MITOTANE - Generic Drug Details

What are the generic drug sources for mitotane and what is the scope of patent protection?

Mitotane is the generic ingredient in one branded drug marketed by Hra Pharma 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 mitotane. One supplier is listed for this compound.

Summary for MITOTANE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	23
Patent Applications:	7,449
What excipients (inactive ingredients) are in MITOTANE?	MITOTANE excipients list
DailyMed Link:	MITOTANE at DailyMed

Recent Clinical Trials for MITOTANE

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

Sponsor	Phase
National Cancer Center, Korea	Phase 2
Exvastat Ltd.	Phase 2
Simbec Orion	Phase 2

See all MITOTANE clinical trials

Pharmacology for MITOTANE

Mechanism of Action

Cytochrome P450 3A4 Inducers

Medical Subject Heading (MeSH) Categories for MITOTANE

Antineoplastic Agents, Hormonal

Anatomical Therapeutic Chemical (ATC) Classes for MITOTANE

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for MITOTANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hra Pharma	LYSODREN	mitotane	TABLET;ORAL	016885-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

EU/EMA Drug Approvals for MITOTANE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
HRA Pharma Rare Diseases	Lysodren	mitotane	EMEA/H/C/000521 Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.	Authorised	no	no	no	2004-04-28

MITOTANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Mitotane

Introduction to Mitotane

Mitotane, also known by its trade name Lysodren, is a specialized chemotherapy drug primarily used in the treatment of adrenocortical carcinoma (ACC), a rare and aggressive form of cancer affecting the adrenal glands. Here, we delve into the market dynamics and financial trajectory of mitotane, highlighting key drivers, regional performances, and future projections.

Global Market Size and Growth

The global mitotane market is poised for significant growth. As of 2024, the market is valued at approximately $17.6 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.4% to reach $29.9 million by 2034[1].

Key Market Growth Drivers

Several factors are driving the growth of the mitotane market:

• Increasing Awareness and Prevalence of Adrenal Gland Cancer: Rising awareness of cancer and the need for proactive treatments are driving demand for mitotane. The drug's efficacy in treating ACC, particularly when surgery is not sufficient, makes it a critical component in cancer treatment protocols[1].
• Orphan Drug Status: Mitotane's orphan drug designation extends market exclusivity, reducing the risk of generic competition and encouraging pharmaceutical investments in its development and marketing, especially in regions like China[1].
• Robust Healthcare Infrastructures: Strong healthcare infrastructures in developing countries, coupled with unmet medical needs, present lucrative opportunities for mitotane producers to expand their revenue streams[1].

Regional Market Performance

North America

North America dominates the global mitotane market, driven by an established healthcare infrastructure, advanced medical research capabilities, and a high prevalence of ACC. The region is home to numerous academic and research institutions that contribute significantly to clinical research and development of mitotane. This strong infrastructure, regulatory oversight, and patient support mechanisms collectively enhance the market outlook for mitotane in North America[4].

United States

In the United States, the mitotane market is valued at $5.6 million in 2024 and is projected to grow at a CAGR of 5.2% to reach $9.32 million by 2034. The favorable regulatory environment and the increasing prevalence of adrenal gland cancer are key factors driving this growth[1].

China

China's mitotane market is also growing, with a market value of $540 thousand in 2024 and a projected growth rate of 5.3% CAGR to reach $900 thousand by 2034. The orphan drug status of mitotane in China mitigates the risk of generic competition and fosters a favorable regulatory environment, encouraging pharmaceutical investments[1].

Distribution Channels

The distribution of mitotane is evolving, with various channels contributing to its market growth:

• Specialty Clinics: This segment is expected to expand at a CAGR of 4.8% from 2024 to 2034, driven by the specialized nature of ACC treatment[1].
• Online Pharmacies: The online pharmacies segment is anticipated to be the fastest-growing, with a CAGR of 4.7% during the forecast period. This growth is attributed to the convenience and accessibility offered by online platforms, particularly beneficial for patients with limited mobility or those living in remote areas[4].

Competitive Landscape

The mitotane market is characterized by a competitive landscape involving several key players:

• HRA Pharma Rare Diseases
• Bristol-Myers Squibb Company
• TherDose Pharma Pvt. Ltd.
• Hikma Pharmaceuticals
• Tizig Pharma Pvt. Ltd.
• Aspen Pharmacare
• Prime Therapeutics
• Novartis Pharmaceuticals Corporation

These companies are engaged in continuous innovation, partnerships, and strategic developments to enhance the efficacy, safety, and market penetration of mitotane[1][4].

Clinical Efficacy and Side Effects

Mitotane has been clinically proven to prolong recurrence-free survival (RFS) in patients with radically resected ACC, as evidenced by long-term follow-up studies. The drug's benefit in RFS is observed regardless of the tumor's hormone secretory status[2].

However, mitotane treatment is not without side effects. Common side effects include gastrointestinal disturbances, neurologic symptoms, leukopenia, and hepatic disorders. To address these issues, novel formulations such as oral (recrystallization from microemulsion, nanosuspension, liposomal) and injectable (micellar) forms are being developed to improve the drug's efficacy and tolerability[5].

Future Projections and Opportunities

The mitotane market is expected to expand beyond its current indications, potentially treating other rare cancers and conditions. This broadening of applications under the orphan drug framework represents a promising growth opportunity.

• Emerging Indications: Further research and clinical trials may uncover new indications for mitotane, extending its market penetration and revenue prospects[1].
• Combination Therapies: Mitotane's use in combination therapies and its application in rare cancer types are expected to broaden treatment possibilities and enhance market growth[1].

Key Takeaways

• The global mitotane market is valued at $17.6 million in 2024 and is projected to grow to $29.9 million by 2034 at a CAGR of 5.4%.
• North America, particularly the United States, dominates the market due to its strong healthcare infrastructure and high prevalence of ACC.
• China's market is driven by the orphan drug status of mitotane, which reduces generic competition and fosters pharmaceutical investments.
• Online pharmacies are emerging as a significant distribution channel, offering convenience and accessibility.
• Mitotane's clinical efficacy in prolonging RFS in ACC patients is well-documented, despite associated side effects.
• Future growth opportunities include new indications and combination therapies.

FAQs

Q: What is the current market size of the global mitotane market? A: The global mitotane market is valued at approximately $17.6 million in 2024[1].

Q: What is the projected growth rate of the mitotane market from 2024 to 2034? A: The mitotane market is expected to grow at a CAGR of 5.4% from 2024 to 2034[1].

Q: Which region dominates the global mitotane market? A: North America, particularly the United States, dominates the global mitotane market due to its established healthcare infrastructure and high prevalence of ACC[4].

Q: What are the common side effects associated with mitotane treatment? A: Common side effects include gastrointestinal disturbances, neurologic symptoms, leukopenia, and hepatic disorders[5].

Q: How is the orphan drug status of mitotane impacting the market in China? A: The orphan drug status of mitotane in China reduces the risk of generic competition and fosters a favorable regulatory environment, encouraging pharmaceutical investments[1].

Cited Sources

1. Fact.MR, Mitotane Market Share and Growth Analysis - 2034, https://www.factmr.com/report/mitotane-market
2. PubMed, Long-Term Outcomes of Adjuvant Mitotane Therapy in Patients With Adrenocortical Carcinoma, https://pubmed.ncbi.nlm.nih.gov/28324035/
3. DelveInsight, Adrenocortical Carcinoma Market Forecast Report 2034, https://www.delveinsight.com/report-store/adrenocortical-carcinoma-market
4. Growth Plus Reports, Mitotane Drug Market 2031 - $22.05 million Revenue Forecast, https://www.growthplusreports.com/report/mitotane-drug-market/9229
5. MDPI, Advanced Adrenocortical Carcinoma: From Symptoms Control to Palliative Care, https://www.mdpi.com/2072-6694/14/23/5901