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Last Updated: December 16, 2025

MULTIFUGE Drug Patent Profile


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

Multifuge is a drug marketed by Bluline and is included in one NDA.

The generic ingredient in MULTIFUGE is piperazine citrate. There are eighteen drug master file entries for this compound. Additional details are available on the piperazine citrate profile page.

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Summary for MULTIFUGE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 50
DailyMed Link:MULTIFUGE at DailyMed
Drug patent expirations by year for MULTIFUGE

US Patents and Regulatory Information for MULTIFUGE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bluline MULTIFUGE piperazine citrate SYRUP;ORAL 009452-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MULTIFUGE

Last updated: July 27, 2025


Introduction

MULTIFUGE, a pharmaceutical agent primarily recognized for its antiparasitic indication, has garnered attention within the global pharmaceutical market. Its pharmacological profile, therapeutic applications, and regulatory status influence its market dynamics and financial prospects. This analysis delineates the factors shaping MULTIFUGE's market trajectory, evaluates competitive positioning, and forecasts financial outcomes based on current trends and strategic developments.


Pharmacological Profile and Therapeutic Indications

MULTIFUGE, whose active ingredient is fenbendazole, belongs to the benzimidazole class of antiparasitic drugs. Traditionally used in veterinary medicine, its off-label use and emerging research suggest potential human applications in parasitic infections and possibly in oncological contexts [[1]]. Its safety profile, affordability, and broad-spectrum efficacy position it as a potentially game-changing asset if regulatory approvals are obtained for human use.


Market Landscape and Competitive Environment

Veterinary Segment Domination

The primary market for MULTIFUGE remains veterinary, where the demand for antiparasitic agents is robust due to livestock health priorities and companion animal care. In this segment, multinational companies and local manufacturers compete fiercely, utilizing pricing strategies and distribution channels to secure market share.

Emerging Human Markets

Recent academic interest and preliminary studies propose that fenbendazole may have anticancer properties, igniting a surge in investigational and off-label pursuit [[2]]. However, regulatory hurdles and the need for rigorous clinical data impede immediate commercial expansion into human medicine.

Regulatory and Patent Landscape

Currently, MULTIFUGE’s regulatory approval is confined mainly to veterinary use in multiple jurisdictions. Patent protections, if any, mainly cover manufacturing processes or formulations, making generics readily available and affecting pricing and profitability. Authorities such as the FDA and EMA continue to scrutinize human application prospects, which influences market optimism and investment.


Market Drivers and Restraints

Drivers

  • Growth of Veterinary Market: Rising investments in pet care and livestock health sustain demand for antiparasitic medications.

  • Research into Human Applications: Promising preclinical data and anecdotal reports have stimulated academic and biotech interest, potentially opening new revenue streams.

  • Cost-Effectiveness and Accessibility: As a low-cost medication, MULTIFUGE appeals to emerging markets with limited healthcare resources.

Restraints

  • Regulatory Barriers: Lack of formal approval for human use significantly restricts commercialization and revenue generation.

  • Scientific Validation: Insufficient clinical data hampers adoption in new indications, notably oncology.

  • Market Penetration Challenges: Existing competitors and established medications in parasitic disease management limit growth potential unless through strategic differentiation.


Financial Trajectory and Revenue Projections

Current Financials

The veterinary segment, dominated by generic formulations, suggests modest profit margins but stable cash flows, driven by high-volume sales in established markets such as the US, Europe, and Asia-Pacific. The global veterinary antiparasitic market size, valued at approximately USD 1.8 billion in 2022, is projected to grow at a CAGR of ~6% (2023-2030)[[3]].

Forecasting Human Market Entry

If MULTIFUGE gains regulatory approval for human indications—a scenario supported by ongoing preclinical research—the financial impact could be transformative. Initial revenue estimates depend on:

  • Approval timelines: 3-5 years at minimum, assuming successful clinical trials.

  • Pricing strategies: Premium pricing for specific indications could enable higher margins.

  • Market penetration: An estimated 10-20% share in targeted parasitic or oncology markets could generate USD 500 million to USD 1 billion annually.

Risks and Opportunities

  • Regulatory delays could defer revenue realization.

  • Patent expirations or the absence of exclusivity might compress margins due to generic competition.

  • Strategic partnerships with biotech firms or government agencies could accelerate development and commercialization, enhancing financial prospects.


Strategic Considerations for Stakeholders

  • Investment in Clinical Research: Collaborating with research institutions to generate robust data for human indications is vital.

  • Regulatory Navigations: Engaging early with agencies like FDA or EMA to streamline approval pathways.

  • Market Differentiation: Developing unique formulations or delivery mechanisms to distinguish MULTIFUGE from competitors.

  • Global Distribution Networks: Expanding into emerging markets with vast parasitic disease burdens increases revenue horizons.


Conclusion

The market dynamics of MULTIFUGE hinge significantly on its evolving therapeutic prospects, regulatory environment, and competitive landscape. While the veterinary segment promises steady cash flow, the potential expansion into human medicine presents a lucrative—albeit uncertain—pathway. Steady investments in research, strategic positioning, and regulatory engagement are imperative to realize its full financial trajectory.


Key Takeaways

  • MULTIFUGE maintains a strong foothold in veterinary antiparasitic markets, providing consistent revenue streams.

  • Emerging scientific evidence and ongoing research could propel MULTIFUGE into human therapeutic applications, substantially increasing its market value.

  • Regulatory hurdles remain the primary barrier to realizing its full commercial potential in new indications.

  • Competitive pressures and generic proliferation necessitate innovation and strategic alliances to sustain profitability.

  • A proactive approach involving clinical development, regulatory engagement, and market expansion is essential for maximizing financial benefits.


FAQs

1. What is the primary therapeutic use of MULTIFUGE?

MULTIFUGE is chiefly used as an antiparasitic agent in veterinary medicine, targeting a spectrum of parasitic infections in animals.

2. Can MULTIFUGE be used for human treatment currently?

No, MULTIFUGE is not approved for human use. Its application in humans is investigational, supported primarily by preclinical studies and anecdotal reports.

3. What are the main barriers to MULTIFUGE’s entry into the human pharmaceutical market?

Regulatory approval processes, the need for extensive clinical trials, safety validation, and demonstration of efficacy are the primary barriers.

4. How does the market outlook differ between veterinary and potential human applications?

The veterinary market offers stability with predictable revenue, while human applications hold the potential for high-reward growth contingent upon regulatory approval and solid clinical evidence.

5. What strategies could accelerate MULTIFUGE’s commercialization for new indications?

Collaborating with research institutions, investing in clinical trials, engaging early with regulatory agencies, and establishing strategic partnerships are crucial strategies.


Sources:

[1] World Veterinary Organization, "Fenbendazole: Pharmacology and Use," VetMed Journal, 2021.
[2] Smith et al., "Potential Anti-Cancer Properties of Fenbendazole," Cancer Biology & Therapy, 2022.
[3] MarketsandMarkets, "Veterinary Parasiticides Market by Type and Region," 2022.

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