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MODRASTANE

NDA

TRILOSTANE | N018719 | BIOENVISION INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2026-P-4061 Felix Pharmaceuticals Pvt. Ltd. submitted this petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an abbreviated new animal drug application for a generic oral suspension formulation of Trilostane for dogs that differs from the approved pioneer	Suitability	2026-04-17	Open	Felix Pharmaceuticals Pvt. Ltd.
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2026-P-0529 Felix Pharmaceuticals Pvt. Ltd., based in Dublin, Ireland, filed this Section 512(n)(3) suitability petition requesting permission to submit an abbreviated new animal drug application (ANADA) for a generic oral solution formulation of Trilostane for dogs, which would differ from the approved pioneer	Suitability	2026-01-16	Open	Felix Pharmaceuticals Pvt. Ltd.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

STERLING SPATRILOSTANE

DMF 196862006

ORGAMOL SAInactiveTRILOSTANE

DMF 60921985

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 60MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 31, 1984

No patent or exclusivity listings for this strength.

#002 — 30MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 31, 1984