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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021445

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NDA 021445 describes ZETIA, which is a drug marketed by Msd Intl Gmbh and is included in one NDA. It is available from eight suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZETIA profile page.

The generic ingredient in ZETIA is ezetimibe. There are twenty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ezetimibe profile page.

Summary for 021445

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021445

Medical Subject Heading (MeSH) Categories for 021445

Suppliers and Packaging for NDA: 021445

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZETIA
ezetimibe
TABLET;ORAL 021445 NDA Rebel Distributors Corp 21695-778 21695-778-30 30 TABLET in 1 BOTTLE (21695-778-30)
ZETIA
ezetimibe
TABLET;ORAL 021445 NDA Rebel Distributors Corp 21695-778 21695-778-90 90 TABLET in 1 BOTTLE (21695-778-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 25, 2002TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jul 25, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Apr 30, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Apr 25, 2017Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021445

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
Msd Intl Gmbh
ZETIA
ezetimibe
TABLET;ORAL021445-001Oct 25, 2002► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

UBS
Citi
Argus Health
Accenture
Baxter
Chinese Patent Office
Farmers Insurance
McKesson
Daiichi Sankyo
McKinsey

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