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Last Updated: April 2, 2026

ISOFLUROPHATE - Generic Drug Details


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

Isoflurophate is the generic ingredient in one branded drug marketed by Merck and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for ISOFLUROPHATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 40
DailyMed Link:ISOFLUROPHATE at DailyMed
Medical Subject Heading (MeSH) Categories for ISOFLUROPHATE

US Patents and Regulatory Information for ISOFLUROPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck FLOROPRYL isoflurophate OINTMENT;OPHTHALMIC 010656-001 Approved Prior to Jan 1, 1982 DISCN No 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

ISOFLUROPHATE Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Isoflurophate?

Isoflurophate is an organophosphate compound historically used as an insecticide and, in certain contexts, in ophthalmology for glaucoma treatment. Its pharmaceutical application has declined due to safety concerns and the advent of safer, more effective alternatives.

Current Market Size and Trends

The global pharmaceutical market for drugs related to cholinesterase inhibition—such as those used in glaucoma—has experienced growth driven by increasing prevalence of ocular diseases. However, isoform-specific drugs have been phased out in favor of newer agents.

  • Estimated global ophthalmic drug market value: $12.6 billion (2022), with an annual growth rate of 6% [1].
  • Isoflurophate's role within this market is negligible in 2023 owing to its limited use.

Key Drivers

  • Rising glaucoma prevalence: Approximately 76 million globally, projected to reach 111 million by 2040 [2].
  • Improved diagnostics and screening programs.
  • Aging populations increasing demand for ocular treatments.

Constraints and Challenges

  • Safety concerns: Isoflurophate's high toxicity led to adverse effects such as cholinergic crises.
  • Regulatory restrictions: Ban or severe restrictions in multiple regions.
  • Competitive landscape: Safer drugs like pilocarpine and newer prostaglandin analogs dominate.

Competitive Alternatives

  • Pilocarpine: Used topically in glaucoma, with a better safety profile.
  • Latanoprost, bimatoprost: First-line treatments, high efficacy, minimal systemic effects [3].

Market Outlook

The use of isoflurophate in pharmaceutical applications is declining. Pharmaceutical companies focus investment on safer, more effective cholinergic drugs, diminishing isoform-related product pipelines. Its legacy role persists mainly in research rather than commercial sales.


What Is the Financial Trajectory for Isoflurophate?

Isoflurophate's commercial trajectory has largely plateaued or declined due to safety issues and regulatory bans.

Revenue Trends

  • Estimated revenues from pharmaceutical sales: negligible in 2023.
  • Historical sales peaked in the 1970s but dropped sharply after safety concerns emerged.

R&D Investment and Pipeline

  • No active development or clinical trials involving isoform-specific formulations.
  • Early research explored its potential for neurodegenerative diseases or as an insecticide, but these projects have been discontinued.

Regulatory and Patent Landscape

  • No recent patents filed for pharmaceutical formulations of isoflurophate.
  • Regulatory agencies (FDA, EMA) have disallowed or highly restricted its use in medicine.

Investment Considerations

  • Asset value: Minimal due to clinical obsolescence.
  • Licensing opportunities: None prominent; intellectual property has expired or been revoked.
  • Market risk: High, with regulatory, safety, and competitive hurdles.

Future Financial Outlook

  • The compound will not generate meaningful revenue unless repurposed uniquely.
  • Any remaining financial activity relates primarily to residual manufacturing rights or legacy product inventories.

What Are the Key Takeaways?

  • Isoflurophate has minimal current market presence as a pharmaceutical agent.
  • Its primary application in ophthalmology is now obsolete, replaced by safer alternatives.
  • Safety concerns and regulatory restrictions have significantly restricted or eliminated its pharmaceutical use.
  • The financial outlook indicates negligible revenue potential for isoform-based uses.
  • Ongoing research or licensing activity is unlikely, with most commercial potential exhausted.

FAQs

  1. Has isoform-specific drug development for isoflurophate resumed recently? No. The safety issues and regulatory bans prevent renewed development.

  2. What existing drugs have replaced isoflurophate in glaucoma treatment? Prostaglandin analogs such as latanoprost and bimatoprost are now first-line therapies.

  3. Are there any ongoing research efforts involving isoflurophate? Limited to academic studies exploring its biochemical properties; no clinical development is active.

  4. What is the regulatory status of isoflurophate? It has been banned or heavily restricted as a pharmaceutical agent in many regions due to safety concerns.

  5. Can isoflurophate be used in other medical areas? Its toxicity makes it unsuitable for therapeutic use outside research contexts; some organophosphates are used as insecticides.


Citations

[1] Research and Markets. Global Ophthalmic Drugs Market Report (2022).
[2] Tham, Y.C., et al. Global Prevalence of Glaucoma and Projections. Ophthalmology (2014).
[3] Bito, L., et al. Pharmacological management of glaucoma. Curr Opin Ophthalmol (2017).

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