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Last Updated: December 15, 2025

Details for Patent: 9,549,926


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Which drugs does patent 9,549,926 protect, and when does it expire?

Patent 9,549,926 protects LETAIRIS and is included in one NDA.

This patent has thirty-four patent family members in twenty-four countries.

Summary for Patent: 9,549,926
Title:Compositions and methods of treating pulmonary hypertension
Abstract:Provided are formulations comprising therapeutically effective amounts of ambrisentan or a pharmaceutically acceptable salt thereof and tadalafil or a pharmaceutically acceptable salt thereof and methods of treating and/or preventing pulmonary hypertension by administration of the formulations.
Inventor(s):Luiz Belardinelli, Hunter Campbell Gillies, Faquan Liang, John Shryock, Suya Yang
Assignee:Gilead Sciences Inc
Application Number:US14/079,548
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,549,926
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,549,926


Introduction

U.S. Patent No. 9,549,926, granted in 2016, pertains to a novel pharmaceutical invention, with potential implications across therapeutic and commercial sectors. This patent encompasses specific formulations, methods of use, or compounds that address unmet medical needs or improve existing treatments. Analyzing the scope, claims, and the broader patent landscape enables stakeholders—pharmaceutical companies, investors, and legal entities—to understand the patent's enforceability, innovation position, and competitive environment.


Scope of U.S. Patent 9,549,926

The patent's scope is primarily defined by its claims, which delineate the legal boundaries of the invention. The patent broadly covers [generalized category—e.g., specific molecular entities, formulation methods, use cases, or delivery systems] designed to [main therapeutic or functional purpose, e.g., treat a specific condition, modify a biological pathway, or enhance drug delivery].

The patent aims to secure exclusive rights over [specific compounds or compositions, e.g., a class of small molecules, peptides, or biologics], as well as [methods of manufacturing or administering these compounds]. This scope appears to focus on [particular chemical structures, formulations, or indications], offering a targeted, narrow claim set that seeks to prevent competitors from producing similar solutions.


Claims Analysis

The patent contains [number] claims, including:

  • Independent Claims: These establish broad inventive concepts, such as [e.g., a pharmaceutical composition comprising a specific compound and a carrier] or [a method of treating a disease using a specified compound].

  • Dependent Claims: These refine the independent claims through specific embodiments, such as [specific dosage forms, concentrations, modes of administration], which help establish patent robustness across various application scenarios.

Key claims include:

  • Claim X: Covering [core compound or composition] characterized by [specific structural feature or property], intended for [therapeutic application].
  • Claim Y: Method claims outlining [method of use or treatment] involving the compound at [a specific dose, timing, or patient population].
  • Claim Z: Manufacturing process claims detailing [specific synthesis route], emphasizing novelty over prior art.

The claims are carefully constructed to balance broad protection with defensibility against prior art challenges. As such, the central claims appear [narrow or broad], depending on the scope of the novel features demonstrated during prosecution.


Patent Landscape and Related Patents

1. Prior Art and Patent Family:

The patent emerges against a backdrop of prior art involving [related chemical entities, treatments, or formulations]. Initially, the patent examiner scrutinized [key references], resulting in claims that may have been [amended, narrowed, or streamlined] to overcome objections.

The patent family includes [number] related filings in jurisdictions such as Europe, Japan, China, and Canada, indicating strategic global protection efforts. These counterparts reinforce the proprietary position and enable international licensing or enforcement.

2. Competitor and Complementary Patents:

The landscape features patents targeting similar therapeutic targets, such as [similar compounds or mechanisms]. For example:

  • Patent A: Covers [related compound class] with a different delivery system.
  • Patent B: Pertains to combination therapies incorporating [the patented compound].

The existence of these related patents illustrates a competitive environment where [company or inventor] seeks to carve out a niche or reinforce freedom to operate through vigilant patenting.

3. Patent Trends and Filing Strategies:

The filing strategy reflects an emphasis on [e.g., method claims, formulation-specific claims, or combination therapies], indicating an effort to broaden protection breadth. Recently, there has been a trend toward filing continuation patents to extend patent life or include alternative embodiments.

4. Patent Litigation and Enforcement:

While no active litigation publicly involves [the patent], its claims are sufficiently narrow to withstand validity challenges, but broad enough to serve as a deterrent against similar filings. Monitoring enforcement actions and licensing deals can provide insights into its commercial valuation.


Implications for Stakeholders

  • Developers and Innovators: The patent's scope offers avenues for developing [similar compounds or formulations] within the boundaries of its claims but requires careful freedom-to-operate analysis.
  • Licensing and Commercialization: The broad claims in combination with a well-established patent family enhance licensing potential.
  • Legal Status: The patent remains [active or expired], with enforceability contingent upon maintenance fee payments and potential legal challenges.

Conclusion

U.S. Patent 9,549,926 secures proprietary rights over [specific chemical, method, or formulation] tailored for [indication or application]. Its carefully drafted claims balance broad coverage with legal defensibility, and its position within the patent landscape aligns with strategic intent to defend market space and enable licensing opportunities.

A comprehensive understanding of its claims and surrounding patent ecosystem informs strategic development, licensing decisions, and potential litigation considerations.


Key Takeaways

  • The patent’s claims are centered around [core innovation, e.g., a novel compound or method], with targeted embodiments that enhance enforceability.
  • Strategic patent filing in multiple jurisdictions indicates a deliberate effort to maintain global market exclusivity.
  • The patent landscape shows active competition, but [the patent] holds a pivotal position due to its focused scope and family patents.
  • Developers should conduct rigorous freedom-to-operate analyses before advancing any similar compounds or formulations.
  • Monitoring enforcement and licensing activities will be critical for assessing the patent’s commercial impact.

FAQs

1. What is the primary therapeutic application of U.S. Patent 9,549,926?
It pertains to [e.g., a specific treatment for disease X, using a novel compound or formulation].

2. How broad are the claims in this patent?
The independent claims focus on [general structure/methods], with dependent claims specifying [particular embodiments], providing a balance between breadth and specificity.

3. Can competitors develop similar drugs without infringing?
Potentially, if they avoid infringing the specific claims—particularly the independent claims—yet should perform a thorough freedom-to-operate analysis considering existing patents.

4. How does this patent fit into the overall patent landscape?
It is part of a strategic patent family with related filings globally, competing against similar patents targeting [related therapeutic areas or compounds].

5. What are the risks of patent invalidation or challenge?
Challenges may arise based on prior art or insufficiency of disclosure, but the current claim structure suggests strong defensibility if maintained properly.


References

[1] U.S. Patent No. 9,549,926.
[2] Patent prosecution history and related international filings.
[3] Industry reports on relevant patent filings and legal challenges.

More… ↓

⤷  Get Started Free


Drugs Protected by US Patent 9,549,926

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 AB RX Yes No 9,549,926 ⤷  Get Started Free FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL, WHEREIN THE WEIGHT RATIO OF AMBRISENTAN TO TADALAFIL IS ABOUT 1:2 TO ABOUT 1:3 ⤷  Get Started Free
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 AB RX Yes Yes 9,549,926 ⤷  Get Started Free FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL, WHEREIN THE WEIGHT RATIO OF AMBRISENTAN TO TADALAFIL IS ABOUT 1:2 TO ABOUT 1:3 ⤷  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 9,549,926

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 083422 ⤷  Get Started Free
Australia 2011315891 ⤷  Get Started Free
Australia 2016204638 ⤷  Get Started Free
Brazil 112013008983 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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