TOLCAPONE - Generic Drug Details

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

Tolcapone is the generic ingredient in two branded drugs marketed by Bausch, Alvogen, Dr Reddys Labs Sa, Endo Operations, and Novast Labs, 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:	108
Clinical Trials:	25
Patent Applications:	6,307
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
Dr Reddys Labs Sa	TOLCAPONE	tolcapone	TABLET;ORAL	210095-001	Aug 1, 2019		DISCN	No	No
Endo Operations	TOLCAPONE	tolcapone	TABLET;ORAL	204584-001	Mar 26, 2015		DISCN	No	No
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-001	Jan 29, 1998	AB	RX	Yes	Yes
Alvogen	TOLCAPONE	tolcapone	TABLET;ORAL	207729-001	Jul 29, 2020		DISCN	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
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-002	Jan 29, 1998
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-002	Jan 29, 1998
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-001	Jan 29, 1998

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/000132 Tasmar 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

TOLCAPONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tolcapone

Introduction

Tolcapone, a potent and reversible inhibitor of catechol O-methyltransferase (COMT), is a crucial adjunct therapy in the treatment of Parkinson's disease (PD). Here, we delve into the market dynamics and financial trajectory of tolcapone, exploring its current market size, growth prospects, key drivers, challenges, and future opportunities.

Current Market Size and Growth Prospects

As of 2022, the global market for COMT inhibitors, which includes tolcapone, was estimated to be worth USD 948.5 million. This market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 8.60% from 2023 to 2030, reaching USD 1835.16 million by 2030[1].

Market Leadership

Tolcapone is the most popular category of product type within the COMT inhibitors market. Its dominance can be attributed to its efficacy in enhancing the therapeutic benefits of levodopa, a primary treatment for Parkinson’s disease[1].

Indication and Combination Therapy

Parkinson’s disease is the leading indication for tolcapone, and it is often used in combination with levodopa. The levodopa combination therapy segment is expected to exhibit the highest CAGR during the forecast period, highlighting the synergistic benefits of these treatments when used together[1].

Pharmacokinetics and Pharmacodynamics

Tolcapone is characterized by its rapid absorption and elimination, following linear and dose-proportional pharmacokinetics. When administered with levodopa and a decarboxylase inhibitor, tolcapone increases the relative bioavailability and plasma elimination half-life of levodopa, leading to more stable plasma levels and reduced formation of 3-O-methyldopa[2].

Regional Market

The COMT inhibitors market, led by tolcapone, is predominantly driven by North America. This region's strong healthcare infrastructure, high prevalence of Parkinson’s disease, and favorable reimbursement policies contribute to its market leadership[1].

Key Market Participants

The global market for COMT inhibitors, including tolcapone, is competitive with several key players such as Orion Corporation, Roche, AbbVie Inc., Acadia Pharmaceuticals, Amneal Pharmaceutical, UCB, Teva Pharmaceutical, Novartis AG, and Lundbeck A/S[1].

Drivers of Market Growth

Several factors are driving the growth of the tolcapone market:

• Increasing Use in Supplementary Therapy: The growing use of COMT inhibitors as supplementary therapy for treating Parkinson’s disease and other conditions, such as ADHD symptoms, is a significant driver.
• Research into Cognitive Benefits: Ongoing research into the potential of COMT inhibitors to improve focus, memory, and cognitive function further propels market growth[1].

Challenges

Despite the growth prospects, the market faces several challenges:

• Reimbursement Issues: Variability in insurance coverage and reimbursement challenges affect patient access to COMT inhibitors.
• Disease Complexity: The complexity of Parkinson’s disease and potential drug-drug interactions pose significant challenges[1].

Market Opportunities

The tolcapone market presents several opportunities for growth:

• Exploring New Indications: Investigating the potential uses of currently available COMT inhibitors for other medical disorders could expand the market.
• Development of Biologic COMT Inhibitors: Research into the development of biologic COMT inhibitors could offer improved therapeutic benefits and further market expansion[1].

Financial Trajectory

The financial trajectory of tolcapone is closely tied to the overall growth of the COMT inhibitors market. With a projected CAGR of 8.60% from 2023 to 2030, the market is expected to more than double in size. This growth will be driven by increasing demand, expanding indications, and advancements in therapeutic applications.

Impact on Generic Drug Market

The dynamics of the generic drug market also influence the financial trajectory of tolcapone. As generic versions of tolcapone become available, competition is expected to increase, leading to lower prices. However, as noted in studies on generic drug industry dynamics, prices tend to remain above long-run marginal costs until there are eight or more competitors in the market[3].

Conclusion

Tolcapone, as a leading COMT inhibitor, is poised for significant growth driven by its efficacy in treating Parkinson’s disease and potential applications in other medical conditions. Despite challenges related to reimbursement and disease complexity, the market is expected to expand substantially, offering lucrative opportunities for pharmaceutical companies.

Key Takeaways

• The global COMT inhibitors market, led by tolcapone, is expected to grow at a CAGR of 8.60% from 2023 to 2030.
• Tolcapone is the most popular product type within the COMT inhibitors market.
• Parkinson’s disease is the primary indication for tolcapone.
• The levodopa combination therapy segment is expected to exhibit the highest CAGR.
• North America dominates the market due to its strong healthcare infrastructure.
• Key drivers include increasing use in supplementary therapy and research into cognitive benefits.
• Challenges include reimbursement issues and disease complexity.
• Opportunities exist in exploring new indications and developing biologic COMT inhibitors.

FAQs

What is the current market size of the COMT inhibitors market?

The global market for COMT inhibitors was estimated to be worth USD 948.5 million in 2022[1].

What is the anticipated growth rate of the COMT inhibitors market from 2023 to 2030?

The market is anticipated to grow at a CAGR of 8.60% from 2023 to 2030[1].

Which product type is leading the COMT inhibitors market?

Tolcapone is the most popular category of product type within the COMT inhibitors market[1].

What is the primary indication for tolcapone?

Parkinson’s disease is the notable segment driving the use of tolcapone[1].

What are the main challenges facing the COMT inhibitors market?

Reimbursement challenges and varying insurance coverage, as well as disease complexity and drug-drug interactions, are the main challenges[1].

Sources

1. Credence Research: COMT Inhibitors Market By Size, Share, Revenue and Trends 2030
2. PubMed: Pharmacokinetics, pharmacodynamics, and tolerability of tolcapone
3. Federal Trade Commission: Generic Drug Industry Dynamics
4. Cognitive Market Research: Tolcapone Market Report 2024 (Global Edition)
5. Wiley Online Library: Practical Evaluation and Management of Insomnia in Parkinson's ...