GADOVERSETAMIDE - Generic Drug Details

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What are the generic sources for gadoversetamide and what is the scope of freedom to operate?

Gadoversetamide is the generic ingredient in two branded drugs marketed by Liebel-flarsheim and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for gadoversetamide.

Summary for GADOVERSETAMIDE

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	3
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	2
Patent Applications:	1,042
DailyMed Link:	GADOVERSETAMIDE at DailyMed

Recent Clinical Trials for GADOVERSETAMIDE

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

Sponsor	Phase
Daniel S. Berman	N/A
Astellas Pharma US, Inc.	N/A
Mallinckrodt	Phase 4

See all GADOVERSETAMIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for GADOVERSETAMIDE

V08CA	Paramagnetic contrast media
V08C	MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for GADOVERSETAMIDE

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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
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-003	Dec 8, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-001	Dec 8, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-002	Dec 8, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-001	Dec 8, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-002	Dec 8, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020975-001	Dec 8, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-003	Dec 8, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 GADOVERSETAMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIMARK IN PLASTIC CONTAINER	gadoversetamide	INJECTABLE;INJECTION	020976-001	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020975-001	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-001	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-002	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-003	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-003	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
Liebel-flarsheim	OPTIMARK	gadoversetamide	INJECTABLE;INJECTION	020937-004	Dec 8, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for GADOVERSETAMIDE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mallinckrodt Deutschland GmbH	Optimark	gadoversetamide	EMEA/H/C/000745 This medicinal product is for diagnostic use only.Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.	Withdrawn	no	no	no	2007-07-23
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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