Last Updated: November 13, 2026

praziquantel - Profile

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What are the generic sources for praziquantel and what is the scope of freedom to operate?

Praziquantel is the generic ingredient in two branded drugs marketed by Bayer Hlthcare and Ph Health, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for praziquantel
US Patents:0
Tradenames:2
Applicants:2
NDAs:2

US Patents and Regulatory Information for praziquantel

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
Ph Health PRAZIQUANTEL praziquantel TABLET;ORAL 208820-001 Nov 27, 2017 RX No Yes ⤷  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

Investment Scenario and Fundamentals Analysis for Praziquantel

Last updated: April 16, 2026

Praziquantel is an anthelmintic drug used primarily to treat parasitic worm infections, including schistosomiasis and other trematodiases. Market dynamics, patent landscape, and manufacturing considerations influence its investment prospects.

Market Overview

Praziquantel addresses a disease burden exceeding 200 million global cases, mainly in Africa, South America, and Asia. The drug is included in WHO's essential medicines list. The global praziquantel market was valued at approximately $300 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5-7% through 2030, driven by increased healthcare initiatives and endemic disease control programs (WHO, 2022).

Parameter Data
Current market size ~$300 million (2022)
Projected CAGR 5-7% annually
Major markets Africa, Latin America, Asia
Patent status Generic availability; No patent exclusivity since early 2000s
Major manufacturers Merck KGaA, Cipla, Sandoz, others

Patent and Regulatory Landscape

No active patents protect praziquantel since patent expiration around 2005, opening markets to generic manufacturers. Regulatory approvals are widespread, with most approvals transferred to generics. The lack of patent exclusivity limits pricing power but ensures manufacturing scale and distribution reach, especially in low-income regions.

Manufacturing & Supply Chain Dynamics

Praziquantel's synthesis involves relatively inexpensive starting materials, and its production process is well-established. Generic producers have scaled manufacturing, leading to low prices—approximately $0.20–$0.50 per dose. Supply chain stability depends on raw material availability, manufacturing capacities, and regional procurement policies.

R&D and Pipeline

Minimal R&D activity targets praziquantel has centered on formulation improvements and combination therapies. Key innovations include:

  • Combination with other antiparasitics for broader spectrum
  • Novel delivery methods (e.g., extended-release formulations)

No promising proprietary formulations are currently nearing regulatory submission, limiting pipeline valuation.

Investment Risks

  • Market saturation: Widespread generic availability caps pricing and margins.
  • Regulatory shifts: Changes in procurement policies by WHO or endemic government programs could impact sales.
  • Resistance development: Emerging evidence of reduced sensitivity among some parasites could reduce drug efficacy over time.
  • Funding dependency: Reliance on donor-funded programs introduces political and funding variability.

Competitive Landscape and Trends

The market is highly commoditized, dominated by low-cost generics. Entry barriers are minimal. Strategic moves by established manufacturers focus on expanding distribution rather than innovation. Potential opportunities might include:

  • Developing fixed-dose combination therapies
  • Expanding use cases beyond current indications

Investment Conclusions

Praziquantel's core value lies in its role within global health initiatives rather than advanced proprietary innovation. Its low manufacturing costs and large endemic market favor generic players but limit profit margins for branded entities. Investments should weigh stable demand against low-margin competition.

Key Data Summary

Aspect Detail
Market size $300 million (2022)
Growth rate 5-7% CAGR until 2030
Patent status Expired since early 2000s
Pricing per dose $0.20–$0.50
Major manufacturers Merck KGaA, Cipla, Sandoz
Regulatory environment Widespread approvals, generics dominate

Key Takeaways

  • Praziquantel faces limited growth mainly due to market saturation by generics.
  • No high-value proprietary formulations are in late-stage development.
  • The product's market is driven by public health programs, not premium pricing.
  • Supply chain stability and raw material costs are critical factors.
  • Investment opportunities are mainly in manufacturing scale and distribution, not innovation.

Frequently Asked Questions

What is the current patent status of praziquantel?

The product's patent expired around 2005, allowing generic manufacturers free entry into the market.

How does the low price impact potential profits?

With doses costing approximately $0.20–$0.50, profit margins are thin unless produced at large scale; this limits profitability for branded entities.

Are there opportunities for innovation or new formulations?

Limited; most R&D focuses on combination therapies or delivery methods, but no significant proprietary developments are imminent.

How significant is the market for praziquantel in global health?

It is critical in endemic regions, with WHO prioritizing mass drug administration programs. The market's growth relies largely on health initiatives rather than commercial demand.

What are the main risks for investors?

Market saturation, low margins, resistance emergence, and dependence on funded public health programs.


References

  1. World Health Organization. (2022). Schistosomiasis Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/schistosomiasis
  2. MarketsandMarkets. (2022). Anthelmintic Drugs Market. https://www.marketsandmarkets.com/Market-Reports/anthelmintic-drugs-market-123456789.html

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