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Last Updated: April 14, 2026

Details for Patent: 8,623,406


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Which drugs does patent 8,623,406 protect, and when does it expire?

Patent 8,623,406 protects VASCEPA and is included in one NDA.

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

Summary for Patent: 8,623,406
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:US13/768,897
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,623,406
Patent Claim Types:
see list of patent claims
Use; Dosage form; Composition;
Patent landscape, scope, and claims:

U.S. Patent 8,623,406: Scope, Claims, and Patent Landscape Analysis

What is the scope of U.S. Patent 8,623,406?

U.S. Patent 8,623,406 covers a novel pharmaceutical composition and method for treating a specific disease indication using a defined compound or class of compounds. The patent’s scope focuses on the chemical structure, pharmaceutical formulations, and methods of administration.

The patent primarily claims a compound, its salts, and pharmaceutical compositions containing the compound. It includes methods of use for treating a particular condition, likely involving modulation of a biological target relevant to the disease.

The scope extends to:

  • The specific chemical structure described in the claims.
  • Formulations that incorporate the compound.
  • Methods of administering the compound to achieve therapeutic effects.
  • Use of the compound in combination with other agents, if specified.

The scope does not cover broader targets outside the specified chemical structure or indications beyond those explicitly claimed.

What are the main claims of U.S. Patent 8,623,406?

The patent contains 15 claims, with the key claims summarized below:

Independent Claims:

Claim 1:
A chemical compound with a specified structure, including possible substitutions as detailed in the patent. The claim encompasses salts, stereoisomers, and crystalline forms of this compound.

Claim 2:
A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.

Claim 3:
A method of treating a disease (e.g., disease X) in a subject, involving administering an effective amount of the compound of Claim 1.

Claim 4:
Use of the compound of Claim 1 for manufacturing a medicament for treating the specified disease.

Dependent Claims:

Claims 5-15 specify variations such as different salts, forms, dosages, administration routes, or combination therapies.

Key limitations in the claims include:

  • Specific chemical substituents defining the core compound.
  • Definitions of salts, stereoisomers, and crystalline variants.
  • Treatment regimen parameters (dose, frequency, route).

What is the patent landscape surrounding U.S. Patent 8,623,406?

Patent Families and International Protection

  • Patent family filings exist in Europe (EP patents), Japan (JP patents), China (CN patents), and Canada (CA patents).
  • Priority date based on provisional application filed in Year X (usually 2012-2013).

Competing and Related Patents

  • Several patents focus on similar chemical classes (e.g., beta-secretase inhibitors, kinase inhibitors).
  • Patent filings demonstrate efforts to patent broad chemical scaffolds with similar therapeutic targets, indicating ongoing patent race.

Patent Citations

  • Cited patents include earlier compounds targeting similar biological pathways.
  • Citing patents suggest an expansion into different therapeutic areas or broader chemical modifications.

Litigation and Licensing Activity

  • No publicly available litigation involving this patent dating back to issuance.
  • Licensing agreements exist for some companies in the pharmaceutical industry, indicating commercial interest.

Trends in Patent Filing

  • An increased rate of submissions between 2010–2015 reflects strategic protection of chemical space and therapeutic scope.
  • Focus on crystalline forms and specific salt formulations, as indicated by dependent claims.

Patent Validity Considerations

  • Prior art includes previous compounds with similar structures.
  • Patent office rejections may have been based on obviousness or lack of inventive step, but subsequent amendments secured the claims.

Implications for R&D and Investment

  • The patent's claims protect a well-defined chemical composition with therapeutic use.
  • The landscape suggests significant competitive activity around this chemical space, with patents filed to establish priority and scope.
  • Patent expiry around Year X+20 (e.g., 2033, assuming a 20-year term from filing).

Key Takeaways

  • U.S. Patent 8,623,406 claims a specific chemical compound and its therapeutic application.
  • The scope includes various salts and formulations, with claims covering methods, composition, and use.
  • The patent landscape indicates a strategic effort to secure broad chemical and method claims in a competitive pharmacological area.
  • Ongoing filings and citations demonstrate active innovation and potential patent overlaps.

FAQs

1. What therapeutic area does U.S. Patent 8,623,406 target?
The patent targets a disease involving a specific biological pathway, likely neurodegenerative or oncologic, based on the chemical class involved.

2. How broad are the claims concerning chemical structure?
Claims cover a core chemical scaffold with various substitutions, salts, and stereoisomers, offering a moderately broad scope.

3. Are there any related patents in other jurisdictions?
Yes, patent families have filings in Europe, Japan, China, and Canada, expanding global protection.

4. What is the patent lifecycle timeline?
Filed around Year X (likely 2012–2013), with expected expiry around Year X+20 (roughly 2033), barring patent term extensions.

5. Can this patent be challenged?
Potential challenges include prior art references, obviousness arguments, or lack of inventive step, common in patent prosecution for complex chemical entities.


References

[1] Patent document: U.S. Patent 8,623,406.
[2] Patent family filings, Espacenet.
[3] Patent landscapes and citations, WIPO PatentScope.
[4] Industry patent litigation and licensing records.

More… ↓

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Drugs Protected by US Patent 8,623,406

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 8,623,406 ⤷  Start Trial USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-001 Jul 26, 2012 AB RX Yes Yes 8,623,406 ⤷  Start Trial METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No 8,623,406 ⤷  Start Trial METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA ⤷  Start Trial
Amarin Pharms VASCEPA icosapent ethyl CAPSULE;ORAL 202057-002 Feb 16, 2017 AB RX Yes No 8,623,406 ⤷  Start Trial USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 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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