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-six 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.
There are two tentative approvals for the generic drug (axitinib), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for INLYTA
International Patents: | 166 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 121 |
Clinical Trials: | 49 |
Patent Applications: | 5,026 |
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 |
---|---|
Lynkcell Europe | Phase 1 |
Consorzio Oncotech | Phase 2 |
Hoffmann-La Roche | Phase 2 |
Pharmacology for INLYTA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for INLYTA
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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 | 202324-002 | Jan 27, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 08236444
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0809471
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 82859
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1679356
Estimated Expiration: ⤷ Try a Trial
Patent: 3626739
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 19119
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 34702
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 34702
Estimated Expiration: ⤷ Try a Trial
Patent: 52047
Estimated Expiration: ⤷ Try a Trial
Patent: 74702
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 93405
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1320
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 69197
Estimated Expiration: ⤷ Try a Trial
Patent: 09019030
Estimated Expiration: ⤷ Try a Trial
Patent: 14193900
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09010761
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0126
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 34702
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 34702
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 18898
Estimated Expiration: ⤷ Try a Trial
Patent: 09136593
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 34702
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0906990
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1237588
Estimated Expiration: ⤷ Try a Trial
Patent: 090127949
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 34866
Estimated Expiration: ⤷ Try a Trial
Patent: 19351
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 81602
Estimated Expiration: ⤷ Try a Trial
Patent: 0911781
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Portugal | 1218348 | ⤷ Try a Trial | |
Spain | 2919351 | ⤷ Try a Trial | |
Guatemala | 200000107 | PROCEDIMIENTO PARA LA OBTENCION DE "COMPUESTOS DE INDAZOL Y COMPOSICIONES FARMACEUTICAS PARA INHIBIR LAS QUINASAS DEPROTEINA Y METODOS PARA SU USO". | ⤷ Try a Trial |
Canada | 2989586 | POLYTHERAPIES FAISANT INTERVENIR UN ANTAGONISTE DE PD-L1 (PD-L1 ANTAGONIST COMBINATION TREATMENTS) | ⤷ Try a Trial |
Jordan | 2319 | مركبات الاندازول والمكونات الصيدلانية لتثبيط عمل انزيمات البروتين وطرق استعمالها (INDAZOLE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS AND METHODS FOR THEIR USE) | ⤷ Try a Trial |
Japan | 2021113220 | PD−L1アンタゴニスト併用療法 (PD-L1 ANTAGONIST COMBINATION THERAPY) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INLYTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1218348 | 122013000016 | Germany | ⤷ Try a Trial | PRODUCT NAME: AXITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903 |
1218348 | 438 | Finland | ⤷ Try a Trial | |
1218348 | PA2013003 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903 |
1218348 | CR 2013 00010 | Denmark | ⤷ Try a Trial | PRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903 |
1218348 | 1390007-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903 |
1218348 | 13C0010 | France | ⤷ Try a Trial | PRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |