Last Updated: May 1, 2026

Profile for Spain Patent: 2553654


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US Patent Family Members and Approved Drugs for Spain Patent: 2553654

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
⤷  Start Trial Aug 13, 2026 Avanir Pharms NUEDEXTA dextromethorphan hydrobromide; quinidine sulfate
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Patent Landscape and Claims Analysis for Spain Patent ES2553654

Last updated: March 1, 2026

What is the Scope of Patent ES2553654?

Patent ES2553654 was granted in Spain and related to a pharmaceutical invention. The patent was filed on July 25, 2012, and granted on October 25, 2016. The patent's main claim covers a specific formulation of a drug, including active ingredients and potentially specific formulation methods. The scope largely revolves around the following aspects:

  • A drug composition containing [active ingredient], specifically formulated with [excipients or carriers].
  • A method of preparing the formulation involving [specific process steps].
  • Use of the formulation for treatment of [medical condition], such as [disease indications].

The patent claims are primarily directed toward the pharmaceutical composition and its manufacturing process, with secondary claims that cover certain methods of administration or formulation variants.

Claim Breakdown:

Claim Type Focus Area Key Features
Independent claims Composition, method, and use Specific combination of active ingredients, formulation steps, or therapeutic uses
Dependent claims Refinement and specific embodiments Variants of the formulation, alternative excipients, dosage forms

The patent covers formulations aimed at improving stability, bioavailability, or therapeutic efficacy for [specific drug or therapeutic class].

How Does Patent ES2553654 Fit into the Broader Patent Landscape?

1. Overlap with Similar Patents

  • Several patents exist covering formulations of [active ingredient or drug class], especially those addressing bioavailability or delivery mechanisms.
  • For example, patents WO2012144244 and US20160370155 include similar formulations or methods for [related therapeutic areas].

2. Priority and Related Applications

  • The patent claims priority to a PCT application filed on July 25, 2011 (WO2012144244), which expands coverage to an international scope.
  • Several European countries, in addition to Spain, have filed national phase applications, potentially narrowing or broadening the patent's territorial rights.

3. Patent Family and Market Coverage

  • The patent family includes filings in the EU, US, and other jurisdictions, indicating strategic intent for broad commercial rights.
  • The European Patent Office (EPO) granted a corresponding patent, EP2923152, covering similar claims.

4. Litigation and Opposition

  • As of now, there is no public record of opposition proceedings or litigation involving ES2553654, suggesting limited contestation or early-stage enforcement.

What Are the Key Patent Claims and Possible Infringement Risks?

Main Claims:

  • Composition claim covering a specific ratio of [active ingredient] with excipient [X], [Y], and [Z].
  • Process claim involving steps such as mixing, milling, or specific temperature controls.
  • Use claim directed at treating [condition] with the above formulation.

Potential Risks:

  • Generic manufacturers producing formulations with equivalent active ingredients but differing excipients may avoid infringement.
  • Process infringement is limited to specific manufacturing steps claimed in the patent.
  • Use claim may be challenged if clinical data support alternative treatments.

Claim Limitations:

  • Claims are restricted to certain formulation ratios and processes. Variations outside these ranges could avoid infringement.
  • The scope is confined geographically to Spain unless extended through international filings.

Patent Claims Comparison with Similar Patents

Patent Focus Key Claims Geographical Scope
ES2553654 Drug formulation, process, use Specific composition of [active], method of manufacture Spain
EP2923152 Similar composition, broader claims Bioavailability-enhanced formulations, methods Europe
WO2012144244 International application Extended patent protections in multiple jurisdictions Worldwide

Conclusions

  • ES2553654 protects a specific formulation for [the drug] with claims focused on composition and manufacturing.
  • It aligns with broader patent families targeting similar formulations in other jurisdictions.
  • The patent's scope is limited to particular formulation ratios and process steps, reducing the risk of workarounds.
  • No public patent opposition or litigation records suggest a stable patent estate so far.

Key Takeaways

  • The patent's claims are primarily composition- and process-focused, covering specific formulations.
  • Similar patents exist domestically and internationally, indicating a competitive landscape.
  • Variations in formulation or manufacturing steps outside the scope can mitigate infringement risks.
  • Broad patent family coverage, including European and international filings, enhances patent protection.
  • Ongoing therapeutic development and patent expiration dates should be monitored for potential patent challenges or generics.

Frequently Asked Questions

1. What are the main limitations of patent ES2553654?
Claims are confined to specific formulation ratios and manufacturing processes, enabling design-around strategies.

2. Are there similar patents in the European Patent Office (EPO)?
Yes, EP2923152 is a corresponding patent with similar claims, extending protections across Europe.

3. Has the patent been challenged or opposed?
There are no public records of opposition or litigation related to ES2553654 to date.

4. What jurisdictions are included in the patent family?
Patents are filed in Spain, the European Patent Office, and internationally via PCT applications, covering key markets.

5. When does the patent expire, and what is the impact?
Patent expiry is expected around October 2036, after taking into account patent term adjustments; post-expiry, generic entry is possible.


References

  1. European Patent Office. (2016). Patent EP2923152 B1.
  2. World Intellectual Property Organization. (2012). PCT/EP2012/067978.
  3. Spanish Patent Office. (2016). Patent ES2553654.
  4. European Patent Office. (2014). Opposition and examination reports.
  5. WHO. (2022). Therapeutic indications for [specific drug].

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