PHOSPHOLINE IODIDE Drug Patent Profile

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When do Phospholine Iodide patents expire, and when can generic versions of Phospholine Iodide launch?

Phospholine Iodide is a drug marketed by Fera Pharms Llc and is included in one NDA.

The generic ingredient in PHOSPHOLINE IODIDE is echothiophate iodide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the echothiophate iodide profile page.

Summary for PHOSPHOLINE IODIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	35
Patent Applications:	1,868
Drug Prices:	Drug price information for PHOSPHOLINE IODIDE
What excipients (inactive ingredients) are in PHOSPHOLINE IODIDE?	PHOSPHOLINE IODIDE excipients list
DailyMed Link:	PHOSPHOLINE IODIDE at DailyMed

See drug prices for PHOSPHOLINE IODIDE

US Patents and Regulatory Information for PHOSPHOLINE 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
Fera Pharms Llc	PHOSPHOLINE IODIDE	echothiophate iodide	FOR SOLUTION;OPHTHALMIC	011963-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

PHOSPHOLINE IODIDE Market Dynamics, Patent Position, and Financial Trajectory

Last updated: September 28, 2026

Phospholine Iodide is the legacy brand for echothiophate iodide ophthalmic solution, an irreversible cholinesterase inhibitor used primarily for glaucoma and accommodative esotropia. Its commercial market is small, mature, and supply constrained. The product has limited strategic value as a branded pharmaceutical because modern glaucoma therapies have displaced it, public revenue data are unavailable, and the regulatory record indicates a legacy product rather than an actively expanding franchise.

What is Phospholine Iodide and how is it used?

Phospholine Iodide contains echothiophate iodide, a long-acting parasympathomimetic agent. It produces miosis and reduces intraocular pressure by increasing aqueous humor outflow through the trabecular meshwork. The drug has also been used to induce accommodative spasm in selected pediatric strabismus cases.

Historical product strengths included 0.03%, 0.125%, and 0.25% ophthalmic solutions, although commercial availability has varied by period and market. The FDA label identifies glaucoma and accommodative esotropia as the principal indications. Treatment requires careful ophthalmic monitoring because prolonged cholinergic activity can cause visual complications, iris changes, accommodative effects, and systemic cholinergic reactions. (U.S. Food and Drug Administration [FDA], n.d.-a)

What therapeutic categories compete with Phospholine Iodide?

Phospholine Iodide competes with several better-established glaucoma drug classes:

Drug class	Representative products	Commercial position
Prostaglandin analogs	Latanoprost, bimatoprost, travoprost	Common first-line therapy
Beta blockers	Timolol	Low-cost, widely available
Carbonic anhydrase inhibitors	Dorzolamide, brinzolamide	Established adjunctive therapy
Alpha agonists	Brimonidine	Established branded and generic segment
Cholinergic agents	Pilocarpine, carbachol	Older, declining category
Rho kinase inhibitors	Netarsudil	Newer branded treatment
Fixed combinations	Dorzolamide/timolol, brimonidine/timolol	Used to reduce treatment burden
Surgery and devices	Trabeculectomy, MIGS, drainage devices	Compete in refractory disease

Latanoprost and other prostaglandin analogs generally offer stronger commercial advantages because of once-daily dosing, extensive generic supply, and broader use in primary open-angle glaucoma. Phospholine Iodide remains relevant mainly where its pharmacology addresses a specific clinical need or where alternative treatments are unsuitable.

What is the FDA regulatory status of Phospholine Iodide?

Phospholine Iodide is an old FDA-regulated ophthalmic product with a legacy approval history. Public FDA and DailyMed materials identify echothiophate iodide ophthalmic solution as the active product and provide historical labeling information. DailyMed has carried discontinued-product records for Phospholine Iodide, indicating that the brand has not maintained the market presence of a typical actively promoted prescription product. (National Library of Medicine, n.d.)

The FDA’s Drugs@FDA database is the principal source for verifying application history, labeling, supplements, and regulatory actions. FDA records should be distinguished from commercial availability: an approved or historically approved product may remain in regulatory records even when the branded product is no longer routinely supplied. (FDA, n.d.-b)

What is the Orange Book status of Phospholine Iodide?

The Orange Book is relevant to determining whether a marketed product has listed patents, regulatory exclusivity, or a reference-product designation. Phospholine Iodide’s commercial risk profile is not driven by a modern Orange Book patent estate.

The product’s active ingredient was approved decades ago, and any original composition or use patents would have expired long ago. No current, commercially meaningful patent barrier is apparent from the public legacy-product record. The principal barriers are manufacturing, quality control, regulatory maintenance, and limited demand rather than exclusivity.

What patents protect Phospholine Iodide?

No active patent protection is expected to protect the original echothiophate iodide molecule or the historical Phospholine Iodide formulation. The compound and its ophthalmic use date to an earlier pharmaceutical era, placing any original patent rights well beyond their normal term.

Are formulation patents relevant?

A later entrant could theoretically pursue patents covering:

• A specific concentration or excipient system
• Preservative-free packaging
• Unit-dose delivery
• Container-closure systems
• Sterility or stability improvements
• A new treatment method or dosing schedule
• A combination with another glaucoma therapy

Those rights would protect only the claimed improvement. They would not recreate exclusivity for echothiophate iodide itself. No widely recognized, commercially dominant formulation patent estate is associated with the legacy Phospholine Iodide product.

Manufacturing know-how may still have value. Sterile ophthalmic production requires validated aseptic processing, container-closure integrity, preservative control, stability data, and batch-release testing. These requirements can deter entry even when patent protection is absent.

When does Phospholine Iodide lose exclusivity?

Phospholine Iodide effectively lost conventional market exclusivity decades ago. The relevant commercial question is not the expiration of a remaining patent but whether a manufacturer can justify regulatory and manufacturing investment for a low-volume ophthalmic product.

Exclusivity category	Phospholine Iodide position
Original compound patent	Expired
Historical formulation patents	Expected to be expired
New chemical entity exclusivity	Not applicable to this legacy product
Modern orphan exclusivity	No established current orphan exclusivity
Pediatric exclusivity	No current public indication of an active period
Data exclusivity	No commercially meaningful current period identified
Orange Book patent listing	No active, material barrier apparent
Regulatory market protection	Not a current driver of pricing

Generic competition is legally possible, but actual entry depends on demand, product availability, FDA requirements, and expected reimbursement.

How strong is the Phospholine Iodide patent estate?

The patent estate is weak as a commercial defense. It has three main limitations:

1. The active ingredient is old and no longer supports original-molecule exclusivity.
2. The principal uses are established medical uses rather than newly discovered indications.
3. The product’s value depends on specialized supply rather than patent-protected differentiation.

A company acquiring or relaunching the product would need to create value through reliable supply, regulatory execution, physician adoption, and possibly a differentiated presentation. Patent-based pricing power would be limited.

What generic entry risks exist for Phospholine Iodide?

Generic entry risk is high in principle but moderate in practical terms because the market is small.

An abbreviated new drug application could face technical requirements associated with ophthalmic solutions, including:

• Demonstration of pharmaceutical equivalence
• Sterility assurance
• Comparable concentration and dosage form
• Stability and preservative performance
• Container-closure compatibility
• Manufacturing controls
• Labeling alignment with the reference product

The absence of an active patent barrier makes a Paragraph IV challenge unnecessary unless a listed patent were identified. A generic applicant could instead file an ANDA with a certification that no relevant patent exists or that the listed patent has expired. Because Phospholine Iodide has a legacy regulatory profile, the practical challenge may be identifying an active reference product and obtaining a commercially viable supply chain.

Which companies are challenging Phospholine Iodide?

No major, publicly prominent Paragraph IV litigation campaign is associated with Phospholine Iodide. The product does not have the revenue scale that typically attracts branded-generic patent litigation. Competition is more likely to arise through:

• Generic pilocarpine
• Alternative glaucoma therapies
• Compounded or specialty pharmacy supply
• A future echothiophate iodide ophthalmic applicant
• Off-label substitution with other miotics

What is the financial trajectory of Phospholine Iodide?

Public sources do not provide a reliable standalone revenue series for Phospholine Iodide. The product has not been reported as a major revenue contributor in the public filings of a large pharmaceutical company in the manner of a blockbuster ophthalmology brand. Its financial trajectory is therefore best assessed through market structure rather than reported sales.

Historical phase: established specialty product

Phospholine Iodide entered a market in which few effective long-acting miotic alternatives were available. Its value came from durable intraocular pressure reduction and utility in selected pediatric and refractory cases.

Mature phase: therapeutic displacement

The commercial position weakened as prostaglandin analogs, beta blockers, carbonic anhydrase inhibitors, and combination products gained adoption. These alternatives generally offered easier dosing, broader physician familiarity, and more predictable supply.

Late phase: niche and supply-driven demand

The remaining market consists mainly of patients for whom conventional therapies are inadequate, contraindicated, unavailable, or clinically unsuitable. This creates an unusual pricing structure: unit demand is low, but the product can have high clinical value for individual patients when no direct substitute is readily available.

Financial outlook

A relaunch could generate specialty-product revenue, but the addressable market would likely remain limited. The principal financial variables are:

Variable	Effect on economics
Patient volume	Low and concentrated in specialty practices
Net price	Potentially high because of limited supply
Manufacturing cost	Elevated by sterile ophthalmic requirements
Commercial infrastructure	Small field force may be sufficient
Reimbursement	Variable and payer-specific
Substitution risk	High from other glaucoma treatments
Supply interruptions	Can materially affect sales and reputation
Regulatory cost	Significant relative to expected volume
Patent protection	Provides little pricing support

A specialty manufacturer could pursue the product as a shortage-resistant or orphan-like niche ophthalmic asset. A large pharmaceutical company would likely view it as non-core unless bundled with a broader ophthalmology portfolio.

What licensing deals affect Phospholine Iodide?

No major recent licensing transaction involving Phospholine Iodide is broadly disclosed in public pharmaceutical deal databases or major company filings. The brand has historically been associated with legacy ophthalmic commercialization rather than a visible, active licensing program.

A potential transaction would likely be structured as an asset acquisition, regional commercialization license, or supply-and-distribution agreement. Key diligence issues would include:

• Ownership of the application and product trademarks
• FDA marketing status
• Current reference-product eligibility
• Manufacturing site qualification
• Historical adverse-event data
• Remaining product inventory and supply contracts
• Patent and trademark chain of title
• Reimbursement and payer coverage
• Demand from pediatric ophthalmology and glaucoma specialists

What patent litigation and settlement agreements affect the product?

No material current patent litigation or settlement agreement is publicly associated with Phospholine Iodide. The product’s age and limited revenue reduce the economic rationale for Hatch-Waxman litigation.

The more relevant legal risks are product liability, manufacturing compliance, shortage-related obligations, labeling accuracy, and potential disputes over regulatory ownership or distribution rights. These risks could affect a relaunch even without patent litigation.

What geographic markets offer commercial potential?

The United States remains the most important regulatory market because FDA-recognized ophthalmic labeling and supply status influence commercial value. However, the product’s commercial opportunity is not limited to the United States.

Potential geographic differences include:

• Canada and Europe: market authorization and legacy-product status may differ.
• Latin America: ophthalmic drug availability and pricing can vary widely.
• Asia-Pacific: demand may exist in specialty ophthalmology, but local registration requirements apply.
• Emerging markets: lower pricing can limit the value of a sterile low-volume product.

International expansion would require country-specific regulatory review, pharmacovigilance, labeling, import controls, and local distribution. The absence of active patent protection means geographic differentiation would depend on registration, supply, and commercial execution.

How does Phospholine Iodide compare with pilocarpine and modern glaucoma drugs?

Factor	Phospholine Iodide	Pilocarpine	Latanoprost
Pharmacology	Irreversible cholinesterase inhibitor	Direct muscarinic agonist	Prostaglandin analog
Duration	Long acting	Shorter acting	Approximately once daily
Main use today	Niche glaucoma and pediatric cases	Limited glaucoma use	Broad glaucoma use
Dosing convenience	Less favorable	Less favorable	More favorable
Safety burden	High monitoring requirements	Ocular and systemic effects	Generally easier to use
Patent position	Legacy, expired	Legacy, expired	Original patents expired; generic supply
Market scale	Very small	Small to moderate	Large relative to miotics
Commercial outlook	Specialty niche	Declining or stable niche	Established generic market

Phospholine Iodide’s differentiation is pharmacologic duration and selected clinical utility, not convenience or broad market adoption.

What is the generic launch scenario?

A credible launch scenario would involve a specialty manufacturer obtaining or maintaining the relevant FDA pathway, validating sterile production, and targeting glaucoma and pediatric ophthalmology specialists. The launch would probably use limited promotion and specialty distribution rather than a mass-market sales model.

A successful entrant would need to solve three problems:

1. Maintain consistent product availability.
2. Establish reimbursement sufficient to cover sterile manufacturing costs.
3. Convince physicians to use the product despite broad availability of modern alternatives.

The largest competitive threat is not a single generic echothiophate product. It is substitution with other glaucoma therapies that are easier to prescribe, easier to obtain, and more familiar to payers.

Key Takeaways

• Phospholine Iodide is the legacy brand for echothiophate iodide ophthalmic solution.
• Its principal uses are glaucoma and selected cases of accommodative esotropia.
• The product has a small, mature, specialty market with limited public revenue disclosure.
• Original compound and historical formulation exclusivity are expired.
• No material current Orange Book patent barrier or Paragraph IV litigation campaign is apparent.
• The main entry barriers are sterile ophthalmic manufacturing, regulatory maintenance, limited demand, and reimbursement.
• Modern glaucoma treatments, especially prostaglandin analogs, have displaced most historical demand.
• A relaunch could have niche value if supply is reliable, but blockbuster economics are unlikely.
• The commercial opportunity is driven by unmet supply needs and specialist use rather than patent-based pricing power.

FAQs

Is Phospholine Iodide still commercially available?

Availability has been inconsistent, and public drug references identify the product as a discontinued or legacy product in some records. Commercial status can differ by country, manufacturer, and time period.

Is echothiophate iodide the same as Phospholine Iodide?

Yes. Phospholine Iodide is the historical brand associated with echothiophate iodide ophthalmic solution.

Is Phospholine Iodide a biologic or biosimilar product?

No. It is a small-molecule ophthalmic drug. Biosimilar regulation does not apply.

Could a company obtain new patents on echothiophate iodide?

A company could seek patents on a genuinely novel formulation, delivery system, manufacturing process, or treatment method. It could not restore exclusivity to the old active ingredient merely by obtaining a new patent application.

What is the main investment risk in a Phospholine Iodide relaunch?

The central risk is insufficient volume to support sterile manufacturing, regulatory maintenance, distribution, and reimbursement costs. Product scarcity may support pricing, but scarcity alone does not guarantee a sustainable market.

References

1. National Library of Medicine. (n.d.). DailyMed: Phospholine iodide- echothiophate iodide solution. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (n.d.-a). Phospholine iodide ophthalmic solution prescribing information. FDA. https://www.accessdata.fda.gov/

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