INLYTA Drug Patent Profile
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When do Inlyta patents expire, 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-four 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 June 14, 2031. 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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Summary for INLYTA
International Patents: | 174 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 50 |
Patent Applications: | 4,096 |
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 |
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
Sponsor | Phase |
---|---|
University of Colorado, Denver | Phase 2 |
Cancer League of Colorado | Phase 2 |
Lynkcell Europe | Phase 1 |
Pharmacology for INLYTA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
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
PD-L1 antagonist combination treatments
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | 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 | 202324-002 | 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 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 | ⤷ 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 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 |
---|---|---|---|
Georgia, Republic of | P20063885 | INDAZOLE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS FOR INHIBITING PROTEIN KINASES, AND METHODS FOR THEIR USE | ⤷ Sign Up |
Denmark | 3102605 | ⤷ Sign Up | |
Israel | 256245 | טיפולים המשלבים אנטגוניסט ל-pd-l1 (Pd-l1 antagonist combination treatments) | ⤷ Sign Up |
Hong Kong | 1085470 | ⤷ 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 | 438 | Finland | ⤷ Sign Up | |
1218348 | 122013000016 | Germany | ⤷ Sign Up | PRODUCT NAME: AXITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903 |
1218348 | C300576 | Netherlands | ⤷ Sign Up | PRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |