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Last Updated: March 29, 2024

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.

Recent Clinical Trials for gadoversetamide

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

SponsorPhase
Daniel S. BermanN/A
Astellas Pharma US, Inc.N/A
MallinckrodtPhase 4

See all gadoversetamide clinical trials

US Patents and Regulatory Information for gadoversetamide

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 IN PLASTIC CONTAINER gadoversetamide INJECTABLE;INJECTION 020976-001 Dec 8, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Liebel-flarsheim OPTIMARK gadoversetamide INJECTABLE;INJECTION 020975-001 Dec 8, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Liebel-flarsheim OPTIMARK IN PLASTIC CONTAINER gadoversetamide INJECTABLE;INJECTION 020976-004 Dec 8, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Liebel-flarsheim OPTIMARK IN PLASTIC CONTAINER gadoversetamide INJECTABLE;INJECTION 020976-002 Dec 8, 1999 DISCN Yes No ⤷  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 gadoversetamide

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 ⤷  Try a Trial ⤷  Try a Trial
Liebel-flarsheim OPTIMARK gadoversetamide INJECTABLE;INJECTION 020975-001 Dec 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
Liebel-flarsheim OPTIMARK gadoversetamide INJECTABLE;INJECTION 020937-004 Dec 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
Liebel-flarsheim OPTIMARK gadoversetamide INJECTABLE;INJECTION 020937-002 Dec 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for gadoversetamide

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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