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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
McKinsey
Johnson and Johnson
Chinese Patent Office
Merck
Healthtrust
Cerilliant
Queensland Health
Express Scripts

Generated: August 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022334

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NDA 022334 describes AFINITOR, which is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug and three Paragraph IV challenges. Additional details are available on the AFINITOR profile page.

The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the everolimus profile page.
Summary for 022334
Tradename:AFINITOR
Applicant:Novartis
Ingredient:everolimus
Patents:7
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022334
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AFINITOR everolimus TABLET;ORAL 022334 NDA Novartis Pharmaceuticals Corporation 0078-0566 N 0078-0566-51
AFINITOR everolimus TABLET;ORAL 022334 NDA Novartis Pharmaceuticals Corporation 0078-0567 N 0078-0567-51

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 30, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 29, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Nov 5, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Oct 26, 2019
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 022334

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 ➤ 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:

Chubb
Healthtrust
Teva
Cerilliant
Cipla
Baxter
Deloitte
McKinsey
Argus Health

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