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Last Updated: May 25, 2022

INLYTA Drug Patent Profile


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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

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Drug patent expirations by year for INLYTA
Drug Prices for INLYTA

See drug prices for INLYTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for INLYTA
Generic Entry Date for INLYTA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Bradley A. McGregorPhase 2
BioGene Pharmaceutical Ltd.Phase 1/Phase 2
H. Lee Moffitt Cancer Center and Research InstitutePhase 2

See all INLYTA clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INLYTA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH PEMBROLIZUMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

PD-L1 antagonist combination treatments
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: AXITINIB IN COMBINATION WITH AVELUMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

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

Patent: 5931
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08236444
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0809471
Estimated Expiration: See Plans and Pricing

Canada

Patent: 82859
Estimated Expiration: See Plans and Pricing

China

Patent: 1679356
Estimated Expiration: See Plans and Pricing

Patent: 3626739
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19119
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 34702
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 34702
Estimated Expiration: See Plans and Pricing

Patent: 52047
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 93405
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1320
Estimated Expiration: See Plans and Pricing

Japan

Patent: 69197
Estimated Expiration: See Plans and Pricing

Patent: 09019030
Estimated Expiration: See Plans and Pricing

Patent: 14193900
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09010761
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0126
Estimated Expiration: See Plans and Pricing

Poland

Patent: 34702
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 34702
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 18898
Estimated Expiration: See Plans and Pricing

Patent: 09136593
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 34702
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0906990
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1237588
Estimated Expiration: See Plans and Pricing

Patent: 090127949
Estimated Expiration: See Plans and Pricing

Spain

Patent: 34866
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 81602
Estimated Expiration: See Plans and Pricing

Patent: 0911781
Estimated Expiration: See Plans and Pricing

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) See Plans and Pricing
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) See Plans and Pricing
Germany 60037211 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INLYTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1218348 5/2013 Austria See Plans and Pricing PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 2013/008 Ireland See Plans and Pricing 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 See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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. 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.