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 seventy-four patent family members in fifty-seven 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:	174
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	158
Patent Applications:	6,907
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

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

Generic Entry Date for axitinib^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,791,140PED 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.

Recent Clinical Trials for axitinib

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

Sponsor	Phase
Incyte Corporation	Phase 1/Phase 2
Cancer League of Colorado	Phase 2
University of Colorado, Denver	Phase 2

See all axitinib clinical trials

Generic filers with tentative approvals for AXITINIB

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

Anatomical Therapeutic Chemical (ATC) Classes for axitinib

L01EK	Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for AXITINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INLYTA	Tablets	axitinib	1 mg and 5 mg	202324	1	2018-02-23

US Patents and Regulatory Information for axitinib

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Glossary

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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	202324-002	Jan 27, 2012		RX	Yes	Yes	10,570,202*PED	⤷ Subscribe			Y	⤷ Subscribe
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes	10,869,924*PED	⤷ Subscribe			Y	⤷ Subscribe
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes	8,791,140*PED	⤷ Subscribe			Y	⤷ Subscribe
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes	6,534,524*PED	⤷ Subscribe			Y	⤷ Subscribe
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No	8,791,140*PED	⤷ Subscribe			Y	⤷ Subscribe
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No	10,869,924*PED	⤷ Subscribe			Y	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for axitinib

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

EU/EMA Drug Approvals for axitinib

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Inlyta	axitinib	EMEA/H/C/002406 Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.	Authorised	no	no	no	2012-09-03
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for axitinib

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Country	Patent Number	Title	Estimated Expiration
Mexico	PA01012795	COMPUESTOS DE INDAZOL Y COMPOSICIONES FARMACEUTICAS PARA INHIBIR A LAS PROTEINAS CINASAS, Y METODOS PARA SU USO. (INDAZOLE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS FOR INHIBITING PROTEIN KINASES, AND METHODS FOR THEIR USE.)	⤷ Subscribe
Brazil	PI0809471	FORMAS CRISTALINAS INÉDITAS DE UM INIBIDOR VEGF-R	⤷ Subscribe
Poland	2134702		⤷ Subscribe
China	118286440	用于治疗癌症的PD-1拮抗剂和VEGFR抑制剂的组合 (Combination of PD-1 antagonist and VEGFR inhibitor for treatment of cancer)	⤷ Subscribe
Cyprus	1121374		⤷ Subscribe
China	105960415	用于治疗癌症的PD-1拮抗剂和VEGFR抑制剂的组合 (Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for axitinib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1218348	PA2013003,C1218348	Lithuania	⤷ Subscribe	PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348	C01218348/01	Switzerland	⤷ Subscribe	FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US
1218348	1390007-1	Sweden	⤷ Subscribe	PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903
1218348	13C0010	France	⤷ Subscribe	PRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903
1218348	CR 2013 00010	Denmark	⤷ Subscribe	PRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903
1218348	2013/008	Ireland	⤷ Subscribe	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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