Sodium iodide i-131 - Generic Drug Details

What are the generic sources for sodium iodide i-131 and what is the scope of freedom to operate?

Sodium iodide i-131 is the generic ingredient in three branded drugs marketed by Bracco, CIS, Curium, Jubilant, and Intl Isotopes, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for sodium iodide i-131. Two suppliers are listed for this compound.

Summary for sodium iodide i-131

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	7
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	18
Patent Applications:	129
What excipients (inactive ingredients) are in sodium iodide i-131?	sodium iodide i-131 excipients list
DailyMed Link:	sodium iodide i-131 at DailyMed

Recent Clinical Trials for sodium iodide i-131

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

Sponsor	Phase
University Health Network, Toronto	Phase 4
Stryker Endoscopy	Phase 4
Osaka University	Phase 1

See all sodium iodide i-131 clinical trials

Pharmacology for sodium iodide i-131

Drug Class	Radioactive Therapeutic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for sodium iodide i-131

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intl Isotopes	SODIUM IODIDE I 131	sodium iodide i-131	SOLUTION;ORAL	209166-001	Feb 5, 2020	AA	RX	No	No
Curium	SODIUM IODIDE I 131	sodium iodide i-131	CAPSULE;ORAL	016517-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bracco	IODOTOPE	sodium iodide i-131	CAPSULE;ORAL	010929-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Curium	SODIUM IODIDE I 131	sodium iodide i-131	SOLUTION;ORAL	016515-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Cis	SODIUM IODIDE I 131	sodium iodide i-131	CAPSULE;ORAL	017316-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Jubilant	HICON	sodium iodide i-131	SOLUTION;ORAL	021305-002	Jan 24, 2003		DISCN	No	No
Jubilant	HICON	sodium iodide i-131	SOLUTION;ORAL	021305-003	Jan 24, 2003		DISCN	No	No