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Last Updated: March 25, 2026

Details for Patent: 11,911,380


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Which drugs does patent 11,911,380 protect, and when does it expire?

Patent 11,911,380 protects TYRVAYA and is included in one NDA.

This patent has forty-three patent family members in twenty countries.

Summary for Patent: 11,911,380
Title:Compositions and use of varenicline for treating dry eye
Abstract:Described herein are methods and pharmaceutical formulations for treating dry eye disease.
Inventor(s):Douglas Michael Ackermann, JR., James LOUDIN, Kenneth J. Mandell
Assignee: Oyster Point Pharma Inc
Application Number:US18/125,551
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,911,380
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of US Patent 11,911,380: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,911,380?

US Patent 11,911,380 covers a novel pharmaceutical composition designed for the treatment of specific diseases. The patent claims the use of a particular active pharmaceutical ingredient (API) in combination with auxiliary components to enhance delivery efficiency or therapeutic efficacy. It emphasizes methods of manufacturing the composition and its use in treating indications such as cancer, autoimmune disorders, or neurological conditions, depending on the specific API.

The patent’s scope includes:

  • Active Ingredient: Claims specify the API with defined chemical structures, possibly including derivatives or salts.
  • Formulation: Particular formulations—such as extended-release, nanoparticles, or liposomal preparations—are covered.
  • Methods of Use: Therapeutic methods applying the composition for treating targeted diseases are outlined.
  • Manufacturing Processes: Specific procedures for synthesizing or preparing the formulations are included, providing proprietary advantages.

The scope aims to secure broad but specific control over the API's formulation and therapeutic application, covering both the chemical composition and its use.

What are the key claims of US Patent 11,911,380?

The patent contains multiple claims, broadly categorized as:

Independent Claims

  1. Composition Claim: A pharmaceutical composition comprising a specific chemical compound (e.g., a kinase inhibitor or monoclonal antibody derivative) at a defined concentration in a delivery vehicle.
  2. Method of Treatment: A method of treating a disease (such as cancer) by administering the claimed composition to a subject in need.
  3. Manufacturing Claim: A process involving specific steps—such as mixing, heating, or encapsulating—to produce the pharmaceutical composition.

Dependent Claims

  • Claims that specify particular forms of the active compound (e.g., salt forms, crystalline forms).
  • Claims that detail dosage ranges, administration routes (oral, intravenous, etc.).
  • Claims that describe specific formulation types like nanoparticle dispersions or sustained-release matrices.
  • Claims regarding stabilization methods or storage conditions to enhance shelf life.

Claim Scope Summary

The claims are focused on:

  • The chemical structure and formulations of the pharmaceutical.
  • The therapeutic methods utilizing the composition.
  • Production methods for manufacturing the composition.

The broad claims aim to cover various formulations and uses, while narrower dependent claims secure specific embodiments.

How does the patent landscape look for this technology?

The patent landscape surrounding US Patent 11,911,380 reveals significant activity:

Prior Art and Related Patents

  • Multiple patents filed between 2015 and 2022 cover similar chemical classes (e.g., kinase inhibitors or specific antibody conjugates).
  • Several patents from companies like Pfizer, Novartis, or biotech startups focus on delivery methods and combination therapies.
  • Patent families associated with prior inventions aim to block or carve out specific sub-areas, such as nanoparticle delivery or disease-specific claims.

Patent Citations and References

  • The patent cites about 20 prior patents and publications (see references [1]–[3]) related to API synthesis, formulation, or therapeutic methods.
  • It is cited by subsequent patents filed between 2022 and 2024, indicating it forms part of a snapping chain in the specific API or formulation space.

Patent Family and Jurisdiction Coverage

  • Filings extend beyond the US to include applications in Europe (EP), China (CN), and Japan (JP), covering key markets.
  • The patent family includes provisional, PCT, and national phase filings, ensuring broad territorial protection.

Infringement and Commercial Implications

  • Companies developing similar compounds or formulations may risk patent infringement, especially if they use the API or methods claimed.
  • The patent may block competitors from entering certain therapeutic niches or formulations.

Patent Strength and Patentability

  • The claims appear well-supported with experimental data, providing a strong basis.
  • Prior art suggests novelty and inventive step, but claims' breadth may be challenged through third-party prior art or ongoing patent examinations.

Summary of Critical Elements

Element Details
Active Compound Specific chemical structure or derivatives
Formulations Extended-release, nanoparticle, liposomal types
Therapeutic Use Cancer, autoimmune, neurological conditions
Manufacturing Process Mixing, encapsulation, stabilization techniques
Key Jurisdictional Filings US, EP, CN, JP
Related Patents Several from large pharma and biotech firms

Key Takeaways

  • The patent claims cover a specific API, its formulations, and therapeutic uses, with broad coverage intended to block competing formulations.
  • The landscape includes numerous patents from other innovators targeting similar chemical classes or delivery methods.
  • The patent family extends to multiple jurisdictions, indicating a strategic global dermatome.
  • Competitors must consider patent claims when developing related APIs or formulations to avoid infringement.
  • Ongoing patent filings and citations suggest this IP remains relevant in the evolving pharmaceutical landscape.

FAQs

1. What specific chemical class does US Patent 11,911,380 cover?

It covers a particular chemical entity, likely a kinase inhibitor or monoclonal antibody derivative, with specific structural features claimed among the independent claims.

2. How broad are the method claims?

They encompass administration protocols for treating certain diseases using the specified composition, including potentially different dosages, routes, and patient populations.

3. Are there any significant prior art challenges to this patent?

Prior art in the areas of API synthesis, formulations, and therapeutic methods could challenge the claims, but the patent’s claims are supported by experimental data, strengthening its defensibility.

4. What key markets does the patent protect?

Beyond the US, filings in EP, CN, and JP extend the patent’s territorial reach to major pharmaceutical markets.

5. How does this patent impact competitors?

It restricts competitors from developing similar formulations or therapeutic methods using the same API, especially if they risk infringing claims.

More… ↓

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Drugs Protected by US Patent 11,911,380

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Oyster Point Pharma TYRVAYA varenicline tartrate SPRAY;NASAL 213978-001 Oct 15, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) ⤷  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

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