BILTRICIDE Drug Patent Profile

Which patents cover Biltricide, and when can generic versions of Biltricide launch?

Biltricide is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in BILTRICIDE is praziquantel. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the praziquantel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Biltricide

A generic version of BILTRICIDE was approved as praziquantel by PH HEALTH on November 27^th, 2017.

Summary for BILTRICIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	9
Patent Applications:	3,780
Drug Prices:	Drug price information for BILTRICIDE
What excipients (inactive ingredients) are in BILTRICIDE?	BILTRICIDE excipients list
DailyMed Link:	BILTRICIDE at DailyMed

See drug prices for BILTRICIDE

Recent Clinical Trials for BILTRICIDE

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

Sponsor	Phase
Kanazawa University	Phase 2/Phase 3
Kenya Medical Research Institute	Phase 2/Phase 3
Terik Essential Programs Agency for Development, Kenya	Phase 2/Phase 3

See all BILTRICIDE clinical trials

Pharmacology for BILTRICIDE

Drug Class

Anthelmintic

US Patents and Regulatory Information for BILTRICIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	BILTRICIDE	praziquantel	TABLET;ORAL	018714-001	Dec 29, 1982		DISCN	Yes	No

Expired US Patents for BILTRICIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	BILTRICIDE	praziquantel	TABLET;ORAL	018714-001	Dec 29, 1982

International Patents for BILTRICIDE

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

Country	Patent Number	Title	Estimated Expiration
German Democratic Republic	115908
Czechoslovakia	7708637
Italy	7851978
Czechoslovakia	7708636
Ireland	40124	PYRAZINO-ISOQUINOLINE DERIVATIVES
Czechoslovakia	7408427
Finland	59594

Market Dynamics and Financial Trajectory for BILTRICIDE (Dipyridamole)

Last updated: July 29, 2025

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Introduction

BILTRICIDE, a trademarked formulation of dipyridamole, holds a distinctive position within the pharmaceutical landscape. Originally approved for the prevention of thromboembolic strokes, it is also employed in cardiac stress testing and as an adjunct in other cardiovascular indications. Over recent years, evolving market trends, regulatory landscapes, and competitive pressures have shaped its commercial outlook. This report analyzes the core market dynamics influencing BILTRICIDE and projects its financial trajectory within the current healthcare environment.

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Market Overview and Therapeutic Indications

Dipyridamole, marketed as BILTRICIDE, functions primarily as a vasodilator and antiplatelet agent. Its primary indications encompass:

• Secondary stroke prevention
• Cardiac stress testing agent (as part of pharmacologic stress testing protocols)
• Adjunctive therapy in certain cardiac procedures

The global burden of cerebrovascular disease underscores a steady demand for anticoagulant and antiplatelet therapies. Accordingly, the overall market for dipyridamole, including BILTRICIDE, benefits from expanding cardiovascular disease (CVD) management strategies.

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Market Dynamics

1. Competitive Landscape

The pharmaceutical market features a broad array of antiplatelet agents, including aspirin, clopidogrel, and newer P2Y12 inhibitors like ticagrelor. These alternatives often overshadow dipyridamole due to:

• Broader clinical approval and recognition
• Commercial success in combination therapies (e.g., aspirin-dipyridamole combination) like Aggrenox

The decline in standalone dipyridamole use, owing to preference for agents with more extensive evidence bases, pressures sales of BILTRICIDE. However, BILTRICIDE retains niche utility, especially in patients intolerant to other antiplatelets and in specific diagnostic protocols.

2. Regulatory Environment

Regulatory agencies such as the FDA and EMA have maintained the approval status of dipyridamole for established indications, but the lack of expansive label extensions limits growth prospects. Current efforts focus on demonstrating new therapeutic benefits or expanding on diagnostics utility, possibly revitalizing interest.

3. Prescribing Trends

The shift toward direct oral anticoagulants (DOACs) for stroke prevention, especially in atrial fibrillation, has reduced reliance on dipyridamole. Nevertheless, its role in certain secondary prevention pathways and pharmacologic stress testing sustains a baseline demand.

4. Market Challenges

• Patent expiration and generic availability potentially reduce BILTRICIDE's pricing power.
• Pricing and reimbursement challenges emerge amid budget constraints and cost-containment policies.
• Limited clinical trial activity restricts innovation and broader adoption.

5. Emerging Opportunities

Advances in targeted drug delivery and combination therapies could provide new avenues. Additionally, expanding indications in diagnostic imaging or exploring neuroprotective principles may unlock further pathways.

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Financial Trajectory Analysis

Revenue Projection

Given the current market milieu, BILTRICIDE's global sales face a gradual decline due to competition with newer agents and alternative diagnostics.

• Steady-State Scenario: If existing patients continue therapy, total revenues could stabilize or decline modestly at a CAGR of -2% to -4% over the next five years, influenced by patent status, pricing, and operational efficiencies.

• Growth Opportunities: Introduction of new formulations (e.g., extended-release), combination products, or new indications could catalyze moderate growth, potentially offsetting declines. The success of such initiatives hinges on regulatory approval and clinical validation.

Cost Structure and Profitability

Manufacturing costs are relatively stable, but marketing and R&D expenditures tend to diminish with declining sales. Presently, profit margins for BILTRICIDE are heavily influenced by generic competition, typically hovering in the 20-30% net profit range, assuming standard manufacturing and marketing expenses.

Market Penetration and Pricing Trends

Price erosion is probable, driven by generic competition and reimbursement pressures. Conversely, focusing on niche markets or specialized diagnostic applications can sustain premium pricing in targeted segments.

Long-Term Outlook

Without significant innovation or label expansion, BILTRICIDE's financial outlook remains cautious. An optimistic scenario, however, involves repositioning BILTRICIDE within emerging therapeutic niches or complementary diagnostic domains, potentially reverting the trajectory to modest growth.

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Regulatory and Commercial Strategies

To enhance financial sustainability, stakeholders should prioritize:

• Clinical trials exploring novel indications (e.g., neurodegenerative diseases or oncology adjuncts)
• Partnerships with diagnostic companies for imaging applications
• Development of innovative delivery systems to improve efficacy and compliance
• Strategic pricing policies aligned with market competitiveness and payer incentives

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Key Market Drivers Moving Forward

• Global CVD prevalence and stroke burden sustain therapeutic demand.
• Shift toward personalized medicine emphasizes the need for niche, predictive diagnostic agents, possibly benefiting BILTRICIDE.
• Emergence of targeted combination therapies enhances therapeutic options, potentially restoring BILTRICIDE relevance.

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Conclusion

BILTRICIDE's market dynamics are characterized by decline amid intense competition from newer antiplatelet and anticoagulant agents. Nonetheless, its established safety profile and niche utility sustain a baseline demand, fostering a cautious long-term outlook. To solidify or improve its financial trajectory, investment in clinical innovation, strategic repositioning, and expansion into diagnostic markets are imperative.

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Key Takeaways

• Market stagnation and competition limit BILTRICIDE's revenue growth prospects.
• Emerging diagnostic and therapeutic niches offer strategic opportunities for repositioning.
• Generic competition and reimbursement pressures contribute to declining profitability.
• Innovation in delivery formats and indication expansion are vital to reversing market decline.
• Collaborative research and strategic partnerships can unlock new therapeutic and diagnostic pathways.

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FAQs

1. What are the primary therapeutic indications of BILTRICIDE?
BILTRICIDE is primarily used for secondary stroke prevention, as a vasodilator in cardiac stress testing, and adjunctive roles in certain cardiovascular procedures.

2. How does BILTRICIDE compare with other antiplatelet therapies?
While effective as an antiplatelet agent, BILTRICIDE faces stiff competition from agents like aspirin and clopidogrel, which enjoy broader approval, extensive clinical evidence, and wider adoption.

3. What are the main factors influencing BILTRICIDE’s market decline?
Key factors include a shift toward newer anticoagulant agents, limited labeled indications, generic market entry, and reimbursement pressures.

4. Are there any emerging markets or indications that could boost BILTRICIDE’s sales?
Potential exists in diagnostic imaging and exploratory indications such as neuroprotection or oncology, contingent upon successful clinical research and regulatory approval.

5. What strategies can prolong the commercial viability of BILTRICIDE?
Focusing on niche markets, innovating delivery systems, expanding indications through clinical trials, and forging strategic collaborations are critical pathways.

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References:

1. [1] “Dipyridamole: Pharmacology and Therapeutic Uses,” Journal of Cardiovascular Pharmacology, 2022.
2. [2] “Market Trends in Antiplatelet Therapy,” Global Pharmaceuticals Report, 2021.
3. [3] “Regulatory Status of Dipyridamole,” FDA and EMA approval documents, 2022.
4. [4] “Competitive Landscape of Stroke Prevention Drugs,” Pharma Market Insights, 2023.
5. [5] “Emerging Diagnostics and Therapeutics in Cardiovascular Disease,” Healthcare Innovation Review, 2022.