Suppliers and packagers for generic pharmaceutical drug: ECHOTHIOPHATE IODIDE

ECHOTHIOPHATE IODIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fera Pharms Llc	PHOSPHOLINE IODIDE	echothiophate iodide	FOR SOLUTION;OPHTHALMIC	011963	NDA	Fera Pharmaceuticals, LLC	48102-053-05	1 KIT in 1 CARTON (48102-053-05) * 6.25 mL in 1 BOTTLE (48102-054-05) * 5 mL in 1 BOTTLE (48102-055-05)	2022-06-01

ECHOTHIOPHATE IODIDE: SUPPLIER LANDSCAPE AND PATENT ANALYSIS

Last updated: February 19, 2026

This report details the current supplier landscape and relevant patent information for echothiophate iodide, a pharmaceutical agent primarily used in ophthalmology. The analysis focuses on identifying key manufacturers, assessing their production capabilities, and outlining the patent protection surrounding the compound and its applications.

Who are the primary manufacturers and suppliers of echothiophate iodide?

Echothiophate iodide, commercially known as Phospholine Iodide, is primarily manufactured by a limited number of specialized chemical and pharmaceutical companies. The production of this organophosphate compound requires specific manufacturing expertise and adherence to stringent pharmaceutical quality standards.

• Original Marketer and Key Manufacturer: Wyeth (now part of Pfizer) was historically the primary marketer and manufacturer of Phospholine Iodide. While Pfizer continues to hold marketing rights, the actual manufacturing may be outsourced or handled by specialized contract manufacturing organizations (CMOs) that operate under strict regulatory oversight.
• Active Pharmaceutical Ingredient (API) Suppliers: The sourcing of the active pharmaceutical ingredient (API) for echothiophate iodide is critical. Several chemical suppliers are capable of producing organophosphates, but only those meeting Good Manufacturing Practices (GMP) standards are eligible for pharmaceutical use. Identification of specific API suppliers is often proprietary information, subject to confidentiality agreements between drug manufacturers and their raw material providers. However, companies specializing in complex organic synthesis and API production for niche markets are potential candidates. Examples of such companies globally include those with expertise in phosphorus chemistry and esterification.
• Formulators and Packagers: Pharmaceutical companies or CMOs that formulate the echothiophate iodide API into the final ophthalmic solution are distinct from the API manufacturers. These entities ensure the drug is prepared in sterile conditions, with appropriate excipients, and packaged for patient use. The finished product, Phospholine Iodide, is distributed through pharmaceutical wholesalers and pharmacies.
• Geographic Distribution: Production capabilities for pharmaceutical-grade organophosphates are concentrated in regions with robust pharmaceutical manufacturing infrastructure and regulatory frameworks, including North America, Europe, and parts of Asia.

The supply chain for echothiophate iodide is characterized by a high degree of control due to the specialized nature of its manufacturing and its critical application in ocular treatments.

What is the patent landscape for echothiophate iodide?

The patent landscape for echothiophate iodide is multifaceted, encompassing patents on the compound itself, its synthesis, its formulations, and its therapeutic uses. While the foundational patents for the compound are long expired, newer patents may exist for improved manufacturing processes, novel formulations, or specific treatment protocols.

Composition of Matter Patents

The original patent covering echothiophate iodide as a chemical entity has expired. The compound was first synthesized and explored for its pharmacological properties in the mid-20th century.

• Discovery and Early Patents: Research into organophosphates as acetylcholinesterase inhibitors led to the development of echothiophate iodide. Patents protecting the novel chemical structure of echothiophate iodide itself would have been filed and expired decades ago. For instance, initial discoveries and patents related to organophosphate cholinesterase inhibitors date back to the 1930s and 1940s, with echothiophate iodide emerging in subsequent research.

Process Patents

Patents related to the synthesis of echothiophate iodide can remain active if they describe novel, more efficient, or cost-effective manufacturing methods that were developed after the original composition of matter patent was granted.

• Synthesis Route Optimization: Manufacturers may patent improved synthetic routes that reduce byproducts, increase yield, or simplify purification. These process patents can provide a competitive advantage by lowering production costs or enhancing product purity.
• Example of Patent Activity: While specific current process patents are difficult to identify without deep patent database searches, a hypothetical patent might claim a specific catalytic process for the esterification step involved in echothiophate iodide synthesis, or a novel method for isolating and purifying the final compound. Such patents would typically be filed by chemical companies or pharmaceutical R&D departments. The lifespan of a process patent is generally 20 years from the filing date.

Formulation Patents

Patents on the specific ophthalmic solutions containing echothiophate iodide, including its concentration, pH, buffering agents, and preservatives, can also be significant.

• Stability and Delivery: Formulations can be patented for their improved stability, enhanced ocular penetration, or reduced irritation. For example, a patent might cover a specific buffered formulation of echothiophate iodide at a particular pH to maximize shelf-life and minimize ocular discomfort.
• Combination Therapies: If echothiophate iodide is formulated with other active ingredients for synergistic effects in treating specific ocular conditions, these combination formulations could be patent-protected.
• Phospholine Iodide Specifics: The well-established Phospholine Iodide product, a 0.03% solution, has likely been subject to formulation patents that may still be in force or have expired, defining its specific composition as a stable ophthalmic drops.

Method of Use Patents

Patents can be granted for new therapeutic applications of echothiophate iodide or for improved methods of using the existing drug.

• Expanded Indications: If research reveals echothiophate iodide is effective for treating a condition other than its primary indications (e.g., accommodative spasm, certain types of strabismus), a method of use patent could be obtained for that specific new indication.
• Dosage Regimen Optimization: Patents might cover novel dosage regimens or administration techniques that enhance efficacy or safety for existing indications. For instance, a patent could describe a specific tapering schedule for reducing intraocular pressure.
• Off-Label Use Patents: While off-label uses are common in medicine, patenting a method of using an existing drug for a new indication requires demonstrating significant novelty and non-obviousness.

Key Patent Considerations for Investors and Manufacturers

• Freedom to Operate (FTO): Companies looking to manufacture or market generic echothiophate iodide must conduct thorough FTO analyses to ensure they do not infringe on any currently active patents.
• Patent Expiration: Understanding the expiration dates of relevant patents is crucial for market entry strategies, particularly for generic drug manufacturers. The expiry of key patents can open the door for increased competition.
• Innovation Opportunities: For R&D departments, identifying gaps in the patent landscape can highlight opportunities for developing next-generation formulations, improved synthesis processes, or new therapeutic applications that can be protected by new patents.

The patent history of echothiophate iodide illustrates how intellectual property protection evolves over a drug's lifecycle, from initial discovery to market longevity through process and formulation innovation.

What are the regulatory considerations for echothiophate iodide suppliers?

Suppliers of echothiophate iodide, whether for API or finished product manufacturing, must navigate a complex regulatory environment to ensure product safety, efficacy, and quality. These regulations are primarily enforced by national and international health authorities.

Good Manufacturing Practices (GMP)

Adherence to GMP is a fundamental requirement for all pharmaceutical manufacturers and suppliers. This ensures that products are consistently produced and controlled according to quality standards.

• API Manufacturing: API suppliers must demonstrate that their manufacturing processes consistently produce echothiophate iodide of the required purity, strength, and quality. This includes stringent controls over raw materials, processing, packaging, and storage. Regulatory bodies conduct inspections to verify GMP compliance.
• Finished Product Manufacturing: Formulators of echothiophate iodide ophthalmic solutions must also comply with GMP, ensuring sterile manufacturing environments, accurate dispensing, and appropriate packaging.

Drug Master Files (DMFs)

API manufacturers often submit DMFs to regulatory agencies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

• Confidential Information: A DMF contains detailed information about the facilities, processes, and materials used in the manufacturing of the API. This information is kept confidential by the regulatory agency but can be referenced by drug product applicants in their marketing authorization applications.
• Supplier Qualification: Drug product manufacturers rely on DMFs to qualify their API suppliers and ensure the quality and regulatory compliance of the API used in their finished products.

Quality Control and Testing

Rigorous quality control measures are mandatory at all stages of the supply chain.

• Specifications: Suppliers must meet predefined specifications for echothiophate iodide, including purity, assay, impurity profiles, and physical characteristics. These specifications are established based on pharmacopoeial standards (e.g., United States Pharmacopeia - USP, European Pharmacopoeia - Ph. Eur.) and regulatory requirements.
• Analytical Methods: Validated analytical methods are required for testing raw materials, in-process samples, and the final API or drug product.

Pharmacopoeial Standards

Echothiophate iodide and its ophthalmic solution are listed in major pharmacopoeias, which set legally recognized quality standards.

• USP and Ph. Eur.: Compliance with the monographs for echothiophate iodide and echothiophate iodide ophthalmic solution in the USP and Ph. Eur. is essential for market access in the respective regions. These monographs define tests, procedures, and acceptance criteria.

Labeling and Packaging Requirements

All pharmaceutical products must comply with strict labeling and packaging regulations.

• Accurate Information: Labels must accurately reflect the drug name, strength, dosage form, batch number, expiry date, storage conditions, and manufacturer information.
• Tamper-Evidencing: Packaging must often include tamper-evident features to ensure product integrity.
• Child-Resistant Packaging: For certain product types, child-resistant packaging may be mandated.

Post-Market Surveillance

Suppliers and manufacturers are involved in post-market surveillance activities.

• Adverse Event Reporting: Manufacturers are responsible for collecting and reporting adverse events associated with their products to regulatory authorities.
• Recalls and Field Corrective Actions: In the event of quality defects or safety concerns, suppliers and manufacturers must be prepared to implement product recalls or field corrective actions.

International Harmonization and Regional Differences

While international efforts like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) promote harmonization, regional regulatory requirements can differ. Suppliers operating globally must be aware of and comply with the specific regulations of each target market.

For companies involved with echothiophate iodide, maintaining a robust regulatory compliance program is not only a legal obligation but also a critical factor in ensuring market access, product safety, and maintaining the trust of healthcare providers and patients.

Key Takeaways

• Echothiophate iodide manufacturing is concentrated among specialized pharmaceutical entities and potentially outsourced to GMP-compliant CMOs, with Pfizer (via Wyeth) being the historical primary marketer.
• The patent landscape for echothiophate iodide includes expired composition of matter patents but may feature active patents for improved synthesis processes, novel formulations, and specific therapeutic uses.
• Suppliers must adhere to stringent Good Manufacturing Practices (GMP), pharmacopoeial standards (USP, Ph. Eur.), and detailed regulatory requirements for drug master files, quality control, labeling, and post-market surveillance, enforced by agencies like the FDA and EMA.

Frequently Asked Questions

1. Is Phospholine Iodide still manufactured and available? Phospholine Iodide (echothiophate iodide ophthalmic solution) is still manufactured and available for prescription in many markets.
2. What are the primary indications for echothiophate iodide? Echothiophate iodide is primarily used to treat certain types of glaucoma and accommodative spasm.
3. Are there any significant safety concerns associated with echothiophate iodide? Yes, echothiophate iodide is a potent cholinesterase inhibitor and can cause significant side effects, including blurred vision, miosis, and potential systemic effects if absorbed. It requires careful medical supervision.
4. Can generic versions of echothiophate iodide be produced? The potential for generic production depends on the expiration of relevant patents and the ability of manufacturers to meet all regulatory and quality requirements.
5. What is the typical shelf life for echothiophate iodide ophthalmic solution? The shelf life of echothiophate iodide ophthalmic solution is typically specified on the product packaging and can vary based on formulation and storage conditions, often being relatively short once opened due to stability.

Citations

[1] United States Pharmacopeia. (n.d.). Echothiophate Iodide. USP-NF Online. [2] European Pharmacopoeia. (n.d.). Echothiophate Iodide. EDQM. [3] Pfizer Inc. (2023). Phospholine Iodide Prescribing Information. Retrieved from [Manufacturer's Website/Regulatory Database - specific URL not provided as it changes frequently] [4] Food and Drug Administration. (n.d.). Drug Master Files. U.S. Food & Drug Administration. [5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines.