LODOXAMIDE TROMETHAMINE - Generic Drug Details

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

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

Summary for LODOXAMIDE TROMETHAMINE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	54
What excipients (inactive ingredients) are in LODOXAMIDE TROMETHAMINE?	LODOXAMIDE TROMETHAMINE excipients list
DailyMed Link:	LODOXAMIDE TROMETHAMINE at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for LODOXAMIDE TROMETHAMINE

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for LODOXAMIDE TROMETHAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ALOMIDE	lodoxamide tromethamine	SOLUTION/DROPS;OPHTHALMIC	020191-001	Sep 23, 1993		DISCN	Yes	No

Expired US Patents for LODOXAMIDE TROMETHAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ALOMIDE	lodoxamide tromethamine	SOLUTION/DROPS;OPHTHALMIC	020191-001	Sep 23, 1993

Lodoxamide Tromethamine Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 9, 2026

Lodoxamide tromethamine is a mature ophthalmic anti-allergy drug with limited commercial momentum. The product, historically marketed as Alomide 0.1% ophthalmic solution, competes against lower-cost generic mast-cell stabilizers, over-the-counter ketotifen, and newer antihistamine/mast-cell stabilizer products such as olopatadine. Its patent and regulatory exclusivity have expired, and no material biosimilar or patent litigation risk applies. The commercial opportunity is concentrated in generic supply, institutional contracts, and selected international markets rather than branded growth.

What is lodoxamide tromethamine used for?

Lodoxamide tromethamine is an ophthalmic mast-cell stabilizer used to treat the signs and symptoms of allergic conjunctivitis, including itching, redness, tearing, and ocular irritation. The U.S. product is a 0.1% ophthalmic solution administered four times daily in affected eyes. The FDA-approved product is prescription-only in the United States. [1]

Lodoxamide inhibits mast-cell degranulation and reduces the release of inflammatory mediators involved in ocular allergy. Its mechanism differs from antihistamine-only products, although many competing products combine antihistamine activity with mast-cell stabilization.

Attribute	Lodoxamide tromethamine
Active ingredient	Lodoxamide tromethamine
Dosage form	Ophthalmic solution
U.S. strength	0.1%
Main indication	Allergic conjunctivitis
Historical brand	Alomide
Original U.S. sponsor	Alcon Laboratories
FDA approval	NDA 019661
Administration	Typically one drop four times daily
Market status	Mature, genericized ophthalmic product

What is the FDA regulatory status of lodoxamide tromethamine?

The FDA approved Alomide ophthalmic solution under NDA 019661. The product was developed for seasonal and perennial allergic conjunctivitis and related ocular allergy symptoms. FDA labeling identifies lodoxamide tromethamine as a topical ophthalmic therapy rather than a systemic drug. [1]

The branded Alomide product is no longer a meaningful growth product in the U.S. market. Generic lodoxamide ophthalmic solution has been marketed by one or more manufacturers over time, although availability can vary by distributor, pharmacy channel, and manufacturing status.

The FDA’s discontinued-product records and product listings distinguish commercial discontinuation from withdrawal for safety or efficacy reasons. Lodoxamide’s commercial maturity reflects loss of market relevance and competitive displacement, not a well-established safety withdrawal. [2]

What is the Orange Book status of lodoxamide tromethamine?

Lodoxamide tromethamine has no commercially meaningful remaining U.S. patent or regulatory exclusivity. The key product is an old small-molecule ophthalmic solution, and its original patents and exclusivity periods expired years ago.

The FDA Orange Book is the primary source for identifying listed patents, exclusivity, and generic approval status for approved drug products. Current Orange Book records do not indicate an active, commercially relevant patent barrier protecting the historical Alomide product. [3]

Exclusivity category	Current position
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No current protection
U.S. formulation exclusivity	Expired
Orange Book patent barrier	No active commercial barrier identified
Generic pathway	ANDA-based competition is available

When does lodoxamide tromethamine lose exclusivity?

Lodoxamide lost meaningful exclusivity after expiration of the original product patents and the applicable FDA regulatory exclusivity period. The exact commercial end point is less important than the current legal position: the product is fully mature and exposed to generic competition.

No active U.S. exclusivity period supports premium pricing for lodoxamide tromethamine. Any remaining manufacturer differentiation is likely to arise from supply reliability, manufacturing cost, packaging, wholesaler relationships, or geographic registration rather than intellectual property.

How many patents cover lodoxamide tromethamine?

No active U.S. Orange Book patent estate appears to provide a material barrier to generic lodoxamide ophthalmic solution. The principal historical protection was associated with the active pharmaceutical ingredient, ophthalmic formulation, and original branded product. Those rights have expired or have no current commercial blocking effect.

The residual intellectual-property position can still include manufacturing know-how, analytical methods, supplier agreements, container-closure specifications, and process controls. Those rights generally do not prevent an approved generic manufacturer from entering if it can meet FDA chemistry, manufacturing, and controls requirements.

What formulations are protected by lodoxamide patents?

The commercially relevant formulation is a sterile 0.1% ophthalmic solution containing lodoxamide tromethamine and excipients that control pH, tonicity, stability, and preservative performance. Historical formulation protection does not appear to create a current U.S. exclusivity barrier.

Manufacturing difficulty remains higher than for an ordinary oral tablet. An ophthalmic solution requires sterile processing, validated filling, particulate control, container-closure integrity, microbiological testing, and stability data. These requirements can reduce the number of active suppliers even when patents no longer block entry.

Are there Paragraph IV challenges for lodoxamide tromethamine?

Lodoxamide is unlikely to generate significant present-day Paragraph IV activity. Paragraph IV litigation is generally relevant when an ANDA applicant challenges an unexpired Orange Book patent. Lodoxamide’s commercial product is an old genericized ophthalmic medicine without a meaningful active patent estate.

Historical ANDA filings may have occurred during the transition from branded Alomide to generic products, but those filings do not create a current market barrier. No active, commercially material Paragraph IV dispute is apparent from the product’s current regulatory position.

What patent litigation affects lodoxamide tromethamine?

No material current U.S. patent litigation is associated with lodoxamide tromethamine. The absence of active Orange Book protection substantially reduces the probability of branded patent litigation, preliminary injunction proceedings, or settlement-driven delayed generic entry.

The more relevant risks are operational:

• sterile manufacturing interruptions;
• product discontinuations by low-volume suppliers;
• FDA inspection findings;
• shortages of ophthalmic containers or preservative components;
• wholesaler delisting;
• substitution by newer allergy products.

These risks can affect individual suppliers without changing the overall legal status of the active ingredient.

How strong is the patent estate for lodoxamide tromethamine?

The patent estate is weak from a current commercial perspective. Its principal characteristics are:

Patent-estate factor	Assessment
Composition-of-matter protection	Expired
Core formulation protection	Expired or commercially nonblocking
Method-of-use protection	Expired or commercially nonblocking
Orange Book leverage	Low
Generic entry risk	High
Ability to sustain premium pricing	Very low
Manufacturing know-how value	Moderate at supplier level
Litigation leverage	Low

Lodoxamide may retain know-how value in sterile ophthalmic production, but know-how is not equivalent to enforceable market exclusivity. A supplier with a reliable FDA-compliant facility may have a practical advantage over smaller competitors, yet that advantage can be lost through price competition or production disruption.

How does lodoxamide compare with competing ophthalmic allergy drugs?

Lodoxamide competes in a crowded market that includes prescription, over-the-counter, generic, and branded products.

Drug	Primary activity	U.S. commercial position	Competitive impact
Lodoxamide	Mast-cell stabilization	Mature generic	Low price, lower prescription visibility
Cromolyn sodium	Mast-cell stabilization	Mature generic	Similar legacy positioning
Ketotifen	Antihistamine plus mast-cell stabilization	OTC	Strong convenience and consumer access
Olopatadine	Antihistamine plus mast-cell stabilization	OTC and prescription legacy	Strong clinical and commercial substitution
Azelastine	Antihistamine	Prescription/OTC depending product	Competes for allergic-eye treatment
Epinastine	Antihistamine plus mast-cell activity	Prescription	Alternative for ocular allergy
Nedocromil	Mast-cell stabilization	Limited availability	Legacy comparator

The main disadvantage for lodoxamide is dosing frequency. Four-times-daily administration is less convenient than once-daily or twice-daily alternatives. Ketotifen and olopatadine also benefit from strong consumer recognition and broad retail availability. Pataday, the OTC olopatadine brand, expanded the nonprescription competitive set after FDA approval for OTC marketing. [4]

What is the market size and financial trajectory for lodoxamide tromethamine?

No current public company reports lodoxamide-specific revenue, volume, or margin data. The product is generally embedded within broader ophthalmology or generic portfolios rather than reported as a standalone commercial asset.

Its financial trajectory can be characterized in four stages:

1. Branded launch and adoption: Alomide generated prescription revenue as a treatment for allergic conjunctivitis.
2. Competitive maturation: Newer antihistamine/mast-cell stabilizers reduced clinical and commercial differentiation.
3. Genericization: Patent expiry opened the market to ANDA competition and compressed pricing.
4. Niche generic phase: Revenue shifted toward low-priced, low-volume supply with periodic availability constraints.

The expected revenue profile is therefore declining or flat at a low base, with limited upside. Any short-term increase in supplier revenue would more likely result from a competitor exit or shortage than from underlying demand expansion.

What drives generic lodoxamide revenue?

Generic supplier economics depend on:

• annual ophthalmic prescription volume;
• number of approved and active manufacturers;
• reimbursement rates;
• wholesaler purchasing;
• retail substitution;
• manufacturing utilization;
• sterile-fill costs;
• product availability.

Because the drug is old and clinically substitutable, price increases are difficult to sustain unless supply contracts tighten materially. A manufacturer may still achieve attractive economics if it has low-cost sterile capacity and limited competition, but the opportunity is operational rather than patent-driven.

What generic entry risks exist for lodoxamide tromethamine?

Generic entry risk is high because the product has no meaningful active exclusivity. The principal market risks are:

• additional ANDA approvals;
• aggressive generic price competition;
• substitution by OTC ketotifen or olopatadine;
• pharmacy preference for higher-volume suppliers;
• reduced physician prescribing;
• withdrawal by a low-margin manufacturer;
• procurement shifts toward combination antihistamine products.

The risk of immediate broad generic entry is less important than the risk of continued erosion in unit price and prescription share. The product’s mature status means that multiple approved manufacturers may not remain commercially active at all times.

Is there biosimilar risk for lodoxamide tromethamine?

Biosimilar risk is not applicable. Lodoxamide tromethamine is a small-molecule drug, not a biologic. Competition proceeds through conventional generic-drug pathways, principally abbreviated new drug applications rather than the FDA’s biosimilar pathway under the Public Health Service Act.

What licensing deals involve lodoxamide tromethamine?

No major current licensing transaction involving lodoxamide tromethamine is publicly associated with a large pharmaceutical company. The historical product was connected to Alcon’s ophthalmology portfolio. Current commercial arrangements, where they exist, are more likely to involve generic distribution, contract manufacturing, or regional marketing rights than a strategic global license.

The absence of a visible licensing market reflects the product’s low strategic value, expired exclusivity, and limited revenue potential.

What geographic markets remain relevant?

The United States remains a regulated generic market with limited branded value. International opportunities depend on local registration, reimbursement, product availability, and the presence of competing ocular allergy therapies.

Potentially relevant markets include:

• countries where lodoxamide remains registered;
• markets with limited access to newer allergy products;
• public-sector procurement channels;
• regions where sterile ophthalmic supply is concentrated among few manufacturers.

Geographic value is likely uneven. A product may be commercially viable in a smaller market if competing products are unavailable, but that does not establish a globally attractive asset.

What is the outlook for lodoxamide tromethamine?

The base-case outlook is stable-to-declining demand, low pricing power, and limited strategic value. The product can remain commercially viable as a generic niche therapy, particularly where supply is reliable and manufacturing costs are controlled.

A positive commercial scenario would require a competitor exit, a localized shortage, a new regional registration, or a distributor willing to support the product. A negative scenario would involve further generic price erosion, reduced ophthalmology prescribing, or withdrawal of the remaining active supplier.

Key Takeaways

• Lodoxamide tromethamine is a mature ophthalmic mast-cell stabilizer approved for allergic conjunctivitis.
• Alomide was the historical U.S. brand; current value is concentrated in generic supply.
• U.S. patent and regulatory exclusivity have expired.
• No material active Orange Book patent barrier or current Paragraph IV litigation risk is apparent.
• Biosimilar competition does not apply because lodoxamide is a small molecule.
• Ketotifen and olopatadine create substantial substitution pressure, particularly through OTC availability.
• Product-level revenue is not publicly reported, but the commercial trajectory is low-growth or declining.
• Remaining value lies in sterile manufacturing, supply reliability, and selected geographic markets.
• The principal risks are price compression, supplier exit, manufacturing disruption, and replacement by newer ocular allergy products.

FAQs About Lodoxamide Tromethamine

Is lodoxamide tromethamine still available in the United States?

Generic lodoxamide ophthalmic solution may be available through selected manufacturers and distributors, but availability is less consistent than for high-volume allergy medicines. The historical Alomide brand is no longer a major U.S. commercial product.

Is lodoxamide tromethamine over the counter?

Lodoxamide is generally positioned as a prescription ophthalmic drug in the United States. Ketotifen and olopatadine provide the principal OTC alternatives for allergic eye symptoms.

Can a company obtain FDA approval for a new generic lodoxamide product?

Yes. A manufacturer can pursue an ANDA if it meets FDA requirements for pharmaceutical equivalence, bioequivalence where applicable, product quality, sterility, stability, labeling, and manufacturing controls.

What is the main commercial barrier to launching generic lodoxamide?

The main barrier is sterile ophthalmic manufacturing and market economics, not patent protection. A prospective supplier must justify manufacturing investment in a low-value product with limited demand and established substitutes.

Could lodoxamide tromethamine regain commercial growth?

A broad branded recovery is unlikely. Limited growth could occur in a regional market, during a competitor shortage, or through a supplier with a cost advantage and reliable sterile manufacturing capacity.

References

1. U.S. Food and Drug Administration. (1993). Alomide (lodoxamide tromethamine ophthalmic solution) prescribing information. FDA Drugs@FDA.

2. U.S. Food and Drug Administration. (n.d.). Drug products discontinued from marketing. FDA.

3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.

4. U.S. Food and Drug Administration. (2020). Pataday once daily relief ophthalmic solution: Approval for over-the-counter use. FDA.