Details for New Drug Application (NDA): 202324

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NDA 202324 describes INLYTA, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INLYTA profile page.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the axitinib profile page.

Summary for 202324

Tradename:	INLYTA
Applicant:	Pf Prism Cv
Ingredient:	axitinib
Patents:	4

Pharmacology for NDA: 202324

Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Suppliers and Packaging for NDA: 202324

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INLYTA	axitinib	TABLET;ORAL	202324	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0145	0069-0145-01	180 TABLET, FILM COATED in 1 BOTTLE (0069-0145-01)
INLYTA	axitinib	TABLET;ORAL	202324	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0151	0069-0151-11	60 TABLET, FILM COATED in 1 BOTTLE (0069-0151-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jan 27, 2012	TE:	AB	RLD:	Yes
Patent:	10,570,202*PED	Patent Expiration:	Aug 3, 2035	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	10,869,924*PED	Patent Expiration:	Jul 12, 2037	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	6,534,524*PED	Patent Expiration:	Oct 29, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202324

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012	7,141,581	⤷ Get Started Free
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012	7,141,581	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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