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Last Updated: April 30, 2025

Drugs in MeSH Category Amebicides


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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott AMPHOTERICIN B amphotericin b INJECTABLE;INJECTION 064141-001 Dec 23, 1996 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Eugia Pharma AMPHOTERICIN B amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 214010-001 Nov 17, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alkopharma Usa AMPHOTEC amphotericin b INJECTABLE, LIPID COMPLEX;INJECTION 050729-002 Nov 22, 1996 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Apothecon FUNGIZONE amphotericin b OINTMENT;TOPICAL 050313-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Amebicides Market Analysis and Financial Projection

The market dynamics and patent landscape for amebicides—a class of drugs targeting Entamoeba histolytica infections—reflect a sector shaped by evolving healthcare demands, regulatory challenges, and strategic intellectual property (IP) practices. Here’s a structured analysis:


Market Dynamics

Growth Drivers

  • Rising Disease Burden: Amebiasis remains prevalent in low-resource regions with poor sanitation. Over 50 million global cases annually drive demand for treatments[2][6].
  • Technological Advancements: PCR-based diagnostics and point-of-care testing improve early detection, while novel formulations (e.g., liposomal delivery) enhance drug efficacy[2][6].
  • Regional Trends:
    • North America dominates (high prevalence of drug-resistant strains and advanced healthcare infrastructure)[2][6].
    • Asia-Pacific is the fastest-growing market due to urbanization, improving healthcare access, and government infectious disease initiatives[2].

Market Segmentation

  • Drug Types: Metronidazole (most prescribed), paromomycin, tinidazole, and diloxanide (luminal amebicide)[2][10][13].
  • Mechanisms: Inactivation of enzymes (e.g., nitroimidazoles), DNA replication inhibition, and protein synthesis disruption[6].
  • Distribution: Hospital pharmacies lead sales, though online pharmacies are rising post-pandemic[2][6].

The global amebiasis treatment market is projected to grow at 8.65% CAGR (2025–2032), reaching $764.63M by 2032 from $374.62M in 2024[2].


Patent Landscape

Key Strategies

  1. Patent Thickets: Though less common than in biologics (e.g., Humira[12]), amebicide manufacturers file secondary patents covering formulations, combinations, and administration methods to extend monopolies. Example:
    • Chloroquine phosphate (an amebicide and antimalarial) has multiple patents on salt forms and combination therapies[13].
  2. Evergreening: Modifications like extended-release formulations or pediatric dosing are patented post-initial approval. For instance, diloxanide, first approved in 1956, saw later patents for co-administration with antiparasitics[10].

Regional IP Disparities

  • U.S. vs. Europe: U.S. patents often outnumber European ones due to weaker evergreening restrictions. Biologic drugs average 4× more U.S. patents, a trend likely mirrored in small molecules[8][9].
  • Asia-Pacific: Emerging markets face delayed generic entry due to fragmented patent laws and slower biosimilar adoption[2][6].

Recent Legislative Pressures

  • The Biologics Price Competition and Innovation Act (BPCIA) aimed to streamline biosimilar approvals but had limited impact due to patent litigation[1].
  • Proposed U.S. bills seek to restrict patent thickets for biologics and small molecules, potentially accelerating generic competition[1][8].

Case Study: Diloxanide

  • Patent Timeline: Initially patented in 1956, diloxanide’s later patents covered enteric coatings and synergistic combinations with metronidazole[10].
  • Market Impact: Despite WHO essential medicine status, accessibility in high-income countries is limited due to expired patents and generic dominance[10].

Challenges and Opportunities

Factor Impact
Drug Resistance Drives R&D for novel agents (e.g., vaccine candidates)[2].
Biosimilar/Geric Entry Slower for biologics (e.g., Enbrel[1]) vs. small-molecule amebicides.
Cost Pressures Patent cliffs for drugs like chloroquine (2025 expirations[4]) may lower prices.

Future Outlook

  • Innovation: AI-driven drug discovery and targeted biologics could disrupt traditional markets[2][11].
  • Policy Reforms: Stricter patentability criteria may reduce evergreening, particularly in the U.S. and EU[8][12].

In summary, the amebicide market balances growth from unmet medical needs against IP practices that delay competition. Legislative reforms and technological advances will critically shape its trajectory.

References

  1. https://www.biopharmadive.com/news/amgen-enbrel-patent-thicket-monopoly-biosimilar/609042/
  2. https://www.databridgemarketresearch.com/reports/global-amebiasis-treatment-market
  3. https://meshb.nlm.nih.gov/record/ui?ui=D000563
  4. https://www.pharmamanufacturing.com/home/article/55249347/key-drugs-losing-patent-protection-in-2025
  5. https://www.theinsightpartners.com/reports/patent-medicine-market
  6. https://www.biospace.com/amebicide-drugs-market-increasing-prevalence-of-parasitic-infections-all-over-the-world-drives-the-market
  7. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(D27)
  8. https://wvutoday.wvu.edu/stories/2025/01/24/wvu-legal-scholar-makes-case-for-equal-protection-among-different-medication-classes
  9. https://www.i-mak.org/wp-content/uploads/2022/09/Overpatented-Overpriced-2022-FINAL.pdf
  10. https://en.wikipedia.org/wiki/Diloxanide
  11. https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1287542/full
  12. https://dash.harvard.edu/server/api/core/bitstreams/0b2cd634-f60c-422f-8861-74725c0c940b/content
  13. https://www.drugs.com/pro/chloroquine.html
  14. https://unitaid.org/uploads/OPC-67683_Patent_Landscape.pdf
  15. https://www.nber.org/system/files/working_papers/w28858/w28858.pdf
  16. https://patents.google.com/patent/US2922743A/en

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