ECHOTHIOPHATE IODIDE - Generic Drug Details

What are the generic 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.

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	011963-004	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	011963-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Fera Pharms Llc	PHOSPHOLINE IODIDE	echothiophate iodide	FOR SOLUTION;OPHTHALMIC	011963-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Echothiophate Iodide Market Dynamics, Patent Position, and Financial Trajectory

Last updated: September 9, 2026

Echothiophate iodide is a legacy ophthalmic cholinesterase inhibitor with a highly limited commercial market. Its principal U.S. product, Phospholine Iodide, has been marketed as a reconstituted ophthalmic solution for glaucoma and accommodative esotropia. The product has no meaningful remaining regulatory exclusivity, no biosimilar pathway, and limited public financial disclosure. Its commercial value is driven by clinical scarcity and specialist demand rather than scale.

The market has contracted as prostaglandin analogs, beta blockers, carbonic anhydrase inhibitors, alpha agonists, laser procedures, and surgery displaced older miotic therapy. Any current revenue is likely derived from a small specialty market, limited inventory, or compounded and institutionally sourced supply rather than a broad branded franchise.

What is echothiophate iodide used for?

Echothiophate iodide is an irreversible cholinesterase inhibitor used ophthalmically to reduce intraocular pressure. It produces miosis and increases aqueous humor outflow through the trabecular meshwork. The drug has also been used to create prolonged miosis and accommodative effects in selected pediatric ophthalmic indications.

The marketed product has historically been supplied as a powder that is reconstituted into an ophthalmic solution. U.S. labeling identifies indications including chronic open-angle glaucoma and accommodative esotropia in selected patients. Treatment requires specialist supervision because of prolonged pharmacologic activity and risks associated with excessive cholinergic stimulation, including ocular inflammation, ciliary spasm, blurred vision, systemic cholinergic effects, and interaction with depolarizing muscle relaxants. (DailyMed, 2010)

Which formulations are protected by echothiophate iodide patents?

The historical commercial formulation is an ophthalmic solution prepared from echothiophate iodide powder. The principal strengths associated with Phospholine Iodide have included 0.03%, 0.125%, and 0.25%, although product availability has varied by market and period.

No commercially meaningful, unexpired U.S. formulation exclusivity is evident from the product’s legacy status. Any historical patents covering the active ingredient, ophthalmic formulation, or use would have expired decades ago. The current commercial barrier is supply and manufacturing complexity, not patent protection.

Product characteristic	Commercial assessment
Active ingredient	Echothiophate iodide
Dosage form	Reconstituted ophthalmic solution
Main therapeutic areas	Glaucoma and accommodative esotropia
Product type	Small-molecule prescription drug
Primary historical brand	Phospholine Iodide
Current patent value	De minimis
Biosimilar exposure	None
Generic substitution risk	Limited by market size and supply availability

What is the FDA regulatory status of echothiophate iodide?

Echothiophate iodide is an old FDA-approved ophthalmic drug, but its regulatory position is materially different from that of an actively promoted branded medicine. FDA materials and product-label databases identify Phospholine Iodide as a legacy prescription product. Product availability has been intermittent, and public drug databases have identified the product as discontinued or unavailable in some periods. (U.S. Food and Drug Administration, n.d.-a; DailyMed, 2010)

The product’s commercial status should be separated from its approval history:

1. The active ingredient has an established FDA-approved ophthalmic use.
2. The branded product has had limited and inconsistent market availability.
3. No current regulatory exclusivity appears to protect the product.
4. The market does not have the scale associated with standard generic ophthalmic therapies.

What is the Orange Book status of echothiophate iodide?

The Orange Book is relevant for determining listed patents, exclusivity, and therapeutic-equivalence information for approved drug products. Echothiophate iodide is a legacy product and does not have a commercially significant Orange Book patent estate comparable to newer ophthalmic medicines.

No active patent-based exclusivity period is publicly associated with the historical Phospholine Iodide franchise. The product’s age indicates that original composition-of-matter and early formulation rights have expired. Any current FDA listing would primarily provide regulatory and product-status information, not a meaningful barrier to competition. (U.S. Food and Drug Administration, n.d.-b)

When does echothiophate iodide lose exclusivity?

Echothiophate iodide lost meaningful exclusivity many years ago. Its commercial history dates to the mid-20th century, and the drug is far beyond the five-year new chemical entity exclusivity period and the applicable patent term for its original approval.

Exclusivity category	Status
New chemical entity exclusivity	Expired
Original composition patent	Expired
Historical formulation patents	Expired or commercially immaterial
Pediatric exclusivity	No current commercial relevance identified
Orphan exclusivity	Not a principal market driver
Data exclusivity	Expired
Current patent exclusivity	None of commercial significance

The expiration of exclusivity did not produce a large generic market. Echothiophate iodide’s declining clinical use, unusual dosage form, small patient population, and manufacturing requirements reduced the economic incentive for conventional generic manufacturers.

How many patents cover echothiophate iodide?

The number of historical patent documents associated with echothiophate iodide is less important than the absence of enforceable commercial rights. The active ingredient was introduced several decades ago, so original compound patents have expired. Historical patents may cover chemical synthesis, salt forms, ophthalmic delivery, packaging, or therapeutic use, but they do not create a current exclusivity position.

A practical patent-risk assessment is:

Patent category	Current commercial risk
Active ingredient	Very low
Ophthalmic solution	Very low
Reconstitution process	Low
Container or packaging	Low
Method of treating glaucoma	Very low
Method of treating accommodative esotropia	Very low
Manufacturing know-how	Moderate operational relevance
Trade secrets and supplier relationships	Potentially meaningful

Manufacturing know-how may matter more than patent rights. A manufacturer must manage active pharmaceutical ingredient sourcing, stability, sterile ophthalmic processing, reconstitution characteristics, packaging, and quality-control requirements. These factors can prevent entry even where patent barriers are absent.

Which companies are challenging echothiophate iodide?

No major current Paragraph IV campaign is associated with echothiophate iodide. The market is too small and commercially uncertain to support the type of litigation commonly seen for high-revenue ophthalmic products.

What patent litigation affects echothiophate iodide?

No material recent U.S. patent litigation involving the principal echothiophate iodide product has shaped market access. There is no widely reported active dispute involving a branded patent holder and a major generic challenger.

The litigation profile differs from products such as latanoprostene bunod, netarsudil, aflibercept, or fixed-combination glaucoma therapies, where formulation, dosing, delivery, and method-of-use patents can support substantial litigation.

Are there Paragraph IV settlements for echothiophate iodide?

No commercially significant Paragraph IV settlement is publicly associated with the historical Phospholine Iodide product. The absence of settlement activity is consistent with the drug’s low revenue potential and limited number of likely applicants.

What is the financial trajectory for echothiophate iodide?

Echothiophate iodide has no transparent, standalone public revenue history. Historical product sales were not generally disclosed separately by the product’s corporate owners, and current sales data are not reported as a distinct public segment.

Its financial trajectory can be characterized in four phases:

Period	Market condition	Financial implication
Early commercial period	Specialist use in glaucoma and pediatric ophthalmology	Established niche revenue
Broad ophthalmic substitution period	Increased use of safer and easier-to-administer agents	Progressive volume decline
Legacy-brand period	Limited promotion and intermittent availability	Low, declining branded revenue
Current specialty-supply period	Scarcity, institutional sourcing, or limited distribution	Potentially higher unit economics but low total volume

The product’s revenue ceiling is constrained by its indication and clinical position. It is not a mass-market glaucoma treatment. First-line glaucoma management generally relies on agents with simpler administration and more favorable tolerability profiles. Echothiophate is more likely to be retained for selected patients who cannot achieve adequate control with alternatives or who have specific accommodative needs.

What is the revenue exposure for manufacturers?

For a diversified pharmaceutical company, echothiophate iodide is unlikely to represent material revenue exposure. The product is more relevant to a specialty manufacturer, hospital supplier, or contract manufacturer with a portfolio of low-volume ophthalmic medicines.

Commercial value may arise from:

• Limited competition.
• Physician familiarity in specific use cases.
• High switching costs when a patient is stable on therapy.
• Institutional need for an approved product when compounded alternatives are unavailable.
• Scarcity premiums during supply interruptions.

These advantages do not eliminate the product’s structural limitations. A small patient population, low prescribing frequency, and limited promotional opportunity restrict total sales.

How strong is the patent estate for echothiophate iodide?

The patent estate is weak from an enforcement perspective. The drug’s principal protection has expired, and no current patent moat appears to support premium valuation.

The stronger commercial assets are operational:

1. FDA approval and an established prescribing history.
2. Manufacturing familiarity with a technically demanding ophthalmic dosage form.
3. Supplier relationships for the active ingredient.
4. Quality systems for sterile ophthalmic production.
5. Distribution access to ophthalmologists, pediatric ophthalmologists, and specialty pharmacies.

These assets can create practical barriers to entry, but they are not equivalent to enforceable patent exclusivity. A competitor with a viable approved product could likely enter without facing a material patent challenge, subject to FDA requirements and commercial economics.

What generic entry risks exist for echothiophate iodide?

Generic entry risk is legally high but commercially moderate.

A potential applicant would face little risk from expired composition or use patents. However, the economic case is weak because the market is small and the product has demanding manufacturing and quality requirements. A generic could also face limited availability of the active ingredient, low forecast volume, and the need to distribute a product used by a narrow specialist population.

The most plausible entry scenarios are:

Scenario	Probability assessment	Market effect
Large generic launch	Low	Significant price pressure if it occurs
Specialty generic launch	Moderate	Improved supply and lower pricing
Compounded substitution	Ongoing possibility	Fragmented pricing and variable availability
Continued single-source supply	Plausible	Preserves scarcity value
Permanent commercial withdrawal	Plausible	Shifts demand to alternatives or compounding

The commercial risk is therefore asymmetric. A single approved competitor could reduce price and capture demand, but the likelihood of multiple competitors entering a low-volume market is limited.

Is there biosimilar risk for echothiophate iodide?

There is no biosimilar risk. Echothiophate iodide is a small-molecule chemical drug, not a biologic. Competition would proceed through an abbreviated or full small-molecule drug application, depending on the regulatory status and reference-product pathway, rather than through the biosimilar framework under the Public Health Service Act.

The relevant competitive risks are generic substitution, alternative glaucoma therapies, pharmacy compounding, and clinical displacement by newer agents.

How does echothiophate iodide compare with competing glaucoma drugs?

Echothiophate iodide competes primarily through clinical need rather than price. Prostaglandin analogs such as latanoprost, bimatoprost, and travoprost generally have stronger commercial positions because they are easier to administer and widely used in chronic glaucoma management. Timolol, dorzolamide, brimonidine, and fixed-dose combinations also have broader prescribing bases.

Product class	Position relative to echothiophate iodide
Prostaglandin analogs	Stronger first-line and chronic-use position
Beta blockers	Broad generic availability and lower cost
Carbonic anhydrase inhibitors	Established alternatives for pressure reduction
Alpha agonists	Common adjunctive therapy
Laser trabeculoplasty	Non-drug alternative for selected patients
Surgery and sustained-release devices	Used when medication is inadequate
Echothiophate iodide	Narrow legacy role with specialist use

Echothiophate’s advantages are prolonged cholinesterase inhibition and utility in selected refractory or unusual cases. Its disadvantages include adverse-effect burden, dosing complexity, limited availability, and the existence of better-established alternatives.

What geographic markets support echothiophate iodide?

The United States has historically been the most visible market because of the documented Phospholine Iodide product and FDA labeling. Current geographic availability is likely uneven. The product’s commercial presence depends on national approval, local procurement, specialist demand, and access to sterile manufacturing.

Region	Commercial outlook
United States	Legacy approval, limited or intermittent availability
European Union	Country-specific availability; no uniform broad-market position
Canada	Limited specialist demand and potential supply constraints
Emerging markets	Low commercial priority due to alternative therapies
Hospital and specialty channels	More relevant than mass retail distribution

The global market is not likely to support substantial investment in new capacity without a committed buyer, supply agreement, or public-health procurement rationale.

What manufacturing and intellectual-property barriers remain?

The main barriers are technical and economic rather than legal. Echothiophate iodide requires a sterile ophthalmic manufacturing process and controlled reconstitution or packaging system. The manufacturer must demonstrate assay, sterility, stability, particulate control, container-closure integrity, and suitable labeling.

The active ingredient also presents a supply-chain concern because demand is low. Low-volume chemicals can be vulnerable to discontinuation by upstream suppliers. That risk can create shortages even when no patent prevents production.

A new entrant would need to justify the cost of:

• Active pharmaceutical ingredient qualification.
• Sterile ophthalmic manufacturing.
• Stability studies.
• FDA application preparation.
• Pharmacovigilance and postmarket compliance.
• Specialty distribution.
• Inventory carrying costs for a low-turnover product.

What is the likely generic launch scenario?

The most likely scenario is continued limited supply, with any entrant targeting the specialist market rather than a broad ophthalmic launch. A successful applicant could obtain meaningful share because the incumbent market is small and physician loyalty may be concentrated around product availability.

Pricing would depend on whether the entrant is an approved generic, a specialty branded product, or a compounded preparation. An approved generic could lower acquisition cost for pharmacies and institutions. A shortage or single-source environment could preserve high unit prices despite low total revenue.

Key Takeaways

• Echothiophate iodide is a legacy ophthalmic drug with a narrow specialist market.
• Phospholine Iodide is the principal historical U.S. brand.
• Original composition, formulation, and use exclusivity are no longer commercially relevant.
• No material active patent estate, Paragraph IV campaign, or settlement activity is associated with the product.
• The drug has no biosimilar exposure because it is a small molecule.
• Financial disclosure is limited because product-level revenue has not been reported separately.
• Market decline reflects therapeutic substitution, adverse-effect concerns, and intermittent availability.
• Manufacturing, sterile processing, API sourcing, and distribution are more important barriers than patents.
• Generic entry is legally feasible but economically uncertain.
• The product’s value lies in scarcity and specialist utility, not market scale.

FAQs About Echothiophate Iodide

Is echothiophate iodide still commercially available in the United States?

Availability has been intermittent and product status has varied. Historical FDA labeling confirms the product’s approved ophthalmic use, but commercial supply has not matched that of widely used glaucoma medicines.

Is Phospholine Iodide a generic drug?

Phospholine Iodide is the historical branded product name for echothiophate iodide ophthalmic solution. Because the underlying drug is old, any current competitor would generally rely on an abbreviated or equivalent small-molecule approval pathway rather than a new chemical entity pathway.

Can echothiophate iodide be compounded?

Compounding may be considered when an approved commercial product is unavailable, subject to applicable federal and state requirements and professional judgment. Compounded preparations may not have the same regulatory status, labeling, or quality controls as an FDA-approved product.

Does echothiophate iodide have orphan-drug value?

The product has a narrow patient population, but narrow use alone does not establish current orphan exclusivity. Its commercial profile is better described as a legacy specialty medicine than as an actively protected orphan franchise.

What is the investment case for echothiophate iodide?

The investment case is limited. Potential value comes from supply scarcity, specialist demand, and the difficulty of maintaining sterile production at low volume. The absence of meaningful patent protection, small revenue base, and competition from modern glaucoma therapies constrain valuation.

References

DailyMed. (2010). Phospholine iodide: Echothiophate iodide ophthalmic solution prescribing information. U.S. National Library of Medicine.

U.S. Food and Drug Administration. (n.d.-a). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/

U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

U.S. Food and Drug Administration. (n.d.-c). FDA drug shortages database. https://dps.fda.gov/drugshortages/