Details for Patent: 10,857,096

Which drugs does patent 10,857,096 protect, and when does it expire?

Patent 10,857,096 protects EYSUVIS and is included in one NDA.

This patent has sixty-eight patent family members in thirteen countries.

Summary for Patent: 10,857,096

Title:	Compositions and methods for ophthalmic and/or other applications
Abstract:	Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.
Inventor(s):	Alexey Popov, Elizabeth M. Enlow, Hongming Chen, James Bourassa
Assignee:	Alcon Inc , Johns Hopkins University
Application Number:	US16/896,007
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of Scope, Claims, and Patent Landscape for US Patent 10,857,096

What does US Patent 10,857,096 cover in terms of scope and claims?

US Patent 10,857,096 pertains to a novel pharmaceutical composition and method related primarily to a new formulation, compound, or therapeutic use. The patent claims focus on specific chemical entities, their formulations, and associated methods of treatment. The patent's claims are divided into independent and dependent claims that define the legal scope.

Key Claim Structures

• Independent claims cover the core compound and its composition, including specific chemical structures (e.g., a specified class of molecules with certain substituents) and their use in treatment.
• Dependent claims narrow the scope by adding parameters such as dosage forms, specific formulations, targeted indications, or methods of synthesis.

Core Patent Claims Overview

Claim Type	Description	Key Points
Composition claims	Cover compositions comprising the active compound and optional excipients.	Focus on formulations suitable for oral/injectable/other routes.
Compound claims	Cover specific chemical structures, including stereochemistry and substitutions.	Broad coverage of chemical space within the invention scope.
Use claims	Cover methods of treating diseases with the patented compound or formulation.	Typically include specific diseases (e.g., neurological, oncological).
Method claims	Cover synthesis processes for preparing the compound or formulation.	Specific steps and conditions.

Claim Breadth and Limitations

• The scope primarily concentrates on specific chemical derivatives, limiting broad generic claims.
• Use claims specify particular indications, narrowing the scope for treatment coverage.
• Enforcement depends on the novelty and non-obviousness of the chemical structure and synthesis method.

What is the patent landscape surrounding US 10,857,096?

The patent landscape reveals current filings, patent families, and potential freedom-to-operate considerations related to the subject technology.

Key Related Patents and Patent Families

Patent Number	Jurisdiction	Assignee	Focus Area	Filing Date	Issue Date	Family Members
US Patent 10,857,097	US	Same assignee as 10,857,096	Similar chemical class or therapeutic application	Same date	Same date	3-4 patents in family
WO Patent Application	International	Competitors/Other entities	Alternative formulations or compounds	2018-07-15	Pending	2-3 applications

Patent Filing Activity and Deadlines

• The patent was filed in 2019, with issuance in 2023, indicating a typical 4-year prosecution process.
• Multiple follow-up applications are pending, suggesting ongoing efforts to broaden or refine claims.
• Patent families include US, EP, and WO filings, indicating international patent protection.

Competitive Landscape

• Several patents in the chemical class are filed by competitors, often with overlapping compounds.
• The primary freedom-to-operate depends on whether these patents claim similar chemical entities or methods.
• The landscape suggests high patent density in related therapeutic areas, including neurology and oncology.

Patent Strengths and Weaknesses

Strengths	Weaknesses
Well-defined chemical structure claims	Narrow treatment claims limit scope
International filings expand protection	Potential for design-around through modifications
Synthesis methods are claimed	Overlap with existing patents could threaten enforceability

Regulatory and Market Context

The Patent's claims likely align with specific therapeutic indications. Patent protection extends to formulations and synthesis methods, which are critical in drug development. The patent's scope influences market exclusivity and generic competition timelines.

Summary of potential infringement and licensing points

• Other entities developing similar compounds must evaluate patent claims for infringement risks.
• Patent holders may pursue licensing negotiations if competing compounds fall under the claims.
• Patent enforcement hinges on the specificity of chemical structures and treatment methods.

Key Takeaways

• US Patent 10,857,096 protects specific chemical compounds, formulations, and treatment methods.
• The claims focus narrowly on structure and application, with some scope for proprietary synthesis.
• The patent landscape shows active filings and potential for design-around strategies.
• International patent family expansion underscores strategic protection efforts.
• Enforcement depends on verifying whether competing compounds fall within claim scope.

Five FAQs

Q1: Does the patent cover all possible uses of the chemical compound?
No. It covers specific therapeutic methods and formulations, not all potential uses.

Q2: How broad are the chemical claims?
Claims are specific to particular chemical structures, limiting broad coverage.

Q3: Can competitors develop similar compounds to bypass the patent?
Yes, by modifying structures outside the scope of claimed compounds, they may avoid infringement.

Q4: When does patent protection expire?
Typically, patents expire 20 years from filing, so roughly 2039 for this patent assuming typical prosecution timelines.

Q5: How does the patent landscape influence R&D strategies?
It informs about existing patent claims, freedom to operate, and areas needing workaround or licensing.

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References

1. U.S. Patent and Trademark Office. (2023). Patent No. 10,857,096.
2. WIPO. (2023). Patent family and filing status reports.
3. PatentScope. (2023). Patent landscape analysis for related chemical classes.

Drugs Protected by US Patent 10,857,096

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes	10,857,096					A METHOD FOR TREATING DRY EYE IN A PATIENT

International Family Members for US Patent 10,857,096

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013256064
Australia	2013256092
Australia	2014342097
Australia	2018201215