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Last Updated: April 18, 2024

Mitotane - Generic Drug Details

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What are the generic drug 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.

Summary for mitotane

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	23
Patent Applications:	7,449
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

Sponsor	Phase
National Cancer Center, Korea	Phase 2
Dr. Jurjan Aman	Phase 2
Exvastat Ltd.	Phase 2

See all mitotane clinical trials

Pharmacology for mitotane

Mechanism of Action	Cytochrome P450 3A4 Inducers

Medical Subject Heading (MeSH) Categories for mitotane

Antineoplastic Agents, Hormonal

US Patents and Regulatory Information for mitotane

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Glossary

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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 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

EU/EMA Drug Approvals for mitotane

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
HRA Pharma Rare Diseases	Lysodren	mitotane	EMEA/H/C/000521 Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.	Authorised	no	no	no	2004-04-28
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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