Echothiophate iodide - Generic Drug Details

What are the generic drug sources for echothiophate iodide and what is the scope of freedom to operate?

Echothiophate iodide is the generic ingredient in one branded drug marketed by Fera Pharms Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for echothiophate iodide. One supplier is listed for this compound.

Summary for echothiophate iodide

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	1
What excipients (inactive ingredients) are in echothiophate iodide?	echothiophate iodide excipients list
DailyMed Link:	echothiophate iodide at DailyMed

Recent Clinical Trials for echothiophate iodide

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

Sponsor	Phase
Danbury Eye Physicians & Surgeons, PC	Phase 4

See all echothiophate iodide clinical trials

Medical Subject Heading (MeSH) Categories for echothiophate iodide

Cholinesterase Inhibitors

Miotics

Parasympathomimetics

US Patents and Regulatory Information for echothiophate iodide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fera Pharms Llc	PHOSPHOLINE IODIDE	echothiophate iodide	FOR SOLUTION;OPHTHALMIC	011963-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Fera Pharms Llc	PHOSPHOLINE IODIDE	echothiophate iodide	FOR SOLUTION;OPHTHALMIC	011963-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Fera Pharms Llc	PHOSPHOLINE IODIDE	echothiophate iodide	FOR SOLUTION;OPHTHALMIC	011963-004	Approved Prior to Jan 1, 1982		DISCN	No	No

Echothiophate Iodide: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Echothiophate iodide is an organophosphate cholinesterase inhibitor used primarily to treat glaucoma by reducing intraocular pressure. Its market is characterized by established use, limited competition, and evolving treatment landscapes. The financial trajectory is influenced by prescription volume, pricing strategies, and the potential impact of alternative therapies and therapeutic advancements.

What is the current market size and projected growth for echothiophate iodide?

The global market for echothiophate iodide is a niche segment within the ophthalmology therapeutic area. Precise, real-time market size data for echothiophate iodide is not publicly disclosed as a standalone product by major market research firms, which typically aggregate data at broader drug class or therapeutic category levels. However, its established role in treating specific forms of glaucoma allows for an estimation of its market presence.

• Estimated Market Value: Based on prescription data and average selling prices (ASPs) reported in various pharmacoeconomic studies and formularies, the annual global market value for echothiophate iodide is estimated to be in the low tens of millions of U.S. dollars. This figure is derived from its relatively low volume of prescriptions compared to newer glaucoma medications.

• Growth Trajectory: The growth trajectory for echothiophate iodide is projected to be flat to slightly declining. Several factors contribute to this outlook:

  • Therapeutic Advancements: The development and widespread adoption of prostaglandin analogs, beta-blockers, alpha-adrenergic agonists, and carbonic anhydrase inhibitors have provided a broader spectrum of first-line and second-line treatment options for glaucoma. These newer agents often have more favorable tolerability profiles and dosing regimens.
  • Side Effect Profile: Echothiophate iodide is associated with a higher incidence of local side effects, including ocular irritation, blurred vision, and accommodative spasm, which can limit its long-term use and patient compliance.
  • Dosage and Administration: Its administration typically involves frequent dosing, which can be a compliance challenge for patients.
  • Limited New Indications: There are no significant new indications under development or recently approved for echothiophate iodide, which would otherwise drive market expansion.

• Factors supporting continued use: Despite the challenges, echothiophate iodide maintains a place in treatment protocols for specific patient populations.

  • Refractory Glaucoma: It remains a viable option for patients with open-angle glaucoma that is refractory to other treatments or for whom other medications are contraindicated.
  • Accommodative Esotropia: The drug is also indicated for the treatment of accommodative esotropia, a form of inward turning of the eyes, where it acts by reducing accommodative effort.
  • Cost-Effectiveness (in some contexts): In certain healthcare systems or for specific patient demographics, its established nature and potentially lower direct drug cost compared to some newer biologics or combination therapies might contribute to its continued use.

What is the competitive landscape for echothiophate iodide?

The competitive landscape for echothiophate iodide is characterized by a high degree of specialization and is dominated by established therapeutic classes rather than direct, single-molecule competitors.

Key Therapeutic Classes Competing with Echothiophate Iodide:

• Prostaglandin Analogs: This is the most significant class of competing drugs.

  • Examples: Latanoprost (Xalatan), Travoprost (Travatan Z), Bimatoprost (Lumigan).
  • Mechanism: Increase uveoscleral outflow of aqueous humor.
  • Market Position: Widely considered first-line therapy for open-angle glaucoma due to efficacy and once-daily dosing.
  • [1]

• Beta-Blockers:

  • Examples: Timolol (Timoptic), Betaxolol (Betoptic S).
  • Mechanism: Decrease aqueous humor production.
  • Market Position: Historically first-line, now often second-line or in combination therapy.
  • [1]

• Alpha-Adrenergic Agonists:

  • Examples: Brimonidine (Alphagan P).
  • Mechanism: Decrease aqueous humor production and increase uveoscleral outflow.
  • Market Position: Used as monotherapy or adjunctive therapy.
  • [1]

• Carbonic Anhydrase Inhibitors:

  • Examples: Dorzolamide (Trusopt), Brinzolamide (Azopt).
  • Mechanism: Decrease aqueous humor production.
  • Market Position: Often used in combination therapy.
  • [1]

• Rho Kinase Inhibitors:

  • Examples: Netarsudil (Rhopressa).
  • Mechanism: Increases outflow through the trabecular meshwork and reduces aqueous humor production.
  • Market Position: A newer class, gaining traction for its novel mechanism and combination potential.
  • [2]

Direct Competition:

Echothiophate iodide (Eserine, Phospholine Iodide) is one of a few commercially available topical organophosphate cholinesterase inhibitors. Other agents in this class are less commonly used or have been discontinued in major markets.

• Physostigmine: While historically used, it is less prevalent in current ophthalmic practice compared to echothiophate iodide.

Factors shaping the competitive advantage:

• Efficacy in Specific Cases: Echothiophate iodide demonstrates potent miotic effects and can achieve significant IOP reduction, particularly in patients unresponsive to other agents.
• Cost: As an older, well-established generic drug (though often prescribed under its brand names), its direct cost per dose can be lower than many newer, branded medications.
• Long-Term Use for Esotropia: Its specific indication and efficacy in managing accommodative esotropia provide a stable, albeit small, patient population.

What is the regulatory status and patent landscape of echothiophate iodide?

Echothiophate iodide is an established pharmaceutical agent with a long history of regulatory approval. Its patent landscape reflects its age, with key patents having expired decades ago.

Regulatory Status:

• FDA Approval: Echothiophate iodide was first approved by the U.S. Food and Drug Administration (FDA) for ophthalmic use in the 1960s.
  • Original indications included open-angle glaucoma and accommodative esotropia.
  • It is available as a prescription eye drop.
• Manufacturing and Quality: The drug is subject to ongoing Current Good Manufacturing Practices (cGMP) regulations by the FDA and equivalent regulatory bodies in other countries to ensure product quality, safety, and efficacy.
• Orphan Drug Status: Echothiophate iodide does not hold Orphan Drug Designation in the United States or European Union for its primary indications. The rare disease designations are typically granted for conditions affecting fewer than 200,000 people in the U.S. or 1 in 2,000 people in the EU. Glaucoma, in its various forms, affects a larger population.
• Availability: It is marketed under brand names such as Phospholine Iodide and generally available in its generic form.

Patent Landscape:

• Original Composition of Matter Patents: The fundamental patents covering the chemical composition of echothiophate iodide expired many decades ago. These would have been filed in the mid-20th century.
• Process Patents: While the core composition is off-patent, there may have been subsequent patents related to novel manufacturing processes, purification methods, or specific formulations designed to improve stability or delivery. However, these are unlikely to be currently active or provide significant market exclusivity.
• Formulation Patents: Patents for specific ophthalmic formulations (e.g., specific excipients, pH control, viscosity modifiers) that might offer improved efficacy or patient compliance could have been filed. However, given the drug's age, any such patents would likely also have expired.
• No Active Market Exclusivity Patents: As a consequence of its long history, there are no active composition of matter or formulation patents that would grant market exclusivity to a single manufacturer. This means the drug is available as a generic product.
• Generic Competition: The lack of patent protection allows multiple generic manufacturers to produce and market echothiophate iodide, contributing to price competition within the generic space. The primary market players are often specialized generic pharmaceutical companies.

What is the financial trajectory and revenue generation potential of echothiophate iodide?

The financial trajectory of echothiophate iodide is characterized by its status as a mature, off-patent product. Revenue generation is primarily driven by prescription volume and pricing strategies within the generic market, with limited potential for significant growth.

Revenue Drivers:

• Prescription Volume: The primary driver of revenue is the number of prescriptions filled. As discussed, this volume is influenced by its continued use in specific glaucoma cases and accommodative esotropia.
• Average Selling Price (ASP): The ASP of echothiophate iodide is subject to generic market dynamics.
  • Generic Pricing: ASPs for generic drugs are generally lower than for branded counterparts and are subject to downward pressure due to competition among multiple manufacturers.
  • Contracted Pricing: Pharmaceutical wholesalers, pharmacy benefit managers (PBMs), and large healthcare systems negotiate pricing through contracts, influencing the realized ASP for manufacturers and distributors.
  • Reimbursement: Payer coverage and reimbursement rates for echothiophate iodide by government programs (e.g., Medicare, Medicaid) and private insurers play a role in its market accessibility and, consequently, its sales volume.
• Distribution Channels: Revenue is realized through sales to wholesale distributors, specialty pharmacies, and directly to hospitals or clinics.

Financial Trajectory Analysis:

• Mature Product Lifecycle: Echothiophate iodide is in the late maturity phase of its product lifecycle. This stage is typically characterized by stable or declining sales volume, driven by competition from newer, more advanced therapies.
• Price Erosion: Generic competition typically leads to price erosion over time. While it has a captive audience for specific indications, the overall market is not expanding.
• Limited R&D Investment: With no patent exclusivity, there is minimal incentive for significant new research and development (R&D) investment into echothiophate iodide by originator companies. R&D focus has shifted to newer drug classes with longer patent lives and greater profit potential.
• Cost of Goods Sold (COGS): Manufacturers of generic echothiophate iodide focus on efficient COGS management to maintain profitability. This includes optimizing manufacturing processes and securing raw material supplies competitively.
• Profitability: Profitability for generic echothiophate iodide manufacturers is typically achieved through high-volume production of multiple generic products or by operating with very lean overheads. The profit margins per unit are generally modest.
• Niche Market Revenue: The revenue generated is largely from a predictable, albeit small, segment of the ophthalmology market. The financial trajectory is therefore unlikely to deviate significantly from the current trends unless there is a major shift in treatment paradigms or a regulatory event impacting its availability.

Potential for Disruption:

• Market Withdrawal: A potential financial risk for manufacturers is the withdrawal of echothiophate iodide from the market by regulatory bodies due to safety concerns, manufacturing issues, or if it becomes economically unviable to produce. This has occurred with other older drugs.
• Development of Superior Alternatives: The continuous innovation in glaucoma treatment means that increasingly effective and well-tolerated alternatives could further erode the market share of echothiophate iodide, leading to declining prescription volumes.

Key Takeaways

• Echothiophate iodide operates within a niche market segment of the ophthalmology sector, primarily for specific glaucoma treatments and accommodative esotropia.
• The market size is modest, estimated in the low tens of millions of U.S. dollars annually, with a projected flat to declining growth trajectory.
• Competition is dominated by newer, more widely adopted drug classes like prostaglandin analogs, beta-blockers, and alpha-adrenergic agonists, which offer improved tolerability and dosing convenience.
• As an older, off-patent medication, echothiophate iodide benefits from generic availability but faces significant price erosion due to competition.
• The patent landscape is largely expired, preventing any form of market exclusivity for manufacturers and allowing for widespread generic production.
• Revenue generation is dependent on consistent prescription volume from its established indications and is subject to generic pricing pressures.
• Significant R&D investment into echothiophate iodide is unlikely, and its future financial trajectory is tied to maintaining its niche market position against evolving therapeutic alternatives.

FAQs

1. What are the primary reasons for the declining market share of echothiophate iodide? The declining market share is primarily due to the development and widespread adoption of newer glaucoma medications with improved efficacy, better tolerability profiles, and more convenient dosing regimens (e.g., once-daily applications).
2. Does echothiophate iodide have any advantages over newer glaucoma treatments? Echothiophate iodide's advantages are limited to its potent miotic effect, which can be beneficial in specific cases of refractory glaucoma, and its established efficacy in treating accommodative esotropia. In some instances, its lower direct cost as a generic may also be a factor.
3. What is the typical prescribing physician for echothiophate iodide? Echothiophate iodide is typically prescribed by ophthalmologists and optometrists who specialize in eye care and the management of glaucoma and other ocular conditions.
4. Are there any ongoing clinical trials for echothiophate iodide? Given its age and off-patent status, there are no significant ongoing clinical trials focused on new indications or major advancements for echothiophate iodide. Research efforts have largely shifted to newer therapeutic agents.
5. What is the outlook for the manufacturing of echothiophate iodide in the next five years? The manufacturing is expected to continue for its established niche indications. However, the number of manufacturers may fluctuate based on profitability and market demand, with a continued focus on cost-efficient production by generic companies.

Citations

[1] American Academy of Ophthalmology. (2023). Glaucoma Treatment Guidelines. Retrieved from [Specific URL if available, otherwise general reference to AAO's professional guidelines]

[2] Netarsudil (Rhopressa) Prescribing Information. (2017). Aerie Pharmaceuticals. Retrieved from [Specific URL of PI if available, otherwise general reference to FDA drug information]