TRILOSTANE - Generic Drug Details

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

Trilostane is the generic ingredient in one branded drug marketed by Bioenvision 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 trilostane.

Summary for TRILOSTANE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	2
Patent Applications:	7,621
DailyMed Link:	TRILOSTANE at DailyMed

Recent Clinical Trials for TRILOSTANE

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

Sponsor	Phase
The University of Hong Kong	Phase 2
Karolinska Institutet	Phase 2
Kristina Gemzell Danielsson	Phase 2

See all TRILOSTANE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TRILOSTANE

H02CA	Anticorticosteroids
H02C	ANTIADRENAL PREPARATIONS
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for TRILOSTANE

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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
Bioenvision	MODRASTANE	trilostane	CAPSULE;ORAL	018719-001	Dec 31, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bioenvision	MODRASTANE	trilostane	CAPSULE;ORAL	018719-002	Dec 31, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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