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Last Updated: August 5, 2020

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LYSODREN Drug Profile

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When do Lysodren patents expire, and what generic alternatives are available?

Lysodren is a drug marketed by Hra Pharma and is included in one NDA.

The generic ingredient in LYSODREN is mitotane. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mitotane profile page.

Drug patent expirations by year for LYSODREN
Drug Prices for LYSODREN

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Recent Clinical Trials for LYSODREN

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

M.D. Anderson Cancer CenterPhase 3
Amercian Australian Asian Adrenal Alliance (A5)Phase 3
European Network for the Study of Adrenal Tumors (ENS@T)Phase 3

See all LYSODREN clinical trials

Pharmacology for LYSODREN
Mechanism of ActionCytochrome P450 3A4 Inducers

US Patents and Regulatory Information for LYSODREN

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:

Johnson and Johnson

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