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Last Updated: April 10, 2020

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XOFIGO Drug Profile


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When do Xofigo patents expire, and what generic alternatives are available?

Xofigo is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-four patent family members in twenty-one countries.

The generic ingredient in XOFIGO is radium ra-223 dichloride. One supplier is listed for this compound. Additional details are available on the radium ra-223 dichloride profile page.

US ANDA Litigation and Generic Entry Outlook for Xofigo

Xofigo was eligible for patent challenges on May 15, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 17, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XOFIGO
International Patents:34
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 24
Drug Prices: Drug price information for XOFIGO
DailyMed Link:XOFIGO at DailyMed
Drug patent expirations by year for XOFIGO
Drug Prices for XOFIGO

See drug prices for XOFIGO

Generic Entry Opportunity Date for XOFIGO
Generic Entry Date for XOFIGO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*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 XOFIGO

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

SponsorPhase
BayerPhase 3
MANA RBMPhase 3
Carolina Urologic Research CenterPhase 3

See all XOFIGO clinical trials

US Patents and Regulatory Information for XOFIGO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare XOFIGO radium ra-223 dichloride SOLUTION;INTRAVENOUS 203971-001 May 15, 2013 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 XOFIGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140212 2014/033 Ireland   Start Trial PRODUCT NAME: RADIUM-223 AND SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/873 20131113
1140212 507 Finland   Start Trial
1140212 C300666 Netherlands   Start Trial PRODUCT NAME: RADIUM-223, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/13/873/001 20131113
1140212 33/2014 Austria   Start Trial PRODUCT NAME: RADIUM-223-DICHLORID; REGISTRATION NO/DATE: EU/1/13/873 20131113
1140212 CR 2014 00027 Denmark   Start Trial PRODUCT NAME: RADIUM-223 OG OPLOESELIGE SALTE DERAF, HERUNDER RADIUM-223 DICHLORID; REG. NO/DATE: EU/1/13/873 20131113
1140212 14C0038 France   Start Trial PRODUCT NAME: RADIUM 223 AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER LE DICHLORURE DE RADIUM 223; REGISTRATION NO/DATE: EU/1/13/873 20131113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Express Scripts
Baxter
McKinsey
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.