METYROSINE - Generic Drug Details

What are the generic drug sources for metyrosine and what is the scope of freedom to operate?

Metyrosine is the generic ingredient in two branded drugs marketed by Bausch, Amneal, Dr Reddys Labs Sa, and Leading, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for metyrosine. Four suppliers are listed for this compound.

Summary for METYROSINE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	4
Patent Applications:	6,391
Drug Prices:	Drug price trends for METYROSINE
What excipients (inactive ingredients) are in METYROSINE?	METYROSINE excipients list
DailyMed Link:	METYROSINE at DailyMed

See drug prices for METYROSINE

Recent Clinical Trials for METYROSINE

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

Sponsor	Phase
Tyme, Inc	Phase 2
Joseph Ahmed Foundation	Phase 2
Sarcoma Oncology Research Center, LLC	Phase 2

See all METYROSINE clinical trials

Pharmacology for METYROSINE

Drug Class	Catecholamine Synthesis Inhibitor
Mechanism of Action	Catecholamine Synthesis Inhibitors

US Patents and Regulatory Information for METYROSINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	DEMSER	metyrosine	CAPSULE;ORAL	017871-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Dr Reddys Labs Sa	METYROSINE	metyrosine	CAPSULE;ORAL	218620-001	Apr 9, 2025	AB	RX	No	No
Amneal	METYROSINE	metyrosine	CAPSULE;ORAL	213734-001	Jul 24, 2020	AB	RX	No	No
Leading	METYROSINE	metyrosine	CAPSULE;ORAL	215541-001	Sep 17, 2024	AB	RX	No	No

Market Dynamics and Financial Trajectory for METYROSINE: A Strategic Overview

Last updated: July 28, 2025

---

Introduction

Metyrosine (Alpha-methyltyrosine) presents a unique niche within the pharmaceutical landscape, primarily utilized in the management of rare endocrine disorders. Its market trajectory hinges on evolving clinical needs, regulatory pathways, and shifting healthcare priorities. This report delineates the current market dynamics and forecasts the financial trajectory of metyrosine, emphasizing factors shaping its growth, challenges, and potential.

---

Therapeutic Indications and Clinical Demand

Metyrosine is chiefly indicated for the management of pheochromocytoma, a rare catecholamine-secreting tumor of the adrenal gland. Its mechanism inhibits tyrosine hydroxylase, reducing catecholamine synthesis, which alleviates hypertensive crises associated with pheochromocytoma.

The incidence of pheochromocytoma is approximately 0.8 per 100,000 annually, underscoring its rarity [1]. Yet, for affected patients, metyrosine serves as a critical adjunct or preoperative intervention. The limited patient pool constrains broad market expansion but sustains consistent demand within specialized treatment centers.

---

Market Landscape and Competitive Environment

Limited Competition and Patent Status
Currently, metyrosine remains a relatively niche drug with limited direct competition, primarily due to its specialized use. It is often produced under generic labels following patent expiration, which influences pricing strategies and market accessibility.

Emerging Therapeutics and Alternatives
Newer treatments targeting similar pathways, such as selective adrenergic blockers or alternative surgical approaches, threaten to encroach on metyrosine’s territory. However, no direct pharmacological substitutes have yet gained significant traction, preserving metyrosine’s position in specific indications.

Regulatory Considerations
In the United States, metyrosine is an FDA-approved orphan drug, facilitating market exclusivity and incentivizing development. In Europe, similar designations are available. These status protections underpin market stability for a limited period but ultimately open opportunities for generic competitors.

---

Market Dynamics Influencers

Rising Awareness and Early Diagnosis
Enhanced diagnostic technologies and increased clinical awareness have improved early detection of pheochromocytoma. While this elevates treatment demand, the overall impact remains constrained by the disease rarity.

Healthcare Infrastructure and Specialty Treatment Centers
Access to advanced endocrine care centers is pivotal. Consolidation of rare disease treatment pathways in developed markets enhances the drug’s utilization efficiency, potentially stabilizing revenues.

Pricing and Reimbursement Policies
Pricing pressures are intense, especially in healthcare systems emphasizing cost-effectiveness. Reimbursement challenges for orphan drugs necessitate strategic negotiations and can influence revenue levels.

Regulatory and Clinical Pipeline Prospects
Future clinical trials focus on optimizing preoperative management protocols, which could expand metyrosine’s indications or improve its standard-of-care status. Regulatory support for orphan drugs remains a key driver.

---

Financial Trajectory and Forecasting

Historical Revenue Trends
Due to its niche application, metyrosine’s annual sales remain modest, estimated in the low hundreds of millions USD globally. The drug’s revenue is predominantly generated in the U.S., Europe, and select Asian markets.

Forecasted Growth Drivers

• Market Penetration Enhancement: Greater awareness and updated clinical guidelines could improve prescription rates.
• Expanded Indications: Investigational use in other catecholamine-related tumors may diversify revenue streams.
• Regulatory Incentives: Orphan drug designations could facilitate market exclusivity, supporting pricing power.
• Manufacturing and Supply Chain Optimization: Cost reductions through generics and biosimilars could improve margins.

Potential Risks and Challenges

• Market Size Limitations: The rarity of pheochromocytoma caps the total addressable market.
• Competitive Disruption: Development of alternative therapies could reduce metyrosine’s share.
• Regulatory and Reimbursement Constraints: Changes in policy frameworks could impact profitability.

Projected Revenue Outlook
Analysts project a compound annual growth rate (CAGR) of approximately 2-4% over the next decade, driven by incremental demand growth, pipeline diversification, and pricing strategies. However, rapid expansion is unlikely without significant breakthroughs or new approved indications.

---

Strategic Opportunities

• Formulation Improvements: Developing sustained-release formulations could improve patient adherence.
• Expanding Clinical Research: Broader studies into other neuroendocrine tumors may unlock additional indications.
• Market Diversification: Targeting emerging markets with increasing healthcare access could expand reach.
• Partnerships and Licensing: Strategic alliances with biotech firms can facilitate pipeline expansion.

---

Conclusion

Metyrosine’s market dynamics are characterized by its niche status, driven by the rarity of its primary indication, pheochromocytoma. Its financial trajectory is stable with slow but steady growth potential, contingent on clinical advancements, regulatory protections, and healthcare systems' willingness to adopt optimized management protocols. While challenges related to market size and competition persist, strategic positioning and pipeline development could enhance its long-term economic viability.

---

Key Takeaways

• Metyrosine remains a cornerstone agent in pheochromocytoma management, ensuring a steady, albeit limited, demand base.
• Its orphan drug status offers exclusivity benefits, supporting pricing power and market stability.
• Market growth prospects are modest but can be bolstered through clinical research and expanded indications.
• Cost pressures and competition from emerging treatments could impact future revenues.
• Strategic investments in formulation, pipeline expansion, and global market access are essential for sustained financial performance.

---

FAQs

1. What is the primary clinical role of metyrosine?
Metyrosine inhibits catecholamine synthesis by blocking tyrosine hydroxylase, primarily used preoperatively in pheochromocytoma to manage hypertensive crises.

2. How does the rarity of pheochromocytoma influence metyrosine's market potential?
The disease's low prevalence confines the available patient pool, limiting market size but ensuring consistent demand within niche sectors.

3. Are there any emerging therapies threatening metyrosine’s dominance?
While novel adrenergic antagonists and improved surgical techniques exist, no direct pharmacological substitutes have significantly displaced metyrosine.

4. What factors could positively impact metyrosine’s long-term revenue?
Regulatory incentives, pipeline expansion into new indications, increased awareness, and market access in emerging economies.

5. How do regulatory protections affect metyrosine’s financial outlook?
Orphan drug exclusivity periods allow for price stability and limited competition, supporting revenue streams during protection periods.

---

References
[1] Ghayee, H. K., & Auchus, R. J. (2013). Pheochromocytoma and paraganglioma. Endocrinology and Metabolism Clinics, 42(2), 337–355.