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Last Updated: July 6, 2020

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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twelve patent family members in fifty-four 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.

US ANDA Litigation and 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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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
University of California, San FranciscoPhase 2
West China HospitalPhase 2
Ulrik LassenPhase 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   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No   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 2013C/015 Belgium   Start Trial PRODUCT NAME: AXITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/777/001 20120905
1218348 92154 Luxembourg   Start Trial PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
McKesson
Baxter
Mallinckrodt
Moodys

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