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Last Updated: November 18, 2019

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XOFIGO Drug Profile

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Which patents cover Xofigo, 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.

Summary for XOFIGO
International Patents:34
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 23
Drug Prices: Drug price information for XOFIGO
DailyMed Link:XOFIGO at DailyMed
Drug patent expirations by year for XOFIGO
Drug Prices for XOFIGO

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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
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2
VU University Medical CenterPhase 3
City of Hope Medical CenterPhase 2

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 CA 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 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 92425 Luxembourg   Start Trial PRODUCT NAME: DICHLORURE DE RADOIM RA 2232 ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(XOFIGO)
1140212 C01140212/01 Switzerland   Start Trial PRODUCT NAME: RADIUM RA-223; REGISTRATION NO/DATE: SWISSMEDIC 62732 29.08.2014
1140212 122014000052 Germany   Start Trial PRODUCT NAME: RADIUM-223-SALZ, INSBESONDERE RADIUM-223-DICHLORID; 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:

McKesson
Baxter
Mallinckrodt
Johnson and Johnson
AstraZeneca
McKinsey

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