ISOVUE-300 Drug Patent Profile

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Which patents cover Isovue-300, and what generic alternatives are available?

Isovue-300 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-300 is iopamidol. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Isovue-300

A generic version of ISOVUE-300 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

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Summary for ISOVUE-300

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	20
Patent Applications:	3,591
Formulation / Manufacturing:	see details
DailyMed Link:	ISOVUE-300 at DailyMed

Drug patent expirations by year for ISOVUE-300

Recent Clinical Trials for ISOVUE-300

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Sponsor	Phase
NYU Langone Health	N/A
M.D. Anderson Cancer Center	N/A
National Cancer Institute (NCI)	N/A

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Pharmacology for ISOVUE-300

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for ISOVUE-300

V08AB	Watersoluble, nephrotropic, low osmolar X-ray contrast media
V08A	X-RAY CONTRAST MEDIA, IODINATED
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for ISOVUE-300

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	018735-002	Dec 31, 1985		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	020327-003	Oct 12, 1994		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ISOVUE-300

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	018735-002	Dec 31, 1985	⤷ Try a Trial	⤷ Try a Trial
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	020327-003	Oct 12, 1994	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ISOVUE-300

See the table below for patents covering ISOVUE-300 around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	A925075		⤷ Try a Trial
Mexico	6161		⤷ Try a Trial
Netherlands	7512208		⤷ Try a Trial
Romania	69615		⤷ Try a Trial
Yugoslavia	42882		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for ISOVUE-300

Recent Clinical Trials for ISOVUE-300

Pharmacology for ISOVUE-300

Anatomical Therapeutic Chemical (ATC) Classes for ISOVUE-300

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