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Last Updated: August 11, 2020

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XTANDI Drug Profile

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

Xtandi is a drug marketed by Astellas and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-five patent family members in twenty-eight countries.

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.

US ANDA Litigation and Generic Entry Outlook for Xtandi

Xtandi was eligible for patent challenges on August 31, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 13, 2027. This may change due to patent challenges or generic licensing.

There have been five 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.

Indicators of Generic Entry

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Drug patent expirations by year for XTANDI
Drug Prices for XTANDI

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Generic Entry Opportunity Date for XTANDI
Generic Entry Date for XTANDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 XTANDI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Oncology Institute of Southern SwitzerlandPhase 2
MedSIRPhase 2
Institute for Research in BiomedicinePhase 2

See all XTANDI clinical trials

Paragraph IV (Patent) Challenges for XTANDI
Tradename Dosage Ingredient NDA Submissiondate
XTANDI CAPSULE;ORAL enzalutamide 203415 2016-08-31

US Patents and Regulatory Information for XTANDI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes   Start Trial   Start Trial   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 XTANDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 122013000155 Germany   Start Trial PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 PA2013029,C1893196 Lithuania   Start Trial PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 SPC/GB13/079 United Kingdom   Start Trial PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1893196 70/2013 Austria   Start Trial PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/836 20130621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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