.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019810

« Back to Dashboard
NDA 019810 describes PRILOSEC, which is a drug marketed by Astrazeneca Pharms and is included in three NDAs. It is available from three suppliers. There are eight 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 eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for NDA: 019810

Tradename:
PRILOSEC
Applicant:
Astrazeneca Pharms
Ingredient:
omeprazole
Patents:4
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 16590-334-30 30 CAPSULE in 1 BOTTLE, PLASTIC (16590-334-30)
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)

Summary 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DELAYED REL PELLETS;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No
Patent:6,147,103*PEDPatent Expiration:Apr 9, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,150,380*PEDPatent Expiration:May 10, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,166,213*PEDPatent Expiration:Apr 9, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 019810

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 19985,599,794*PED► subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 19984,636,499*PED► subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 19895,599,794*PED► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc