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Last Updated: July 25, 2024

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INLYTA Drug Patent Profile


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Which patents cover Inlyta, and what generic alternatives are available?

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 seventy-two patent family members in fifty-seven 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.

There are two tentative approvals for the generic drug (axitinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for INLYTA
Drug Prices for INLYTA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
University of Colorado, DenverPhase 2
Cancer League of ColoradoPhase 2
Lynkcell EuropePhase 1

See all INLYTA clinical trials

Pharmacology for INLYTA
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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  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 202324-002 Jan 27, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y 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

EU/EMA Drug Approvals for INLYTA

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 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
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE VEGF-R
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 08236444
Patent: Crystalline forms of 6- [2- (methylcarbamoyl) phenylsulfanyl] -3-E- [2- (pyridin-2-yl) ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0809471
Patent: FORMAS CRISTALINAS INÉDITAS DE UM INIBIDOR VEGF-R
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 82859
Patent: NOUVELLES FORMES CRISTALLINES D'UN INHIBITEUR DU VEGF-R (NOVEL CRYSTALLINE FORMS OF A VEGF-R INHIBITOR)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1679356
Patent: Novel crystalline forms of a vegf-r inhibitor
Estimated Expiration: ⤷  Sign Up

Patent: 3626739
Patent: Crystalline forms of 6- [2- (methylcarbamoyl) phenylsulfanyl] -3-e- [2- (pyridin-2-yl) ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 19119
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 34702
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 34702
Patent: FORMES CRISTALLINES DE 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE UTILES POUR LE TRAITEMENT D'UNE CROISSANCE CELLULAIRE ANORMALE CHEZ DES MAMMIFERES (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS)
Estimated Expiration: ⤷  Sign Up

Patent: 52047
Patent: FORMES CRISTALLINES DE 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE UTILES POUR LE TRAITEMENT D'UNE CROISSANCE CELLULAIRE ANORMALE CHEZ DES MAMMIFERES (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS)
Estimated Expiration: ⤷  Sign Up

Patent: 74702
Patent: FORMES CRISTALLINES DE 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE UTILES POUR LE TRAITEMENT D'UNE CROISSANCE CELLULAIRE ANORMALE CHEZ DES MAMMIFERES (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS)
Estimated Expiration: ⤷  Sign Up

Patent: 49063
Patent: FORMES CRISTALLINES DE 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE UTILES POUR LE TRAITEMENT D'UNE CROISSANCE CELLULAIRE ANORMALE CHEZ DES MAMMIFERES (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 34702
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 93405
Patent: 適用於治療哺乳動物異常細胞生長的 甲基-氨甲酰基 苯基硫基 吡啶- -基 乙烯基 吲唑的晶型 (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN- 2-YL)ETHENYL]INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS 6-[2-(-)]-3-E-[2-(- 2-)])
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1320
Patent: צורות קריסטל של 6 - [2-מתילקרבמויל) פנילסולפניל] - 3 - e - [2- (פירידינ - 2 -איל) אתניל אינדאזול המתאימות לטיפול בגדילת תאים לא נורמאלית ביונקים (Crystalline forms of 6-[2-(methylcarbamoyl) phenylsulfanyl]-3- e -[2- (pyridin- 2- yl] ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 69197
Estimated Expiration: ⤷  Sign Up

Patent: 09019030
Patent: NEW CRYSTALLINE FORM OF VEGF-R INHIBITOR
Estimated Expiration: ⤷  Sign Up

Patent: 14193900
Patent: NOVEL CRYSTALLINE FORM OF VEGF-R INHIBITOR
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 09010761
Patent: FORMAS CRISTALINAS DE 6-[2-(METILCARBAMOIL)FENILSULFANIL]-3-E-[2-( PIRIDIN-2-IL)ETENIL]INDZOL ADECUADAS PARA EL TRATAMIENTO DEL CRECIMIENTO CELULAR ANORMAL EN MAMIFEROS. (CRYSTALLINE FORMS OF 6- [2- (METHYLCARBAMOYL) PHENYLSULFANYL] -3-E- [2- (PYRIDIN-2-YL) ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0126
Patent: CRYSTALLINE FORMS OF 6- [2- (METHYLCARBAMOYL) PHENYLSULFANYL] -3-E- [2- (PYRIDIN-2-YL) ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 34702
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 34702
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 18898
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 6-[2-(МЕТИЛКАРБАМОИЛ)ФЕНИЛСУЛЬФАНИЛ]-3-Е-[2-(ПИРИДИН-2-ИЛ)ЭТЕНИЛ]ИНДАЗОЛА, ПРИГОДНЫЕ ДЛЯ ЛЕЧЕНИЯ АНОМАЛЬНОГО РОСТА КЛЕТОК У МЛЕКОПИТАЮШИХ (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE, SUITABLE FOR TREATMENT OF ABNORMAL GROWTH OF CELLS IN MAMMALS)
Estimated Expiration: ⤷  Sign Up

Patent: 09136593
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 6-[2-(МЕТИЛКАРБАМОИЛ)ФЕНИЛСУЛЬФАНИЛ]-3-Е-[2-(ПИРИДИН-2-ИЛ)ЭТЕНИЛ]ИНДАЗОЛА, ПРИГОДНЫЕ ДЛЯ ЛЕЧЕНИЯ АНОМАЛЬНОГО РОСТА КЛЕТОК У ИЛЕКОПИТАЮШИХ
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 34702
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0906990
Patent: Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl) ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1237588
Estimated Expiration: ⤷  Sign Up

Patent: 090127949
Patent: CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 34866
Estimated Expiration: ⤷  Sign Up

Patent: 19351
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 81602
Estimated Expiration: ⤷  Sign Up

Patent: 0911781
Patent: Novel crystalline forms of a VEGF-R inhibitor
Estimated Expiration: ⤷  Sign Up

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
Israel 201320 צורות קריסטל של 6 - [2-מתילקרבמויל) פנילסולפניל] - 3 - e - [2- (פירידינ - 2 -איל) אתניל אינדאזול המתאימות לטיפול בגדילת תאים לא נורמאלית ביונקים (Crystalline forms of 6-[2-(methylcarbamoyl) phenylsulfanyl]-3- e -[2- (pyridin- 2- yl] ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals) ⤷  Sign Up
Russian Federation 2766890 КОМБИНИРОВАННЫЕ СПОСОБЫ ЛЕЧЕНИЯ АНТАГОНИСТАМИ PD-L1 (COMBINED METHODS FOR TREATING WITH PD-L1 ANTAGONISTS) ⤷  Sign Up
Israel 146710 ⤷  Sign Up
European Patent Office 1218348 COMPOSES D'INDAZOLE ET COMPOSITIONS PHARMACEUTIQUES INHIBANT LES PROTEINES KINASES, ET PROCEDES D'UTILISATION DE CEUX-CI (INDAZOLE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS FOR INHIBITING PROTEIN KINASES, AND METHODS FOR THEIR USE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INLYTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1218348 1390007-1 Sweden ⤷  Sign Up PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903
1218348 2013/008 Ireland ⤷  Sign Up 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 PA2013003 Lithuania ⤷  Sign Up PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 CA 2013 00010 Denmark ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.