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Axitinib - Generic Drug Details

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What are the generic drug sources for axitinib and what is the scope of freedom to operate?

Axitinib is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Axitinib has one hundred and thirty-eight patent family members in fifty-six countries.

There are four drug master file entries for axitinib. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for axitinib

International Patents:	138
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Suppliers / Packagers:	2
Bulk Api Vendors:	101
Clinical Trials:	124
Patent Applications:	2,985
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for axitinib
What excipients (inactive ingredients) are in axitinib?	axitinib excipients list
DailyMed Link:	axitinib at DailyMed

Recent Clinical Trials for axitinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ipsen	Phase 2
Asan Medical Center	Phase 2
Southwest Oncology Group	Phase 3

See all axitinib clinical trials

Generic filers with tentative approvals for AXITINIB

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET;ORAL
		1MG	TABLET;ORAL
		5MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for axitinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Paragraph IV (Patent) Challenges for AXITINIB

Tradename	Dosage	Ingredient	NDA	Submissiondate
INLYTA	TABLET;ORAL	axitinib	202324	2018-02-23

US Patents and Regulatory Information for axitinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes			Y	Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes

Expired US Patents for axitinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012

International Patents for axitinib

Country	Patent Number	Estimated Expiration
Norway	2013004
Yugoslavia	92901
Slovenia	1218348
Iceland	2791
Estonia	05585
Norway	20015797

Supplementary Protection Certificates for axitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1218348	2013C/015	Belgium		PRODUCT NAME: AXITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/777/001 20120905
1218348	C300576	Netherlands		PRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
1218348	92154	Luxembourg		PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
1218348	C01218348/01	Switzerland		FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US
1218348	5/2013	Austria		PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348	2013/008	Ireland		PRODUCT NAME: AXITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/777/001 EU/1/12/777/006 20120903