Trilostane - Generic Drug Details

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
DailyMed Link:	trilostane at DailyMed

Recent Clinical Trials for trilostane

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

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

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

Market Dynamics and Financial Trajectory for Trilostane

Last updated: February 15, 2026

Market Overview

Trilostane, marketed primarily as Mitotane and Hefin, is primarily used in the treatment of cushings syndrome and certain adrenal tumors. Its market presence is limited compared to blockbuster drugs but remains vital within niche endocrine disorder treatments.

Manufacture and Indications

• Originally developed by Sterling Drug, now owned by Pfizer, for human use.
• Used off-label in veterinary medicine for canine hyperadrenocorticism.
• The drug’s application in veterinary medicine accounts for a significant part of its revenue.

Market Size and Growth

The global endocrine disorder treatment market was valued at approximately USD 12.6 billion in 2022, with narrow absorption for trilostane due to limited human indications and a stronger veterinary presence. The veterinary endocrinology segment, where trilostane is significant, is forecasted to grow at 6% annually through 2028.

Competitive Landscape

• No direct generic competitors for trilostane are FDA-approved yet, but multiple off-label and compounded formulations exist.
• Alternatives in human indications include ketoconazole, which has a more extensive generic pipeline.
• Veterinary market rivals include mitotane, osilodrostat, and other hormone modulators.

Regulatory Status

• In the United States, trilostane is prescribed off-label for veterinary use; no approved human indication exists.
• In Europe, it remains under clinical investigation for potential new indications.

Financial Trajectory

• Revenue Trends: Pfizer’s pharmacy division reports limited direct revenue; veterinary sales potentially account for USD 50-100 million globally, with growth driven by increasing pet ownership.
• Pricing: Veterinary formulations range from USD 1 to USD 5 per tablet, depending on dosage and market, with compounded versions often less expensive but less regulated.
• Research and Development: Limited pharmaceutical R&D dedicated specifically to trilostane suggests reliance on existing formulations. Any pipeline development is likely focused on veterinary applications, with potential human trials if new indications are pursued.

Market Drivers

1. Rising pet ownership: Increased awareness of endocrine disorders in dogs boosts veterinary demand.
2. Limited human treatment options: The absence of approved new drugs stimulates interest in repurposing trilostane.
3. Regulatory hurdles: Approval delays or restrictions for new indications limit market expansion.
4. Pricing dynamics: The use of compounded drugs in veterinary medicine suppresses margins versus branded formulations.

Market Challenges

• Patent expiration: No active patents prevent generic entry but also limit exclusivity-driven revenue.
• Regulatory approval: A lengthy and costly process for new human or veterinary indications.
• Competitive alternatives: Drugs like osilodrostat and ketoconazole cover similar indications with broader approvals or established markets.

Future Outlook

• Growth is expected primarily in veterinary applications due to demographics and pet healthcare expenditure.
• Human market expansion hinges on successful trials and regulatory approval.
• The global market may see a compound annual growth rate (CAGR) of 4-6% for veterinary trilostane over the next five years.

Key Takeaways

• Trilostane's revenue is concentrated mainly within the veterinary segment.
• Market growth is driven by pet health trends, with limited expansion prospects for human use without new indications.
• Competition mainly stems from off-label compounded products and alternative drugs.
• Investment and R&D are likely to focus on veterinary applications, with potential in human markets contingent on clinical development.

FAQs

1. What are the main uses of trilostane?
   Primarily used in veterinary medicine for canine hyperadrenocorticism; limited human use for adrenal tumors under clinical investigation.

2. Who are the major manufacturers of trilostane?
   Pfizer is the main producer for veterinary formulations; no recent approvals for new drugs or human indications.

3. How does market competition affect trilostane?
   Off-label use of compounded drugs and alternatives like osilodrostat and ketoconazole reduce market share potential.

4. What is the future growth outlook for trilostane?
   Limited in human applications; veterinary use expected to grow at 6% annually through 2028, driven by pet healthcare trends.

5. Are there regulatory concerns for expanding trilostane's indications?
   Yes, obtaining approvals involves clinical trials and regulatory review, which can be costly and time-consuming.

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Sources

1. MarketWatch, "Endocrine Disorder Treatment Market Forecast," 2023.
2. Pfizer Annual Report, 2022.
3. American Veterinary Medical Association, Pet Demographic Data, 2022.
4. European Medicines Agency, Clinical Trial Approvals, 2023.
5. GlobalData, Veterinary Pharmaceuticals Market Analysis, 2023.