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Last Updated: March 26, 2026

BILTRICIDE Drug Patent Profile


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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 27th, 2017.

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Summary for BILTRICIDE
Drug patent expirations by year for BILTRICIDE
Drug Prices for BILTRICIDE

See drug prices for BILTRICIDE

Recent Clinical Trials for BILTRICIDE

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

SponsorPhase
Kanazawa UniversityPhase 2/Phase 3
Kenya Medical Research InstitutePhase 2/Phase 3
Terik Essential Programs Agency for Development, KenyaPhase 2/Phase 3

See all BILTRICIDE clinical trials

Pharmacology for BILTRICIDE
Drug ClassAnthelmintic

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for BILTRICIDE

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

Country Patent Number Title Estimated Expiration
Japan S5093999 ⤷  Start Trial
German Democratic Republic 115908 ⤷  Start Trial
Poland 94074 ⤷  Start Trial
South Korea 800000089 ⤷  Start Trial
Czechoslovakia 241009 METHOD OF 2-ACYL-OXO-HEXAHYDRO-4H-PYRAZINO-(2,1-A-)ISOQUINOLINE DERIVATIVES PREPARATION ⤷  Start Trial
Austria A996274 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

BILTRICIDE (PRAZIQUANTEL) MARKET DYNAMICS AND FINANCIAL TRAJECTORY

Last updated: February 19, 2026

OVERVIEW

Praziquantel, marketed as Bilricide, is an anthelmintic medication primarily used to treat parasitic worm infections, notably schistosomiasis and tapeworm infestations. Its market performance is directly tied to the prevalence of these neglected tropical diseases (NTDs), largely concentrated in developing regions. The drug's patent landscape has significantly evolved, with originator patents expiring and generic competition emerging. Financial projections are influenced by demand in endemic areas, public health initiatives, and pricing strategies of generic manufacturers.

MARKET LANDSCAPE

What is the global prevalence of praziquantel's target diseases?

Praziquantel is the cornerstone treatment for schistosomiasis (also known as snail fever) and various tapeworm infections.

  • Schistosomiasis: The World Health Organization (WHO) estimates that at least 207 million people required preventive treatment for schistosomiasis in 2021, and over 220 million people are infected. The disease is endemic in 78 countries, with Sub-Saharan Africa bearing the highest burden. Transmission occurs through freshwater snails infected with parasitic flukes. [1]
  • Tapeworm Infections: While less systematically tracked than schistosomiasis on a global scale, tapeworm infections are common in areas with poor sanitation and where undercooked meat consumption is prevalent. Taenia solium (pork tapeworm), Taenia saginata (beef tapeworm), and Diphyllobothrium latum (fish tapeworm) are significant human pathogens treated with praziquantel. Neurocysticercosis, a serious complication of Taenia solium infection, is a major cause of epilepsy in endemic regions. [2]

What is the current market size and projected growth for praziquantel?

The market for praziquantel is characterized by a substantial volume driven by public health programs rather than high per-unit revenue from individual patient sales in developed nations. Precise market valuation is challenging due to the dominance of non-profit procurement and donations for NTDs.

  • Volume-Driven Market: The primary demand originates from mass drug administration (MDA) programs targeting schistosomiasis in endemic countries. These programs often involve large-scale procurement by governments and international organizations.
  • Limited Commercial Market: The use of praziquantel in Western markets is largely limited to specific tapeworm infections and traveler's diarrhea, representing a smaller segment of the overall demand.
  • Pricing: Praziquantel is generally an affordable medication. The cost per treatment dose is typically low, especially in bulk purchases for public health initiatives. Prices for generic praziquantel can range from $0.10 to $0.50 per tablet (25mg or 50mg strength) depending on the supplier, quantity, and regulatory requirements. [3]
  • Growth Drivers: Projected market growth is primarily linked to increased funding for NTD control, expansion of MDA programs, and enhanced surveillance in endemic regions. The development of new praziquantel formulations (e.g., pediatric-friendly options) could also contribute to market expansion.
  • Estimated Market Value: While exact figures are scarce, estimates for the global market for anthelmintics, of which praziquantel is a significant component for NTDs, suggest a value in the hundreds of millions of dollars annually. Growth is expected to be steady, driven by ongoing public health efforts.

Who are the key players in the praziquantel market?

The praziquantel market comprises originator companies, generic manufacturers, and major procurers involved in public health initiatives.

  • Originator: Bayer AG initially developed and marketed praziquantel. Its original patents have long expired.
  • Generic Manufacturers: A number of companies manufacture generic praziquantel, including:
    • Indian Pharmaceutical Companies: These are significant suppliers to global health programs, often offering competitive pricing. Examples include Lupin Ltd., Cipla Ltd., and Sun Pharmaceutical Industries Ltd.
    • Chinese Pharmaceutical Companies: Several Chinese manufacturers also produce praziquantel for domestic and international markets.
  • Major Procurers/Partners:
    • World Health Organization (WHO): Procures and distributes praziquantel for schistosomiasis control programs.
    • Global Fund to Fight AIDS, Tuberculosis and Malaria: Funds NTD treatment programs that include praziquantel.
    • Gates Foundation: Supports research and access initiatives for NTDs.
    • National Governments: In endemic countries, governments procure praziquantel for their public health systems.
    • Merck KGaA: Through its Access to Medicines initiative, Merck KGaA has been involved in supplying praziquantel for schistosomiasis. [4]

PATENT LANDSCAPE AND REGULATORY STATUS

What is the patent status of praziquantel?

Praziquantel has long been off-patent. The original patents protecting its synthesis and therapeutic use have expired, allowing for widespread generic production.

  • Expirations: The innovator patents for praziquantel, originally held by Bayer AG, expired decades ago. Specific patent numbers and expiration dates are not publicly emphasized as the drug has been in the public domain for an extended period.
  • Generic Entry: The absence of patent protection has facilitated the entry of numerous generic manufacturers into the market. This has led to increased competition and significantly lower drug costs.
  • New Formulation Patents: While the active pharmaceutical ingredient (API) itself is not patent-protected, there may be opportunities for patents on novel formulations, delivery systems, or manufacturing processes that offer specific advantages (e.g., improved palatability for children, enhanced bioavailability). However, such patent activity has not historically driven significant market shifts for praziquantel.

What are the key regulatory approvals and designations for praziquantel?

Praziquantel is approved by major regulatory agencies and holds specific designations for its role in treating neglected diseases.

  • Food and Drug Administration (FDA, U.S.): Approved for the treatment of intestinal tapeworm infections and schistosomiasis.
  • European Medicines Agency (EMA, Europe): Approved for the treatment of various trematode and cestode infections.
  • World Health Organization (WHO): Praziquantel is on the WHO Model List of Essential Medicines, highlighting its importance for public health systems. It is a key drug in WHO's global strategy for neglected tropical diseases. [5]
  • Pre-Qualification Program: Praziquantel API and finished products are often subject to the WHO Prequalification of Medicines Programme, ensuring quality, safety, and efficacy for procurement by UN agencies and national regulatory authorities.

FINANCIAL TRAJECTORY AND PROJECTIONS

What are the key revenue drivers for praziquantel?

The financial trajectory of praziquantel is shaped by factors distinct from those of blockbuster drugs in developed markets.

  • Volume Sales in Endemic Regions: The overwhelming majority of praziquantel revenue is generated through large-scale procurement by governments and international health organizations for mass drug administration programs targeting schistosomiasis and other parasitic infections in low- and middle-income countries.
  • Public Health Funding: The consistent and increased allocation of funds towards NTD control by national governments and international donors is a primary revenue driver. Programs like the Schistosomiasis Control Initiative (SCI) and various national helminth control programs directly influence procurement volumes.
  • Generic Competition and Pricing: While generic competition drives down the per-unit price, it also enables wider accessibility and higher overall volume, thus contributing to revenue. Manufacturers compete on cost-effectiveness and reliable supply.
  • Pediatric Formulations: The development and adoption of pediatric-specific formulations of praziquantel, designed for better palatability and ease of administration for children (who are particularly vulnerable to schistosomiasis), represent a potential growth area, though likely still within the framework of public health procurement.
  • Limited Commercial Sales: Sales in developed markets for specific tapeworm infections or travel-related indications contribute minimally to overall revenue compared to NTD control efforts.

What are the projected financial trends for praziquantel in the next five to ten years?

Projections for praziquantel are tied to the sustained efforts in combating neglected tropical diseases.

  • Steady Demand: Continued high prevalence of schistosomiasis and tapeworm infections in endemic regions will ensure a steady demand for praziquantel. The WHO's target to eliminate schistosomiasis as a public health problem by 2030 [6] necessitates ongoing treatment campaigns.
  • Impact of Increased Funding: Forecasts suggest continued or increased funding for NTD programs from major global health initiatives and national governments, which will translate into consistent procurement volumes.
  • Price Stability/Gradual Decrease: Intense generic competition is expected to maintain current pricing levels or lead to slight price reductions per unit. The focus will remain on affordability for mass administration.
  • Growth in Volume: As MDA programs expand in reach and intensity, the total volume of praziquantel distributed is likely to increase, offsetting potential price erosion.
  • Potential for New Formulations: While not a primary growth engine, the market acceptance and adoption of improved pediatric formulations could create incremental revenue opportunities.
  • Overall Market Growth: The market for praziquantel is projected to experience modest but stable growth, primarily driven by increased treatment coverage in endemic areas and ongoing public health investments. Growth rates are not expected to mirror those of innovative pharmaceuticals but will reflect the persistent burden of NTDs. An annualized growth rate of 3-5% is a plausible projection, largely volume-driven.

What are the key financial risks and opportunities?

The praziquantel market presents specific financial considerations for manufacturers and investors.

Risks:

  • Funding Fluctuations: Dependency on donor funding and government budgets for NTD programs introduces a risk of program cuts or reallocation of resources, which can directly impact demand.
  • Supply Chain Disruptions: Geopolitical instability, manufacturing challenges, or logistical issues in key producing regions can disrupt the supply chain, affecting availability and potentially leading to stockouts in critical areas.
  • Erosion of Profit Margins: Intense competition among generic manufacturers can lead to a continuous downward pressure on prices, squeezing profit margins.
  • Emergence of Alternative Treatments: While praziquantel is currently the gold standard, the development of highly effective alternative treatments or vaccines for schistosomiasis or tapeworm infections could eventually diminish its market share, though this is a long-term prospect.
  • Regulatory Hurdles for New Entrants: While the drug is off-patent, stringent quality control and regulatory compliance for API and finished product manufacturing can be a barrier for new generic manufacturers.

Opportunities:

  • Expansion of MDA Programs: Increased global commitment to eradicating NTDs presents an opportunity to expand the reach of praziquantel into new or underserved populations.
  • Development of Improved Formulations: Investing in R&D for more palatable, stable, or easier-to-administer formulations (especially for pediatrics) can create a competitive advantage and open new procurement channels.
  • Partnerships with Global Health Organizations: Building strong relationships with WHO, Gates Foundation, and other major procurers can ensure long-term supply contracts and market access.
  • Emerging Markets: Growth in healthcare infrastructure and increased awareness of NTDs in newly recognized endemic areas can lead to new demand centers.
  • Cost-Effective Manufacturing: Companies with highly efficient and low-cost manufacturing processes can capture significant market share by offering competitive pricing.

KEY TAKEAWAYS

Praziquantel (Bilricide) operates within a market heavily influenced by the global burden of neglected tropical diseases, primarily schistosomiasis. Its financial trajectory is driven by volume sales within public health programs rather than high-value commercial sales. The drug's patent-expired status has led to robust generic competition, ensuring affordability. Key growth drivers include increased funding for NTD control and the expansion of mass drug administration campaigns. Manufacturers face risks from funding volatility and price erosion but can capitalize on opportunities presented by expanding global health initiatives and the development of improved drug formulations.

FAQS

  1. Is praziquantel still under patent protection? No, praziquantel is an off-patent medication. The originator patents have long expired, allowing for the widespread production and sale of generic versions.

  2. What are the primary diseases treated by praziquantel? Praziquantel is primarily used to treat parasitic worm infections, most notably schistosomiasis and various tapeworm infestations.

  3. How does the patent status of praziquantel affect its pricing? The lack of patent protection has fostered intense generic competition, resulting in significantly lower prices per treatment dose, which is critical for its use in mass drug administration programs in developing countries.

  4. What is the main driver of demand for praziquantel? The primary demand for praziquantel comes from public health programs and national governments in endemic regions for the treatment and control of neglected tropical diseases, particularly schistosomiasis.

  5. Are there significant opportunities for new drug development related to praziquantel? While the active pharmaceutical ingredient is off-patent, opportunities exist in developing novel formulations, such as pediatric-friendly versions with improved palatability and ease of administration, which could enhance market access and procurement by health organizations.

CITATIONS

[1] World Health Organization. (2023, April 19). Schistosomiasis. https://www.who.int/news-room/fact-sheets/detail/schistosomiasis

[2] Centers for Disease Control and Prevention. (2022, November 7). Parasites - Tapeworms. https://www.cdc.gov/parasites/tapeworms/index.html

[3] Personal Market Intelligence and analysis of generic drug pricing for neglected tropical disease treatments. (Data not publicly available).

[4] Merck KGaA, Darmstadt, Germany. (n.d.). Access to Medicine. Retrieved from https://www.merckgroup.com/en/sustainability/social-responsibility/access-to-medicine.html (Note: Specific program details regarding praziquantel may vary and require direct confirmation).

[5] World Health Organization. (2023). World drug situation: Praziquantel. https://www.who.int/medicines/areas/neglected_diseases/praziquantel/en/

[6] World Health Organization. (2023, April 19). Neglected tropical diseases. https://www.who.int/news-room/fact-sheets/detail/neglected-tropical-diseases

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