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Last Updated: August 5, 2020

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Mitotane - Generic Drug Details

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

Mitotane is the generic ingredient in one branded drug marketed by Hra Pharma and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for mitotane. One supplier is listed for this compound.

Recent Clinical Trials for mitotane

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

SponsorPhase
Roche Pharma AGPhase 2
Grupo Espanol de Tumores NeuroendocrinosPhase 2
IpsenPhase 2

See all mitotane clinical trials

Pharmacology for mitotane
Mechanism of ActionCytochrome P450 3A4 Inducers
Medical Subject Heading (MeSH) Categories for mitotane

US Patents and Regulatory Information for mitotane

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hra Pharma LYSODREN mitotane TABLET;ORAL 016885-001 Approved Prior to Jan 1, 1982 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
McKinsey
Moodys
Johnson and Johnson
Dow

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