United States Patent 8,293,742: Claim Scope, Exclusivity, and Brimonidine Patent Landscape

US Patent 8,293,742 protects methods of reducing ocular redness with low-concentration brimonidine, principally concentrations from 0.001% to 0.05% w/v. Its narrower claims cover a brimonidine ocular drop at pH 5.5 to 6.5, including use within 24 hours after LASIK and treatment of chronic red eye. The patent is method-of-use focused rather than a broad composition patent.

The patent is commercially relevant to brimonidine tartrate ophthalmic solution 0.025%, marketed in the United States as Lumify by Bausch + Lomb. The claims do not cover every brimonidine product. They target low-dose redness reduction, specific formulation parameters, and selected clinical uses.

What does US Patent 8,293,742 protect?

The patent has six claims. Claims 1 and 3 are the principal independent claims.

Claim	Protected subject matter	Key limitations
1	Method of reducing eye redness	Brimonidine; ocular condition; 0.001% to 0.05% w/v
2	Narrower version of claim 1	Brimonidine concentration limited to 0.001% to 0.025% w/v
3	Low-dose brimonidine ocular-drop method	Topical administration into ocular tissue; pH 5.5 to 6.5; 0.001% to 0.025% w/v; ocular drop
4	LASIK-related use	Claim 3 method performed within approximately 24 hours after LASIK
5	Chronic red-eye use	Claim 1 method applied to chronic red eye
6	Chronic red-eye use with formulation limits	Claim 3 method applied to chronic red eye

The patent does not claim brimonidine generally. It claims a particular therapeutic use at concentrations substantially below traditional glaucoma formulations.

How broad is claim 1 of US 8,293,742?

Claim 1 is the broadest claim because it does not expressly require an ocular drop, topical delivery, a specified pH, chronic red eye, or post-LASIK administration.

Its core elements are:

A method for reducing eye redness.
A patient having an ocular condition.
Administration of brimonidine.
Brimonidine concentration between approximately 0.001% and 0.05% w/v.

The claim may reach a product containing brimonidine at 0.025% when that product is administered to reduce redness. The claim is potentially broader than the commercial Lumify indication because it refers to a patient having an ocular condition and does not limit the ocular condition to chronic red eye.

The phrase “consisting essentially of” narrows the claim compared with an open “comprising” claim. It generally permits additional components or procedural features that do not materially alter the basic and novel characteristics of the claimed method. The legal effect would depend on the specification and prosecution history, including whether the patentee distinguished prior art based on the exclusion of particular ingredients, steps, or therapeutic agents.

What concentrations fall within claim 1?

The stated concentration range is approximately:

Lower boundary: 0.001% w/v
Upper boundary: 0.05% w/v

A 0.025% w/v formulation is within the express range. A 0.1% brimonidine product, such as concentrations associated with glaucoma products, is outside the literal concentration range of claim 1.

The word “about” creates a boundary issue. A court would likely assess whether a concentration slightly above or below a stated endpoint is equivalent to the claimed range. The outcome would depend on intrinsic evidence, prosecution history, analytical precision, and the technical meaning of concentration in the patent field.

What formulations are protected by claims 3 and 6?

Claim 3 is narrower than claim 1 and requires all of the following:

Topical administration.
Administration into ocular tissue.
A composition consisting essentially of brimonidine.
pH between approximately 5.5 and 6.5.
Brimonidine concentration between approximately 0.001% and 0.025% w/v.
Formulation as an ocular drop.

Claim 6 adds chronic red eye to those limitations.

This claim structure is important because a competing product can avoid literal infringement by falling outside one required limitation. Potential design-around variables include:

Brimonidine concentration above 0.025%.
pH outside the 5.5 to 6.5 range.
A dosage form other than an ocular drop.
Non-topical administration.
A different active ingredient.
A product whose formulation contains components that materially change the claimed “consisting essentially of” composition.

A formulation outside the literal range may still present doctrine-of-equivalents risk, but the risk is reduced if the claimed numerical range was added during prosecution to overcome prior art.

Does the patent cover Lumify?

Lumify contains brimonidine tartrate ophthalmic solution at 0.025% and is approved for the temporary relief of ocular redness in adults and children two years of age and older, subject to the product labeling. That concentration falls within claims 1, 2, and 3 on its face if the product meets the claimed pH and ocular-drop requirements. It also falls within claim 6 when used to treat chronic red eye, assuming the clinical condition satisfies the claim construction.

Product or use	Likely relationship to Patent 8,293,742
Brimonidine 0.025% ocular drop for redness	Within the central scope of claims 1-3 if other limitations are met
Brimonidine 0.025% at pH 5.5-6.5	Strongest overlap with claim 3
Brimonidine 0.1%, 0.15%, or 0.2% glaucoma formulation	Outside the express concentration ranges
Brimonidine used only for intraocular pressure reduction	May not satisfy the eye-redness treatment limitation
Brimonidine administered by a non-ocular route	Unlikely to satisfy claims 3 and 6
Redness treatment using oxymetazoline, tetrahydrozoline, or naphazoline	Does not use the claimed active ingredient

The patent does not necessarily protect every sale of Lumify. Method claims generally require proof of the claimed use, and induced-infringement theories require evidence concerning the defendant’s knowledge and conduct. Product labeling, promotional materials, instructions, and actual use can be relevant.

When does US Patent 8,293,742 lose exclusivity?

The patent was issued on October 23, 2012. Public patent records identify a March 19, 2008 priority date and a March 19, 2009 nonprovisional filing date. On the ordinary United States patent-term calculation, the projected base expiration is March 19, 2029, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and any later USPTO correction.

Event	Date
Earliest identified priority date	March 19, 2008
Nonprovisional filing date	March 19, 2009
Patent issued	October 23, 2012
Projected base term expiration	March 19, 2029
PTE or PTA effect	Must be checked in USPTO and FDA records

The 2008 priority date does not ordinarily establish the 20-year term endpoint by itself. The relevant term calculation generally runs from the earliest effective nonprovisional filing date, subject to statutory adjustments.

FDA regulatory exclusivity and patent exclusivity are separate. FDA exclusivity may expire before the patent, and an ANDA applicant may still need to address listed patents after regulatory exclusivity ends.

What is the Orange Book status of brimonidine redness products?

The FDA Orange Book is the controlling public source for patents submitted for approved drug products. Orange Book listing status must be assessed by product, NDA, patent number, use code, and current FDA publication.

Lumify is an FDA-approved brimonidine tartrate ophthalmic product for ocular redness. Its regulatory protection is distinct from Alphagan P and other brimonidine products approved for glaucoma. The same active ingredient can appear in different NDAs with different indications, dosage strengths, labeling, and patent listings.

Patent 8,293,742 is best characterized as a method-of-use patent associated with low-dose brimonidine redness treatment. An Orange Book listing, if maintained for the relevant NDA, would not automatically block every brimonidine generic. Its practical effect would depend on the listed use code and the applicant’s proposed labeling.

How do Paragraph IV challenges apply?

A generic applicant seeking approval for a brimonidine product may submit an ANDA certification addressing each relevant Orange Book patent:

Paragraph I: No patent information has been submitted.
Paragraph II: The patent has expired.
Paragraph III: The applicant will wait until patent expiration.
Paragraph IV: The patent is invalid, unenforceable, or will not be infringed.
Section viii statement: The applicant seeks approval without the patented method of use.

For Patent 8,293,742, a section viii carve-out may be commercially significant if the ANDA product is labeled only for glaucoma and excludes ocular-redness treatment. A carve-out is less effective if the proposed labeling, promotional conduct, or remaining indication encourages the patented low-dose redness use.

A Paragraph IV notice concerning an Orange Book-listed patent can trigger a patent infringement action under 35 U.S.C. §271(e)(2). A timely action can create a statutory stay of FDA approval, generally for up to 30 months, subject to statutory exceptions and court developments.

The supplied claim text does not establish whether a particular generic applicant has filed a Paragraph IV certification or whether litigation has been initiated.

What patent litigation affects brimonidine redness products?

The patent itself does not disclose litigation status. Litigation must be assessed through court dockets, FDA patent-listing records, and Orange Book updates.

For a potential challenger, the principal litigation issues would likely include:

Infringement issues

The challenger would examine whether:

The product contains brimonidine within the claimed range.
The proposed indication includes reducing ocular redness.
The formulation is an ocular drop.
The pH falls within the claimed range.
The proposed use is chronic red eye or post-LASIK treatment.
The “consisting essentially of” limitation is satisfied.

Validity issues

Potential validity arguments could involve:

Anticipation by earlier low-dose brimonidine references.
Obviousness based on glaucoma formulations, ocular alpha-2 agonist literature, and routine dose-ranging.
Written-description support for the claimed concentration and pH ranges.
Enablement across the full breadth of the claims.
Indefiniteness involving “about,” “ocular condition,” “chronic red eye,” and “consisting essentially of.”

The strongest validity challenge would require prior art that teaches or makes obvious low-dose brimonidine for ocular redness, not merely brimonidine for glaucoma at materially higher concentrations.

How strong is the patent estate for low-dose brimonidine?

Patent 8,293,742 has meaningful commercial relevance because its claims align with the 0.025% brimonidine redness product. Its strength is concentrated rather than broad.

Strength factor	Assessment
Commercial product overlap	High for 0.025% redness products
Ingredient coverage	Limited to brimonidine
Concentration coverage	0.001% to 0.05% in claim 1; narrower in claims 2-6
Dosage-form coverage	Broadest claim does not require a drop; claim 3 does
Indication coverage	Eye-redness reduction, with chronic red eye in claims 5-6
Post-LASIK protection	Narrow claim 4
Biosimilar relevance	None; brimonidine is a small molecule
Generic relevance	High
Design-around potential	Moderate, depending on label, concentration, pH, and dosage form

The patent is stronger against a direct copy of a 0.025% redness eye drop than against a product using a different alpha-adrenergic active ingredient or a materially different brimonidine concentration.

How does Patent 8,293,742 compare with glaucoma brimonidine patents?

Brimonidine glaucoma products generally use higher concentrations and are labeled to reduce intraocular pressure. Patent 8,293,742 is directed to ocular redness reduction at lower concentrations.

Attribute	Redness patent	Typical glaucoma product
Main therapeutic objective	Reduce ocular redness	Lower intraocular pressure
Relevant brimonidine concentration	0.001% to 0.05%	Commonly 0.1% to 0.2%
Key product	Lumify 0.025%	Alphagan P and generic equivalents
Regulatory pathway	Approved redness product	Approved glaucoma products
Patent type	Method of treatment	May include composition, formulation, and method claims
Biosimilar pathway	Not applicable	Not applicable
Main competitive threat	Generic or alternative redness drops	Generic brimonidine ophthalmic solutions

A generic glaucoma product at 0.1% or 0.2% would generally fall outside the express concentration ranges in Patent 8,293,742. The patent therefore does not create a blanket monopoly over brimonidine ophthalmic products.

What manufacturing and intellectual-property barriers remain?

The patent does not claim a complex manufacturing process. Its principal barrier is use-based protection for a low-concentration ocular product. A competing manufacturer would still need to address:

Pharmaceutical-grade brimonidine or brimonidine tartrate.
Sterile ophthalmic manufacturing.
Container-closure compatibility.
pH control and buffering.
Preservative strategy.
Stability at low active concentration.
FDA quality and facility requirements.
Labeling that avoids patented redness indications, where legally available.

Manufacturing know-how can create practical barriers even when the patent claims are avoided. Those barriers are regulatory and operational rather than necessarily patent-based.

What generic launch scenarios exist?

Three launch pathways are commercially plausible.

Full-label challenge

A generic applicant seeks approval for the redness indication and challenges listed patents through Paragraph IV certifications. This creates the highest litigation exposure but permits the broadest commercial opportunity.

Section viii carve-out

The applicant removes the patented redness indication and markets brimonidine for an unpatented use, such as glaucoma. This can reduce method-of-use patent risk but limits the addressable market.

Post-expiration launch

The applicant accepts the patent and launches after the applicable expiration date. This avoids an early patent challenge but delays market entry and may allow the brand to retain market share.

The commercial value of a challenge depends on whether Patent 8,293,742 is the only blocking patent or one element of a larger formulation and method-of-use estate.

Are biosimilar risks relevant to brimonidine?

No. Brimonidine is a chemically synthesized small molecule, not a biologic. The relevant pathway is an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act, not a biosimilar application under the Public Health Service Act.

The competitive risk comes from generic ophthalmic solutions, authorized generics, alternative redness agents, and potential OTC products using different active ingredients.

Key Takeaways

US Patent 8,293,742 is a low-dose brimonidine method-of-use patent for reducing ocular redness.
Claim 1 covers brimonidine at approximately 0.001% to 0.05% w/v.
Claims 2 and 3 narrow the principal concentration ceiling to approximately 0.025%.
Claim 3 requires topical ocular delivery, pH 5.5 to 6.5, and an ocular-drop formulation.
Claims 5 and 6 target chronic red eye; claim 4 targets administration within approximately 24 hours after LASIK.
Lumify 0.025% is within the central technical scope of the claims when used for ocular redness and when the formulation satisfies the applicable pH limitation.
The projected base patent expiration is March 19, 2029, subject to USPTO term adjustments and other statutory modifications.
The patent does not broadly cover all brimonidine products or glaucoma formulations at 0.1% to 0.2%.
Generic entry depends on Orange Book listings, use codes, Paragraph IV certifications, section viii carve-outs, and any related formulation patents.
Biosimilar law is not relevant because brimonidine is a small molecule.

FAQs About US Patent 8,293,742

Does US Patent 8,293,742 cover brimonidine tartrate?

It can cover brimonidine tartrate products when the product delivers brimonidine within the claimed concentration range and is used for reducing ocular redness. The claims recite brimonidine rather than limiting the active ingredient to a particular salt, but the complete specification and prosecution history control claim construction.

Is a 0.025% brimonidine eye drop within the patent claims?

Yes, a 0.025% brimonidine ocular drop falls within the stated concentration ranges of claims 1, 2, and 3, subject to the remaining claim elements. Claim 3 also requires pH between approximately 5.5 and 6.5 and topical administration into ocular tissue.

Can a generic brimonidine glaucoma product infringe this patent?

A glaucoma product at 0.1% or 0.2% is outside the express concentration ranges. Infringement would also require the claimed redness-reduction method or conduct that induces the patented use.

Does the patent cover treatment after cataract surgery?

The claims expressly identify administration within approximately 24 hours after LASIK, not cataract surgery. A post-cataract use could implicate broader claims only if it satisfies their ocular-redness, brimonidine, and concentration limitations.

What is the main design-around strategy?

The most direct strategies are to use a different active ingredient, select a materially different brimonidine concentration, omit the patented redness indication, use a formulation outside the claimed pH range, or avoid the claimed ocular-drop configuration. Each approach requires separate infringement and regulatory analysis.

References

U.S. Patent No. 8,293,742. (2012). Methods of reducing ocular redness. United States Patent and Trademark Office. https://patents.google.com/patent/US8293742B2/en
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
U.S. Food and Drug Administration. (2017). Lumify label: Brimonidine tartrate ophthalmic solution, 0.025%. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
United States Code. (2024). 35 U.S.C. §§ 154, 271, and 282. https://uscode.house.gov/
United States Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation. https://www.uspto.gov/patents/laws/patent-term-calculator

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	⤷ Start Trial	⤷ Start Trial				RELIEVES REDNESS OF THE EYE DUE TO MINOR EYE IRRITATIONS	⤷ Start Trial
Bausch And Lomb Inc	LUMIFY PRESERVATIVE FREE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	218424-001	Apr 19, 2024		OTC	Yes	Yes	⤷ Start Trial	⤷ 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
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,293,742

Which drugs does patent 8,293,742 protect, and when does it expire?

Summary for Patent: 8,293,742