Tolcapone - Generic Drug Details

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

Tolcapone is the generic ingredient in two branded drugs marketed by Bausch, Alvogen, Dr Reddys Labs Sa, Novast Labs, and Ph Health, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for tolcapone. Three suppliers are listed for this compound.

Summary for tolcapone

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	26
Patent Applications:	8,188
Drug Prices:	Drug price trends for tolcapone
What excipients (inactive ingredients) are in tolcapone?	tolcapone excipients list
DailyMed Link:	tolcapone at DailyMed

See drug prices for tolcapone

Recent Clinical Trials for tolcapone

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

Sponsor	Phase
University of Colorado, Denver	Phase 2
University of California, Berkeley	Early Phase 1
University of California, San Francisco	Early Phase 1

See all tolcapone clinical trials

Pharmacology for tolcapone

Drug Class	Catechol-O-Methyltransferase Inhibitor
Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for tolcapone

N04BX	Other dopaminergic agents
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for tolcapone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	TOLCAPONE	tolcapone	TABLET;ORAL	204584-001	Mar 26, 2015		DISCN	No	No
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-002	Jan 29, 1998		DISCN	No	No
Alvogen	TOLCAPONE	tolcapone	TABLET;ORAL	207729-001	Jul 29, 2020		DISCN	No	No
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-001	Jan 29, 1998	AB	RX	Yes	Yes
Dr Reddys Labs Sa	TOLCAPONE	tolcapone	TABLET;ORAL	210095-001	Aug 1, 2019		DISCN	No	No
Novast Labs	TOLCAPONE	tolcapone	TABLET;ORAL	208937-001	Aug 7, 2018	AB	RX	No	No

Expired US Patents for tolcapone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-001	Jan 29, 1998	5,236,952
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-002	Jan 29, 1998	5,476,875
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-002	Jan 29, 1998	5,236,952
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-001	Jan 29, 1998	5,476,875

EU/EMA Drug Approvals for tolcapone

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Viatris Healthcare Limited	Tasmar	tolcapone	EMEA/H/C/000132Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors.Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa.Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.	Authorised	no	no	no	1997-08-27

Market Dynamics and Financial Trajectory for Tolcapone

Last updated: July 28, 2025

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Introduction

Tolcapone, marketed as Tasmar, is a central nervous system-active drug primarily indicated for Parkinson’s disease management. As a COMT (catechol-O-methyltransferase) inhibitor, tolcapone enhances the efficacy of levodopa by prolonging its half-life, thereby improving motor fluctuations in Parkinson's patients. Despite its therapeutic benefits, its market presence has been constrained by safety concerns. Analyzing tolcapone’s current market dynamics and forecasting its financial trajectory involves understanding regulatory, competitive, and clinical landscapes.

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Regulatory and Safety Landscape

The commercialization of tolcapone has been significantly influenced by its safety profile. High-profile adverse effects, particularly hepatotoxicity, prompted the FDA to restrict its use in 1998, limiting it to patients unresponsive to other therapies [1]. The European Medicines Agency (EMA) later adopted similar restrictions. These safety concerns have curtailed widespread adoption, creating barriers to market expansion and driving a cautious regulatory environment.

The safety profile continues to impact the drug’s market. Current prescribing guidelines emphasize careful liver function monitoring, which limits its appeal to clinicians and patients preferring safer alternatives. The risk-benefit assessment remains central to regulatory considerations, influencing potential label expansions or restrictions.

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Market Demand and Clinical Adoption

While tolcapone's efficacy in managing motor fluctuations remains undisputed in clinical circles, its utilization is predominantly confined to refractory cases. This conservative prescribing trend is shaped by safety concerns and the availability of newer dopamine agonists or COMT inhibitors with more favorable safety profiles, such as entacapone and opicapone.

Market penetration is further hampered by the advent of these alternatives—as well as non-pharmacologic therapies—leading to a niche positioning for tolcapone. Nonetheless, in specialized centers and among patients with limited options, tolcapone's role persists, especially in advanced Parkinson's management.

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Competitive Landscape

The competitive environment is characterized by several COMT inhibitors with improved safety profiles. Entacapone (Comtan) has long been the primary alternative, offering comparable efficacy with a more favorable safety profile and more straightforward dosing. Opicapone (Ongentys), approved by the European Medicines Agency in 2016 and by the FDA in 2020, offers once-daily dosing and a lower hepatotoxicity risk, further diminishing tolcapone's market share.

This competitive pressure, combined with safety-related prescribing hesitations, constrains tolcapone's growth. Nevertheless, its unique pharmacodynamics—particularly its ability to penetrate the blood-brain barrier more effectively—may sustain niche interest where specific patient needs are unmet.

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Economic and Financial Trajectory

Historical Revenue and Market Share

Historically, tolcapone's sales have been limited due to safety restrictions and competition. The initial launch in the 1990s experienced moderate uptake, primarily in the US and Europe. However, post-1998 regulatory restrictions led to significant revenue declines, and sales plateaued or diminished sharply thereafter.

Patent and Market Exclusivity

Tolcapone's patent protection has long expired, with its initial U.S. patent expiring in the early 2000s. Generic formulations proliferated, further decreasing potential revenue. Its status as an off-patent drug makes it less attractive for investment and development, with most pharmaceutical companies favoring newer agents.

Potential for Market Rebound

Future financial growth hinges on regulatory resourcement efforts—such as seeking expanded indications, improving safety profiles, or developing novel formulations designed for better safety. Recent preclinical advances suggest that innovative delivery methods or adjunct therapies could mitigate hepatotoxicity, possibly rekindling interest.

However, these strategies face hurdles, including high R&D costs and uncertain regulatory pathways. The current market’s structural constraints imply a predominantly niche role, with limited upside unless significant safety hurdles are resolved.

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Emerging Developments and Future Outlook

Research and Development

Investigations into modified formulations or combination therapies aim to reduce adverse effects, potentially expanding tolcapone’s use. Clinical trials exploring hepatoprotective agents or biomarker-guided dosing could offer pathways to mitigate risks.

Regulatory Prospects

Regulatory agencies remain cautious. Any attempts at re-labeling or expanding indications necessitate rigorous safety data—likely involving extensive clinical trials. Given current trends favoring drugs with proven safety, the prospects for tolcapone resurgence remain modest.

Market Penetration in Niche Segments

A targeted approach—focusing on treatment-resistant cases or personalized medicine tailored to genetic profiles—may carve small, sustainable segments for tolcapone. But overall market share remains limited.

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Conclusion

The market dynamics surrounding tolcapone are predominantly influenced by safety concerns, competitive alternatives, and regulatory constraints. Its financial trajectory faces stagnation, characterized by limited sales, minimal growth prospects, and a diminished role in Parkinson’s therapy due to superior safety profiles of other COMT inhibitors. For stakeholders, the key lies in navigating the balance between advancing safety measures and leveraging niche applications, should innovative formulations or indications materialize.

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Key Takeaways

• Safety concerns, particularly hepatotoxicity, remain the primary obstacle limiting tolcapone’s broader market adoption.
• The availability of newer, safer COMT inhibitors like opicapone and entacapone restricts tolcapone's market share.
• Patent expiration and generic availability have reduced potential revenue streams, maintaining tolcapone as a niche product.
• Future financial growth hinges on breakthroughs in safety profile or targeted niche applications—both of which face significant challenges.
• The drug’s role is likely to persist in specialized settings, with limited prospects for significant market expansion.

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FAQs

Q1: Why was tolcapone restricted by regulatory agencies?
A1: Tolcapone was linked to severe hepatotoxicity, including rare cases of liver failure, prompting restrictions and severe monitoring requirements to mitigate risks.

Q2: How does tolcapone compare to other COMT inhibitors?
A2: Tolcapone penetrates the blood-brain barrier more effectively but carries higher hepatotoxicity risk; in contrast, entacapone and opicapone offer safer profiles but with different pharmacodynamics.

Q3: Is there any ongoing research to improve tolcapone’s safety profile?
A3: Limited, but preclinical studies explore modified formulations and adjunct therapies aimed at reducing hepatotoxicity, though none have advanced significantly.

Q4: What is the market outlook for tolcapone in the next five years?
A4: It is expected to remain confined to niche markets, with minimal growth, primarily due to safety concerns and competition from newer agents.

Q5: Could patent protections be renewed or extended for tolcapone?
A5: Unlikely, as patents have expired, and no new formulations have been filed to extend exclusivity, rendering the drug generic and less economically attractive.

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References

1. Food and Drug Administration. FDA ALERT: Liver Injury Associated with Parkinson’s Disease Medication Tolcapone (Tasmar). 1998.