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Serving 500+ biopharmaceutical companies globally:

Baxter
Julphar
Queensland Health
Harvard Business School
Chinese Patent Office
Novartis
Moodys
QuintilesIMS
Farmers Insurance
Cerilliant

Generated: July 24, 2017

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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 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-eight patent family members in forty-six countries.

There are sixty-seven drug master file entries for esomeprazole magnesium. Twenty-five 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 list67
Suppliers / Packagers: see list25
Bulk Api Vendors: see list63
Clinical Trials: see list655
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. Strength Dosage Form
► Subscribe► Subscribe22MGCAPSULE, DELAYED RELEASE;ORAL
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► Subscribe ► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
Hetero Labs Ltd Iii
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL202784-002Sep 21, 2015BXRXNoNo► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010ABRXYesNo► Subscribe► SubscribeY ► 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;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-002Oct 20, 2006► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006► Subscribe► 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
7,745,466Form of S-omeprazole► Subscribe
8,076,361Form of S-omeprazole► Subscribe
6,747,155 Process► 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
Saudi Arabia974► Subscribe
Hungary0001849► Subscribe
Portugal1104417► Subscribe
China1258295► Subscribe
New Zealand510993► 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
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
017Luxembourg► Subscribe92017, EXPIRES: 20230525
871Luxembourg► Subscribe91871, EXPIRES: 20230525
0483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
C/GB01/006United Kingdom► SubscribePRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Healthtrust
Argus Health
Dow
Fish and Richardson
Queensland Health
Boehringer Ingelheim
Harvard Business School
Novartis
Chinese Patent Office

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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