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Last Updated: July 12, 2020

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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 seven 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. Four suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 022334
Tradename:AFINITOR
Applicant:Novartis
Ingredient:everolimus
Patents:6
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 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)
Paragraph IV (Patent) Challenges for 022334
Tradename Dosage Ingredient NDA Submissiondate
AFINITOR TABLET;ORAL everolimus 022334 2014-12-10
AFINITOR TABLET;ORAL everolimus 022334 2014-06-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 30, 2009TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Feb 26, 2023
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
Patent:  Start TrialPatent Expiration:Mar 9, 2020Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 6, 2020Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 022334

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

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