You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

Details for New Drug Application (NDA): 203971

✉ Email this page to a colleague

NDA 203971 describes XOFIGO, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the XOFIGO profile page.

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 203971

Tradename:	XOFIGO
Applicant:	Bayer Hlthcare
Ingredient:	radium ra-223 dichloride
Patents:	0

Pharmacology for NDA: 203971

Mechanism of Action	alpha-Particle Emitting Activity

Suppliers and Packaging for NDA: 203971

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XOFIGO	radium ra-223 dichloride	SOLUTION;INTRAVENOUS	203971	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-208	50419-208-01	6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	162mCi/6ML (27mCi/ML)
Approval Date:	May 15, 2013	TE:		RLD:	Yes

Expired US Patents for NDA 203971

Subscribe to access the full database, or Get Started Free
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	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

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

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.