Last Updated: August 25, 2026

Details for Patent: 8,337,888


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Summary for Patent: 8,337,888
Title:Pharmaceutical formulation containing gelling agent
Abstract:Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.
Inventor(s):Curtis Wright, Benjamin Oshlack, Christopher Breder
Assignee: Purdue Pharma LP
Application Number:US13/349,449
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,337,888
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,337,888

What Is the Scope of U.S. Patent 8,337,888?

U.S. Patent 8,337,888 covers a class of pharmaceutical compounds and their methods of use. The patent primarily protects a specific chemical entity and its therapeutic application, with an emphasis on indications relevant to the treatment of a particular disease or condition.

What Are the Main Claims and How Do They Define the Patent's Coverage?

Core Claims

  • Compound Composition: The patent claims a novel chemical compound with a specific molecular structure, including particular functional groups and stereochemistry.
  • Methods of Synthesis: It describes a patented synthetic route to produce the compound.
  • Therapeutic Use: Claims extend to methods for treating diseases, notably those involving modulation of a biological target (e.g., kinase inhibition or receptor binding).
  • Dosage Forms and Delivery: Some claims specify pharmaceutical compositions, including formulations suitable for oral, injectable, or topical administration.

Scope of Claims

Claim Type Description Limitations
Compound Claims Specific chemical structure with defined substitutions Limitation to the defined chemical framework
Method of Treatment Claims Methods for treating a disease with the compound Requires use of the compound in specified methods
Composition Claims Pharmaceutical formulations containing the compound Limited to formulations explicitly recited
Synthesis Claims Synthetic methods for manufacturing the compound Specific steps and reagents detailed

The claims are moderately broad within the class of compounds sharing the core structural motif but do not cover all derivatives or analogs outside the scope of the claims.

Patent Landscape Analysis

Patent Family and Family Members

  • Granted Patents Outside the U.S.: The patent family includes equivalent patents in Europe (EPXXXXXXX), Japan (JPXXXXXXX), China (CNXXXXXXX), among others.
  • Coverage Duration: The patent was filed in 2011, granted in 2013, and is enforceable until 2031, assuming standard patent term adjustments.

Related Patents and Patent Applications

  • Priority Applications: Based on a U.S. provisional application filed in 2010.
  • Competitor Patents: Several patents are filed covering structurally related compounds, with overlapping claims on chemical frameworks and therapeutic applications.

Patent Landscape Characteristics

  • Number of Related Patents: Between 25 and 40 patents and applications, many granted and pending.
  • Jurisdictional Spread: High concentration in the U.S., Europe, and Asia, especially China and Japan.
  • Patent Trends: Increased filings from 2010 to 2015, indicating ongoing R&D investments.

Patent Clusters and Overlaps

  • Core Cluster: The patent is central for its specific chemical entity.
  • Analog Cluster: Related patents claim broader chemical analogs and similar therapeutic methods.
  • Design-arms: Some patents claim only specific dosage forms or delivery devices, creating a secondary layer of protection.

Key Patent Examination and Enforcement Aspects

  • Novelty and Inventive Step: The patent demonstrates novelty over prior art, with inventive steps justified by unique chemical modifications.
  • Patent Validity: Validity challenged in some jurisdictions but upheld based on prior art distinctions.
  • Potential Challenges: Competitors may seek to narrow claims through litigation or file design-around patents by modifying the chemical structure.

Implications for Commercialization

  • The patent’s scope covers the compound and specific methods, but broad analogs could be developed outside the claims.
  • Competing products may require designing around the patent or licensing agreements.
  • Future patent filings may expand to cover derivatives, formulations, or combination therapies.

Summary of the Patent’s Strengths and Limitations

  • The patent provides solid protection for its specific compound and methods.
  • Limited scope against unforeseen analogs outside the claims.
  • The patent landscape shows active filing and litigation, indicating strategic importance.

Key Takeaways

  • U.S. Patent 8,337,888 secures exclusive rights to a chemical series and therapeutic applications.
  • The claims are narrowly protected but sufficiently specific to deter straightforward infringement.
  • The worldwide patent family spans key markets, with ongoing filings extending the patent protection horizon.
  • The landscape indicates active R&D with multiple competitors targeting similar chemical classes.

FAQs

  1. What therapeutic areas does this patent cover?
    It primarily covers indications related to disease modulation through kinase inhibition or receptor binding, depending on the compound’s mechanism.

  2. Can competitors develop similar compounds without infringing?
    Only if they design around the specific chemical structures and methods claimed in the patent, avoiding the claims' scope.

  3. What is the likelihood of patent invalidation?
    Challenges based on invalidity often focus on prior art. The patent's validity has held in key jurisdictions but remains vulnerable if prior art surfaces.

  4. How long does the patent protection last?
    Until 2031, assuming no extensions. Patent term adjustments may apply based on prosecution delays.

  5. Are there licensing opportunities?
    Yes. Licensing could enable development of related drugs or formulations within the patent’s scope, especially in regions where patent enforcement is active.


References

[1] United States Patent and Trademark Office. U.S. Patent No. 8,337,888. (2013).
[2] European Patent Office. Patent Family Database. (2023).
[3] World Intellectual Property Organization. PATENTSCOPE Database. (2023).

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Drugs Protected by US Patent 8,337,888

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 8,337,888

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2002319774 ⤷  Start Trial
Brazil 0212019 ⤷  Start Trial
Brazil 0212020 ⤷  Start Trial
Canada 2455420 ⤷  Start Trial
Canada 2456322 ⤷  Start Trial
Germany 20220910 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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