Is there a generic for Trilostane?

The FDA Orange Book does not currently list an approved generic (ANDA) for Trilostane. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Trilostane?

MODRASTANE (NDA 018719, BIOENVISION) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Trilostane are approved?

Trilostane is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Trilostane

Trilostane is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:MODRASTANE · NDA 018719

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
MODRASTANE×2	BIOENVISION	NDA 018719	—	Dec 31, 1984

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Trilostane — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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