TASMAR Drug Patent Profile

When do Tasmar patents expire, and when can generic versions of Tasmar launch?

Tasmar is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in TASMAR is tolcapone. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolcapone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tasmar

A generic version of TASMAR was approved as tolcapone by NOVAST LABS on August 7^th, 2018.

Summary for TASMAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	19
Patent Applications:	5,422
Drug Prices:	Drug price information for TASMAR
What excipients (inactive ingredients) are in TASMAR?	TASMAR excipients list
DailyMed Link:	TASMAR at DailyMed

See drug prices for TASMAR

Recent Clinical Trials for TASMAR

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

Sponsor	Phase
University of Chicago	Phase 2
University of Colorado, Denver	Phase 2
Corino Therapeutics, Inc.	Early Phase 1

See all TASMAR clinical trials

Pharmacology for TASMAR

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

US Patents and Regulatory Information for TASMAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-001	Jan 29, 1998	AB	RX	Yes	Yes
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697-002	Jan 29, 1998		DISCN	No	No

Expired US Patents for TASMAR

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 TASMAR

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

International Patents for TASMAR

See the table below for patents covering TASMAR around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	91396
Finland	871041
Australia	6976487
Ireland	870609

Supplementary Protection Certificates for TASMAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0237929	68/1997	Austria		PRODUCT NAME: TOLCAPONE; REGISTRATION NO/DATE: EU/1/97/044/001 - EU/1/97/044/006 19970827
0237929	SPC/GB97/088	United Kingdom		PRODUCT NAME: TOLCAPONE; REGISTERED: CH 54055/01 19970225; CH 54055/02 19970225; UK EU/1/97/044/001 19970827; UK EU/1/97/044/002 19970827; UK EU/1/97/044/003 19970827; UK EU/1/97/044/004 19970827; UK EU/1/97/044/005 19970827; UK EU/1/97/044/006 19970827
0237929	C970041	Netherlands		PRODUCT NAME: TOLCAPON; REGISTRATION NO/DATE: EU/1/97/044/001-6 19970827
0237929	97C0112	Belgium		PRODUCT NAME: TOLCAPONE; REGISTRATION NO/DATE: EU/1/97/044/001 19970827

TASMAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tasmar

Introduction to Tasmar

Tasmar, also known as tolcapone, is a drug used to treat patients with Parkinson's disease, particularly those experiencing motor fluctuations who are responsive to levodopa but have not responded to or are intolerant of other COMT (catechol-O-methyltransferase) inhibitors[4].

Clinical Use and Efficacy

Tasmar is designed to increase the availability of levodopa in the brain by inhibiting the enzyme COMT, which breaks down levodopa. Clinical studies have shown that Tasmar can reduce 'off' time and increase 'on' time in patients with Parkinson's disease. For instance, studies revealed a reduction of about 20 to 30% in 'off' time in patients taking Tasmar compared to those on placebo[4].

Regulatory History

Tasmar received its initial marketing authorization in the European Union in 1997 but was suspended in 1998 due to reports of fatal liver injury. The suspension was lifted in 2004 after the implementation of a risk management plan to ensure safe use. This plan includes strict monitoring of liver function in patients[4].

Market Position

Tasmar operates in a competitive market for Parkinson's disease treatments, which includes other COMT inhibitors and drugs like Xadago (safinamide) and ADS-5102 (amantadine extended-release). Despite its niche, Tasmar has a specific patient population it targets—those who have failed to respond to or are intolerant of other treatments[4].

Financial Performance

The financial performance of Tasmar is closely tied to its marketing authorization holder, Meda AB, and later acquisitions. Here are some key financial insights:

Revenue and Sales

Tasmar's revenue is influenced by its market penetration and the overall demand for Parkinson's disease treatments. While specific revenue figures for Tasmar alone are not readily available, the drug contributes to the broader revenue streams of its parent companies. For example, Meda AB's financial reports would include Tasmar's performance as part of their overall CNS (Central Nervous System) product portfolio.

Cost and Pricing

The cost of Tasmar includes production, research and development, and regulatory compliance expenses. The pricing strategy is critical, as it must balance profitability with patient access and affordability. Given the niche market, Tasmar's pricing is likely competitive with other Parkinson's disease treatments.

Profitability

The profitability of Tasmar is affected by several factors, including production costs, market competition, and regulatory compliance expenses. The drug's profitability can be inferred from the overall financial health of its marketing authorization holder. For instance, if Meda AB or subsequent owners report increased revenues and profitability in their CNS segment, it could indicate a positive financial trajectory for Tasmar.

Challenges and Opportunities

Safety Concerns

One of the significant challenges for Tasmar is its association with liver injury, which can be fatal in rare cases. This has led to strict monitoring requirements and a risk management plan, which can impact patient compliance and physician prescribing habits[4].

Market Competition

The market for Parkinson's disease treatments is highly competitive, with several drugs available, including Xadago and ADS-5102. Tasmar must differentiate itself through its efficacy and safety profile to maintain market share.

Regulatory Environment

Changes in regulatory environments can significantly impact Tasmar's market dynamics. For example, the suspension and subsequent reinstatement of its marketing authorization highlight the importance of regulatory compliance and safety monitoring.

Future Outlook

Market Expansion

Tasmar's future outlook depends on its ability to expand its market presence, potentially through new indications or improved safety profiles. However, given its niche market, significant expansion might be challenging.

Partnerships and Acquisitions

Strategic partnerships or acquisitions could enhance Tasmar's market position. For instance, collaborations with other pharmaceutical companies specializing in CNS treatments could improve distribution and marketing efforts.

Key Takeaways

• Clinical Efficacy: Tasmar is effective in reducing 'off' time and increasing 'on' time in Parkinson's disease patients.
• Regulatory History: The drug has faced regulatory challenges due to safety concerns but has been reinstated with strict monitoring.
• Market Position: Tasmar operates in a competitive market and targets a specific patient population.
• Financial Performance: The financial health of Tasmar is tied to its parent company's overall performance in the CNS segment.
• Challenges and Opportunities: Safety concerns, market competition, and regulatory environments are key factors influencing Tasmar's market dynamics.

FAQs

Q: What is Tasmar used for?

Tasmar is used to treat patients with Parkinson's disease, particularly those experiencing motor fluctuations who are responsive to levodopa but have not responded to or are intolerant of other COMT inhibitors.

Q: What are the main side effects of Tasmar?

Common side effects include nausea, loss of appetite, diarrhea, dyskinesia, dystonia, headache, dizziness, sleep disorders, and liver injury in rare cases.

Q: Why was Tasmar's marketing authorization suspended?

Tasmar's marketing authorization was suspended in 1998 due to reports of fatal liver injury but was reinstated in 2004 after the implementation of a risk management plan.

Q: How does Tasmar compare to other Parkinson's disease treatments?

Tasmar differentiates itself through its efficacy in reducing 'off' time and increasing 'on' time, but it faces competition from other drugs like Xadago and ADS-5102.

Q: What is the future outlook for Tasmar?

The future outlook for Tasmar depends on its ability to expand its market presence, potentially through new indications or improved safety profiles, and strategic partnerships or acquisitions.

Cited Sources

1. European Medicines Agency (EMA) - Tasmar: This source provides detailed information on Tasmar's clinical use, efficacy, and regulatory history[4].
2. Annual Reports: While not directly related to Tasmar, these reports provide context on the broader pharmaceutical market and strategies employed by other CNS-focused companies[3].
3. Financial Reports: These reports offer insights into the financial performance of pharmaceutical companies, which can be extrapolated to understand the financial dynamics of specific drugs like Tasmar[5].