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Last Updated: April 19, 2021

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INLYTA Drug 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 thirty-eight 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

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Summary for INLYTA
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
National Cancer Institute (NCI)Phase 1
M.D. Anderson Cancer CenterPhase 1
Nektar TherapeuticsPhase 1/Phase 2

See all INLYTA clinical trials

Pharmacology for INLYTA
Paragraph IV (Patent) Challenges for INLYTA
Tradename Dosage Ingredient NDA Submissiondate
INLYTA TABLET;ORAL axitinib 202324 2018-02-23

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

Supplementary Protection Certificates for INLYTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1218348 PA2013003,C1218348 Lithuania   Start Trial PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 C300576 Netherlands   Start Trial PRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
1218348 C 2013 006 Romania   Start Trial 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
1218348 1390007-1 Sweden   Start Trial PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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