Axitinib - Generic Drug Details

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What are the generic sources for axitinib and what is the scope of patent protection?

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^: ⤷ 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.

Recent Clinical Trials for axitinib

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

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

See all axitinib clinical trials

Generic filers with tentative approvals for AXITINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	5MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	1MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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	202324-001	Jan 27, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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	⤷ 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

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
Colombia	5190686	COMPUESTO DE INDAZOL Y COMPOSICIONES FARMACEUTICAS PARA LA INHIBICION DE PROTEINA KINASA	⤷ Sign Up
Czech Republic	20014634		⤷ Sign Up
Brazil	PI0012352	compostos de indazol ou sal farmaceuticamente aceitável e composição farmacêutica	⤷ Sign Up
Spain	2293906		⤷ Sign Up
Slovenia	2134702		⤷ Sign Up
Uruguay	26231	COMPUESTOS DE INDAZOL Y COMPOSICIONES FARMACEUTICAS PARA LA INHIBICION DE PROTEINA KINASA Y METODO PARA SU USO. BAJO LEY 17.164	⤷ Sign Up
Denmark	3102605		⤷ Sign Up
>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	438	Finland	⤷ Sign Up
1218348	92154	Luxembourg	⤷ Sign Up	PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
1218348	5/2013	Austria	⤷ Sign Up	PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348	C01218348/01	Switzerland	⤷ Sign Up	FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US
1218348	C 2013 006	Romania	⤷ Sign Up	PRODUCT NAME: AXITINIB,OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/777/001, RO EU/1/12/777/002, RO EU/1/12/777/003, RO EU/1/12/777/004, RO EU/1/12/777/005, RO EU/1/12/777/006; DATE OF NATIONAL AUTHORISATION: 20120903; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/777/001, EMEA EU/1/12/777/002, EMEA EU/1/12/777/003, EMEA EU/1/12/777/004, EMEA EU/1/12/777/005, EMEA EU/1/12/777/006; DATE OF FIRST AUTHORISATION IN EEA: 20120903
1218348	13C0010	France	⤷ Sign Up	PRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903
1218348	PA2013003	Lithuania	⤷ Sign Up	PRODUCT NAME: AXITINIBUM; 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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