U.S. Patent 11,833,245: Scope, Claims, Expiration Risk, and Brimonidine Patent Landscape

U.S. Patent No. 11,833,245 protects methods of using a 0.025% brimonidine ophthalmic drop to reduce ocular redness, particularly non-disease-related redness treated for cosmetic improvement. The independent claims require a narrow product profile: brimonidine as the sole redness-reducing active ingredient, benzalkonium chloride, and a pH of 5.5 to 6.5. Dependent claims add low rebound hyperemia, normal intraocular pressure, non-disease-related redness, aesthetic use, and long-term administration.

The patent is method-of-use focused. It does not, based on the supplied claims, independently claim the brimonidine composition, a manufacturing process, a container, or a dosing schedule. Its principal commercial relevance is the use of a Lumify-type 0.025% brimonidine product for cosmetic eye redness. The patent number, claims, and prosecution record should be read together with the FDA-approved labeling for Lumify and any later patent-term or terminal-disclaimer data maintained by the USPTO.[1][2]

What does U.S. Patent 11,833,245 protect?

The patent protects two overlapping method categories.

Claim group	Independent or dependent	Core limitation
Claims 1-7 and 15-19, 25-26	Dependent from claim 1	Ocular drop with 0.025% brimonidine, benzalkonium chloride, pH 5.5-6.5
Claims 8-14 and 20-24, 27-28	Dependent from claim 8	0.025% brimonidine as the sole redness-reducing active ingredient, benzalkonium chloride, pH 5.5-6.5
Claims 2, 9	Dependent	Low incidence of rebound hyperemia
Claims 3, 10	Dependent	Excessive eye redness before administration
Claims 4, 11, 15, 20	Dependent	Redness not associated with ocular disease or surgery
Claims 5, 12	Dependent	Retention of normal intraocular pressure
Claims 6, 13, 16, 21	Dependent	Improvement of aesthetic appearance
Claims 7, 14, 17, 22	Dependent	Combination of non-disease-related redness, aesthetic improvement, and normal intraocular pressure
Claims 18, 19, 23, 24, 26, 28	Dependent	Long-term administration

The patent therefore targets a specific therapeutic-use scenario rather than all brimonidine eye-drop products.

What are the two independent claims?

How does claim 1 define the protected method?

Claim 1 is a “consisting of” method claim. It requires:

A human subject with ocular hyperemia.
Topical administration to an eye.
An ocular drop.
Brimonidine at 0.025% weight by volume.
Brimonidine as the sole active ingredient.
One or more non-therapeutic components.
Benzalkonium chloride among those components.
A pH between 5.5 and 6.5.
Reduction of ocular hyperemia.

The “consisting of” language is important. It may exclude additional active ingredients from the claimed method, although construction depends on the specification, prosecution history, and applicable claim-construction principles. A competing product containing another redness-reducing active ingredient would face a stronger non-infringement argument under claim 1, while it could still raise issues under claim 8 if the additional ingredient does not qualify as another “redness reducing active ingredient.”

How does claim 8 differ from claim 1?

Claim 8 uses “comprising” and is broader in transitional language. It requires:

0.025% weight-by-volume brimonidine;
brimonidine as the sole redness-reducing active ingredient;
administration as an ocular drop;
pH of 5.5 to 6.5;
benzalkonium chloride; and
reduction of ocular hyperemia.

Because “comprising” generally permits additional unrecited elements, claim 8 may be more difficult to avoid through formulation changes. The limitation that brimonidine must be the sole redness-reducing active ingredient remains material.

Which claim limitations create the highest infringement risk?

The highest-risk combination is a product and labeling package that matches all of the following:

Limitation	Commercial significance
Brimonidine 0.025% w/v	Directly maps to the Lumify strength
Sole redness-reducing active ingredient	Limits combination products but captures single-active products
Benzalkonium chloride	Creates a formulation fingerprint
pH 5.5-6.5	Narrows the chemical profile
Ocular drop	Covers ordinary topical drop administration
Cosmetic or non-disease-related redness	Aligns with OTC eye-redness use
Long-term use	Expands exposure beyond occasional administration
Low rebound hyperemia and normal intraocular pressure	Adds evidentiary and labeling relevance

The core risk is therefore not every brimonidine ophthalmic product. It is a 0.025% brimonidine redness-relief drop with the claimed excipient and pH profile, marketed or instructed for cosmetic eye redness.

What formulations are protected by U.S. Patent 11,833,245?

The claims require benzalkonium chloride but do not specify its concentration. They also do not recite a complete excipient list, container system, viscosity, osmolarity, preservative concentration, or dosing volume.

Formulation elements expressly required

Brimonidine at 0.025% w/v.
Benzalkonium chloride.
pH between 5.5 and 6.5.
Ocular-drop dosage form.

Formulation elements not expressly required

A particular brimonidine salt, unless required by the specification or claim construction.
A particular benzalkonium chloride concentration.
A specific buffer.
A specific tonicity agent.
A particular bottle or dropper.
A specific dosing frequency.
A specific treatment duration in the independent claims.

The claim language does not establish that every 0.025% brimonidine formulation is covered. A formulation with a pH outside the claimed range, no benzalkonium chloride, or a different dosage form may avoid literal infringement, subject to any doctrine-of-equivalents analysis.

Does the patent cover Lumify?

The claims closely correspond to the commercial profile of Lumify redness reliever eye drops, which contain brimonidine tartrate equivalent to brimonidine 0.025% and are labeled for relief of redness of the eye due to minor irritations.[3] The FDA-approved product labeling and the patent claims should be compared for:

active concentration;
preservative identity;
pH;
indication;
dosing instructions;
warning language;
duration of use; and
whether the product is positioned for cosmetic improvement or treatment of a disease.

A formulation match alone does not establish infringement. Method claims generally require performance of the claimed use. Product labeling, promotional materials, regulatory submissions, and actual use can become relevant to induced-infringement and contributory-infringement theories under the Patent Act.[4]

What is the FDA regulatory status of the relevant brimonidine products?

Brimonidine has multiple ophthalmic regulatory uses and strengths. Prescription brimonidine ophthalmic products are primarily associated with lowering intraocular pressure in glaucoma and ocular hypertension. The 0.025% redness-relief product is a separate regulatory and commercial application from prescription brimonidine products.

The FDA approved Lumify, brimonidine tartrate ophthalmic solution 0.025%, for temporary relief of ocular redness due to minor eye irritations.[3] The prescription indication, strength, labeling, and patient population should not be treated as interchangeable with the cosmetic redness-relief indication.

Product category	Typical strength	Principal use	Relevance to Patent 11,833,245
Brimonidine prescription ophthalmic products	Commonly 0.1%, 0.15%, or 0.2%	Intraocular-pressure reduction	Usually outside the 0.025% limitation
OTC redness-relief brimonidine product	0.025%	Temporary eye-redness relief	Directly relevant
Combination glaucoma products	Varies	Intraocular-pressure reduction	May fall outside “sole redness-reducing active ingredient” limitations
Non-brimonidine redness relievers	Varies	Ocular redness relief	Outside the brimonidine limitation

The patent’s normal-intraocular-pressure claims do not convert the patent into a glaucoma patent. They describe a redness-relief method in which pressure remains normal.

What is the Orange Book status of U.S. Patent 11,833,245?

The Orange Book is principally relevant to approved drug products submitted under an NDA and to patent information listed by the NDA holder under FDA regulations.[5] An OTC drug marketed through a different regulatory pathway may not have the same Orange Book patent-listing profile as a conventional prescription NDA product.

For this patent, the key diligence issue is whether Patent 11,833,245 is listed against the relevant FDA application for the 0.025% brimonidine product. A patent number alone does not establish Orange Book listing, and the patent’s enforceability does not depend solely on Orange Book inclusion. Current Orange Book and Drugs@FDA records should be checked for:

the relevant application number;
listed patent number;
patent use code;
delisting status;
pediatric exclusivity;
application type; and
any listing corrections or disputes.[3][5]

When does U.S. Patent 11,833,245 lose exclusivity?

The supplied claims do not provide the patent’s filing date, priority date, issue date, patent-term-adjustment period, patent-term-extension period, or terminal disclaimer. Those records control the enforceable expiration date.

For a utility patent subject to the modern U.S. patent term, the ordinary term is generally 20 years from the earliest effective nonprovisional filing date, subject to statutory adjustments and disclaimers.[6] Patent No. 11,833,245 issued on December 5, 2023, but the issue date alone does not establish expiration.

Exclusivity item	Analysis
Patent issue date	December 5, 2023
Ordinary statutory term	Generally 20 years from the applicable earliest nonprovisional filing date
Patent-term adjustment	Must be confirmed in the USPTO continuity and patent data
Patent-term extension	Must be confirmed under 35 U.S.C. § 156
Terminal disclaimer	Must be checked for linked patents
Regulatory exclusivity	Separate from patent term
Orange Book listing	Must be verified against the relevant FDA application

A reliable expiration date requires the USPTO continuity data and patent-term calculation, not the claims alone.[1][6]

How strong is the patent estate?

The patent has meaningful commercial value but a narrower claim perimeter than a composition patent.

Strengths

The 0.025% concentration is specific and commercially identifiable.
Benzalkonium chloride and pH 5.5-6.5 create a concrete formulation profile.
Claims 1 and 8 provide two different transition structures.
The dependent claims cover cosmetic use, non-disease-related redness, normal intraocular pressure, rebound hyperemia, and long-term administration.
The claims align with an approved OTC redness-relief use, improving the potential relevance of product labeling and commercial instructions.

Vulnerabilities

The independent claims require several cumulative limitations.
The pH range may be design-aroundable.
Benzalkonium chloride may be replaced by another preservative or a preservative-free container system.
A competitor could develop a different concentration or a different active ingredient.
“Low incidence of rebound hyperemia,” “excessive” redness, “normal” intraocular pressure, and “long-term” use may create claim-construction and proof issues.
Method claims require evidence of the claimed administration and use.
The record supplied does not establish patent-term adjustment, terminal disclaimers, written-description support, enablement history, or prosecution amendments.

The strongest claims for enforcement are likely the core composition-and-use combinations in claims 1 and 8, while the clinical-result limitations may add narrowing value but introduce factual disputes.

Which companies are most likely to challenge the patent?

Potential challengers would include manufacturers developing:

OTC brimonidine 0.025% redness-relief products;
private-label versions of the same product;
generic or authorized-generic versions of the relevant approved product;
preservative-free brimonidine drops;
products with a pH outside 5.5-6.5;
alternative alpha-adrenergic redness relievers; and
combination products in which brimonidine is not the sole redness-reducing active ingredient.

A conventional Paragraph IV challenge is most relevant if the patent is listed in the Orange Book against an applicable NDA. If the product is marketed through an OTC pathway without an Orange Book-listed patent, a competitor may instead face ordinary patent litigation, declaratory-judgment proceedings, or an inter partes review petition at the Patent Trial and Appeal Board.[5][7]

What Paragraph IV and litigation risks exist?

The principal litigation theories would be:

Literal infringement based on a product label or instructions matching the claimed cosmetic redness-relief use.
Induced infringement based on marketing or instructions encouraging administration of a matching formulation.
Direct infringement by users, with the manufacturer alleged to induce the use.
Invalidity based on anticipation or obviousness.
Lack of written description or enablement for the full scope of the claimed clinical results.
Non-infringement based on pH, preservative, concentration, active-ingredient, or indication differences.

A litigation review should search PACER, PTAB decisions, USPTO Patent Center, FDA Orange Book records, and ANDA litigation notices for Patent 11,833,245. The supplied claims do not identify any complaint, settlement, Paragraph IV notice, inter partes review, post-grant review, or consent judgment.

What generic launch scenarios exist?

Launch scenario	Patent exposure
0.025% brimonidine, benzalkonium chloride, pH 5.5-6.5, redness-relief labeling	High
Same formulation with non-cosmetic disease indication only	Depends on label and actual use
Same concentration, different preservative	Potentially lower literal-infringement risk
Same concentration, pH below 5.5 or above 6.5	Potentially lower literal-infringement risk
0.01% or 0.05% brimonidine	Outside the express concentration limitation
Brimonidine plus another redness-reducing active	Potentially outside the sole-active limitation
Different alpha-adrenergic active	Outside the brimonidine limitation
Preservative-free multidose delivery system	May avoid the benzalkonium-chloride limitation

A design-around must be tested against every asserted claim, including the possibility that a product avoids claim 1 but falls within claim 8 or an equivalent claim in a related patent.

How does this patent compare with prescription brimonidine patents?

Patent 11,833,245 is differentiated by indication and concentration.

Attribute	Patent 11,833,245	Typical prescription brimonidine estate
Core use	Reducing ocular redness	Lowering intraocular pressure
Strength focus	0.025%	Commonly higher strengths
Patient use	Cosmetic or minor-irritation redness	Glaucoma or ocular hypertension
Claim type	Method of treatment/use	Composition, formulation, treatment, or combination use
Key clinical limitation	Low rebound hyperemia and normal pressure	Pressure reduction and tolerability
Primary competitive threat	OTC redness-relief competitors	Generic glaucoma products and combination therapies

The estates may overlap at the molecule level but differ materially in concentration, indication, formulation, and regulatory labeling.

Does the patent create a biosimilar risk?

No conventional biosimilar pathway is implicated. Brimonidine is a small-molecule active ingredient, not a biologic. Competitive products would generally involve an ANDA, an OTC regulatory pathway, or a separate NDA, depending on the product and labeling. The relevant risk is generic or follow-on-drug competition, not biosimilar substitution under the Public Health Service Act.[8]

Are manufacturing and geographic barriers significant?

The patent claims do not recite a manufacturing process. A manufacturer could potentially produce a non-infringing formulation by changing the preservative system, pH, concentration, or active ingredient. Manufacturing know-how, sterile ophthalmic production capacity, container-closure qualification, stability data, and FDA compliance may still create commercial barriers independent of Patent 11,833,245.

The patent is a U.S. right. It does not by itself block products in Canada, Europe, Japan, China, or other jurisdictions. Separate foreign counterparts, national-phase applications, grants, continuations, and expiration dates must be reviewed country by country.

Key Takeaways

Patent 11,833,245 is a U.S. method-of-use patent directed to 0.025% brimonidine eye drops for ocular redness.
The principal formulation limitations are benzalkonium chloride and pH 5.5-6.5.
Claims 1 and 8 are the key independent claims.
Claims 8-14 use broader “comprising” language than claim 1, but still require brimonidine to be the sole redness-reducing active ingredient.
The claims strongly target a Lumify-type product and cosmetic redness-relief use.
Prescription brimonidine glaucoma products are generally differentiated by strength and indication.
The patent is not a biosimilar barrier because brimonidine is a small molecule.
A Paragraph IV strategy depends on whether the patent is listed against the relevant FDA application.
The enforceable expiration date cannot be determined from the claim text or issue date alone; USPTO term data, continuations, terminal disclaimers, and any patent-term adjustment must be reviewed.
Likely design-around paths include changing pH, preservative, concentration, dosage form, or redness-reducing active ingredient.

Frequently Asked Questions

Is Patent 11,833,245 a composition patent?

No. The supplied claims are method claims. They require administration of a specified ocular-drop formulation but do not independently claim the formulation as an article of manufacture.

Does using 0.025% brimonidine automatically infringe the patent?

No. Infringement would require all material claim limitations, including the relevant pH range, benzalkonium chloride, ocular-drop administration, and claimed redness-relief use.

Can a preservative-free brimonidine product avoid the patent?

It may avoid literal infringement of claims requiring benzalkonium chloride. The full patent family and any related claims would still require review.

Does normal intraocular pressure have to be demonstrated for every use?

Only claims that expressly recite retention of normal intraocular pressure include that limitation. Claims 1 and 8 do not include it as an express limitation.

Can a company sell a different brimonidine strength for eye redness?

A different strength would not literally satisfy the express 0.025% limitation. Other patents, regulatory requirements, and potential equivalents issues would remain relevant.

References

United States Patent and Trademark Office. (2023). U.S. Patent No. 11,833,245. https://patents.google.com/patent/US11833245B2/en
United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
U.S. Food and Drug Administration. (2017). Drugs@FDA: Lumify, brimonidine tartrate ophthalmic solution, 0.025%. https://www.accessdata.fda.gov/scripts/cder/daf/
United States Code. (2023). 35 U.S.C. §§ 271 and 281. https://uscode.house.gov/
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
United States Code. (2023). 35 U.S.C. §§ 154 and 156. https://uscode.house.gov/
U.S. Patent and Trademark Office. (2024). Patent Trial and Appeal Board. https://www.uspto.gov/patents/ptab
United States Code. (2023). 42 U.S.C. § 262. https://uscode.house.gov/

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch And Lomb Inc	LUMIFY	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	208144-001	Dec 22, 2017		OTC	Yes	Yes	11,833,245	⤷ Start Trial				RELIEVES REDNESS OF THE EYE DUE TO MINOR EYE IRRITATIONS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	112016004054	⤷ Start Trial
Canada	2732521	⤷ Start Trial
Canada	2782817	⤷ Start Trial
Canada	2832953	⤷ Start Trial
Canada	2865593	⤷ Start Trial
Cyprus	1115727	⤷ Start Trial
Denmark	2320911	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,833,245

Which drugs does patent 11,833,245 protect, and when does it expire?

Summary for Patent: 11,833,245