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Serving leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Novartis
Cerilliant
Chinese Patent Office
US Department of Justice
Merck
Covington
Argus Health
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Generated: December 14, 2017

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 nine 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 eleven 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:1
Applicant:1
Ingredient:1
Patents:8
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 022334

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 0078-0566-51 28 BLISTER PACK in 1 CARTON (0078-0566-51) > 1 TABLET in 1 BLISTER PACK (0078-0566-61)
AFINITOR everolimus TABLET;ORAL 022334 NDA Novartis Pharmaceuticals Corporation 0078-0567 0078-0567-51 28 BLISTER PACK in 1 CARTON (0078-0567-51) > 1 TABLET in 1 BLISTER PACK (0078-0567-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 30, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 26, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Feb 26, 2023
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:May 5, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Expired Orange Book Patents for NDA: 022334

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisAFINITOReverolimusTABLET;ORAL022334-001Mar 30, 2009► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-004Mar 30, 2012► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-003Jul 9, 2010► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-002Mar 30, 2009► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Deloitte
Fuji
Farmers Insurance
Daiichi Sankyo
Cantor Fitzgerald
Harvard Business School
Healthtrust
Citi
Julphar

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