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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 202324

Generic Entry Date for 202324^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 3, 2035	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Jul 12, 2037	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	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	202324-001	Jan 27, 2012	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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