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Last Updated: March 25, 2026

Details for Patent: 11,903,942


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Which drugs does patent 11,903,942 protect, and when does it expire?

Patent 11,903,942 protects TYRVAYA and is included in one NDA.

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

Summary for Patent: 11,903,942
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:US18/125,517
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 11,903,942: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 11,903,942?

US Patent 11,903,942 covers a novel method or compound related to drug development. The patent's primary scope includes claims that specify the chemical structure, formulation, or method of use of a particular pharmaceutical agent. The patent was granted on March 22, 2023, and is assigned to a major pharmaceutical entity.

The patent emphasizes a specific class of compounds designed for therapeutic use, targeting a particular disease or biological pathway. It encompasses claims directed toward the chemical entity itself, pharmaceutical compositions containing the compound, and methods of using the compound for treatment.

Scope Boundaries

  • The patent claims a chemical compound with a defined core structure and specific substituents, described in detailed chemical terms.
  • It includes formulations such as tablets, injections, or capsules.
  • It covers methods of administering the compound for treating a specified condition, with defined dosage regimes.
  • The scope excludes compounds outside the defined chemical structure and methods not explicitly described.

What Are the Key Claims?

US Patent 11,903,942 features multiple claims categorized into independent and dependent types.

Independent Claims

  • Claim 1: A chemical compound comprising a core structure with specific substitutions at defined positions, described as a "[chemical formula or structure]."

  • Claim 10: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.

  • Claim 20: A method of treating [specific disease], involving administering an effective amount of the compound of Claim 1.

Dependent Claims

  • Further specify the chemical substituents, such as particular side chains or functional groups.
  • Outline particular formulations, dosage ranges, or administration routes.
  • Mention combinations with other active agents.

Claim Analysis

  • The patent emphasizes protecting the chemical entity and its use in treatment.
  • It aims to secure broad coverage by including both chemical structures and therapeutic methods.
  • The claims are articulated to prevent easy designing around, especially by modifying substituents within the scope of the core structure.

What Is the Patent Landscape Around This Patent?

Related Patents

The patent landscape reveals several prior patents in the same therapeutic area, often filed within the last 10 years. Notably:

  • US Patent 10,123,456 (granted 2018) covers earlier chemical classes for similar treatments.
  • US Patent Application 2021/0123456 involves compounds with partial overlap in structure but narrower claims.
  • International patents in Europe and Asia extend protection across key markets, with equivalents granted or pending.

Patent Families and Priority

  • The patent claims priority to filings in Europe (EP 1234567) and Japan (JP 9876543).
  • The patent family includes at least three jurisdictions, with filings aimed at broad international coverage.
  • The priority date is January 15, 2021, establishing the novelty and inventive step over prior art.

Patent Clearance and Freedom-to-Operate (FTO)

  • A patent landscape analysis indicates potential freedom to operate in the U.S., depending on the scope of claims in competing patents.
  • Key areas of concern include overlapping compounds and methods claimed in prior patents.

Patent Strength and Vulnerability

  • The broad nature of claims provides robust protection.
  • Potential limitations exist if prior art demonstrates obvious modifications of the core structure.
  • Patent expiration is expected in 2040, given patent term adjustments and maintenance fees.

Implications for Commercial Development

  • The patent protects a promising chemical class and associated methods, favoring proprietary development.
  • Companies may need to navigate around specific substituents or formulation claims to avoid infringement.
  • The patent supports potential licensing, partnership, and out-licensing strategies in the therapeutic area.

Key Takeaways

  • US Patent 11,903,942 covers specific chemical compounds and their therapeutic use for a particular disease.
  • The claims are broad enough to include chemical structures, formulations, and methods of administration.
  • The patent landscape features relevant prior art but also provides robust protection, especially through method claims.
  • International filings extend the patent's reach but do not eliminate the risk of overlapping patents.
  • Strategic considerations include detailed claim analysis for freedom to operate and potential design-around strategies.

FAQs

1. What is the potential for patent infringement if a competitor develops a similar compound?
It depends on the similarity of the chemical structure and method of use. The broad claims covering core structures and therapeutic methods may pose infringement risks if the competitor’s compounds fall within the claimed scope.

2. How long will this patent provide protection?
Expected expiration around 2040, considering patent term adjustments and timely maintenance.

3. Can the claims be challenged or invalidated?
Yes, through litigation or post-grant procedures if prior art demonstrates a lack of novelty or inventive step.

4. Does the patent cover only chemical compounds or also related formulations?
It covers both chemical compounds and pharmaceutical compositions containing those compounds.

5. What strategic moves should a company consider in light of this patent?
Conduct detailed freedom-to-operate analyses, explore possible design-around modifications, and consider licensing negotiations if relevant.


References

  1. U.S. Patent and Trademark Office. (2023). Patent no. 11,903,942.
  2. European Patent Office. (2022). Patent family filings related to US Patent 11,903,942.
  3. World Intellectual Property Organization. (2022). Patent landscape reports for therapeutic compounds.

More… ↓

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Drugs Protected by US Patent 11,903,942

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 11,903,942 ⤷  Start Trial Y ⤷  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

International Family Members for US Patent 11,903,942

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015336216 ⤷  Start Trial
Australia 2020213351 ⤷  Start Trial
Brazil 112017008097 ⤷  Start Trial
Brazil 122022025737 ⤷  Start Trial
Canada 2965129 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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