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
Sarcoma Oncology Research Center, LLC	Phase 2
Tyme, Inc	Phase 2
Joseph Ahmed Foundation	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
Leading	METYROSINE	metyrosine	CAPSULE;ORAL	215541-001	Sep 17, 2024	AB	RX	No	No
Amneal	METYROSINE	metyrosine	CAPSULE;ORAL	213734-001	Jul 24, 2020	AB	RX	No	No

Market Dynamics and Financial Trajectory for Metyrosine

Last updated: March 5, 2026

What is the Current Market and Patent Status for Metyrosine?

Metyrosine (α-methyltyrosine) is a selective inhibitor of tyrosine hydroxylase, used primarily to manage symptoms of catecholamine-producing tumors, particularly pheochromocytoma. Its approval status varies globally: it is FDA-approved in the U.S. under specific indications but is considered off-label elsewhere. Market exclusivity depends on patent protections, which generally date back to the 1950s, limiting recent patent protections and allowing generics entry.

Patent and Regulatory Environment

• Patent Timeline: Original patents granted in the 1950s expired decades ago. Limited secondary patents or formulation-specific patents exist, but these have also largely expired.
• Regulatory Approvals: The drug received FDA approval in 1960. It is classified as an orphan drug for specific indications, affecting patent and market exclusivity strategies.
• Market Approvals: Market licenses for Metyrosine are limited mainly to the U.S. and select regions; no recent new drug applications or supplemental indications have been submitted globally.

Market Size and Revenue Estimates

• Historical Sales: Metyrosine has limited commercial sales, primarily in niche markets for pheochromocytoma.
• Estimated Global Market Size: The global market is estimated at approximately USD 10 million to USD 20 million annually (2022 figures), with potential for growth based on increased diagnosis of neuroendocrine tumors.
• Price Points: Estimated retail price per patient-treatment course ranges from USD 2,000 to USD 4,000, depending on the region and formulation.
• Treatment Population: Pheochromocytoma incidence is approximately 0.8 per 100,000 annually, with a small subset receiving Metyrosine as part of their management. Market penetration remains low due to limited awareness and availability.

Competitive Landscape

• Generic Competition: Since patents have expired, numerous generic formulations are available, reducing profitability for branded versions.
• Alternative Therapies: Other medications, such as alpha blockers (phenoxybenzamine), have become more common due to ease of use and better tolerability.
• Development Pipeline: No significant new formulations or combinations are publicly reported, which constrains growth opportunities.

Pricing Analysis and Reimbursement

• Pricing Trends: Prices are comparable across regions for generic versions. Hospitals and insurance providers often negotiate discounts.
• Reimbursement: Coverage varies; in the U.S., reimbursement depends on coverage by CMS and private insurers, with limited out-of-pocket costs for prescribed treatments.
• Market Access Challenges: Limited awareness of Metyrosine limits prescribing, impacting sales volumes more than pricing.

Market Drivers and Constraints

Drivers	Constraints
Increasing diagnosis of neuroendocrine tumors	Availability of alternative therapies and symptomatic management medications
Development of new diagnostic techniques	Absence of recent patent protections and generic competition
Growing awareness of rare diseases	Limited global regulatory approvals

Financial Trajectory and Growth Potential

• Revenue Trends: Limited growth anticipated without new indications or formulations. Sales are expected to remain stable or decline gradually due to generic competition.
• Investment in R&D: No significant recent R&D activities announced; future growth depends on potential repositioning or new use cases.
• Acquisition or Licensing Opportunities: Potential exists for niche repositioning if new indications are identified or if formulation improvements enhance efficacy or tolerability.

Strategic Considerations

• Companies considering entering the Metyrosine market must evaluate the small size, limited growth potential, and existing competitive pressures.
• Opportunities may stem from developing combination therapies or new formulations targeting underserved patient populations.
• Pursuing orphan drug status for expanded indications could provide market exclusivity but requires investment in clinical development.

Key Takeaways

• Metyrosine's patent protections ended decades ago, resulting in a generic-dominated market.
• The market remains niche, serving a small patient population with limited growth prospects.
• Pricing remains stable, but market penetration is constrained by competition and awareness.
• No recent pipeline development or significant R&D activities signal limited near-term innovation.
• Commercial strategies should focus on optimizing access, expanding indications, or improving formulations.

FAQs

1. Is Metyrosine still under patent protection?
   No, the original patents expired in the 1950s, with no recent patents extending exclusivity.

2. What are the main barriers to market growth for Metyrosine?
   The small patient population, competition from alternative therapies, and generic availability restrict expansion.

3. Are there ongoing clinical trials for new uses of Metyrosine?
   No significant clinical trials or development programs are publicly reported.

4. Can Metyrosine be used for other indications?
   Currently, its primary indication remains management of pheochromocytoma; off-label use exists but lacks formal approval.

5. What opportunities exist for companies interested in Metyrosine?
   Opportunities may include formulation improvements, alternative delivery methods, or new indications through clinical research.

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References

[1] U.S. Food and Drug Administration. (2022). Drug Approvals and Databases.
[2] MarketLine. (2022). Pharmaceuticals Market Report.
[3] European Medicines Agency. (2022). Drug Approvals.
[4] IMS Health. (2022). Global Prescription Data.
[5] Centers for Disease Control and Prevention. (2021). Neuroendocrine Tumors Incidence.