INLYTA Drug Patent Profile

When do Inlyta patents expire, and when can generic versions of Inlyta launch?

Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-one patent family members in fifty-six countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Inlyta

Inlyta was eligible for patent challenges on January 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 14, 2030. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for INLYTA

International Patents:	161
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	45
Patent Applications:	5,193
Drug Prices:	Drug price information for INLYTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INLYTA
What excipients (inactive ingredients) are in INLYTA?	INLYTA excipients list
DailyMed Link:	INLYTA at DailyMed

See drug prices for INLYTA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for INLYTA

NDA:

202324

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 INLYTA

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

Sponsor	Phase
Bradley A. McGregor	Phase 2
BioGene Pharmaceutical Ltd.	Phase 1/Phase 2
H. Lee Moffitt Cancer Center and Research Institute	Phase 2

See all INLYTA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for INLYTA

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 INLYTA

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 INLYTA

INLYTA is protected by four US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting INLYTA

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	202324-002	Jan 27, 2012		RX	Yes	Yes				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No				Y

Expired US Patents for INLYTA

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 INLYTA

When does loss-of-exclusivity occur for INLYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INLYTA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3971209	COMBINAISON D'UN ANTAGONISTE PD-1 ET D'UN INHIBITEUR VEGFR POUR LE TRAITEMENT DU CANCER (COMBINATION OF A PD-1 ANTAGONIST AND A VEGFR INHIBITOR FOR TREATING CANCER)
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)
Germany	60037211

Supplementary Protection Certificates for INLYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1218348	C 2013 006	Romania		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