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Esomeprazole magnesium - Generic Drug Details

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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.

This ingredient has two hundred and thirty-nine patent family members in forty-eight countries.

There are sixty-five drug master file entries for esomeprazole magnesium. Twenty-four 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 list65
Suppliers / Packaging: see list24
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: esomeprazole magnesium

Tentative approvals for ESOMEPRAZOLE MAGNESIUM

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, DELAYED RELEASE;ORAL22MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001RXNo8,466,175*PED► subscribeY► subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001RXYes8,466,175*PED► subscribeY► subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-002Oct 20, 2006RXYes5,714,504*PED► 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
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 20064,853,230*PED► subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-002Oct 20, 20064,786,505*PED► subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-004Dec 15, 20115,900,424*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
8,076,361Form of S-omeprazole► subscribe
6,677,455 Potassium salt of S-omeprazole► subscribe
5,877,192 Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of 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
Sweden9803772► subscribe
European Patent Office1240159► subscribe
Hong Kong1034510► 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
870Luxembourg► subscribe
90006-4Sweden► subscribePRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
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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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