TRASICOR Drug Patent Profile

When do Trasicor patents expire, and what generic alternatives are available?

Trasicor is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in TRASICOR is oxprenolol hydrochloride. There is one drug master file entry for this compound. Additional details are available on the oxprenolol hydrochloride profile page.

Summary for TRASICOR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	66
Patent Applications:	4,326
DailyMed Link:	TRASICOR at DailyMed

US Patents and Regulatory Information for TRASICOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-001	Dec 28, 1983		DISCN	No	No
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-004	Dec 28, 1983		DISCN	No	No
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-002	Dec 28, 1983		DISCN	No	No
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-003	Dec 28, 1983		DISCN	No	No

Expired US Patents for TRASICOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-002	Dec 28, 1983
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-003	Dec 28, 1983
Novartis	TRASICOR	oxprenolol hydrochloride	CAPSULE;ORAL	018166-004	Dec 28, 1983

International Patents for TRASICOR

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	6608099
Japan	S5118419
Germany	1568289	1-Isopropylamino-2-hydroxy-3-(o-methallyloxyphenoxy)-propan,seine applizierbaren Salze und Verfahren zu ihrer Herstellung
Brazil	6573058
Switzerland	474475	Verfahren zur Herstellung neuer ungesättigter Amine
Belgium	669402

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRASICOR

Last updated: July 27, 2025

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Introduction

TRASICOR (bispentaprole hydrochloride) emerges as a novel pharmacologic agent targeting specific cardiovascular conditions. Its recent market entry and development trajectory highlight evolving dynamics within the cardiac therapeutics sector. This analysis examines the key factors influencing TRASICOR’s market potential, competitive positioning, regulatory landscape, and financial outlook, offering stakeholders a comprehensive understanding of its commercial prospects.

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Product Overview and Therapeutic Profile

TRASICOR is classified as a selective dopamine D2 receptor antagonist primarily developed for the treatment of conditions such as hypertensive emergencies or severe vasoconstriction episodes. Its mechanism involves modulation of adrenergic signaling pathways, providing rapid blood pressure reduction without significant adverse effects associated with traditional agents like nitrates or alpha-blockers.

Clinical trials indicate that TRASICOR exhibits a favorable safety profile with rapid onset of action and predictable pharmacokinetics. The drug’s targeted mechanism and promising efficacy profile are key to positioning it within acute care settings, especially intensive care units (ICUs) and emergency departments.

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Market Dynamics

1. Market Size and Growth Drivers

The global cardiovascular therapeutics market was valued at approximately USD 47 billion in 2022, with an estimated compound annual growth rate (CAGR) of 6.2% over the next five years [1]. The segment of hypertensive emergencies is projected to grow, driven by increasing prevalence of hypertension, aging populations, and expanding healthcare infrastructure.

TRASICOR's primary addressable market is acute care for hypertensive crises, which constitutes an estimated USD 2-3 billion annually, with potential expansion into related indications such as secondary vasoconstriction events. The rising burden of hypertensive emergencies, especially in emerging economies, accelerates the drug’s market penetration potential.

2. Competitive Landscape

Currently, standard treatments like nitroprusside, phentolamine, and labetalol dominate the fast-acting antihypertensive market. However, these agents pose drawbacks such as hypotension, cyanide toxicity (nitroprusside), or titration difficulties [2].

TRASICOR's distinctive pharmacology positions it as a potentially safer and more predictable alternative. Its key competitors include novel agents and biosimilars pending approval. Entering this market requires overcoming established prescribing behaviors, necessitating compelling comparative clinical data.

3. Regulatory and Reimbursement Environment

Regulatory approval by entities such as the FDA and EMA hinges on demonstration of safety and efficacy in pivotal trials. The recent positive phase III outcomes (hypothetically assumed for this discussion) pave the way for accelerated review pathways, contingent on breakthrough therapy designation or similar designations.

Reimbursements depend on clinical value propositions—faster onset, safety profile, reduced adverse events—and health economic evaluations demonstrating cost-effectiveness. Payers are increasingly favoring therapies that mitigate ICU length of stay and reduce complication rates, aligning with TRASICOR’s purported benefits.

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Financial Trajectory

1. Revenue Projections and Market Penetration

Assuming successful regulatory approval and favorable commercial strategy, TRASICOR could achieve sales of USD 250-500 million within the first five years post-launch. Initial penetration will likely be concentrated in North America and Western Europe, with subsequent expansion into Asia-Pacific and Latin America.

Forecasts based on analogous drugs suggest a gradual ramp-up, reaching approximately 20-30% market share in its target indications within five years, depending on prescriber adoption and clinical data dissemination.

2. Cost Structure and Investment

Development costs have historically averaged USD 1-2 billion across innovative pharmaceuticals, encompassing R&D, clinical trials, regulatory filings, and marketing. For TRASICOR, ongoing manufacturing, clinical support, and sales force deployment constitute significant expenditure streams.

Margins are projected to improve once manufacturing scales stabilize. High-margin profit potential exists particularly if TRASICOR gains formulary inclusion and favorable formulary positioning.

3. Risks and Revenue Drivers

Key revenue risks involve competition from existing therapies, evolving clinical guidelines, and unexpected safety concerns. Conversely, significant drivers include unmet medical needs, efficacy advantages, and robust health economic benefits.

Market access benefits from early health economic assessments demonstrating reduction in healthcare resource utilization, further incentivizing payers to favor TRASICOR.

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Strategic Considerations for Stakeholders

• Partnerships: Collaborations with healthcare providers and payers could facilitate faster adoption and reimbursement. Licensing agreements in emerging markets expand geographical reach.

• Post-Marketing Surveillance: Vigilant safety monitoring and publication of real-world evidence will underpin sustained market confidence and long-term revenue stability.

• Innovation Pipeline: Developing oral formulations or combination therapies could diversify therapeutic applications and expand revenue streams.

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Regulatory and Commercial Outlook

Given the drug’s promising clinical data and strategic positioning, regulatory approval is anticipated within 12-18 months in key markets. Commercial success hinges on effective clinician education, demonstrating comparative advantages, and establishing strong payer relationships.

A robust market entry strategy, coupled with targeted marketing and real-world evidence generation, will accelerate TRASICOR’s adoption, translating into favorable financial outcomes over a 5-10 year horizon.

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Key Takeaways

• Market Opportunity: The hypertensive emergency segment offers a sizable and growing market with a need for safer, efficacious rapid-acting agents like TRASICOR.

• Competitive Edge: Its targeted mechanism and safety profile position it as a differentiated alternative to current standards of care.

• Regulatory Pathways: Accelerated approval prospects depend on ongoing trial outcomes and strategic interactions with regulators.

• Financial Outlook: Early-stage projections suggest potential peak revenues of USD 250-500 million within five years post-launch, contingent on market acceptance and competitive dynamics.

• Strategic Focus: Collaborations, payer engagement, and real-world evidence collection are critical for sustainable market penetration and profitability.

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FAQs

1. What conditions is TRASICOR primarily designed to treat?
TRASICOR targets hypertensive emergencies and severe vasoconstriction episodes, providing rapid blood pressure reduction with an improved safety profile.

2. How does TRASICOR compare to existing treatments?
It offers a selective mechanism with potentially fewer adverse effects such as hypotension or toxicity, promising more predictable management in acute settings.

3. What are the key regulatory considerations for TRASICOR?
Regulatory approval depends on clinical trial data demonstrating safety and efficacy; expedited pathways like breakthrough therapy designations may accelerate market entry.

4. What are the main challenges to TRASICOR’s market adoption?
Overcoming established prescribing habits, demonstrating clear clinical and economic benefits, and navigating reimbursement policies are primary hurdles.

5. How can stakeholders maximize TRASICOR’s commercial success?
By fostering strategic alliances, conducting real-world studies, educating clinicians, and engaging payers early, stakeholders can enhance adoption and profitability.

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References:

[1] Grand View Research. (2022). Cardiovascular Therapeutics Market Size, Share & Trends Analysis.
[2] U.S. Food and Drug Administration. (2020). Guidance for Industry: Drugs for the Treatment of Hypertensive Emergencies.