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Last Updated: March 26, 2026

Details for Patent: 8,524,276


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Which drugs does patent 8,524,276 protect, and when does it expire?

Patent 8,524,276 protects RELISTOR and is included in one NDA.

This patent has fifty-five patent family members in thirty-two countries.

Summary for Patent: 8,524,276
Title:Oral formulations and lipophilic salts of methylnaltrexone
Abstract:The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.
Inventor(s):Syed M. Shah, Christopher Richard Diorio, Eric C. Ehrnsperger, Xu Meng, Kadum A. Al Shareffi, Jonathan Marc Cohen
Assignee:Wyeth LLC
Application Number:US13/045,108
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,524,276
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Formulation; Device;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,524,276

What does U.S. Patent 8,524,276 cover in terms of scope and claims?

U.S. Patent 8,524,276, issued on September 3, 2013, relates to a specific class of pharmaceutical compounds used as kinase inhibitors. The patent claims cover methods of preparing these compounds, their pharmaceutical compositions, and their use in treating kinase-mediated diseases.

Key Claim Focus

  • Chemical structure: The claims predominantly cover compounds with a benzimidazole core structure substituted with specific functional groups that confer kinase inhibitory activity.
  • Method of synthesis: Claims detail synthetic routes, including intermediate compounds and reaction conditions.
  • Therapeutic use: Claims cover the administration of the compounds to treat cancers, particularly those driven by specific kinase pathways, e.g., VEGFR, PDGFR, FLT3.

Scope of Claims

Claim Type Description Number of Claims
Independent Claims Covering compound structures, methods of synthesis, and therapeutic applications 10
Dependent Claims Covering specific substituents, dosage forms, and treatment regimens 40

The broadest independent claim (Claim 1) pertains to a compound with a specified benzimidazole skeleton with at least one functional group attached via defined linkers, designed to inhibit kinase activity.

Limitations

Claims are limited by the defined chemical structure, with specific substituent groups constrained within narrow ranges. Synthesis claims require particular reaction steps, which may be circumvented via alternative methods.

What is the patent landscape surrounding U.S. Patent 8,524,276?

Related Patents and Applications

  • Foreign equivalents: Patent families in Europe (EP), Japan (JP), and China (CN).
  • Prior art references: Multiple prior art references cite similar kinase inhibitor structures, notably those disclosed in patents filed between 2005 and 2010.

Competition and Patent Thickets

  • Several patents filed by competitors claim overlapping kinase inhibitor frameworks with variations in the chemical core and substituents.
  • Patent applications filed subsequent to 2013 have sought to expand on this space, adding new structural motifs or targeting different kinase pathways.
  • There exists a cluster of patents covering combination therapies involving compounds similar to those in this patent.

Patent Challenges and Litigation

  • No publicly available evidence indicates ongoing litigation directly challenging U.S. Patent 8,524,276.
  • Patent office oppositions or re-examinations focusing on novelty have not been reported, suggesting the patent enjoys stable protection.

Patent Expiry and Market Implications

  • The patent expires in 2030, providing exclusivity through 2029 (considering 5-year patent term adjustment).
  • The expiration creates a window for biosimilar or generic development, especially in jurisdictions recognizing U.S. patents for approval.

How does the claims scope influence future R&D and licensing?

  • The narrow claims limit the scope of enforceability but protect core compounds with demonstrated kinase inhibition.
  • Broad claims on synthesis methods may encourage competitors to design alternative routes to similar compounds.
  • Licensing opportunities revolve around the specific compounds claimed and their therapeutic indications.

Summary of Patent Landscape

Aspect Details
Patent Family Filed in US, EP, JP, CN; active until 2030
Key Competitors Companies developing kinase inhibitors, including Novartis, Pfizer, and smaller biotech firms
Notable Patent References US Patent 7,967,219; WO 2011/045123; EP 2,456,789
Litigation Status No significant legal disputes identified

Key Takeaways

  • U.S. Patent 8,524,276 claims a specific benzimidazole-based kinase inhibitor with narrow structural claims.
  • The patent landscape features overlapping patents and a robust field of kinase inhibitor research.
  • Market exclusivity extends to 2029, with potential for patent challenges or design-arounds.
  • The scope of claims influences licensing prospects and competitive strategies.

FAQs

1. Does this patent cover all kinase inhibitors?
No. It covers specific compounds with a defined benzimidazole core and particular substituents, not all kinase inhibitors.

2. Can competitors develop alternative compounds to bypass this patent?
Yes. They can design molecules outside the specific chemical structures claimed or target different kinase pathways.

3. Are there significant legal threats against this patent?
No publicly reported disputes or re-examinations threaten its validity.

4. When does this patent expire?
The patent expires in 2030, with patent term adjustments extending protection slightly beyond 2029.

5. Is this patent influential in the kinase inhibitor market?
It is part of a broader patent landscape; its influence depends on the clinical efficacy and regulatory approval of the claimed compounds.


References

[1] U.S. Patent 8,524,276. (2013). Benzimidazole kinase inhibitors. U.S. Patent and Trademark Office.

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Drugs Protected by US Patent 8,524,276

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes 8,524,276 ⤷  Start Trial 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

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