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Last Updated: May 25, 2022

XOFIGO Drug Patent 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.

DrugPatentWatch® 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
Finished Product Suppliers / Packagers: 1
Clinical Trials: 29
Drug Prices: Drug price information for XOFIGO
What excipients (inactive ingredients) are in XOFIGO?XOFIGO excipients list
DailyMed Link:XOFIGO at DailyMed
Drug patent expirations by year for XOFIGO
Drug Prices for XOFIGO

See drug prices for XOFIGO

DrugPatentWatch® Estimated 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 4
Carolina Urologic Research CenterPhase 3
MANA RBMPhase 3

See all XOFIGO clinical trials

US Patents and Regulatory Information for XOFIGO

XOFIGO is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XOFIGO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XOFIGO

Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THERAPEUTIC TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER, SYMPTOMATIC BONE METASTASES AND NO KNOWN VISCERAL METASTATIC DISEASE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for XOFIGO

See the table below for patents covering XOFIGO around the world.

Country Patent Number Title Estimated Expiration
Denmark 1140212 See Plans and Pricing
Canada 2358498 PREPARATION ET UTILISATION DU RADIUM 223 POUR CIBLER DES TISSUS CALCIFIES A DES FINS DE TRAITEMENT PALLIATIF CONTRE LA DOULEUR, DE TRAITEMENT DU CANCER DES OS ET DE CONDITIONNEMENT DE SURFACES OSSEUSES (THE PREPARATION AND USE OF RADIUM-223 TO TARGET CALCIFIED TISSUES FOR PAIN PALLIATION, BONE CANCER THERAPY, AND BONE SURFACE CONDITIONING) See Plans and Pricing
Norway 310544 See Plans and Pricing
Turkey 200201442 See Plans and Pricing
Eurasian Patent Organization 200100642 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XOFIGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140212 14C0038 France See Plans and Pricing 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
1140212 92425 Luxembourg See Plans and Pricing PRODUCT NAME: DICHLORURE DE RADOIM RA 2232 ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(XOFIGO)
1140212 C300666 Netherlands See Plans and Pricing PRODUCT NAME: RADIUM-223, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/13/873/001 20131113
1140212 507 Finland See Plans and Pricing
1140212 1490034-4 Sweden See Plans and Pricing PRODUCT NAME: RADIUM-223; REG. NO/DATE: EU/1/13/873 20131113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Express Scripts
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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.