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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

5 petitions (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2026-P-7889 · 4 docket documents Felix Pharmaceuticals Pvt. Ltd. submitted this petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act seeking permission to file an abbreviated new animal drug application for a generic chewable tablet formulation of Trilostane that differs from the pioneer product VETORYL CAPSU	Suitability	2026-07-16	Open	Felix Pharmaceuticals Pvt. Ltd.
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2026-P-4061 · 5 docket documents 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 at a strength of 20 mg/mL, which differs from t	Suitability	2026-04-17	Open	Felix Pharmaceuticals Pvt. Ltd.
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2026-P-0529 · 5 docket documents 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.
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2025-P-6404 · 5 docket documents 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 Trilostane soft chewable tablet that differs from the pioneer product Vetoryl (NADA 141-29	Suitability	2025-11-24	Granted	Felix Pharmaceuticals Pvt. Ltd.
Suitability Citizen Petition from NORBOOK LABORATORIES LIMITED FDA-2023-P-0851 · 6 docket documents Norbrook Laboratories Limited filed this suitability 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 Trilostane 20 mg/mL Oral Suspension, a generic version of the pioneer product Vetoryl Capsule	Suitability	2023-03-08	Granted	NORBOOK LABORATORIES LIMITED

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

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trilostane for Androgen-Independent Prostate Cancer NCT00181597	Phase 2	Completed	Genzyme, a Sanofi Company	24	2004-03 → 2006-01
Randomized Study of Letrozole and Trilostane for Medical Abortion NCT01615211	Phase 2	Terminated	Kristina Gemzell Danielsson	36	2012-05 → 2013-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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