MAXITROL Drug Patent Profile

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

Maxitrol is a drug marketed by Sandoz and Harrow Eye and is included in three NDAs.

The generic ingredient in MAXITROL is dexamethasone; neomycin sulfate; polymyxin b sulfate. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dexamethasone; neomycin sulfate; polymyxin b sulfate profile page.

Summary for MAXITROL

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	4
Drug Prices:	Drug price information for MAXITROL
What excipients (inactive ingredients) are in MAXITROL?	MAXITROL excipients list
DailyMed Link:	MAXITROL at DailyMed

See drug prices for MAXITROL

Recent Clinical Trials for MAXITROL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Virginia Commonwealth University	PHASE1
Brandon Eye Associates, PA	Phase 4
University of Science Malaysia	N/A

See all MAXITROL clinical trials

Pharmacology for MAXITROL

Drug Class	Aminoglycoside Antibacterial Corticosteroid Polymyxin-class Antibacterial
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for MAXITROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	MAXITROL	dexamethasone; neomycin sulfate; polymyxin b sulfate	OINTMENT;OPHTHALMIC	050065-002	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Harrow Eye	MAXITROL	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	050023-002	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Sandoz	MAXITROL	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	062341-001	May 22, 1984	AT	RX	No	No

Maxitrol Market Dynamics, Financial Trajectory, Patent Status, and Generic Competition

Last updated: September 21, 2026

Maxitrol is a mature ophthalmic prescription product containing neomycin sulfate, polymyxin B sulfate, and dexamethasone. Its commercial position is driven by clinical familiarity, low manufacturing complexity, and broad generic availability rather than active patent protection. Bausch + Lomb owns the branded commercial franchise, while product-level revenue is not separately disclosed in public financial filings. The financial trajectory is therefore best characterized as a mature, declining branded asset with residual value in ophthalmic distribution, institutional purchasing, and generic-equivalent demand.

What is Maxitrol and how is it used?

Maxitrol combines two antibiotics with a corticosteroid:

Component	Pharmacologic role
Neomycin sulfate	Aminoglycoside antibacterial
Polymyxin B sulfate	Antibacterial, active against selected gram-negative organisms
Dexamethasone	Corticosteroid that reduces ocular inflammation

The product is marketed in ophthalmic suspension and ointment forms. FDA labeling covers steroid-responsive inflammatory ocular conditions in which a bacterial infection exists or bacterial infection risk is present. The product is not intended for routine treatment of viral, fungal, or mycobacterial eye disease. Prolonged corticosteroid exposure can increase intraocular pressure and contribute to cataract formation or secondary infection risks (U.S. Food and Drug Administration [FDA], n.d.-a; DailyMed, n.d.-a).

Maxitrol is primarily used in ophthalmology and optometry settings, including postoperative care and treatment of inflammatory external-eye conditions. Its commercial demand is linked to procedure volumes, prescribing preferences, infection-control practices, and substitution policies.

What is the FDA regulatory status of Maxitrol?

Maxitrol is an FDA-approved prescription ophthalmic drug. The product is regulated as a conventional small-molecule combination rather than as a biologic. It does not require a biosimilar pathway.

The principal regulatory characteristics are:

Regulatory issue	Maxitrol status
Dosage forms	Ophthalmic suspension and ophthalmic ointment
Prescription status	Prescription-only
Active ingredients	Neomycin sulfate, polymyxin B sulfate, dexamethasone
FDA pathway	Original NDA product and generic ANDA equivalents
Biologic classification	No
Biosimilar exposure	None
Therapeutic-equivalence competition	Yes
Current market structure	Branded product plus generic equivalents

Generic versions may be approved through abbreviated new drug applications when they demonstrate pharmaceutical equivalence and bioequivalence or otherwise satisfy FDA requirements for the relevant dosage form. The FDA Orange Book lists therapeutically equivalent products where applicable, allowing substitution under state pharmacy laws and payer rules (FDA, n.d.-b).

What patents protect Maxitrol?

Maxitrol has no commercially meaningful active patent barrier associated with its core formulation. The product is based on an older fixed combination of established active ingredients, and any original formulation or composition patents would have expired long ago.

The relevant intellectual-property position is:

IP category	Current commercial effect
Original composition patents	Expired or commercially obsolete
Formulation patents	No known active barrier supporting exclusivity
Method-of-use patents	No material current exclusivity identified
Manufacturing patents	No publicly established barrier to generic production
Orange Book patent protection	No active patent estate identified as a meaningful generic-entry obstacle
Regulatory exclusivity	No current exclusivity period
Trademark	Maxitrol brand remains commercially relevant

The absence of an active patent barrier does not eliminate all competitive protection. Manufacturing know-how, supplier qualification, product quality, preservative control, suspension uniformity, sterile filling, and ophthalmic packaging remain operational requirements. Those factors can affect generic entry and supply reliability, but they do not create durable market exclusivity comparable to a valid patent.

When does Maxitrol lose exclusivity?

Maxitrol lost practical exclusivity many years ago. The product is a legacy ophthalmic combination with generic competition and no current new chemical entity exclusivity, orphan-drug exclusivity, pediatric exclusivity, or meaningful patent term remaining.

Its exclusivity timeline can be summarized as follows:

Period	Commercial status
Initial launch period	Branded prescription product with regulatory and commercial protection
Post-patent period	Generic manufacturers enter through the ANDA pathway
Current period	Mature multisource market with limited brand-only pricing power

Generic competition is the main reason the product cannot sustain historical branded pricing. Prescribers may continue to request Maxitrol by name, but pharmacy substitution, formulary controls, and payer reimbursement generally shift volume toward lower-cost equivalents.

How strong is the Maxitrol patent estate?

The Maxitrol patent estate is weak from a current commercial perspective. Its value lies in brand recognition and channel access, not in enforceable exclusivity.

Patent strength assessment

Factor	Assessment
Composition-of-matter protection	None remaining
Active formulation claims	No material protection identified
Method-of-use protection	Weak or absent
Patent litigation leverage	Low
Generic-entry deterrence	Low
Trademark value	Moderate within ophthalmic prescribing
Manufacturing complexity	Moderate because the products must be sterile and consistent
Long-term pricing power	Low

The ointment and suspension formats create separate manufacturing and regulatory requirements, but they do not materially strengthen the patent estate. A generic competitor can target one dosage form independently of the other.

Which companies compete with Maxitrol?

Competition comes from three groups: generic Maxitrol-equivalent products, branded combination ophthalmic products, and single-agent therapies used in place of fixed combinations.

Generic competitors

Generic manufacturers compete primarily on reimbursement, wholesaler availability, contract pricing, and pharmacy substitution. Public FDA records identify multiple approved generic versions of neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic suspension or ointment products, depending on dosage form and market availability (FDA, n.d.-b).

The leading commercial pressure points are:

• Lower generic acquisition cost
• Formulary preference
• Automatic substitution
• Retail pharmacy purchasing
• Hospital and ambulatory-surgery-center contracts
• Periodic shortages or discontinuations affecting individual suppliers

Branded and therapeutic competitors

Maxitrol competes with products such as:

• Tobradex, containing tobramycin and dexamethasone
• Generic tobramycin/dexamethasone products
• Prednisolone acetate ophthalmic products
• Antibiotic-only products such as polymyxin B/trimethoprim
• Other steroid-antibiotic combinations

The competitive choice depends on organism coverage, allergy history, inflammation severity, clinician preference, postoperative protocols, and payer coverage. Tobramycin/dexamethasone products may be favored where prescribers prefer tobramycin over neomycin because of concerns about neomycin hypersensitivity.

What formulations are protected by Maxitrol?

Maxitrol’s two principal dosage forms are ophthalmic suspension and ophthalmic ointment. Neither format has a material current exclusivity position.

Ophthalmic suspension

The suspension requires control of particle size, physical uniformity, redispersibility, preservative performance, and sterile manufacturing. These requirements can create quality and supply barriers for smaller manufacturers. They do not prevent approved generic substitution.

Ophthalmic ointment

The ointment requires sterile or aseptic production, consistent drug dispersion, ophthalmic-grade excipients, and controlled tube filling. Ointment products may have different patient acceptance and administration characteristics from suspensions, creating some brand persistence. The formulation remains vulnerable to generic competition.

The practical commercial protection from formulation differences is limited. Prescribers can switch between equivalent products or select another antibiotic-steroid combination when reimbursement, supply, or tolerability changes.

What is the Orange Book status of Maxitrol?

Maxitrol is subject to the FDA’s conventional drug-listing and therapeutic-equivalence framework. The key commercial point is that the product’s regulatory position does not provide an active patent-based block against generic versions.

Orange Book relevance includes:

1. Identification of the reference listed drug.
2. Listing of therapeutically equivalent generic products.
3. Assessment of substitution eligibility.
4. Review of any patent or exclusivity information submitted for the listed product.

No current Orange Book patent listing is known to create a meaningful delay for generic Maxitrol entry. The product has no remaining market exclusivity comparable to that of recently approved branded ophthalmic drugs (FDA, n.d.-b).

Have companies filed Paragraph IV challenges against Maxitrol?

Paragraph IV litigation is not a material current issue for Maxitrol. Paragraph IV certifications are most important when a generic applicant challenges an unexpired listed patent. Maxitrol’s legacy status and lack of commercially relevant active patent protection reduce the incentive for high-value patent litigation.

The likely generic pathways are:

Challenge type	Relevance to Maxitrol
Paragraph IV patent challenge	Low
Paragraph III certification	Not commercially central
Paragraph I certification	Possible where no patent information is listed
ANDA approval without patent delay	Commercially relevant
Patent litigation settlement	No major public settlement identified

The absence of a major Paragraph IV dispute means that generic access is governed primarily by FDA approval, manufacturing readiness, supply arrangements, and commercial contracting.

What patent litigation affects Maxitrol?

No major active patent litigation is publicly associated with the Maxitrol brand as a current commercial threat. The product’s legal exposure is more likely to involve ordinary trademark, product liability, manufacturing, labeling, or supply-chain disputes than exclusionary patent litigation.

The litigation profile differs from newer ophthalmic products that rely on patents covering:

• Sustained-release delivery systems
• Preservative-free multidose containers
• Novel suspension technologies
• Drug-device combinations
• New chemical entities
• Long-acting ocular implants

Maxitrol has no comparable high-value delivery-system patent platform.

What is the financial trajectory for Maxitrol?

Bausch + Lomb does not separately report Maxitrol revenue in its public segment disclosures. The company reports ophthalmic pharmaceuticals and related categories at broader portfolio levels, so product-specific sales, gross margin, and unit volume are not independently available from corporate filings (Bausch + Lomb Corporation, 2024).

The financial trajectory is therefore defined by market mechanics rather than disclosed product revenue.

Revenue trajectory

Driver	Effect on Maxitrol
Generic substitution	Reduces branded unit share and net price
Brand recognition	Supports residual prescription demand
Ophthalmic procedure volumes	Supports category demand
Payer controls	Compresses branded reimbursement
Supply disruptions	Can temporarily shift volume among suppliers
Product maturity	Limits premium pricing
Combination convenience	Preserves some prescribing demand
Portfolio distribution	Supports continued channel presence

Maxitrol can retain positive contribution margin as a mature product because its active ingredients are inexpensive and development costs have already been absorbed. The principal financial risks are price erosion, declining brand share, retailer and wholesaler bargaining power, manufacturing costs, and competition from alternative steroid-antibiotic combinations.

The brand’s economics are more consistent with a maintenance asset than a growth asset. Revenue can remain stable in nominal terms during periods of supply disruption or temporary generic shortages, but such gains are usually transient.

What generic launch scenarios exist for Maxitrol?

Three scenarios define the likely commercial outlook.

Base case: continued mature generic erosion

Generic products remain available, payers favor low-cost alternatives, and Maxitrol retains a smaller branded share. Revenue declines gradually, with profitability supported by low active-ingredient costs and established manufacturing infrastructure.

Upside case: supply disruption among generics

A shortage, discontinuation, or quality issue affecting one or more generic suppliers could temporarily increase branded demand. The effect would depend on wholesaler inventory, pharmacy substitution rules, and Bausch + Lomb’s ability to maintain supply. This would be a volume opportunity rather than a return to durable exclusivity.

Downside case: brand delisting or reduced channel support

If reimbursement worsens, wholesalers reduce inventory, or the manufacturer prioritizes other ophthalmic products, Maxitrol could lose additional share. Clinicians would have multiple therapeutic substitutes, limiting switching costs.

What manufacturing and IP barriers affect Maxitrol?

The product has moderate operational barriers but weak legal barriers. Manufacturing requires sterile ophthalmic production, validated filling, container-closure integrity, microbial control, and consistent product performance. Suspension products also require control of particle characteristics and dose uniformity.

These barriers can reduce the number of reliable suppliers. They can also create episodic shortages if a manufacturer experiences a quality event or production interruption. They do not support significant long-term pricing power because multiple established pharmaceutical manufacturers can produce comparable products.

How does Maxitrol compare with Tobradex?

Factor	Maxitrol	Tobradex
Antibiotic component	Neomycin plus polymyxin B	Tobramycin
Steroid	Dexamethasone	Dexamethasone
Commercial age	Legacy product	Legacy product
Generic competition	Extensive	Extensive
Patent strength	Low	Low for core legacy product
Key differentiation	Familiar fixed combination and ointment availability	Prescriber preference for tobramycin
Main risk	Generic price erosion and neomycin sensitivity concerns	Generic erosion and therapeutic substitution

Neither product has the exclusivity profile of a newly launched ophthalmic drug. Competition is primarily clinical and commercial rather than patent-based.

Key Takeaways

• Maxitrol is a mature ophthalmic combination of neomycin, polymyxin B, and dexamethasone.
• Bausch + Lomb is the branded commercial owner; product-level revenue is not separately disclosed.
• Generic competition has eliminated practical exclusivity.
• No current patent estate appears to create a meaningful barrier to generic entry.
• Paragraph IV litigation and patent settlements are not material current risks.
• The product’s main commercial assets are brand recognition, physician familiarity, and established distribution.
• Sterile ophthalmic manufacturing creates operational barriers but not durable legal exclusivity.
• Financial performance is likely characterized by gradual price and share erosion, with temporary upside possible during generic supply disruptions.
• Tobradex and generic antibiotic-steroid combinations are the principal therapeutic competitors.
• Maxitrol is best classified as a mature maintenance product rather than a growth pharmaceutical asset.

FAQs

Is Maxitrol still under patent protection?

No commercially meaningful patent protection remains for the legacy Maxitrol combination. Generic products compete through the FDA approval and therapeutic-equivalence system.

Is Maxitrol available as a generic?

Yes. Generic neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic products are available in relevant dosage forms, subject to manufacturer and market availability.

Does Maxitrol have biosimilar competition?

No. Maxitrol is a conventional small-molecule ophthalmic drug, not a biologic. Its competitors are generic drugs and alternative ophthalmic therapies.

Can pharmacies automatically substitute generic Maxitrol?

Substitution depends on the specific FDA therapeutic-equivalence designation, state pharmacy law, payer rules, and prescriber instructions. Pharmacies commonly substitute approved therapeutically equivalent products where permitted.

What would increase Maxitrol sales?

A shortage or discontinuation affecting generic suppliers, stronger postoperative procedure volumes, improved formulary access, or renewed prescriber preference could increase sales. Those factors would not restore patent-based exclusivity.

References

Bausch + Lomb Corporation. (2024). Annual report and Form 10-K. U.S. Securities and Exchange Commission.

DailyMed. (n.d.-a). Maxitrol: Neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic suspension and ointment. U.S. National Library of Medicine.

U.S. Food and Drug Administration. (n.d.-a). Maxitrol prescribing information. FDA.

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

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