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 two 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. Eleven 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:	2

Pharmacology for NDA: 022334

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for 022334

Antineoplastic Agents
Immunosuppressive Agents

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 30, 2009	TE:	AB	RLD:	Yes
Patent:	8,410,131*PED	Patent Expiration:	May 1, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	9,006,224	Patent Expiration:	Jul 1, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 30, 2009	TE:	AB	RLD:	Yes
Patent:	8,410,131*PED	Patent Expiration:	May 1, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022334

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	8,436,010*PED	⤷ Subscribe
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	5,665,772*PED	⤷ Subscribe
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	5,665,772*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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