mitotane: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Esteve	LYSODREN	mitotane	TABLET;ORAL	016885	NDA	ESTEVE PHARMACEUTICALS, S.A.	68118-080-60	1 BOTTLE in 1 CARTON (68118-080-60) / 100 TABLET in 1 BOTTLE	1978-10-15
Esteve	LYSODREN	mitotane	TABLET;ORAL	016885	NDA	HRA Pharma Rare Diseases	76336-080-60	1 BOTTLE in 1 CARTON (76336-080-60) / 100 TABLET in 1 BOTTLE	1978-10-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 29, 2026

Mitotane supply is concentrated in a small number of established manufacturers and distributors. In the U.S., access is typically routed through branded product holders and specialty distributors rather than broad commodity chemical channels. For procurement and continuity planning, the key practical question is which organizations hold the regulated supply chain for mitotane tablets and how many independent production sites are qualified for commercial demand.

Who supplies mitotane tablets in the US?

What are the main commercial sources

Mitotane is marketed in the U.S. as Lysodren (mitotane) for adrenocortical carcinoma. Supply is organized around the product’s authorized marketing channel and specialty distribution networks under FDA oversight and U.S. labeling requirements (Orange Book listing governs ANDA ecosystem for generics).

Primary practical sourcing path (U.S.)

Branded manufacturer and its distribution partners
Specialty wholesalers and 340B/retail specialty channels that carry Lysodren inventory
Patient access programs that coordinate limited-channel dispensing for shortages (when present)

How procurement typically works

Hospital and specialty pharmacy procurement relies on contracted buy rates from specialty distributors
Smaller wholesalers may carry inventory during normal supply but are exposed during manufacturing outages
Substitution is constrained by product equivalence rules: mitotane is a narrow-use oncology endocrine therapy with limited interchangeable supply

Featured snippet answer: In the U.S., mitotane supply is anchored by Lysodren distribution through branded supply channels and specialty wholesalers rather than a broad multi-source generic market structure.

How many mitotane manufacturers supply the global market?

Supplier concentration

Global commercial supply of mitotane is limited by:

Small treated-patient population driving low volume economics
Complex regulatory release testing and batch QA expectations
Long manufacturing timelines and specialized quality systems for a niche cytotoxic-like endocrine agent

Result: The supplier base is narrow, which increases continuity risk during:

Batch failures
Regulatory hold-ups
Raw material lead-time interruptions

Geographic sourcing reality

For international procurement, buyers usually source through:

Local authorized distributors tied to the brand’s authorized importer/exporter
Regional wholesalers with access to the brand supply contract
Limited number of parallel distribution routes, when permitted

What is the Orange Book status of mitotane (Lysodren) and what does it imply for suppliers?

Orange Book determines generic entry and supply expansion

The FDA Orange Book lists branded products and any approved generic/bioequivalent versions, along with patent information tied to exclusivity and formulation/method claims.

If mitotane has limited or no approved ANDA competitors, supply remains concentrated in branded channels.

Featured snippet answer: Orange Book status is the gating item for whether additional generic suppliers exist. Where few or no ANDAs are approved, procurement remains dependent on brand-linked supply.

What supplier risks exist for mitotane procurement (shortages, lead times, single-site exposure)?

Single-site and batch-failure exposure

In niche, low-volume oncology manufacturing, continuity risk often comes from:

Single active commercial manufacturing site(s)
Tight intermediate and packaging material availability
Low buffer inventory at specialty distributors

Contracting and inventory planning implications

Procurement teams typically manage mitotane availability using:

Longer lead-time forecasts
Safety stock at specialty pharmacy or hospital pharmacy level
Blanket purchase agreements where permitted
Preferential allocation clauses tied to fulfillment priority

Regulatory and quality events that disrupt supply

Supply interruptions most often trace back to:

Manufacturing change controls
cGMP inspection outcomes
Stability/labeling batch release delays
Documentation holds (e.g., deviation investigations)

How does mitotane active ingredient supply (API) differ from finished-dose tablet supply?

API availability may not translate into finished-dose market access

Mitotane procurement can be conceptually separated into:

API supply (bulk mitotane)
Finished-dose tablets (what prescribers dispense and what Orange Book governs)

Even if API exists through chemical procurement channels, finished-dose availability is the binding constraint because:

Finished-dose cGMP and FDA labeling control commercialization
Tablets require validated formulation, stability, and labeling compliance
Substitution is not equivalent to “API-only” sourcing

Procurement lens

Hospitals and specialty pharmacies buy finished-dose products.
Manufacturers and contract development partners manage API qualification and incoming QC testing within approved supply agreements.

Who distributes mitotane tablets to specialty pharmacies and hospitals?

Distribution channel structure

Mitotane distribution typically flows through:

Authorized specialty wholesalers
Specialty pharmacy networks with oncology endocrine treatment expertise

Distribution is not just logistics. It includes:

Temperature and handling controls consistent with product labeling
Serial-level tracking as required by supply chain policies
Lot-level traceability for recalls and quality events

What buyers should check

Availability by NDC/label strength (since strength and labeling are substitution constraints)
Lead time by lot and whether multi-lot fulfillment is possible
Recall history by lot through established distributor quality feeds

What are the practical “supplier candidates” to approach for mitotane?

Categories of entities that actually move mitotane inventory

Authorized specialty distributors carrying Lysodren tablets
Specialty pharmacies that maintain oncology dispensing contracts
Wholesalers with oncology allocation agreements for low-frequency supply

Categories that often fail as direct sourcing solutions

Generic API chemical brokers without finished-dose regulatory status
Non-authorized distributors that cannot provide complete lot documentation
Channels that cannot map product to FDA-labeled NDC/strength

Featured snippet answer: In practice, the workable “supplier” is the authorized distributor or specialty pharmacy with finished-dose Lysodren inventory, with documentation and lot traceability.

When do mitotane generics or new suppliers become likely based on patent and exclusivity timelines?

Supply expansion depends on ANDA approval

Supplier diversification is driven by:

ANDA approval for mitotane tablets
Paragraph IV challenges (if any) that accelerate generic entry
Patent expiration for relevant formulation and method patents

Why timelines matter for procurement strategy

Even without an imminent generic approval, procurement teams plan for:

Brand manufacturing disruptions around known change controls
Potential short-term allocation during demand spikes or production downtime

Featured snippet answer: New supplier entries are typically an ANDA approval story, not a “raw API becomes available” story.

How does mitotane compare with other niche oncology drugs on supplier count and shortage risk?

Relative risk drivers

Compared with higher-volume oncology therapies, mitotane has:

Smaller patient base, reducing the economic incentive for multiple independent manufacturers
Higher procurement fragility in specialty distribution networks
Higher dependence on brand supply continuity

Net effect

Procurement for mitotane has a higher “single source” feel than many mainstream oncology drugs, even if more than one distributor exists.

Key Takeaways

Mitotane tablet supply is concentrated in brand-linked regulated channels, with procurement primarily routed through authorized specialty distributors and specialty pharmacies.
Orange Book status is the determinant of whether true additional FDA-approved generic suppliers exist; where generic competition is limited, supplier diversification is limited.
Continuity risk is elevated due to low-volume economics, potential single-site exposure, and batch-release sensitivities.
Procurement that treats mitotane like a commodity chemical often fails; the binding constraint is finished-dose regulated supply (NDC-labeled tablets) with lot traceability.

FAQs

1) Who sells mitotane tablets (Lysodren) to hospitals in the U.S.?
Authorized specialty wholesalers and specialty pharmacies that carry Lysodren inventory under FDA-labeled NDC/strength.

2) Can I source mitotane by buying the API instead of tablets?
API availability does not replace the need for FDA-compliant finished-dose tablets for clinical use and dispensing substitution constraints.

3) What is the Orange Book significance for finding additional mitotane suppliers?
Orange Book identifies whether ANDAs exist and how patent/exclusivity timelines affect the probability of new FDA-approved tablet suppliers.

4) What procurement steps reduce mitotane shortage exposure?
Longer lead-time forecasting, safety stock planning via specialty channels, and allocation-aware contracting with authorized distributors.

5) What triggers mitotane supply disruptions most often?
Manufacturing batch release delays, stability documentation issues, quality deviations that place lots on hold, and packaging/labeling constraints tied to cGMP controls.

References (APA)

No sources were provided in the prompt, and no verifiable supplier list, distributor names, NDC-linked sourcing, or FDA Orange Book entries were included.

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