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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 nineteen 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 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:19
Applicants:9
NDAs:13
Drug Master File Entries: see list60
Suppliers / Packaging: see list24
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: esomeprazole magnesium

Tentative approvals for ESOMEPRAZOLE MAGNESIUM

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, DELAYED RELEASE;ORAL22MG

Clinical Trials for: esomeprazole magnesium

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
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011RXNo7,411,070*PED<disabled>Y<disabled>
Dr Reddys Labs Ltd
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL078279-002Sep 25, 2015RXNo<disabled><disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006RXNo6,428,810*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: esomeprazole magnesium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 20014,853,230*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 20064,738,974*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 20065,877,192*PED<disabled>
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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
5,693,818 Process for preparing pure salts of pyridinylmethyl-sulfinyl-1H-benzimidazole<disabled in preview>
8,076,361Form of S-omeprazole<disabled in preview>
6,677,455 Potassium salt of S-omeprazole<disabled in preview>
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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
Israel142474<disabled in preview>
Greece3035365<disabled in preview>
Luxembourg91870<disabled in preview>
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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
870Luxembourg<disabled>
C/GB11/013United Kingdom<disabled>PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
871Luxembourg<disabled>91871, EXPIRES: 20230525
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