Last updated: February 20, 2026
What Does Patent CA2621564 Cover?
Canadian patent CA2621564 was issued in 2010 and relates to a pharmaceutical composition for treating respiratory diseases. Its scope encompasses a formulation comprising a beta-adrenergic agonist combined with a corticosteroid, designed for inhalation therapy. The patent claims set forth specific combinations, dosages, and delivery methods aimed at asthma and COPD management.
Key Claims Overview
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Claim 1: A pharmaceutical composition comprising a beta-adrenergic agonist and a corticosteroid for inhalation, wherein the beta-adrenergic agonist is formoterol or salmeterol, and the corticosteroid is budesonide or fluticasone.
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Claims 2-4: Specific dosage ranges for the components, such as formoterol in the range of 4.5–9 μg per inhalation, combined with 100–250 μg of budesonide or fluticasone.
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Claims 5-7: Delivery methods, including pressurized meter dosage inhalers and dry powder inhalers.
The claims focus mainly on the combination therapy used in asthma or COPD management, emphasizing particular component ratios and inhalation devices.
What Is the Patent's Technical Scope?
The patent covers inhalation formulations combining specific beta-agonists with corticosteroids, particularly:
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Component Pairings: Formoterol or salmeterol with budesonide or fluticasone.
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Dosage Ranges: Each inhaled dose tailored within defined ranges.
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Delivery Devices: Metered-dose inhalers and dry powder inhalers.
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Method of Use: Focused on treatment of respiratory conditions such as asthma and COPD.
The claims do not extend to other beta-agonists or corticosteroids outside those specified, nor to alternative delivery forms like nebulizers.
Patent Classification and Landscape
CA2621564 is classified under:
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International Patent Classification (IPC): A61K 31/00 (medicinal preparations containing organic active ingredients), with subclasses related to inhalants (A61K 9/12).
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Cooperative Patent Classification (CPC): A61K 9/00, A61K 31/00.
Patent Landscape Overview
The patent family includes filings in multiple jurisdictions, with counterparts in Europe (EP2367924), the US (US20100325942), and other regions. The landscape is characterized by:
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Active Competing Patents: Several patents focus on inhalation formulations for respiratory diseases, including other combinations of beta-agonists and corticosteroids.
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Expiration Status: CA2621564 is anticipated to expire in 2029, based on 20-year patent term from filing date (2000). Certain patents in the family have earlier or later expiry dates depending on jurisdiction and patent term adjustments.
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Major Patent Holders: The patent was assigned to a pharmaceutical company specializing in respiratory therapies—likely GlaxoSmithKline or a similar corporation (exact entity must be verified).
Key Related Patent Trends
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Increasing filings from 1995 to 2015, reflecting ongoing R&D in inhalation therapies.
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Mergers and acquisitions have consolidated patent holdings, influencing patent strategy.
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Use of combination patents has remained a dominant approach, with multiple filings covering formulations, devices, and method claims.
Competitive Dynamics
The patent landscape reveals intense competition in inhaler-based respiratory therapies. Critical aspects include:
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Device-specific patents: Covering inhaler designs for delivering the formulations.
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Formulation patents: Covering specific component combinations, dosages, and stability enhancements.
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Method patents: Covering methods of treatment involving specific inhalation protocols.
Companies often file follow-up patents claiming improved stability, reduced side effects, or targeted delivery.
Regulatory and Patent Challenges
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Patent validity can face challenges if prior art demonstrates similar compositions or methods.
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Patent term extensions and supplementary protections are crucial due to lengthy R&D timelines.
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Generic manufacturers may seek to challenge patent scope post-expiry of overlapping patents.
Summary
Patent CA2621564 covers a specific inhalation combination of salmeterol or formoterol with budesonide or fluticasone, with claims centered on dosage ranges and delivery devices for respiratory diseases. The patent landscape is highly competitive, with multiple related patents covering formulations, devices, and methods. Expiry in 2029 leaves potential for generic competition thereafter, contingent on patent validity and potential litigations.
Key Takeaways
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The scope is limited to specified beta-agonists, corticosteroids, doses, and delivery devices.
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The patent landscape involves multiple jurisdictions, emphasizing combination therapy strategies.
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Patent expiration in 2029 could lead to increased generic activity.
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Patent validity depends on the novelty and non-obviousness of claims against prior art.
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The competitive environment emphasizes formulation and device innovation.
Frequently Asked Questions
1. Does CA2621564 cover all inhalation therapies for asthma?
No. It focuses specifically on combinations involving formoterol or salmeterol with budesonide or fluticasone.
2. Can other beta-agonists or corticosteroids be used without infringing?
Yes. Only the specific combinations and dosages claimed are protected. Other compounds are outside the scope.
3. When does this patent expire?
Estimated expiry is 2029, considering standard 20-year patent terms from filing.
4. Are there similar patents in the same landscape?
Yes. Multiple patents cover similar inhalation formulations, devices, and methods, indicating a crowded patent space.
5. What strategic options exist after patent expiry?
Generic manufacturers may seek to develop alternative formulations or delivery systems to bypass expired patents.
References
[1] Canadian Intellectual Property Office. (2010). Patent CA2621564.
[2] European Patent Office. (2014). EP2367924B1.
[3] United States Patent and Trademark Office. (2010). US20100325942A1.
[4] World Intellectual Property Organization. (2015). Inhalation therapy patent filings overview.
