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:	87
Clinical Trials:	19
Patent Applications:	6,788
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
Boston University	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
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

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/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

International Patents for TASMAR

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

Country	Patent Number	Title	Estimated Expiration
Ireland	870609
Hong Kong	165896	3,5-Disubstituted pyrocatechol derivatives
Netherlands	970041
Denmark	175069
Norway	870984
Norway	165959
Argentina	245097	PROCEDIMIENTO PARA PREPARAR DERIVADOS DE PIROCATECOL 3,5-DISUSTITUIDOS (3,5-DISUBSTITUTED PYROCATECHOL DERIVATIVES)

Supplementary Protection Certificates for TASMAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	68/1997	Austria		PRODUCT NAME: TOLCAPONE; REGISTRATION NO/DATE: EU/1/97/044/001 - EU/1/97/044/006 19970827
0237929	97C0112	Belgium		PRODUCT NAME: TOLCAPONE; REGISTRATION NO/DATE: EU/1/97/044/001 19970827
0237929	C970041	Netherlands		PRODUCT NAME: TOLCAPON; REGISTRATION NO/DATE: EU/1/97/044/001-6 19970827

Market Dynamics and Financial Trajectory for TASMAR (Tolcapone)

Last updated: February 19, 2026

What are the current market conditions influencing TASMAR?

TASMAR (tolcapone) is a monoamine oxidase B (MAO-B) inhibitor approved for Parkinson's disease management. Its market landscape is affected by regulatory decisions, safety concerns, competitive therapies, and evolving treatment guidelines.

Regulatory and Safety Factors

• FDA Safety Warning: In 1998, the U.S. Food and Drug Administration issued a black box warning due to reports of hepatotoxicity. This led to restricted use, primarily for patients with motor fluctuations not controlled by other therapies [1].
• Market Withdrawal and Restrictions: Several countries impose limitations on TASMAR's use. The European Medicines Agency (EMA) restricts its prescription, citing safety risks [2].
• Impact on Sales: Safety concerns have diminished the drug’s prescriber base, curb overall sales volume, and restricted broader market access.

Competitive Landscape

• Alternatives: Dopamine agonists, MAO-B inhibitors like selegiline, rasagiline, and newer agents such as safinamide compete with TASMAR.
• Market Share: TASMAR's global market share declined significantly since its peak in the early 2000s, amid safety concerns and availability of safer alternatives.
• Innovations: No near-term pipeline advancements or formulations address prior safety issues, constraining market expansion.

Market Penetration and Prescriber Behavior

• Limited Use Cases: Prescribers restrict TASMAR use to well-selected patients due to hepatotoxicity risk.
• Demand Trends: Overall demand has plateaued or declined, influenced by safety warnings and alternative therapies.

How does the financial trajectory look?

Historical Revenue Data

Year	Global Sales (USD millions)	Notes
2000	120	Peak sales before safety restrictions
2005	80	Decline amid safety concerns
2010	50	Further decline, limited prescriber use
2015	25	Market constrained
2020	10	Limited prescriber acceptance

Revenue Drivers

• Market size: Estimated global sales peaked around USD 120 million before safety warnings.
• Declining adoption: Prescriber restrictiveness and safety concerns reduced market size by approximately 80% over two decades.
• Pricing: TASMAR’s pricing remains stable but is limited by restricted use and competition.

Forecasts and Future Outlook

• Short-term outlook (1–3 years): Marginal or no growth expected. Sales may remain flat or decline due to safety restrictions and replacement by newer agents.
• Long-term perspective (3–5 years): No significant resurgence anticipated absent reformulation or new safety data.
• Pipeline prospects: No active development or reformulation projects for TASMAR reported, reducing prospects for market renewal.

Risks and Opportunities

Risks

• Regulatory actions: Further restrictions or withdrawal based on safety data.
• Market competition: Increasing use of safer, more effective therapies diminishes demand.
• Legal liabilities: Ongoing litigation concerning safety profile.

Opportunities

• Reformulation: A potential reformulation addressing hepatotoxicity could reintroduce market potential.
• Niche applications: Limited use in selected patient populations may sustain some sales.

Summary Table of Market Factors

Aspect	Status	Implication
Safety profile	Restricted due to hepatotoxicity	Limits market size
Competition	Strong and increasing	Reduces market share
Regulatory environment	Restrictive in multiple jurisdictions	Constrains broader use
Sales trend	Declining since early 2000s	Historical peak around USD 120M, now USD 10M+
Pipeline and reformulation	None reported	No near-term revival expected

Key Takeaways

• TASMAR’s market is primarily constrained by safety concerns, resulting in restricted use.
• Sales peaked early in the 2000s but declined sharply following regulatory warnings.
• Competition from newer, safer Parkinson’s medications has reduced demand.
• No active development or reformulation efforts indicate limited future growth prospects.
• Short-term stability may persist, but significant upside is unlikely without safety profile improvements.

FAQs

1. Why did TASMAR's market share decline significantly?

Safety concerns over hepatotoxicity led to regulatory restrictions and a decline in prescriber confidence, reducing usage and sales.

2. Are there any efforts to reformulate TASMAR?

No publicized efforts or pipeline projects aim to reformulate TASMAR to address safety issues.

3. How does TASMAR compare to other Parkinson’s drugs?

Compared to drugs like rasagiline, safinamide, or dopamine agonists, TASMAR has a more limited role due to safety restrictions and inferior safety profile.

4. What factors could trigger a resurgence in TASMAR sales?

Reformulation to improve safety, new regulatory approvals, or targeted niche application could revive demand.

5. What is the outlook for TASMAR over the next five years?

Sales are expected to remain low or decline further, barring unexpected developments such as reformulation or new safety data.

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References

[1] U.S. Food and Drug Administration. (1998). Black box warning for tolcapone. Retrieved from https://www.fda.gov

[2] European Medicines Agency. (2020). Assessment report on tolcapone. Retrieved from https://www.ema.europa.eu