List of Excipients in Branded Drug ALAWAY PRESERVATIVE FREE

Generic Drugs Containing ALAWAY PRESERVATIVE FREE

Company	Ingredient	NDC	Excipient
Bausch & Lomb Incorporated	ketotifen fumarate	24208-600	GLYCERIN
Bausch & Lomb Incorporated	ketotifen fumarate	24208-600	HYDROCHLORIC ACID
Bausch & Lomb Incorporated	ketotifen fumarate	24208-600	SODIUM HYDROXIDE
Bausch & Lomb Incorporated	ketotifen fumarate	24208-600	WATER

What are the Most Frequently-Used Excipients in ALAWAY PRESERVATIVE FREE?

# Of NDCs	Excipient
1	GLYCERIN
1	HYDROCHLORIC ACID
1	SODIUM HYDROXIDE
1	WATER

Alaway Preservative Free Excipient Strategy and Commercial Opportunities

Last updated: August 24, 2026

Alaway Preservative Free is a ketotifen fumarate ophthalmic solution for temporary relief of itchy eyes caused by pollen, ragweed, grass, animal hair and dander. Its commercial differentiation depends less on the active ingredient than on preservative-free formulation, multidose microbial-control packaging, ocular comfort and over-the-counter brand access. The strongest opportunities are private-label development, preservative-free allergy-eye-care extensions, device licensing and regional commercialization.

What is Alaway Preservative Free?

Alaway Preservative Free contains ketotifen fumarate equivalent to ketotifen 0.025% in an ophthalmic solution. Bausch + Lomb markets the product in the United States as an over-the-counter allergy eye drop.[1]

Attribute	Alaway Preservative Free
Active ingredient	Ketotifen fumarate
Equivalent ketotifen strength	0.025%
Dosage form	Sterile ophthalmic solution
Route	Topical ocular
Preservative status	Preservative-free
Indication	Temporary relief of itchy eyes caused by allergic conjunctivitis
U.S. commercial status	OTC
Primary commercial differentiator	Preservative-free multidose delivery
Brand owner	Bausch + Lomb
Therapeutic class	Ocular antihistamine and mast-cell stabilizer

Ketotifen has dual pharmacology: it blocks histamine activity and stabilizes mast cells. The active ingredient is mature and broadly understood. Product value therefore resides in delivery, tolerability, consumer trust and retail distribution rather than active-ingredient exclusivity.

What excipients are used in Alaway Preservative Free?

Public product information identifies a short excipient system centered on glycerin, pH adjusters and water. The exact formulation should be taken from the current package insert or DailyMed record because inactive-ingredient disclosures can differ by presentation and manufacturing update.[1,2]

Excipient or formulation component	Likely function
Glycerin	Tonicity adjustment, humectancy and ocular comfort
Hydrochloric acid and/or sodium hydroxide	pH adjustment
Water for injection or purified pharmaceutical water	Solvent and continuous phase
Container-closure system	Sterility maintenance and multidose microbial protection

The formulation has a deliberately narrow excipient profile. That reduces the risk of preservative-associated ocular-surface irritation and simplifies consumer communication. It also limits opportunities to differentiate the liquid phase through conventional excipient substitution.

Why is glycerin commercially important?

Glycerin can support isotonicity and reduce the discomfort associated with topical ocular administration. It is widely accepted in ophthalmic products, has established regulatory precedent and is inexpensive at commercial scale.

Its limitations are equally important. Glycerin alone does not create a preservative-free multidose product. It does not provide sufficient antimicrobial protection after repeated bottle opening. Microbial control must come from the sterile manufacturing process, bottle design, dispensing valve and container-closure integrity.

What role does pH adjustment play?

Hydrochloric acid and sodium hydroxide allow the manufacturer to place the formulation within an acceptable ocular pH range and control product stability. pH affects:

• Ketotifen chemical stability
• Solubility and solution clarity
• Ocular comfort
• Preservative-free container compatibility
• Extractables and leachables risk
• Sterilization and filling conditions

For a product with a simple excipient system, pH control becomes a major critical quality attribute. Small changes can affect comfort, stability and packaging performance.

How does preservative-free packaging protect Alaway?

A preservative-free multidose ophthalmic product requires a container-closure system that reduces microbial ingress during normal use. The commercial platform may use a one-way valve, sterile air pathway, antimicrobial device architecture or another controlled-dispensing mechanism. Public consumer labeling does not establish the full engineering design.

The package is therefore part of the product’s formulation strategy. The relevant development work includes:

1. Container-closure integrity testing.
2. Microbial ingress studies.
3. Delivered-volume consistency.
4. Priming and re-priming performance.
5. Drop-size control.
6. Tip contamination testing.
7. Extractables and leachables assessment.
8. In-use stability after opening.
9. Shipping and temperature-cycle testing.
10. Compatibility with automated filling and assembly.

This creates a higher barrier than a conventional preserved ophthalmic solution. A competitor cannot necessarily copy the liquid composition and achieve equivalent regulatory performance with a standard bottle.

What patents protect Alaway Preservative Free?

The mature ketotifen active ingredient is unlikely to provide meaningful composition-of-matter exclusivity for a modern product. Commercial protection is more likely to arise from formulation, packaging, device and manufacturing claims.

Potential protection category	Relevance to Alaway Preservative Free
Ketotifen composition of matter	Low strategic value; active ingredient is old
Basic ketotifen ophthalmic solution	Likely weak or expired as a blocking right
Preservative-free formulation	Potentially relevant, but narrow if based only on excipient omission
Multidose dispensing device	Potentially strong if claims cover valve, airflow or contamination control
Container-closure assembly	Potentially relevant to design-around analysis
Sterile filling process	May protect manufacturing efficiency or product quality
In-use stability	Potential claim subject if linked to composition and packaging
Method of treating allergic conjunctivitis	Possible secondary protection, but generic substitution risk remains
Trade dress and brand assets	Important for OTC shelf competition, but not patent exclusivity

A public, authoritative assessment of product-specific patent numbers, expiration dates and ownership requires a current patent-family and regulatory-record review. The core ketotifen patents do not appear to be the principal barrier to entry. Any enforceable estate would more likely involve the device or the combination of formulation and package.

When does Alaway Preservative Free lose exclusivity?

The product does not have a single obvious small-molecule patent cliff comparable to a recently launched prescription drug. Its commercial exclusivity is layered:

• Active-ingredient exclusivity is historically exhausted.
• OTC brand protection continues through trademark and consumer recognition.
• Packaging patents may expire on family-specific schedules.
• Manufacturing know-how may remain protected as trade secrets.
• Regulatory exclusivity depends on the product’s approval pathway and applicable FDA records.
• Retail placement and brand contracts can delay practical competition even after patent expiry.

For OTC products, the practical entry date often depends more on FDA regulatory status, product quality and retail economics than on a single patent expiration date.

What is the FDA and Orange Book status of Alaway Preservative Free?

Alaway Preservative Free is sold as an OTC ophthalmic allergy product. The FDA’s Drug Facts labeling identifies ketotifen fumarate and the allergic-eye indication.[1] The relevant regulatory pathway should be assessed through the current Drugs@FDA, DailyMed and FDA OTC monograph databases.[2-4]

Orange Book analysis requires care. Products approved through an NDA may have listed patents and exclusivity records. Products marketed under an OTC monograph or other non-NDA pathway generally do not present the same Orange Book patent-listing profile. A commercial diligence review should not assume that an OTC label automatically creates Orange Book-listed patents.

Paragraph IV litigation is also not automatic. A generic applicant can file an ANDA only where the reference product and regulatory pathway support that filing. If the product is not an ANDA reference product in the conventional sense, competition may instead arise through another OTC approval route, an alternative NDA, private-label licensing or a formulation/device workaround.

Which products compete with Alaway Preservative Free?

The main competitive set includes ketotifen products and preservative-free antihistamine or mast-cell-stabilizing eye drops.

Product category	Representative ingredient	Strategic comparison
Alaway Preservative Free	Ketotifen 0.025% equivalent	Preservative-free, OTC, established allergy brand
Conventional Alaway or generic ketotifen	Ketotifen	Usually lower packaging complexity; may contain a preservative
Zaditor and generic equivalents	Ketotifen	Direct active-ingredient competition
Pataday products	Olopatadine	Strong brand and once-daily positioning; multiple strengths and presentations
Preservative-free olopatadine products	Olopatadine	Compete directly on ocular-surface tolerability
Cromolyn or mast-cell stabilizer products	Cromolyn or related agents	Older mechanism and less direct consumer substitution
Artificial tears	Lubricants	Symptom-relief substitutes, especially for mixed allergy and dryness

The most important comparison is not ketotifen versus another ketotifen product. It is preservative-free ketotifen versus preservative-free olopatadine and other premium ocular allergy products.

How strong is the patent estate for Alaway Preservative Free?

The patent estate is likely moderate at the product-platform level and weak at the active-ingredient level.

Strengths

• Preservative-free multidose delivery can support device and system claims.
• Package performance is difficult to reproduce without engineering and microbial-validation work.
• A combined claim covering formulation, bottle and in-use stability can raise design-around costs.
• OTC brands benefit from trademark recognition and consumer trust.

Weaknesses

• Ketotifen is an old active ingredient.
• Glycerin, water and pH adjustment are conventional excipient choices.
• A competitor may use a different preservative-free bottle platform.
• Single-dose units can avoid some multidose device claims.
• Alternative antihistamines can compete without practicing ketotifen claims.
• OTC consumers can switch based on price, retailer placement and perceived comfort.

The strongest defensible position is likely a package-and-formulation combination, not a broad claim to ketotifen in a preservative-free solution.

What generic entry risks exist for Alaway Preservative Free?

Generic and private-label entry risks fall into four groups.

1. Conventional ketotifen substitution

A competitor can market a preserved ketotifen product at a lower price. This is the simplest route but does not replicate the preservative-free benefit.

2. Alternative preservative-free packaging

A rival can use a different multidose valve, a sterile unit-dose ampoule or a different container material. This is the main design-around risk for device patents.

3. Alternative active ingredients

Olopatadine and other ocular antihistamines can capture consumers who prioritize once-daily dosing, stronger brand positioning or perceived efficacy.

4. Retail private label

Retailers can sell a preservative-free allergy eye drop under store brands if a contract manufacturer supplies a compliant formulation and validated container system. Private-label products can pressure price without directly challenging Bausch + Lomb’s core patents.

What commercial opportunities exist in the excipient strategy?

Can the formulation be used for private-label products?

Yes. The simple excipient profile is attractive for contract development because it reduces raw-material complexity. The main development burden shifts to:

• Sterile manufacturing
• Filling accuracy
• Device assembly
• Microbial ingress control
• In-use stability
• Packaging qualification
• Regulatory comparability

A private-label entrant would need a defensible container platform or a licensed dispensing system. Copying the liquid composition alone would not replicate the commercial product.

Are there opportunities for new preservative-free formulations?

Potential opportunities include:

• Higher-comfort formulations using alternative tonicity agents
• Reduced drop volume to improve ocular comfort and minimize waste
• Unit-dose presentations for travel and occasional use
• Multiuse bottles with improved dose counting
• Products designed for contact-lens users, subject to labeling and compatibility evidence
• Combination allergy-and-dry-eye positioning
• Pediatric-friendly dispensing systems
• Recyclable or lower-material packaging
• Regional products using locally available pharmaceutical excipients

Each opportunity must preserve clarity, sterility, stability and dosing performance. Excess excipient complexity can weaken the product by increasing irritation, manufacturing risk and regulatory burden.

Is a licensing deal commercially attractive?

The most valuable licensing targets are likely:

• Preservative-free ophthalmic dispensing platforms
• One-way valve technologies
• Sterile multidose bottle systems
• Low-volume drop-forming nozzles
• Container-closure systems with strong microbial-ingress data
• Contract manufacturers with validated sterile ophthalmic capacity

A license covering a proven device platform could reduce development time and patent risk. The transaction value would depend on territory, exclusivity, minimum volumes, tooling ownership, regulatory transfer rights and freedom-to-operate coverage.

What manufacturing and IP barriers affect market entry?

Manufacturing is a material barrier. Ophthalmic solutions require sterile processing, validated filling, environmental control and container-closure testing. Preservative-free multidose products add device-specific risks that conventional preserved drops do not have.

The critical manufacturing risks are:

• Inconsistent drop size
• Valve failure or incomplete resealing
• Microbial contamination during repeated use
• Interaction between formulation and polymer components
• Leachables from the bottle or tip
• Inadequate sterility assurance after transport
• Poor priming at first use
• Elevated scrap rates during automated assembly

The IP barrier is narrower but potentially important. Freedom-to-operate work should cover device claims, valve geometry, sterile air pathways, bottle materials, filling methods and in-use microbial-control claims in the United States, Europe, Canada, Japan and other target markets.

How does Alaway Preservative Free compare with Pataday?

Issue	Alaway Preservative Free	Pataday preservative-free products
Active ingredient	Ketotifen	Olopatadine
Core consumer claim	Preservative-free allergy relief	Preservative-free allergy relief
Dosing positioning	Product-specific label instructions	Some products have once-daily positioning
Differentiation	Established ketotifen brand and package	Olopatadine efficacy, brand and dosing options
Primary IP risk	Device and presentation claims	Formulation, dosage and device claims
Substitution risk	High from olopatadine	High from ketotifen and generic products

Alaway’s commercial defense is strongest when consumers value preservative avoidance and already recognize the brand. Pataday’s competitive advantage may be stronger where once-daily convenience drives purchase decisions.

Key Takeaways

• Alaway Preservative Free uses a simple ophthalmic excipient system centered on glycerin, pH adjustment and water.
• The product’s main innovation is the preservative-free multidose delivery platform, not ketotifen itself.
• Active-ingredient patent protection is unlikely to block entry because ketotifen is an established molecule.
• Device, container-closure, formulation-combination and manufacturing patents are the most relevant IP categories.
• Private-label competition is commercially feasible but requires validated sterile manufacturing and a reliable multidose package.
• Preservative-free olopatadine products are the most important branded competitive threat.
• The strongest licensing opportunities involve dispensing devices, microbial-control packaging and sterile ophthalmic manufacturing.
• Orange Book and Paragraph IV conclusions depend on the current FDA approval pathway and listed regulatory records; OTC status alone does not establish an Orange Book patent barrier.

FAQs

Is glycerin in Alaway Preservative Free a preservative?

No. Glycerin is primarily used for tonicity adjustment, humectancy and ocular comfort. It does not replace the microbial-control function of a conventional ophthalmic preservative.

Can a company launch a preservative-free ketotifen eye drop without copying Alaway?

Yes. A competitor can pursue a different formulation, container, valve, unit-dose package or manufacturing process. The principal risk is practicing device or combination claims rather than using ketotifen itself.

Are single-dose ketotifen units a meaningful commercial alternative?

Yes. Unit-dose packaging can reduce multidose contamination concerns and may avoid some device claims. Its disadvantages include higher packaging cost, more material per dose and less consumer convenience for frequent users.

What is the largest commercial weakness of preservative-free ketotifen?

Price pressure is the main weakness. Consumers may switch to lower-cost preserved ketotifen, generic products or alternative antihistamines unless preservative-free tolerability has clear perceived value.

Which excipient changes could create a differentiated product?

The most practical changes involve tonicity, buffering, drop-volume control and comfort. Any change must maintain ketotifen stability, sterility, clarity, ocular tolerability and compatibility with the dispensing system.

References

1. Bausch + Lomb. (n.d.). Alaway Preservative Free ketotifen fumarate ophthalmic solution, 0.035% labeling. U.S. Food and Drug Administration labeling materials.

2. National Library of Medicine. (n.d.). DailyMed: Ketotifen fumarate ophthalmic solution. https://dailymed.nlm.nih.gov/

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

4. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

5. U.S. Food and Drug Administration. (n.d.). FDA regulation of OTC ophthalmic drug products. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs