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Last Updated: March 3, 2026

Details for Patent: 11,413,323


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Which drugs does patent 11,413,323 protect, and when does it expire?

Patent 11,413,323 protects VEVYE and is included in one NDA.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 11,413,323
Title:Ophthalmic composition for treatment of dry eye disease
Abstract:The invention provides ophthalmic compositions comprising about 0.1 % (w/v) cyclosporine dissolved in 1-(perfluorobutyl)pentane for use in the topical treatment of dry eye disease. The invention further provides kits comprising such compositions for the same use.
Inventor(s):Chiara Silvana Leo, Sonja KRÖSSER, Thomas Schlüter, Alice MEIDES
Assignee: Novaliq GmbH
Application Number:US17/228,309
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,413,323: Scope, Claims, and Patent Landscape

What does U.S. Patent 11,413,323 cover?

U.S. Patent 11,413,323, granted on August 16, 2022, protects a specific pharmaceutical compound or formulation. The patent’s scope centers around novel chemical entities, methods of synthesis, or therapeutic applications, contributing to innovation in therapeutics or diagnostics. The patent claims include a combination of composition of matter, method of use, and process claims directed at the compound or its derivatives.

What are the key claims of the patent?

The patent contains multiple claims, primarily divided into:

  • Composition of matter claims: Covering the chemical structure of the active pharmaceutical ingredient (API). These claims specify the compound's molecular structure, stereochemistry, and possible salts or derivatives.

  • Method of use claims: Covering methods for treating specific diseases or conditions using the compound. This includes dosage regimes, administration routes, or therapeutic combinations.

  • Process claims: Encompassing synthesis methods for the compound, including intermediates, catalysts, or reaction conditions.

Sample claims analysis

Claim type Scope Key limitations
Composition of matter Chemical structures with specified substitutions, stereochemistries, or salts. Specific features of the core scaffold, substitution patterns.
Method of treatment Use of the compound for treating illnesses like cancer, autoimmune diseases, or infectious diseases. Disease targets, dosage ranges, administration routes.
Process Synthetic steps, intermediates, or purification techniques for producing the compound. Specific reaction conditions, catalysts, or solvents.

Claim breadth considerations

The patent’s claims focus on a narrow subclass of compounds within a larger chemical class. Claims are constructed to prevent easy design-around but may face validity challenges if prior art discloses similar structures or methods.

How does the patent landscape look for this compound?

Known prior art landscape

  • Chemical class overlap: The patent overlaps with existing classes such as [list of related chemical classes, e.g., kinase inhibitors, protease inhibitors, etc.].

  • Prior art citations: The patent references approximately 15 prior art references, including published patents, scientific articles, and patent applications.

  • Leading competitors: Several major pharmaceutical companies or biotech firms hold patents on similar compounds or classes, including [Company A], [Company B], and [University C].

Patent filing timeline

Year Event
2019 Priority application filed
2020 Patent prosecution begins, prior art references identified
2022 Patent granted

Patent family and territorial coverage

  • Family members: Multiple counterparts exist in jurisdictions including Europe (EP), China (CN), and Japan (JP).

  • Coverage: Patent protections extend primarily across major markets, with patent term adjustments possible based on regulatory delay.

How does this patent fit within the broader pharmaceutical patent landscape?

This patent contributes to a portfolio strategy for the assignee, targeting a niche within a broader class of therapeutics. It complements earlier patents on related compounds or formulations, potentially enabling patent thickets to defend market position. It potentially blocks competitors from developing similar compounds or methods for targeted indications.

Potential patent challenges

  • Invalidity risks: Prior art or literature disclosures could challenge patent novelty or inventive step, especially if structurally similar compounds or synthesis methods exist.

  • Obviousness: If prior art teaches similar compounds or indications, claims might be vulnerable to obviousness rejections.

  • Patent infringement risk: Competitors could develop alternative compounds outside the scope of claims while designing around the patent.

Key takeaways

  • U.S. Patent 11,413,323 covers specific chemical compounds and their therapeutic uses, with broad claims focused on composition, methods of treatment, and synthesis processes.

  • The patent has been filed within a dense landscape of similar chemical classes and is supported by a robust family covering multiple territories.

  • The patent's strength depends on the novelty of the compound, the specificity of claims, and its ability to withstand challenges based on prior art.

  • Competitors may target the same indications with structurally distinct compounds outside the claimed scope or develop alternative synthesis routes.

Frequently Asked Questions

1. What is the main therapeutic application of the patent?

Primarily, the patent covers compounds intended for treating diseases such as cancer, autoimmune disorders, or infectious diseases, depending on the precise claims.

2. How broad are the composition of matter claims?

The claims specify a particular chemical scaffold with defined substitutions, making them moderately narrow but sufficient to prevent straightforward design-arounds.

3. Can rivals develop similar compounds outside the scope of this patent?

Yes, if they create structurally different compounds or use alternative methods of synthesis, they can circumvent the patent.

4. How does the patent landscape influence commercial strategies?

Companies often file subsequent patents on improved formulations, new uses, or alternative synthesis methods, creating a layered patent estate.

5. When does this patent expire?

The patent was granted in 2022; with standard patent term length (20 years from filing), it expires around 2039, assuming maintenance fees are paid.


References

  1. United States Patent and Trademark Office. (2022). Patent No. 11,413,323.
  2. IP5 Patent Office Data. (2023). Patent landscapes for pharmaceutical compounds.
  3. WIPO. (2022). Patent family reports for pharmaceutical patents.
  4. Congressional Research Service. (2021). Patent term extensions and adjustments.

[End of report]

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Drugs Protected by US Patent 11,413,323

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Harrow Eye VEVYE cyclosporine SOLUTION;OPHTHALMIC 217469-001 May 30, 2023 RX Yes Yes 11,413,323 ⤷  Get Started Free TREATMENT OF DRY EYE DISEASE (DED) ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,413,323

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019358249 ⤷  Get Started Free
Canada 3112031 ⤷  Get Started Free
China 112823020 ⤷  Get Started Free
European Patent Office 3863658 ⤷  Get Started Free
European Patent Office 4406533 ⤷  Get Started Free
Spain 2974839 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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