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Last Updated: July 29, 2021

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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.

Summary for mitotane
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 85
Clinical Trials: 21
Patent Applications: 7,517
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in mitotane?mitotane excipients list
DailyMed Link:mitotane at DailyMed
Recent Clinical Trials for mitotane

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

SponsorPhase
KABS laboratoriesPhase 2
Simbec OrionPhase 2
Exvastat Ltd.Phase 2

See all mitotane clinical trials

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 ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
McKinsey
Moodys
Johnson and Johnson
Dow

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