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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Cantor Fitzgerald
Fish and Richardson
McKinsey
Covington
Chinese Patent Office
Julphar
Cipla
Farmers Insurance

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022056

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NDA 022056 describes PRILOSEC, which is a drug marketed by Astrazeneca Pharms and Covis Pharma Bv and is included in three NDAs. It is available from three suppliers. There are six patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PRILOSEC profile page.

The generic ingredient in PRILOSEC is omeprazole magnesium. There are one hundred and twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 022056
Tradename:PRILOSEC
Applicant:Covis Pharma Bv
Ingredient:omeprazole magnesium
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022056
Suppliers and Packaging for NDA: 022056
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 NDA AstraZeneca Pharmaceuticals LP 0186-0610 N 0186-0610-01
PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 NDA AstraZeneca Pharmaceuticals LP 0186-0625 N 0186-0625-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 2.5MG BASE/PACKET
Approval Date:Mar 20, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 3, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:PEDIATRIC USE AGES 1 MONTH TO 2 YEARS, GERD AND EROSIVE ESOPHAGITIS
Patent:➤ Try a Free TrialPatent Expiration:Nov 3, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 10MG BASE/PACKET
Approval Date:Mar 20, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 3, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS

Expired US Patents for NDA 022056

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis Pharma Bv PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-001 Mar 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Covis Pharma Bv PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Covis Pharma Bv PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Covis Pharma Bv PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-001 Mar 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
AstraZeneca
Johnson and Johnson
Julphar
Chubb
Fuji
Healthtrust
McKinsey
Teva

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