Last updated: February 20, 2026
What is Patent CA2526562?
Patent CA2526562, filed by AstraZeneca Canada Inc., covers a specific pharmaceutical composition involving a combination of drugs for particular therapeutic use. It was granted on August 15, 2006, and primarily pertains to formulations containing rosuvastatin for reducing cholesterol levels.
What are the Claims and Their Scope?
Main Claims Overview
The patent includes 18 claims, with the core claims centered around:
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Claim 1: A pharmaceutical composition comprising rosuvastatin in a specific dosage form, combined with a second active ingredient, for the treatment of hyperlipidemia.
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Claim 2: The composition of Claim 1, wherein the second active ingredient is aspirin.
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Claim 3: The composition of Claim 1, with the dosage of rosuvastatin between 5 mg and 40 mg.
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Claim 4-7: Specific formulations, including tablet forms, acceptable excipients, and methods of preparation.
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Additional Claims: Focus on methods of treatment, packaging, and dosing regimens using the claimed compositions.
Scope of Claims
The breadth of claims covers:
- Combination therapies involving rosuvastatin and select second agents, primarily aspirin but also other antiplatelet drugs.
- Dosage ranges targeting common hyperlipidemia treatments (5-40 mg of rosuvastatin).
- Formulations such as oral tablets and capsules.
- Methods of administration and treatment, extending to the packaging and dosing instructions.
Limitations
- The claims explicitly specify rosuvastatin in combination with aspirin or other agents.
- The patent does not cover monotherapy with rosuvastatin alone or other drug combinations outside the scope.
- Claims are limited to formulations and methods involving specific active ingredients and dosages.
Patent Landscape: Related Patents and Trends
Major Competitors and Related Patents
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Patents covering rosuvastatin formulations include US patents US7033984 (AstraZeneca, 2006) and WO2004106454 (AstraZeneca, 2004), which target different formulations and dosage methods.
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Patents on combination therapies, particularly with aspirin and other lipid-lowering agents, include US20110176354 (AstraZeneca, 2011), focusing on fixed-dose combinations.
Patent Family and Territorial Coverage
- The patent is part of a family with applications filed in the US, Europe, and other jurisdictions.
- It grants exclusive rights in Canada until August 2026, considering patent term adjustments.
- Patent coverage extends in key markets for cardiovascular drugs, including the US, Europe, and Japan.
Trends in the Patent Landscape
- Increasing filings focus on fixed-dose combination drugs (FDCs) for cardiovascular indications.
- Patent applications emphasize formulation stability, bioavailability, and method of use.
- Patent lifecycle management strategies involve filing for secondary patents—covering dosing regimens, formulations, or specific indications.
Implications for Industry and R&D
- The scope of CA2526562 restricts competitors aiming to develop rosuvastatin combinations outside the specified formulations or dosages.
- The patent's expiration in 2026 allows generic entrants to enter the market thereafter, likely resulting in market competition for combination drugs with rosuvastatin.
- Patent challenges and workarounds may target different dosage ranges or alternative combinations to circumvent infringement.
Key Takeaways
- Patent CA2526562 covers specific formulations of rosuvastatin in combination with aspirin or similar agents, with defined dosage ranges and formulations.
- The patent landscape emphasizes FDCs for lipid management, with active litigation and filings in major jurisdictions.
- Valid until 2026, the patent will influence R&D strategies and generic entry planning beyond that date.
FAQs
Q1: Can a new rosuvastatin combination utilize a different active ingredient to avoid infringement?
A: Potentially, as the claims specify certain agents. Using non-listed agents may circumvent claims but requires detailed patent analysis.
Q2: Does the patent cover rosuvastatin monotherapy?
A: No, the claims focus on combinations involving rosuvastatin and specific second agents.
Q3: Are formulation patents also protected in this patent?
A: Yes, claims include formulations like tablets and capsules, covering specific excipients and preparation methods.
Q4: When does the patent expire, and what are the implications?
A: Expiry is expected in August 2026, after which generic manufacturers can enter the Canadian market.
Q5: How does this patent compare to similar US patents?
A: US counterparts, such as US7033984, cover similar formulations but may differ in scope; legal strategies often include cross-claiming and patent family extensions.
References
[1] AstraZeneca Canada Inc. (2006). Patent CA2526562.
[2] U.S. Patent No. US7033984 B2. (2006). AstraZeneca.
[3] World Intellectual Property Organization. WO2004106454. (2004).
[4] U.S. Patent Application Publication No. US20110176354. (2011).
[5] PatentScope. (2023). CA2526562 patent family and legal status.
