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Last Updated: November 13, 2019

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 two 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 thirty-one drug master file entries for this compound. Thirty-four 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 0186-0610-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-0610-01)
PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 NDA Covis Pharma 70515-610 70515-610-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-610-01)

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

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