List of Excipients in Branded Drug PATADAY ONCE DAILY RELIEF

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Alcon Laboratories Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	0065-0816	BENZALKONIUM CHLORIDE
Alcon Laboratories Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	0065-0816	BORIC ACID
Alcon Laboratories Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	0065-0816	HYDROCHLORIC ACID
Alcon Laboratories Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	0065-0816	HYDROXYPROPYL .GAMMA.-CYCLODEXTRIN
Alcon Laboratories Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	0065-0816	HYPROMELLOSE
Alcon Laboratories Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	0065-0816	MANNITOL

PATADAY Once Daily Relief Excipient Strategy and Commercial Opportunities

Last updated: August 22, 2026

PATADAY Once Daily Relief is an over-the-counter ophthalmic solution containing olopatadine hydrochloride equivalent to 0.2% olopatadine. Its commercial proposition is once-daily allergic-conjunctivitis relief in a multidose bottle. The current formulation uses benzalkonium chloride, phosphate buffer, sodium chloride, pH adjustment agents, and purified water. The strongest excipient opportunities are preservative-free delivery, improved ocular comfort, enhanced retention, and differentiated packaging rather than a new active ingredient.[1]

The product has limited conventional patent leverage because olopatadine and early ophthalmic patents are mature. Commercial protection depends more heavily on brand recognition, FDA monograph positioning, retail distribution, consumer advertising, packaging, device performance, and formulation execution.

What is PATADAY Once Daily Relief?

PATADAY Once Daily Relief is Alcon’s OTC ophthalmic allergy product for temporary relief of itchy and watery eyes associated with ocular allergies. The active ingredient is olopatadine hydrochloride, an antihistamine and mast-cell stabilizer. The product is administered once daily, which differentiates it from older ophthalmic allergy products requiring dosing several times per day.[1]

Attribute	PATADAY Once Daily Relief
Active ingredient	Olopatadine hydrochloride
Active concentration	Equivalent to 0.2% olopatadine
Dosage form	Sterile ophthalmic solution
Route	Topical ocular
Frequency	One drop in each affected eye once daily
Regulatory category	OTC ophthalmic drug
Manufacturer/brand owner	Alcon
Primary indication	Temporary relief of itchy and watery eyes caused by ocular allergies
Preservative	Benzalkonium chloride, 0.01% in the labeled formulation
Prescription predecessor	PATANOL and related olopatadine ophthalmic products

PATADAY should be distinguished from PATADAY Extra Strength, which contains olopatadine equivalent to 0.7% and has a different formulation and dosing profile. Excipient conclusions for the 0.2% product should not automatically be applied to the 0.7% product.

What excipients are used in PATADAY Once Daily Relief?

The labeled excipient system contains benzalkonium chloride, dibasic sodium phosphate, sodium chloride, hydrochloric acid or sodium hydroxide for pH adjustment, and purified water.[1]

Excipient class	PATADAY function	Commercial relevance
Benzalkonium chloride	Preservative and antimicrobial protection	Enables multidose packaging but may create ocular-surface tolerability concerns
Dibasic sodium phosphate	Buffering and pH control	Supports olopatadine stability and patient comfort
Sodium chloride	Tonicity adjustment	Helps align the solution with ocular physiological conditions
Hydrochloric acid/sodium hydroxide	Final pH adjustment	Controls solubility, stability, and comfort
Purified water	Vehicle	Provides the aqueous ophthalmic medium

The formulation is intentionally conventional. A clear aqueous solution supports low-cost manufacturing, familiar regulatory controls, rapid filling, and broad retail availability.

Why benzalkonium chloride matters commercially

Benzalkonium chloride is effective, inexpensive, and widely accepted in multidose ophthalmic products. Its weakness is repeated exposure. Ophthalmology literature has associated chronic benzalkonium chloride exposure with ocular-surface irritation, tear-film disruption, and epithelial effects, particularly in patients using multiple preserved products or treating chronic conditions.[2]

PATADAY is generally used seasonally, which reduces cumulative exposure compared with chronic glaucoma therapy. Even so, preservative sensitivity remains a credible basis for product switching. A preservative-free version could target contact-lens wearers, patients with dry eye, children, and consumers who use multiple allergy or glaucoma drops.

What is the best excipient strategy for PATADAY?

The optimal strategy is a tiered portfolio rather than a single reformulation. The base product should retain the low-cost preserved aqueous solution, while premium variants use preservative-free packaging and comfort-oriented excipients.

Preservative-free multidose delivery

The clearest opportunity is replacing benzalkonium chloride with a preservative-free multidose system. Options include:

• One-way valve bottles that prevent microbial backflow.
• Airless or pressure-assisted dispensing systems.
• Metered-dose containers.
• Single-dose units for high-sensitivity users.
• Alternative antimicrobial systems with a lower ocular-surface burden.

A preservative-free product must demonstrate container-closure integrity, microbial robustness, dose uniformity, extractables and leachables control, and acceptable in-use stability. The device becomes part of the drug product’s quality system. The principal risk is that a premium package can materially increase cost of goods and manufacturing complexity.

Ocular comfort optimization

The formulation can be optimized around pH, osmolality, buffer capacity, and surface interaction. Sodium phosphate and sodium chloride provide a conventional starting system, but development teams could evaluate:

• Lower buffer concentrations to reduce irritation.
• Alternative tonicity agents.
• Polyols such as glycerol or propylene glycol where compatible with ocular comfort and stability.
• Hypromellose, hydroxypropyl methylcellulose, or other low-level viscosity agents.
• Surface-tension modifiers that improve drop spreading.
• Mucoadhesive polymers that increase residence time without causing blurred vision.

The trade-off is direct. Higher viscosity can improve retention but may create transient blur, stringiness, or a less acceptable drop sensation. More complex excipient systems can also increase preservative demand, filtration challenges, and analytical burden.

Contact-lens positioning

The current OTC label instructs users to remove contact lenses before administration and wait at least 10 minutes before reinsertion.[1] A formulation and packaging strategy that improves compatibility with contact-lens users could address a commercially valuable segment, but the label cannot be changed solely through marketing. The sponsor would need supporting compatibility, safety, and clinical data.

Potential development objectives include lower preservative exposure, reduced sorption into lens materials, shorter reinsertion intervals, and lower risk of lens discoloration or surface deposits. These claims would require product-specific evidence.

Enhanced retention and once-daily performance

Olopatadine already has a once-daily commercial position at the 0.2% strength. Excipient development should therefore protect the dosing interval rather than imply that excipients alone create a new pharmacologic effect.

A modest viscosity increase or mucoadhesive approach could support ocular retention. The development risk is that retention gains may not translate into a clinically meaningful advantage over the existing product. A sponsor would need to establish tolerability, dose uniformity, preservative efficacy where relevant, and comparative clinical performance.

How does PATADAY compare with competing ophthalmic allergy products?

PATADAY competes across active ingredient, dosing frequency, comfort, preservative status, price, and retail placement.

Product type	Representative active	Typical differentiation	Excipient opportunity
Olopatadine 0.2%	Olopatadine	Once-daily relief	Preservative-free multidose and comfort
Olopatadine 0.7%	Olopatadine	Higher-strength once-daily positioning	Premium delivery and ocular-surface tolerability
Ketotifen	Ketotifen fumarate	OTC allergy category familiarity	Preservative-free and fast-comfort positioning
Cromolyn sodium	Cromolyn sodium	Mast-cell stabilization	Less frequent dosing and better convenience
Antihistamine/decongestant products	Antihistamine plus vasoconstrictor	Redness relief	Lower irritation and reduced rebound concerns
Prescription combination products	Antihistamine or mast-cell stabilizer combinations	Physician-directed therapy	Device, comfort, and adherence differentiation

Olopatadine’s main commercial advantage is dosing convenience. Its main formulation vulnerability is that the standard multidose product uses benzalkonium chloride while competing products increasingly market preservative-free or “gentle” positioning.

What formulation patents protect PATADAY?

The commercially relevant protection for PATADAY is more likely to arise from formulation, device, packaging, and brand assets than from a long-lived patent covering olopatadine itself.

Early olopatadine patents and prescription-product rights are mature. The original active-ingredient and therapeutic patent estate does not provide a reliable basis for long-term exclusivity over OTC olopatadine products. Current freedom-to-operate analysis should separate four categories:

1. Olopatadine composition patents.
2. Ophthalmic formulation patents.
3. Multidose preservative-free dispensing systems.
4. Method-of-use and dosing patents.

A product-specific Orange Book analysis is also limited because PATADAY Once Daily Relief is marketed OTC. OTC products generally do not receive the same Orange Book patent-listing framework used for prescription NDAs. The FDA’s OTC Drug Facts labeling and monograph or NDA history are therefore more important regulatory references than Orange Book listings for the current consumer product.[3]

Are method-of-use patents relevant?

Method-of-use patents may cover once-daily administration, treatment of allergic conjunctivitis, or specific patient populations. Their commercial value depends on claim scope, expiration, enforceability, and whether the competing product label induces the claimed use.

For an OTC olopatadine product, method-of-use protection is weaker as a practical commercial barrier than brand and distribution control. Generic or private-label manufacturers can often enter with an equivalent active ingredient and avoid narrow claims through labeling or formulation design, subject to FDA requirements and litigation risk.

When does PATADAY lose exclusivity?

PATADAY’s original prescription exclusivity and early product patents have expired or reached the end of their practical life. The product’s current OTC position is not based on an unexpired active-ingredient monopoly.

Protection category	Current commercial assessment
Olopatadine active ingredient	Mature; no meaningful new-molecule exclusivity
Early ophthalmic patents	Generally expired or commercially exhausted
Prescription NDA exclusivity	Expired
OTC regulatory position	Remains commercially relevant but is not conventional patent exclusivity
Brand trademark	Potentially durable if maintained and used
Formulation and device patents	Product-specific; require current patent-family review
Trade dress and packaging	Potentially enforceable against confusingly similar products
Consumer brand equity	Major practical barrier in retail channels

A precise expiration schedule for every formulation, packaging, and device patent cannot be inferred from the OTC label. A current patent-family and prosecution review is required for a definitive claim chart.

Are there Paragraph IV challenges to PATADAY?

Paragraph IV litigation is principally relevant to abbreviated new drug applications referencing a listed prescription product. PATADAY Once Daily Relief is an OTC product, so the commercial entry pathway is not identical to a conventional prescription NDA challenge.

Potential entrants may use:

• An ANDA referencing an eligible prescription olopatadine product.
• An OTC monograph pathway where applicable.
• A new OTC NDA.
• A private-label or store-brand arrangement.
• A formulation or device design that avoids asserted claims.

The key competitive question is whether an entrant can match olopatadine concentration, sterility, stability, dosing, packaging, labeling, and retail economics without infringing any surviving formulation or device claims. A Paragraph IV filing should not be presumed from the existence of generic olopatadine products in the market.

What is the FDA regulatory status of PATADAY?

FDA approved olopatadine ophthalmic products as prescription medicines before the OTC switch. FDA later approved the switch of PATADAY 0.2% to nonprescription status, allowing consumer purchase without a prescription.[4]

The OTC regulatory model creates several barriers:

• The product must satisfy applicable OTC labeling requirements.
• The formulation must meet ophthalmic sterility and quality standards.
• The sponsor must support the safety of nonprescription use.
• Packaging must prevent contamination and support appropriate consumer administration.
• Advertising claims must remain consistent with the approved or monograph-based positioning.

The OTC switch creates a consumer-market advantage, but it also exposes the product to direct price competition from store brands and generic-equivalent products.

What generic entry risks exist for PATADAY?

Generic entry risk is high at the active-ingredient level and moderate at the branded OTC level.

High active-ingredient risk

Olopatadine is a mature antihistamine. Competitors can use the same active ingredient if they meet applicable FDA requirements and avoid enforceable claims. The active ingredient itself is unlikely to prevent competition.

Moderate formulation risk

A competitor could reproduce the basic aqueous formulation using common excipients. The technical challenge is manageable because the formulation does not depend on an unusually complex delivery technology.

Higher device and preservative-free risk

Preservative-free multidose delivery is more difficult to copy if protected by active patents, proprietary manufacturing controls, or a specialized container system. Even without patent protection, device qualification and supply-chain execution raise entry costs.

Strongest practical protection

The strongest current barriers are likely:

• Brand recognition.
• Retail shelf position.
• Consumer advertising.
• Seasonal demand forecasting.
• Established safety perception.
• Alcon’s ophthalmic commercial infrastructure.
• Packaging and device reliability.

Which companies are competing with PATADAY?

Competition comes from large ophthalmic companies, generic manufacturers, pharmacy retailers, and private-label operators. The relevant competitor groups include:

• Alcon’s own olopatadine portfolio.
• Generic olopatadine manufacturers.
• Ketotifen OTC manufacturers.
• Branded ophthalmic allergy companies.
• Retail pharmacy private-label suppliers.
• Digital and e-commerce sellers offering lower-priced equivalents.

The competitive landscape is fragmented at the product level but concentrated at the retail-distribution level. A technically equivalent product may still struggle to gain share without pharmacy placement, seasonal inventory, consumer advertising, and competitive pricing.

What commercial opportunities exist for excipient suppliers?

Excipient suppliers can pursue several value propositions around PATADAY-type products.

Preservative-free platform systems

A validated multidose preservative-free container system can be used across allergy, dry-eye, redness-relief, and glaucoma products. The opportunity is broader than a single olopatadine SKU.

Comfort-focused excipient packages

Suppliers can offer prequalified systems for pH, osmolality, viscosity, and surface spreading. The commercial value increases when the system reduces development time and supports a “gentle,” “sensitive-eye,” or preservative-free positioning.

Low-cost private-label formulations

Common excipients and standard aqueous processing support retailer and generic entry. Suppliers that can provide consistent pharmaceutical-grade materials, regulatory files, and supply assurance can compete on manufacturing reliability rather than proprietary chemistry.

Device-excipient integration

The most defensible opportunity combines formulation and packaging. A supplier that controls a validated bottle, closure, nozzle, sterilization process, and filling method can create switching costs for the finished-dose manufacturer.

Single-dose packaging

Unit-dose vials address preservative-sensitive users and reduce contamination concerns. The disadvantages are higher packaging costs, larger material consumption, lower convenience for daily seasonal use, and more waste.

What manufacturing and intellectual-property barriers matter?

Manufacturing barriers are manageable for the preserved product but higher for preservative-free systems. Critical controls include:

• Sterile filtration or aseptic processing.
• Low bioburden raw materials.
• Container-closure integrity.
• Drop-size and dose-volume consistency.
• Olopatadine assay and degradation monitoring.
• Preservative-content uniformity.
• Particulate control.
• In-use stability.
• Extractables and leachables.
• Compatibility between the formulation, nozzle, and bottle.

The principal IP barriers are likely to involve dispensing architecture, container components, filling methods, and specific formulation ranges. Common excipients such as sodium chloride, phosphate buffers, and benzalkonium chloride generally provide limited standalone patent differentiation. The commercial value is in the complete system.

What revenue exposure does PATADAY create for Alcon?

Alcon does not generally disclose PATADAY revenue as a standalone line item in public financial reporting. Revenue exposure therefore must be assessed through the broader Vision Care and pharmaceutical portfolio rather than a product-specific reported figure.[5]

The main revenue risks are:

• OTC price compression.
• Private-label substitution.
• Seasonal demand volatility.
• Consumer migration to generic olopatadine.
• Preservative-free competitors.
• Retailer bargaining power.
• Product recalls or sterility events.
• Weak differentiation between 0.2% and higher-strength olopatadine products.

The main growth opportunities are:

• Premium preservative-free products.
• Extra-strength and extended-line variants.
• Retailer-exclusive packs.
• Pediatric and sensitive-eye positioning where supported.
• E-commerce subscription or seasonal replenishment.
• International expansion subject to local regulatory approval.
• Cross-selling with dry-eye and contact-lens products.

What is the likely generic launch scenario?

The most likely entry sequence is a lower-priced olopatadine product using a conventional preserved aqueous solution, followed by private-label versions and, later, differentiated preservative-free products.

Entry scenario	Timing logic	Commercial effect
Conventional generic olopatadine	Low technical complexity	Price pressure and shelf substitution
Retail private label	Retailer-controlled distribution	Strong price competition
Preservative-free single-dose product	Higher packaging cost	Premium niche competition
Preservative-free multidose product	Device and quality complexity	More direct threat to premium PATADAY positioning
Novel viscosity or comfort formulation	Requires stronger evidence	Potential differentiation if clinically meaningful

A conventional generic is the primary threat to volume and price. A preservative-free multidose competitor is the more serious threat to premium margin.

Key Takeaways

• PATADAY Once Daily Relief contains olopatadine equivalent to 0.2% in an aqueous ophthalmic solution.
• Its labeled excipients include benzalkonium chloride, dibasic sodium phosphate, sodium chloride, pH adjusters, and purified water.
• The strongest formulation opportunity is a preservative-free multidose product.
• Ocular comfort, contact-lens compatibility, viscosity, and drop-delivery performance are the main technical differentiation areas.
• Olopatadine’s original active-ingredient exclusivity is mature, making brand, retail access, packaging, and device performance more important than legacy compound patents.
• OTC status reduces prescription-channel barriers but increases exposure to generic, private-label, and retailer competition.
• Alcon’s product-specific PATADAY revenue is not separately disclosed in public reporting.
• The highest-value IP opportunity is likely in the complete formulation-device system, not in common excipients used individually.

FAQs

Can benzalkonium chloride be removed from PATADAY without changing the active ingredient?

Yes. A sponsor could develop a preservative-free version using unit-dose packaging or a validated multidose container. The product would require new stability, sterility, compatibility, and in-use performance data.

Would a preservative-free PATADAY automatically receive new patent protection?

No. Patentability would depend on the specific formulation, container, dispensing system, manufacturing process, or use claims. Removing benzalkonium chloride alone would usually be insufficient for broad patent protection.

Is PATADAY suitable for contact-lens wearers?

The labeled product requires contact lenses to be removed before administration and reinsertion after the specified waiting period. A shorter waiting period or broader compatibility claim would require product-specific support.[1]

Is olopatadine 0.2% technically difficult to manufacture?

The basic preserved aqueous solution is not unusually complex. The main manufacturing controls involve sterility, assay, degradation, preservative performance, container compatibility, and consistent drop delivery.

Which excipient has the greatest commercial value in a next-generation product?

No single excipient is likely to create the main value. The strongest opportunity is an integrated preservative-free formulation and dispensing system that improves comfort while preserving sterility, dose uniformity, and once-daily convenience.

References

1. Alcon Laboratories, Inc. (2020). PATADAY Once Daily Relief ophthalmic solution 0.2% olopatadine hydrochloride: Drug Facts labeling. U.S. Food and Drug Administration.

2. Baudouin, C., Labbé, A., Liang, H., Pauly, A., & Brignole-Baudouin, F. (2010). Preservatives in eyedrops: The good, the bad and the ugly. Progress in Retinal and Eye Research, 29(4), 312-334. https://doi.org/10.1016/j.preteyeres.2010.03.001

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

4. U.S. Food and Drug Administration. (2020). FDA approves first over-the-counter eye allergy drops. FDA Consumer Updates.

5. Alcon Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.