XOFIGO Drug Patent Profile

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.

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

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	30
Drug Prices:	Drug price information for XOFIGO
What excipients (inactive ingredients) are in XOFIGO?	XOFIGO excipients list
DailyMed Link:	XOFIGO at DailyMed

See drug prices for XOFIGO

Recent Clinical Trials for XOFIGO

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

Sponsor	Phase
GenesisCare USA	Phase 3
Bayer	Phase 4
Carolina Urologic Research Center	Phase 3

See all XOFIGO clinical trials

Pharmacology for XOFIGO

Drug Class	Radioactive alpha-Particle Emitting Therapeutic Agent
Mechanism of Action	alpha-Particle Emitting Activity

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

Expired US Patents for XOFIGO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	XOFIGO	radium ra-223 dichloride	SOLUTION;INTRAVENOUS	203971-001	May 15, 2013

International Patents for XOFIGO

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	003496	ПРИМЕНЕНИЕ РАДИЯ-223 ДЛЯ НАПРАВЛЕННОЙ ДОСТАВКИ К КАЛЬЦИФИЦИРОВАННЫМ ТКАНЯМ В ЦЕЛЯХ ВРЕМЕННОГО ОСЛАБЛЕНИЯ БОЛИ, ТЕРАПИИ РАКА КОСТИ И КОНДИЦИОНИРОВАНИЯ КОСТНОЙ ПОВЕРХНОСТИ (THE USE OF RADIUM-223 TO TARGET CALCIFIED TISSUES FOR PAIN PALLIATION, BONE CANCER THERAPY, AND BONE SURFACE CONDITIONING)
Mexico	PA01006823	PREPARACION Y USO DE RADIO-223 PARA MARCAR TEJIDOS CALCIFICADOS PARA EL ALIVIO DEL DOLOR, TERAPIA PARA EL CANCER DE HUESOS, Y ACONDICIONAMIENTO DE LA SUPERFICIE DE LOS HUESOS. (THE PREPARATION AND USE OF RADIUM-223 TO TARGET CALCIFIED TISSUES FOR PAIN PALLIATION, BONE CANCER THERAPY, AND BONE SURFACE CONDITIONING.)
European Patent Office	1140212	UTILISATION DU RADIUM 223 POUR CIBLER DES TISSUS CALCIFIES A DES FINS DE TRAITEMENT PALLIATIF ET TRAITEMENT CONTRE LA DOULEUR DU CANCER DES OS (THE USE OF RADIUM-223 TO TARGET CALCIFIED TISSUES FOR PAIN PALLIATION AND THERAPY OF BONE CANCER)
Norway	310544
Portugal	1140212

Supplementary Protection Certificates for XOFIGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140212	CR 2014 00027	Denmark		PRODUCT NAME: RADIUM-223 OG OPLOESELIGE SALTE DERAF, HERUNDER RADIUM-223 DICHLORID; REG. NO/DATE: EU/1/13/873 20131113
1140212	CA 2014 00027	Denmark		PRODUCT NAME: RADIUM-223 OG OPLOESELIGE SALTE DERAF, HERUNDER RADIUM-223 DICHLORID; REG. NO/DATE: EU/1/13/873 20131113
1140212	14C0038	France		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		PRODUCT NAME: DICHLORURE DE RADOIM RA 2232 ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(XOFIGO)
1140212	2014/033	Ireland		PRODUCT NAME: RADIUM-223 AND SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/873 20131113