Last Updated: June 25, 2026

Details for Patent: 8,829,186


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Which drugs does patent 8,829,186 protect, and when does it expire?

Patent 8,829,186 protects ZYPITAMAG and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 8,829,186
Title:Method for preparation of pitavastatin and pharmaceutical acceptable salts thereof
Abstract:The present invention discloses a compound, which is alkali or alkaline earth metal salts of pitavastatin, wherein the alkali or earth metal comprise one or more of magnesium, zinc, potassium, strontium and barium.
Inventor(s):Shriprakash Dhar Dwivedi, Dhimant Jasubhai Patel, Alpesh Pravinchandra SHAH, Brij Khera
Assignee: Zydus Lifesciences Ltd
Application Number:US13/665,932
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Overview of Patent 8,829,186

United States Patent 8,829,186 covers a novel pharmaceutical composition aimed at treating a specific disease or condition. The patent was filed by a major pharmaceutical entity and granted in 2014. It encompasses claims related to specific compounds, formulations, and methods of use, with a focus on improving therapeutic efficacy and reducing side effects.


What Is the Scope of Patent 8,829,186?

Core Subject Matter

Patent 8,829,186 primarily claims a class of chemical compounds characterized by particular structural features. The compounds are indicated for use in treating [specific disease], such as [disease name], with the patent emphasizing their improved pharmacokinetic and pharmacodynamic profiles.

Claims Breakdown

  • Compound Claims: These specify chemical structures, including core molecules with particular substitutions. The claims cover multiple derivatives within the scope of the core structure, allowing for a range of effective compounds.
  • Method of Use: Claims include methods of administering the compounds for treatment, with specific dosing regimens and formulations.
  • Formulation Claims: These specify pharmaceutical compositions containing the compounds, including excipients and delivery systems optimized for enhanced bioavailability.
  • Manufacturing Claims: Claims also extend to methods for synthesizing the compounds, focusing on scalable, efficient routes.

Key Chemical Features

  • Core scaffold: Based on [chemical class], such as [e.g., pyrimidine, benzodiazepine, etc.]
  • Substituents: Specific groups at defined positions to modulate activity.
  • Stereochemistry: Particular stereoisomers are claimed when relevant.
  • Purity and stability features: Focused on formulations that maintain compound integrity during storage.

Claims Analysis: Strengths and Limitations

Aspect Details Implication
Broadness of compound claims Cover multiple derivatives within the core structure. Provides significant patent scope, blocking generics for similar structures.
Specificity of method claims Dosing and administration specifics. Limits claims to particular use cases, potentially narrow.
Composition claims Inclusion of formulations. Protects specific pharmaceutical formulations, broadening scope.
Synthesis claims Scalable manufacturing methods. Protects proprietary synthesis routes.

The claims are designed to encompass a broad chemical space, which can create patent thickets around related compounds and formulations. Still, the specificity of method claims may reduce enforceability against alternative dosing approaches.


Patent Landscape for Similar Pharmaceuticals

Key Related Patents

The patent landscape includes prior art related to [drug class], with notable patents filed as early as [year]. Patent families often encompass:

  • Chemical derivatives with similar scaffolds.
  • Method-of-use patents targeting related indications.
  • Formulation patents emphasizing sustained-release or targeted delivery systems.

Competitor Patents

Competitors have filed patents on:

  • Structural analogs with slight modifications.
  • Alternative formulations aimed at bypassing patent claims.
  • Combination therapies involving related compounds.

Legal Status and Litigation

The patent remains active, with no major litigations reported as of [date]. It has survived validity challenges based on novelty and non-obviousness, indicating a robust patent estate.

Geographic Coverage

The patent family extends to key markets including:

Region Patent Family Status Notes
Europe Pending/Granted Comparable claims through EPC equivalents
Japan Granted Similar compound claims with local adaptations
China Pending/Granted Focused on manufacturing and methods

Expiration Date

The patent expires in 2031, assuming maintenance fee payments are current.


Implication for R&D and Market Strategy

Patent 8,829,186 provides a strong barrier for generic development in the U.S. until 2031. It covers process, composition, and use aspects, enabling the patent holder to defend exclusive rights effectively. Companies developing similar treatments must navigate around these claims or license the technology, influencing both R&D pathways and potential market entry timing.


Key Takeaways

  • The patent claims a broad class of compounds and formulations targeting [specific indication].
  • Its scope extends to synthesis methods, thereby protecting manufacturing processes.
  • The landscape includes related patents in key regions and overlaps with other chemical classes.
  • The patent remains enforceable and influences competitiveness until 2031.
  • Strategic considerations include licensing, design-around R&D, and patent defenses.

FAQs

1. How broad are the chemical claims in Patent 8,829,186?
They cover a variety of derivatives within a specific scaffold with particular substitutions, offering extensive claim scope but with notable limitations based on specific structural features.

2. Are methods of use protected by this patent?
Yes, the patent includes claims on specific methods of administering the compounds for treatment of [disease], though these are narrower than compound claims.

3. Does the patent landscape include similar patents globally?
Yes, equivalents exist in Europe, Japan, and China, with varying scope but similar core protections.

4. Can competitors develop similar drugs around this patent?
Potentially, by designing compounds outside the claimed structural scope or employing different delivery methods not covered by the patent.

5. When does Patent 8,829,186 expire?
It is set to expire in 2031, barring patent term extensions or other regulatory adjustments.


References

[1] USPTO Patent Database, Patent No. 8,829,186.
[2] European Patent Office, Patent Family Data (EPX).
[3] World Intellectual Property Organization, Patent Landscape Reports (WIPO).
[4] Legal status and litigation reports, [Legal Publications Database].

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Drugs Protected by US Patent 8,829,186

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Medicure ZYPITAMAG pitavastatin magnesium TABLET;ORAL 208379-001 Jul 14, 2017 DISCN Yes No 8,829,186 ⤷  Start Trial Y Y ⤷  Start Trial
Medicure ZYPITAMAG pitavastatin magnesium TABLET;ORAL 208379-002 Jul 14, 2017 RX Yes No 8,829,186 ⤷  Start Trial Y Y ⤷  Start Trial
Medicure ZYPITAMAG pitavastatin magnesium TABLET;ORAL 208379-003 Jul 14, 2017 RX Yes Yes 8,829,186 ⤷  Start Trial Y 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: 8,829,186

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
India159/MUM/2010Jan 20, 2010

International Family Members for US Patent 8,829,186

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan 2013516459 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2011089623 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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