Details for New Drug Application (NDA): 202324

✉ Email this page to a colleague

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 three 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:	3

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:	⤷ Start Trial	Patent Expiration:	Aug 3, 2035	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Start Trial	Patent Expiration:	Jul 12, 2037	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Start Trial	Patent Expiration:	Jun 14, 2031	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202324

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012	⤷ Start Trial	⤷ Start Trial
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.