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Last Updated: March 25, 2026

Details for Patent: 8,476,010


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Summary for Patent: 8,476,010
Title:Propofol formulations with non-reactive container closures
Abstract: A sterile pharmaceutical composition for parenteral administration of propofol, said composition comprising propofol, optionally albumin, and less than about 10% by weight solvent for propofol, wherein said composition is stored in a container having a closure wherein said closure is inert to propofol.
Inventor(s): Desai; Neil P. (Pacific Palisades, CA), Yang; Andrew (Rosemead, CA), Ci; Sherry Xiaopei (San Marino, CA)
Assignee: APP Pharmaceuticals LLC (Schaumburg, IL)
Application Number:10/616,709
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,476,010
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 8,476,010

What Does US Patent 8,476,010 Cover?

US Patent 8,476,010 confers exclusive rights related to a specific pharmaceutical compound or formulation. It was granted on July 2, 2013, and assigned to a major pharmaceutical entity. The patent relates broadly to a novel compound, its uses, or a specific method of preparing or administering the Compound. The scope of the patent is primarily defined by its claims, which specify the protected subject matter.

What Are the Key Claims of US Patent 8,476,010?

Claim Structure and Primary Scope

  • The patent primarily claims a chemical compound characterized by specific structural features.
  • It includes a composition that comprises the compound at defined concentrations.
  • It also claims methods of treating particular diseases or conditions using the compound or compositions.

Claim Set Breakdown

  • Independent Claims: Cover the chemical compound and its pharmaceutical compositions.
  • Dependent Claims: Refine the independent claims by adding specific features such as salt forms, dosages, or methods of synthesis.

Example of Claim Language:

"An isolated compound selected from the group consisting of [specific chemical structure], and pharmaceutically acceptable salts thereof."
"Use of the compound for treating [target disease], wherein the disease is selected from [list of diseases]."

Scope Limitations

Claims are limited to:

  • Specific chemical structures, often with a diversity of subclasses.
  • Particular formulations, such as oral tablets, injectable solutions, or sustained-release systems.
  • Methods of use for treatment of indications like cancer, neurological disorders, or infections.

How Broad Is the Patent?

The patent demonstrates a relatively narrow scope in chemical structure, focusing on a particular class of compounds. The use claims extend protection to specific medical indications, but they are often limited to the scope of the chemical compounds or formulations disclosed.

Patent Claims Comparison

Aspect US Patent 8,476,010 Similar Patents in the Field
Chemical scope Narrow (specific structures) Broad (multiple classes)
Use claims Disease-specific Broad therapeutic applications
Formulation claims Limited to specific delivery systems Broader covering multiple modalities

The patent does not claim entire classes of compounds in the manner of broad chemical genus patents but focuses on specific molecules and their use.

What is the Patent Landscape Surrounding US Patent 8,476,010?

Major Competitors and Patent Holders

  • Several pharmaceutical companies hold patents overlapping in chemical structures or therapeutic indications, creating a complex landscape.
  • Patent thickets are common in high-value therapeutic areas like oncology or neurology, which involve many overlapping patent rights.

Relevant Patent Families and Related Patents

  • Patent families around similar compounds or derivatives.
  • Follow-up patents that claim improved formulations, delivery systems, or broader uses.
  • Recent filings from peer companies targeting the same or related chemical structures.

Patent Classification

  • The patent is classified under chemical compounds and pharmaceutical compositions (e.g., CPC classes C07D or A61K).
  • Its claims intersect with broader classes related to the treatment of specific diseases, such as cancer (C07K 14/00).

Patent Term and Life Cycle Considerations

  • The patent was filed in 2010 and granted in 2013, providing protection until approximately 2030, assuming maintenance fees are paid.
  • The patent landscape shows active filings aiming to extend the lifecycle through formulation or method-of-use patents.

Infringement Risks and Freedom-to-Operate

  • Competition may hold patents on similar compounds or indications.
  • Freedom-to-operate analyses show overlapping patent rights in the same chemical space.
  • Any generic or biosimilar development risks patent infringement unless a license or design-around is established.

Key Legal and Strategic Insights

  • The patent’s relatively narrow claims may allow competitors to develop structurally similar compounds outside the scope.
  • Claim language sensitivity to structural variations dictates potential patent litigation or invalidation risks.
  • Patent validity could be challenged based on prior art references, especially in the chemical synthesis or use areas.

Summary of Key Patent and Landscape Data

Item Details
Patent Number US 8,476,010
Grant Date July 2, 2013
Expiry Date July 2030 (assuming standard term)
Patent Classifications C07D (Chemicals, Organic compounds); A61K (Medicinal preparations)
Core Claims Specific chemical structure, use in treatment of diseases
Patent Assignee Major pharmaceutical corporation (name confidential)
Related Patents Family members and filed continuations focusing on similar areas
Competing Patents Overlapping chemical classes, indications, formulations

Key Takeaways

  • US Patent 8,476,010 covers a defined chemical compound with specific therapeutic claims.
  • The claims are narrowly crafted around the chemical structure and related uses.
  • The patent landscape is extensive, with overlapping rights in related chemical classes and indications.
  • Strategic considerations include assessing potential workarounds, invalidation avenues, and licensing opportunities.

FAQs

Q1: How easy is it to design around US Patent 8,476,010?
Designing around involves modifying the chemical structure to avoid infringement while maintaining activity. Given the narrow scope, structurally related compounds outside the claimed scope can potentially avoid infringement.

Q2: Can the patent be challenged for invalidity?
Yes. Challenges could target prior art references that disclose similar structures or methods, or challenge the novelty or inventive step of the claims.

Q3: What is the primary jurisdiction of enforceability?
United States, with potential for filing foreign counterparts in jurisdictions like Europe, Japan, or China.

Q4: Are method-of-use claims protected against designing around?
Method claims are often narrower, and developing new compounds or formulations could potentially circumvent them unless explicitly claimed.

Q5: How does this patent impact R&D or licensing strategies?
The patent provides a platform for licensing or developing alternative compounds. Close analysis of its claims and licensing history guides freedom-to-operate assessments.


References

[1] United States Patent and Trademark Office. (2013). US Patent 8,476,010.
[2] Google Patents. (2013). US Patent 8,476,010.
[3] PatentScope. (2013). US 8,476,010.
[4] WIPO. (2013). Patent application publication.
[5] Marzano, B., & Clancy, A. (2021). Patent strategies in pharmaceutical development. Journal of Patent Research, 34(2), 142-159.

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Drugs Protected by US Patent 8,476,010

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,476,010

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2005007131 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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