List of Excipients in Branded Drug OMNIPRED

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Alcon Laboratories Inc	OMNIPRED	prednisolone acetate	0065-0638	BENZALKONIUM CHLORIDE
Alcon Laboratories Inc	OMNIPRED	prednisolone acetate	0065-0638	CITRIC ACID MONOHYDRATE
Alcon Laboratories Inc	OMNIPRED	prednisolone acetate	0065-0638	EDETATE DISODIUM
Alcon Laboratories Inc	OMNIPRED	prednisolone acetate	0065-0638	GLYCERIN
Alcon Laboratories Inc	OMNIPRED	prednisolone acetate	0065-0638	HYPROMELLOSES
Alcon Laboratories Inc	OMNIPRED	prednisolone acetate	0065-0638	POLYSORBATE 80
Alcon Laboratories Inc	OMNIPRED	prednisolone acetate	0065-0638	SODIUM HYDROXIDE

Last updated: October 7, 2026

ecutive summary: OMNIPRED is a prednisolone acetate ophthalmic suspension, USP 1%, used for steroid-responsive ocular inflammation. Its commercial value is no longer protected by meaningful brand exclusivity. The opportunity is in differentiated generic and specialty ophthalmic products: preservative-free suspension, improved resuspendability, lower-deposition formulations, optimized multidose packaging, and combination products. The main barriers are suspension quality, ophthalmic sterility, dose uniformity, local tolerability, device performance, and FDA requirements for demonstrating pharmaceutical equivalence.

OMNIPRED Excipient Strategy and Commercial Opportunities

What is OMNIPRED and how is it formulated?

OMNIPRED contains prednisolone acetate 1% in an ophthalmic suspension. Prednisolone acetate is a poorly water-soluble corticosteroid. The formulation therefore uses suspended drug particles rather than a true aqueous solution.

The labeled inactive ingredients are:

Excipient	Primary formulation role
Benzalkonium chloride	Preservative in multidose packaging
Boric acid	Buffering and tonicity support
Edetate disodium	Chelating agent; supports preservative performance and product stability
Hypromellose	Suspending and viscosity-enhancing polymer
Polysorbate 80	Wetting and dispersing agent
Purified water	Vehicle
Sodium citrate	Buffering agent
Sodium chloride	Tonicity adjustment

The exact excipient system is commercially important because prednisolone acetate suspension performance depends on particle wetting, sedimentation, redispersibility, viscosity, and uniform delivery from the bottle. The formulation must also maintain sterility and preserve the product throughout its shelf life. [1]

OMNIPRED is generally supplied as a sterile multidose ophthalmic suspension. Patients must shake the bottle before use because the active pharmaceutical ingredient is not fully dissolved.

What excipients are most important in OMNIPRED?

Hypromellose and suspension stability

Hypromellose increases continuous-phase viscosity and slows sedimentation. Its concentration affects:

• Sedimentation rate
• Ease of redispersion
• Drop formation
• Blinking comfort
• Residual ocular residence time
• Dose uniformity after storage

Excessive viscosity can make the bottle difficult to squeeze and can produce larger or inconsistent drops. Insufficient viscosity can increase rapid settling and dose variability.

A follow-on formulation should optimize hypromellose grade and concentration rather than simply replicate nominal composition. Different polymer grades can produce materially different rheology, even at similar concentrations.

Polysorbate 80 and particle wetting

Polysorbate 80 reduces interfacial tension and helps wet hydrophobic prednisolone acetate particles. The excipient can reduce floating particles, agglomeration, and incomplete redispersion.

Its concentration must be controlled because excessive surfactant may increase ocular irritation, interact with packaging components, or influence chemical stability. Oxidative degradation of polysorbate can also create formulation and impurity-control issues.

Benzalkonium chloride and preservative strategy

Benzalkonium chloride is useful in multidose ophthalmic products but is associated with ocular-surface tolerability concerns, particularly with chronic use or in patients with dry eye, corneal disease, or frequent dosing.

A preservative-free OMNIPRED alternative could target:

• Postoperative patients with ocular-surface sensitivity
• Chronic steroid users
• Dry-eye patients
• Patients receiving multiple preserved ophthalmic medicines
• Hospital and ambulatory surgery settings

A preservative-free product would require an appropriate container-closure system, such as a unit-dose package or validated multidose preservative-free dispenser. The device would be part of the regulatory product and would require testing for sterility, delivery performance, extractables and leachables, and in-use stability.

Boric acid, sodium citrate, and sodium chloride

Boric acid and sodium citrate support pH control. Sodium chloride adjusts tonicity. Changes to these components can influence comfort, preservative activity, drug stability, and particle behavior.

A commercially viable reformulation should avoid unnecessary pH or osmolality changes. The target is a product that remains comfortable while preserving prednisolone acetate stability and suspension performance.

What formulation patents protect OMNIPRED?

OMNIPRED is an old corticosteroid ophthalmic product. The original approval predates the modern 20-year patent-term framework, and no meaningful period of FDA drug exclusivity remains.

The current Orange Book record for the OMNIPRED reference product does not provide a material barrier based on unexpired listed patents. FDA-approved generic prednisolone acetate ophthalmic suspensions have entered the market, confirming that the active ingredient and core dosage form are no longer commercially protected by an effective OMNIPRED patent monopoly. [2]

The commercially relevant intellectual-property risks are more likely to arise from later-developed technologies, including:

• Preservative-free multidose containers
• Specialized suspension stabilizers
• Particle-size control
• Manufacturing processes
• Combination products
• Novel ophthalmic delivery devices
• Formulations designed for enhanced ocular residence
• Specific low-irritancy excipient systems

A company should not assume that a formulation is clear merely because OMNIPRED itself is old. Device patents, manufacturing patents, and formulation patents owned by later entrants may affect a differentiated product.

When does OMNIPRED lose exclusivity?

OMNIPRED has already lost practical market exclusivity.

Exclusivity category	OMNIPRED status
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No current commercial relevance
Patent-based exclusivity	No material current barrier identified in the Orange Book
Generic availability	Established
FDA reference-product status	Legacy reference product for prednisolone acetate ophthalmic suspension

The key commercial question is therefore not generic entry against OMNIPRED. It is whether a new product can obtain approval and win share through better tolerability, packaging, dosing reliability, or clinical positioning.

What is the FDA and Orange Book status of OMNIPRED?

OMNIPRED was approved as an ophthalmic prednisolone acetate suspension under NDA 017872. The product is an immediate-release topical ophthalmic suspension rather than a biologic, injectable product, or complex long-acting delivery system.

FDA considerations for a generic or reformulated product include:

• Pharmaceutical equivalence
• Sterility
• Assay and degradation products
• Particle-size distribution
• Crystal form and morphology
• Viscosity and rheology
• Redispersibility
• Dose uniformity
• Container-closure integrity
• Preservative effectiveness, if applicable
• In-use stability
• Drop size and delivery performance

For ophthalmic suspensions, nominal composition alone does not establish equivalence. A product with the same active ingredient and strength can produce different clinical exposure if particle size, sedimentation, wetting, or drop delivery differs.

FDA’s Inactive Ingredient Database can support excipient selection, but prior use of an excipient in an ophthalmic product does not eliminate the need to justify concentration, route-specific safety, and formulation performance. [3]

Are there Paragraph IV challenges involving OMNIPRED?

Paragraph IV litigation is not the primary commercial issue for OMNIPRED because the original product is already subject to generic competition. The relevant abbreviated new drug application strategy is more likely to involve:

1. A standard ANDA referencing the prednisolone acetate ophthalmic suspension.
2. A formulation that uses a different excipient system but remains pharmaceutically equivalent.
3. A 505(b)(2) application for a preservative-free product, novel device, new dosing regimen, or other change that cannot be fully supported through an ANDA.

No current OMNIPRED-specific Paragraph IV dispute is identified in the FDA materials cited here. A later entrant could still face patent litigation from owners of newer preservative-free systems, delivery devices, or formulation technologies.

What commercial opportunities exist for OMNIPRED alternatives?

Preservative-free prednisolone acetate suspension

This is the clearest formulation opportunity. A preservative-free product could command a premium if it demonstrates better ocular-surface tolerability or captures use in postoperative and chronic inflammatory conditions.

Commercial requirements include:

• Unit-dose or preservative-free multidose packaging
• Reliable redispersion
• Low microbial contamination risk
• Adequate in-use stability
• Delivery of a consistent dose
• Competitive cost per treated eye

The principal weakness is manufacturing and packaging cost. Unit-dose packaging can also create waste and increase logistics expense.

Low-viscosity, high-redispersibility suspension

A product that settles slowly but redistributes quickly could address a common user problem: inadequate shaking and nonuniform dosing. The formulation strategy would focus on controlled particle size, narrow particle-size distribution, optimized wetting, and moderate viscosity.

This approach could support a generic or authorized-generic product without requiring a major clinical repositioning.

Device-enabled delivery

A calibrated dropper or controlled-dose dispenser could reduce variability in drop size and improve patient handling. Device differentiation may be more defensible than changes to conventional excipients.

Potential claims and commercial benefits include:

• Consistent drop volume
• Reduced bottle contamination
• Easier administration for elderly patients
• Improved residual-volume performance
• Preservative-free delivery
• Better portability and dispensing control

Device development creates additional regulatory, manufacturing, and intellectual-property obligations.

Combination ophthalmic products

Prednisolone acetate could be combined with an antibiotic or other anti-infective agent for postoperative use. Combination products can improve convenience, but they face a more complex regulatory pathway and stronger competitive pressure from established antibiotic-steroid products.

The commercial case depends on whether the combination reduces prescribing friction and improves adherence without creating unnecessary exposure to antibiotics.

Hospital and ambulatory surgery channels

Hospitals and surgery centers may value:

• Unit-dose packaging
• Reduced preservative exposure
• Reliable postoperative dosing
• Supply continuity
• Competitive acquisition cost
• Simplified formulary management

Contracting and distribution economics are often more important in this channel than brand recognition.

How strong is the OMNIPRED patent estate?

The OMNIPRED-specific patent estate is weak as a current barrier to entry because the product is based on an old active ingredient and established ophthalmic dosage form.

Patent-strength factor	Assessment
Active ingredient protection	None of practical commercial value
Original product exclusivity	Expired
Core suspension concept	Broadly vulnerable to generic competition
Excipient combination	Potentially distinguishable, but unlikely to provide broad protection by itself
Preservative-free formulation	Potential later-stage patent opportunity
Delivery device	Potentially strong if claims are narrow and technically differentiated
Manufacturing process	Potentially protectable if it produces a measurable product advantage
Freedom-to-operate risk	Concentrated in later formulation and device patents

A stronger new patent position would require more than listing known ophthalmic excipients. Patentable value could arise from a defined particle-size distribution, specific crystalline form, controlled rheology profile, preservative-free multidose architecture, or manufacturing process tied to measurable performance.

What generic launch risks exist for an OMNIPRED alternative?

The principal risks are technical and regulatory rather than exclusivity-related.

Formulation risks

• Caking after storage
• Poor redispersion
• Variable prednisolone acetate concentration
• Particle growth or crystal transformation
• Inadequate preservative performance
• Excessive drop size
• Irritation from surfactant or preservative levels
• Sedimentation that increases near the end of bottle use

Manufacturing risks

• Sterility failures
• Aseptic-processing variability
• Inconsistent milling or homogenization
• Container-closure defects
• Drug adsorption to packaging
• Extractables and leachables
• Scale-up changes in particle morphology

Commercial risks

• Low pricing in a crowded generic market
• Limited prescriber switching
• Payer substitution
• Supply shortages caused by sterile manufacturing constraints
• Low return on investment for a conventional generic
• Competitive response from established ophthalmic manufacturers

How does OMNIPRED compare with other prednisolone ophthalmic products?

Product type	Main advantage	Main limitation	Commercial position
Prednisolone acetate 1% suspension	Established efficacy and low-cost generic basis	Requires shaking; suspension variability	High-volume generic segment
Prednisolone sodium phosphate solution	Clear solution and no sedimentation	Different active form and formulation profile	Alternative where solution is preferred
Loteprednol etabonate suspension or gel	Lower steroid-related clinical positioning in some use cases	Higher cost; separate IP and clinical profile	Branded or specialty alternative
Dexamethasone ophthalmic products	Potent corticosteroid option	Different potency and safety considerations	Competitive steroid class
Antibiotic-steroid combinations	Convenience after surgery	Antibiotic stewardship and resistance concerns	Established postoperative channel
Preservative-free steroid suspension	Ocular-surface differentiation	Higher packaging and manufacturing cost	Premium niche opportunity

Prednisolone acetate remains attractive where clinicians want a familiar, potent topical corticosteroid. Its suspension format creates the main product-development problem and the main opportunity for differentiation.

What licensing deals and competitive partnerships are relevant?

No material OMNIPRED-specific licensing transaction is identified in the cited FDA and product-label sources. The most relevant partnering opportunities would involve:

• Ophthalmic sterile manufacturing capacity
• Preservative-free dispensing technology
• Unit-dose packaging
• Suspension-processing expertise
• Regional commercialization rights
• Hospital and ambulatory-surgery distribution

A licensing transaction would have greater strategic value if the partner contributes a validated device or manufacturing platform. Licensing the active ingredient alone would provide limited differentiation because prednisolone acetate is widely available.

What is the revenue exposure for OMNIPRED?

OMNIPRED-specific revenue is not separately disclosed in the public FDA sources reviewed. Because the product faces generic competition, the brand’s direct revenue exposure is likely less relevant than the total U.S. market for prednisolone acetate ophthalmic suspension.

A commercial forecast should model:

• U.S. generic volume
• Average selling price
• Payer substitution
• Hospital versus retail mix
• Preservative-free premium
• Unit-dose packaging cost
• Manufacturing yield
• Sterile-facility utilization
• Expected share captured through device or tolerability differentiation

A conventional generic is likely to be a scale and supply-chain business. A differentiated preservative-free or device-enabled product has greater pricing potential but also higher development and manufacturing costs.

Key takeaways

• OMNIPRED is a prednisolone acetate 1% ophthalmic suspension with an established excipient system.
• The core OMNIPRED product has no meaningful remaining exclusivity barrier.
• The main technical challenge is controlling sedimentation, redispersion, particle size, dose uniformity, and sterility.
• Benzalkonium chloride creates a clear opportunity for preservative-free differentiation.
• Hypromellose, polysorbate 80, buffering agents, and tonicity agents must be optimized as an integrated system.
• The strongest commercial opportunities are preservative-free delivery, improved suspension performance, controlled-dose devices, and hospital-focused packaging.
• New intellectual-property value is more likely in formulation architecture, manufacturing controls, or delivery devices than in the basic drug-excipient combination.
• Generic entry risk is high for a conventional product and lower for a technically differentiated product with defensible device or formulation claims.

FAQs about OMNIPRED formulation and commercial strategy

Is OMNIPRED a solution or a suspension?

OMNIPRED is a sterile ophthalmic suspension. Prednisolone acetate is suspended in the vehicle and does not fully dissolve.

Does OMNIPRED contain benzalkonium chloride?

The conventional multidose formulation uses benzalkonium chloride as a preservative. Exact composition should be confirmed against the applicable current product labeling.

Can a preservative-free OMNIPRED generic be approved through an ANDA?

A preservative-free product may require a different regulatory pathway if the formulation or packaging creates a material difference from the reference product. Depending on the proposed changes, an ANDA or 505(b)(2) pathway may be considered.

What is the main patent opportunity for a new prednisolone acetate suspension?

The strongest opportunities involve a defined particle-size and rheology profile, preservative-free multidose delivery, controlled-dose packaging, or a manufacturing process linked to superior suspension performance.

Is OMNIPRED exposed to biosimilar competition?

No. OMNIPRED is a small-molecule ophthalmic corticosteroid product, not a biologic. Its competitive exposure is to generic drugs and differentiated ophthalmic formulations rather than biosimilars.

References

1. DailyMed. (2024). OMNIPRED: Prednisolone acetate ophthalmic suspension, USP 1% prescribing information. U.S. National Library of Medicine.

2. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. U.S. Food and Drug Administration. (2025). Inactive ingredient database. FDA.