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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 eighteen 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-three suppliers are listed for this compound.

Summary for Generic Name: esomeprazole magnesium

Tradenames:5
Patents:18
Applicants:9
NDAs:13
Drug Master File Entries: see list60
Suppliers / Packaging: see list23
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: esomeprazole magnesium

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
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-002Apr 30, 2010RXNo7,745,466<disabled>Y <disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006RXNo5,714,504*PED<disabled> <disabled>
Horizon Pharma Usa
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010RXYes8,557,285<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, 20016,875,872*PED<disabled>
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 20145,877,192*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 20085,714,504*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
6,677,455 Potassium salt of S-omeprazole<disabled in preview>
6,143,771 Compounds<disabled in preview>
8,076,361Form of S-omeprazole<disabled in preview>
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International Patent Family for Ingredient: esomeprazole magnesium

Country Document Number Estimated Expiration
Taiwan538040<disabled in preview>
Canada2139653<disabled in preview>
Australia774278<disabled in preview>
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Supplementary Protection Certificates for Tradename: ESOMEPRAZOLE MAGNESIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
870Luxembourg<disabled>
90006-4Sweden<disabled>PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
00517Netherlands<disabled>PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
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