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Last Updated: December 3, 2021

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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

Anatomical Therapeutic Chemical (ATC) Classes for gadoversetamide

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

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Boehringer Ingelheim
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