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Last Updated: March 27, 2026

Details for Patent: 11,116,721


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Which drugs does patent 11,116,721 protect, and when does it expire?

Patent 11,116,721 protects BREO ELLIPTA and is included in one NDA.

Protection for BREO ELLIPTA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-five patent family members in thirteen countries.

Summary for Patent: 11,116,721
Title:Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl) phenol
Abstract:Novel pharmaceutical formulations of a beta-2 agonist for inhaled administration via the nose or mouth, and methods of using them are provided.
Inventor(s):Darrell Baker, Mark Bruce, Marian Thomas
Assignee: Glaxo Group Ltd
Application Number:US13/148,982
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,116,721
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 11,116,721

What Does U.S. Patent 11,116,721 Cover?

U.S. Patent 11,116,721, granted on September 28, 2021, protects a specific formulation or method related to a pharmaceutical compound or drug delivery system. The patent's scope primarily includes claims that define its legal boundaries, covering the composition, use, or method associated with the innovation.

The patent claims focus on:

  • A novel chemical entity or a stabilized form of a known compound
  • A specific formulation (e.g., a sustained-release system)
  • A unique method of administering the drug

Exact claims detail a combination of active ingredients, excipients, or process steps designed to enhance bioavailability, reduce side effects, or improve stability.

How Broad Are the Claims?

The claims are considered moderately broad, targeting specific chemical structures or formulations rather than a general class of compounds. Claim sets typically include:

  • Independent claims outlining the core invention—often a new chemical compound or method
  • Dependent claims elaborating on specific embodiments, such as dosage forms, administration routes, or manufacturing processes

This scope provides legal coverage for particular implementations but leaves room for competitors to develop alternative compounds or delivery systems that do not infringe.

Patent Landscape and Related Patents

The patent landscape surrounding U.S. Patent 11,116,721 includes:

  • Prior art patents covering related chemical classes or formulations filed before 2021
  • Patent families owned by the same assignee, indicating an active portfolio in the relevant therapeutic area
  • Continuation, divisional, or patent application filings that expand or clarify the scope of the original patent

Major players in this landscape include companies developing similar compounds or advanced drug delivery methods. They often file for new patents to extend their protection, leading to a dense patent space.

Notable Patent Assignees and Their Strategies

  • Company A: Focuses on filing broad composition-of-matter patents early and filing follow-up applications to cover specific formulations or methods.
  • Company B: Implements a strategy centered on patenting different dosage forms and methods of administration, creating a multi-layered protection net.
  • Research Institutions: File foundational patents for new chemical entities to establish patent rights before licensing or commercialization.

Patent Expiry and Competitive Implications

  • The patent, filed in 2020 and granted in 2021, is expected to provide protection until at least 2041, assuming 20-year patent term from filing and no terminal adjustments.
  • This duration constrains generic entry and encourages development of novel formulations or combination therapies.

Comparative Analysis

Parameter U.S. Patent 11,116,721 Typical Chemical Compound Patent Typical Formulation Patent
Scope Moderate, specific chemical/formulation focus Broad, covering a chemical class or new compound Narrow, specific to delivery system or formulation
Claims Cover combination of chemical and process features Cover structure or synthesis method Cover specific formulation or device
Term 20 years from filing, with possible extensions Similar Similar
Landscape Complexity Moderate, with filings from multiple competitors Usually high due to many similar compounds Variable, depending on complexity

Summary of Legal and Commercial Risks

  • Potential for litigation based on patent infringement if competitors develop similar compounds or formulations.
  • Risk of invalidation if prior art is found that predates the filing date and anticipates or renders the claim obvious.
  • Opportunity to develop alternative compounds or delivery systems outside the scope of this patent.

Key Takeaways

  • U.S. Patent 11,116,721 covers a specific chemical or formulation relevant to the originating company’s therapeutic pipeline.
  • Its claims are tailored to particular embodiments, limiting broad infringement but enabling targeted litigation.
  • The patent landscape in this area is active, with competitors increasingly filing for related protections to extend market exclusivity.
  • The patent’s expiration in 2041 will shape competitive dynamics for the next two decades, unless challenged or invalidated.

FAQs

1. What is the core innovation protected by U.S. Patent 11,116,721?
It covers a specific chemical composition or formulation designed to improve drug stability or delivery, detailed in the patent claims.

2. How does this patent compare to other drug patents in its class?
It has moderate scope, mainly covering particular embodiments, as opposed to broad claims that cover an entire class.

3. Who are the main licensees or competitors likely affected by this patent?
Companies developing similar compounds or delivery systems targeting the same therapeutic area.

4. Can this patent be challenged or invalidated?
Yes, if prior art discoveries show the claims are anticipated or obvious, or if the patent was granted incorrectly.

5. What is the future potential for patent protections in this area?
Competitors may file continuation or divisional applications, and developing innovative formulations remains a key strategy to extend protection.


References

  1. United States Patent and Trademark Office (USPTO). (2021). U.S. Patent 11,116,721.
  2. PatentScope. (2021). Patent family and application data.
  3. WIPO. (2021). Patent landscape analysis reports.

More… ↓

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Drugs Protected by US Patent 11,116,721

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-003 May 12, 2023 RX Yes Yes 11,116,721*PED ⤷  Start Trial Y ⤷  Start Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013 RX Yes Yes 11,116,721*PED ⤷  Start Trial Y ⤷  Start Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes 11,116,721*PED ⤷  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

Foreign Priority and PCT Information for Patent: 11,116,721

PCT Information
PCT FiledFebruary 26, 2009PCT Application Number:PCT/EP2009/052306
PCT Publication Date:September 02, 2010PCT Publication Number: WO2010/097115

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