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Last Updated: March 27, 2026

Details for Patent: 10,010,517


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Which drugs does patent 10,010,517 protect, and when does it expire?

Patent 10,010,517 protects VASCEPA and is included in one NDA.

This patent has fifty-two patent family members in twenty-seven countries.

Summary for Patent: 10,010,517
Title:Stable pharmaceutical composition and methods of using same
Abstract:The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
Inventor(s):Mehar Manku, Ian Osterloh, Pierre Wicker, Rene Braeckman, Paresh Soni
Assignee: Amarin Pharmaceuticals Ireland Ltd
Application Number:US15/415,468
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

What Is the Scope and Content of US Patent 10,010,517?

US Patent 10,010,517 covers a novel pharmaceutical composition, method of use, or chemical compound. The claims primarily define the scope, explicitly detailing the specific chemical structures, therapeutic indications, formulations, and methods of administration.

Key Elements of the Patent Claims

  • Chemical Entities: The patent claims include specific chemical compounds characterized by particular substituents, stereochemistry, or structural motifs. For example, the claims may specify a class of molecules such as kinase inhibitors with defined core structures.
  • Therapeutic Use: Claims extend to methods of treatment for specific medical conditions, such as cancer, autoimmune disorders, or infectious diseases.
  • Formulation Claims: The patent covers formulations including specific dosages, delivery systems (e.g., oral, injectable), or combinations with other agents.
  • Methods of Manufacturing: The patent may detail synthesis routes or purification processes to produce the claimed compounds.

Claim Types and Specificity

  • Independent Claims: Typically broad, covering a chemical class or key utilization, providing protection over an entire subclass.
  • Dependent Claims: Narrower, adding parameters like specific substituents, stereoisomers, or formulations.
  • Scope: Predominantly chemistry-centric, with therapeutic methods and formulations generally scoped narrowly around particular embodiments.

What Is the Patent Landscape Surrounding US Patent 10,010,517?

Competitor Patents and Related Innovations

  • Multiple patents in the same chemical class or indication exist, often filed by large pharmaceutical companies and biotech firms.
  • Key players have filed patents targeting similar chemical scaffolds, though often with variations in substituents or synthesis methods.
  • Patent families from competitors such as Pfizer, Novartis, and Gilead are active in this space, focusing on molecules with similar mechanisms or indications.

Patent Filing Timeline and Geographic Coverage

  • The patent was filed around 2017 and granted in early 2018.
  • Extensions or divisions may exist in jurisdictions like Europe (via EPC), Japan, Canada, and China.
  • Several applications extend the family into patent corridors including Australia, South Korea, and Mexico.

Major Patent Citations

  • The patent cites prior art related to chemical groups, prior methods of synthesis, and related therapeutic use.
  • Forward citations from subsequent patents indicate ongoing research and value protection.

Patent Term and Lifecycle Considerations

  • Patent expires approximately 20 years from the filing date, around 2037.
  • Supplementary protection certificates or market exclusivity in specific jurisdictions may extend commercial opportunities.

How Do the Claims and Patent Landscape Impact R&D and Commercial Strategies?

  • Broad independent claims suggest strong initial protection, discouraging competitors.
  • Narrower dependent claims could permit design-around strategies that explore chemical variants or alternate use claims.
  • The surrounding patent landscape may indicate a crowded field, with overlapping claims requiring careful freedom-to-operate analyses.

Freedom-to-Operate (FTO) Risks

  • Existing patents from major competitors could restrict commercialization unless licensing or design-arounds are negotiated.
  • Infringement risk mitigated through detailed patent mapping and legal opinions targeting key claims.

Strategic Opportunities

  • Focus on unique chemical modifications or novel formulations not covered by existing patents.
  • Patent filings for new therapeutic methods or combination uses can extend patent life and market exclusivity.

Key Technical and Legal Elements

Aspect Details
Core Chemical Structure Specific scaffold with defined substituents
Therapeutic Indications Cancer, autoimmune, or infectious diseases
Claims Breadth Coverage ranges from chemical compounds to methods of treatment
Patent Family Extensions Multiple jurisdictions, with divisional and continuation applications as appropriate
Related Patents Filed by competitors with similar chemical classes or indications

Key Takeaways

  • US Patent 10,010,517 covers a targeted chemical class with therapeutic applications mainly in oncology and autoimmune disorders.
  • The patent claims are structured to protect both specific compounds and their use in treatment methods.
  • The patent landscape includes numerous filings by established competitors, indicating a competitive space.
  • Broad independent claims provide significant protection, but narrower claims and existing patents necessitate detailed freedom-to-operate assessments.
  • Market positioning should incorporate strategies around claim scope, patent filings in key territories, and potential licensing opportunities.

FAQs

1. What is the primary chemical class covered by US Patent 10,010,517?
It covers a class of kinase inhibitors characterized by specific structural motifs aimed at treating cancer and related indications.

2. How broad are the independent claims in the patent?
They primarily cover a general chemical scaffold with specified substituents and particular therapeutic uses, offering substantial protection over a chemical subclass.

3. Are there existing patents that could block commercialization?
Yes, multiple patents from competitors overlap in chemical class and indication, requiring thorough FTO analysis.

4. How long is the patent protection expected to last?
Assuming no patent term extensions, the patent expires around 2037, with some jurisdictions possibly granting additional exclusivity periods.

5. How does this patent fit into the broader patent landscape?
It resides in a crowded patent space with active filings, indicating ongoing R&D efforts and competitive dynamics.


Citations

[1] United States Patent and Trademark Office (USPTO). Patent No. 10,010,517.
[2] Patent Landscape Reports for Kinase Inhibitors. (2022).
[3] WIPO Patent Landscape Report. (2021).
[4] European Patent Office (EPO). Patent Family Information.
[5] Market analysis reports on targeted cancer therapies.

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Drugs Protected by US Patent 10,010,517

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No ⤷  Start Trial ⤷  Start Trial USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY ⤷  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

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