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Federal Trade Commission
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Baxter
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019810

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NDA 019810 describes PRILOSEC, which is a drug marketed by Astrazeneca Pharms and Covis Pharma Bv and is included in three NDAs. It is available from four 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 019810
Tradename:PRILOSEC
Applicant:Astrazeneca Pharms
Ingredient:omeprazole
Patents:4
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 019810
Medical Subject Heading (MeSH) Categories for 019810
Suppliers and Packaging for NDA: 019810
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810 NDA STAT RX USA LLC 16590-334 16590-334-60 60 CAPSULE in 1 BOTTLE, PLASTIC (16590-334-60)
PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810 NDA STAT RX USA LLC 16590-334 16590-334-30 30 CAPSULE in 1 BOTTLE, PLASTIC (16590-334-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 14, 1989TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Apr 9, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ SubscribePatent Expiration:May 10, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ SubscribePatent Expiration:Apr 9, 2019Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 019810

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Baxter
Accenture
Medtronic
Argus Health
Julphar
Colorcon
Merck
Cerilliant

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