs marketed by Astrazeneca Pharms, Ivax Sub Teva Pharms, Aurobindo Pharma Ltd, Astrazeneca Lp, Mylan Pharms Inc, Torrent Pharms Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, and Horizon Pharma Usa, and is included in thirteen 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 sixty-six patent family members in forty-five countries.

There are sixty-six drug master file entries for esomeprazole magnesium. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: esomeprazole magnesium

Tradenames:5
Patents:20
Applicants:9
NDAs:13
Drug Master File Entries: see list66
Suppliers / Packagers: see list26
Bulk Api Vendors: see list63
Clinical Trials: see list278
Patent Applications: see list20
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:esomeprazole magnesium at DailyMed

Pharmacology for Ingredient: esomeprazole magnesium

Tentative approvals for ESOMEPRAZOLE MAGNESIUM

Applicant Application No. Form Dosage
► Subscribe► SubscribeCAPSULE, DELAYED RELEASE;ORAL22MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010RXYesYes9,220,698► Subscribe ► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001RXYesNo8,466,175*PED► SubscribeY► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010RXYesNo9,161,920► Subscribe ► Subscribe
Mylan Pharms Inc
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL078936-001Aug 2, 2015RXNoNo► Subscribe► Subscribe
Dr Reddys Labs Ltd
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL202461-002Sep 27, 2013RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: esomeprazole magnesium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 20015,877,192*PED► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 20016,875,872*PED► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 20014,636,499► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 20015,690,960*PED► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-004Dec 15, 20115,690,960*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,076,361Form of S-omeprazole► Subscribe
7,745,466Form 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

Country Document Number Estimated Expiration
Norway995852► Subscribe
TunisiaSN98074► Subscribe
European Patent Office1240159► Subscribe
World Intellectual Property Organization (WIPO)0027366► Subscribe
Germany69909316► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90006-4Sweden► SubscribePRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
2011005Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
00483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
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
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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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