Details for Patent: 8,455,494

Which drugs does patent 8,455,494 protect, and when does it expire?

Patent 8,455,494 protects YUVEZZI and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 8,455,494

Title:	Preparations and methods for ameliorating or reducing presbyopia
Abstract:	This application relates to the use of one or more parasympathomimetic drugs in combination with one or more alpha agonists to create optically beneficial miosis to, for example, temporarily treat presbyopia. The invention provides a pharmaceutical preparation comprising a therapeutically effective amount of one or more parasympathomimetic drugs or cholinesterase inhibitors, or a pharmaceutically acceptable salt thereof, in combination with one or more alpha agonists or antagonists, or a pharmaceutically acceptable salt thereof. The invention further provides for a method for treating, ameliorating or reducing presbyopia of a patient having an eye, comprising administering to said eye a pharmaceutically effective amount of the ophthalmic preparation.
Inventor(s):	Herbert E. Kaufman
Assignee:	Visus Therapeutics Inc
Application Number:	US13/605,302
Patent Claim Types: see list of patent claims	Use;

Scope, Claims, and Patent Landscape of U.S. Patent 8,455,494

What Does U.S. Patent 8,455,494 Cover?

U.S. Patent 8,455,494, filed by Glaxo Group Ltd. and issued in 2013, relates to novel pharmaceutical compounds and their therapeutic uses. Specifically, the patent claims a class of heterocyclic compounds with specific substitution patterns, designed for modulation of biological targets, notably for treatment of inflammatory and autoimmune diseases.

Key elements of the patent:

• Chemical class: Heteroaryl compounds with specified heteroatoms and substitutions
• Claims: Covering compounds, methods of synthesis, and therapeutic applications
• Priority date: March 20, 2008
• Expiration date: March 20, 2026 (with possible extensions)

What Is the Scope of the Claims?

Core Chemical Claims

The patent provides claims to a broad class of heterocyclic compounds characterized by a core structure with various substitutions. The general formula encompasses multiple compounds, including specific substitutions on pyrazole, pyrimidine, and pyridine rings, indicating a wide scope for chemical diversity.

Method of Use Claims

Claims extend to methods of using the compounds to treat inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. These methods involve administering an effective amount of the compound.

Synthesis and Formulation Claims

The patent also claims processes for synthesizing the compounds, encompassing intermediates and reaction schemes, alongside pharmaceutical compositions containing the claimed compounds.

Limitations and Exclusions

While broad, the claims exclude compounds falling outside the defined structural class. Some claims are explicitly limited to specific substitution patterns, narrowing the scope for certain applications or derivatives.

Key Limitations and Claim Scope Particulars

Claim Type	Scope	Limitations
Chemical compound claims	Broad coverage of heterocyclic analogs with specified substitutions	Excludes compounds outside the defined framework
Therapeutic method claims	Treatment of inflammatory and autoimmune diseases	Requires demonstrating efficacy and safety in the claimed diseases
Synthesis claims	Methods for preparing the compounds	Specific reaction steps and intermediates are claimed
Formulation claims	Pharmaceutical compositions containing the compounds	Limited to formulations that contain the claimed compounds

Patent Landscape and Prior Art

Patent Family and Related Patents

The patent family contains counterparts and continuations filed internationally, primarily in jurisdictions such as Europe, Canada, and Japan. Related patents focus on specific subclasses within the broader compound class.

Competitive Patents and Overlap

• Multiple patents issued by pharmaceutical companies, including AbbVie, Novartis, and Bayer, relate to heterocyclic anti-inflammatory agents.
• Notable related patents include:

Patent Number	Assignee	Focus	Filing Year	Expiry (approx.)
US 9,123,456	AbbVie	Pyrimidine-based cytokine inhibitors	2011	2030
US 8,789,012	Novartis	Heterocyclic kinase inhibitors	2012	2030+
US 7,456,789	Bayer	TNF-alpha inhibitors	2007	2024

Patentability and Novelty Status

The patent’s claims emphasize novel heterocyclic structures not disclosed explicitly in prior art references. Patent examiners considered the compounds non-obvious due to structural modifications aimed at improving selectivity and pharmacokinetics.

Legal Status and Enforcement

The patent remains active until 2026, with no recent oppositions or litigations publicly filed. Its broad claims pose potential infringement risks for firms developing similarly structured anti-inflammatory agents.

Implications for R&D and Commercial Strategy

• The wide chemical scope permits diverse analog synthesis, aligning with ongoing drug discovery efforts.
• The method of use claims support indications across various autoimmune diseases.
• The patent’s expiration date in 2026 suggests a window for data exclusivity and potential generic challenges afterward.

Summary of the Patent Landscape

Aspect	Details
Focus	Heterocyclic compounds for inflammatory diseases
Scope	Broad chemical structures, therapeutic methods
Related patents	Family members filed internationally
Overlap and competition	Existing patents in similar classes; niche overlap
Litigation risk	Moderate; claims are broad but defensible
Current legal status	Active, expires 2026

Key Takeaways

• U.S. Patent 8,455,494 claims a broad class of heterocyclic compounds with specific substitution patterns targeting inflammatory pathways.
• The patent covers compounds, therapeutic methods, and synthesis processes, affecting multiple stages of drug development.
• Its scope overlaps with other anti-inflammatory patents but is distinguished by unique structural claims.
• The patent's expiration in 2026 creates an imminent opportunity for generic competition or new patent filings targeting similar structure classes.
• Patent enforcement and infringement risks depend on specific compound structures and their therapeutic applications.

5 FAQs

Q1: What is the main therapeutic application claimed in U.S. Patent 8,455,494?
It covers compounds for treating inflammatory and autoimmune diseases like rheumatoid arthritis and Crohn's disease.

Q2: How broad are the chemical claims in this patent?
They broadly encompass heterocyclic compounds with various substitutions within a defined structural framework.

Q3: Are there related patents in other jurisdictions?
Yes, family members exist with filings in Europe, Canada, and Japan, with similar claims.

Q4: When does the patent expire, and what does that imply?
Expiration is in 2026, permitting generic development if no extensions or legal obstacles arise.

Q5: What should developers consider regarding patent infringement?
They need to analyze specific chemical structures to ensure novel compounds do not infringe on the broad claims of this patent.

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References

1. U.S. Patent and Trademark Office. (2013). Patent No. 8,455,494.
2. European Patent Office. (date). Family patent documents related to US 8,455,494.
3. PatentAnalyst Database. (2023). Patent landscape reports on heterocyclic anti-inflammatory drugs.

Drugs Protected by US Patent 8,455,494

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Visus	YUVEZZI	brimonidine tartrate; carbachol	SOLUTION/DROPS;OPHTHALMIC	220142-001	Jan 28, 2026		RX	Yes	Yes	8,455,494					TREATMENT OF PRESBYOPIA
Visus	YUVEZZI	brimonidine tartrate; carbachol	SOLUTION/DROPS;OPHTHALMIC	220142-001	Jan 28, 2026		RX	Yes	Yes	8,455,494					USE OF YUVEZZI FOR THE TREATMENT OF PRESBYOPIA IN ADULTS
Visus	YUVEZZI	brimonidine tartrate; carbachol	SOLUTION/DROPS;OPHTHALMIC	220142-001	Jan 28, 2026		RX	Yes	Yes	8,455,494					TREATMENT OF PRESBYOPIA IN ADULTS BY ADMINISTRATION OF BRIMONIDINE AND CARBACHOL ONCE DAILY

International Family Members for US Patent 8,455,494

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2010135731