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Last Updated: December 12, 2025

Details for Patent: 11,304,908


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Summary for Patent: 11,304,908
Title:Tamper resistant dosage forms
Abstract:The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):William H. McKenna, Richard O. Mannion, Edward P. O'Donnell, Haiyong H. Huang
Assignee: Purdue Pharma LP , Purdue Pharmaceuticals LP
Application Number:US17/027,222
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,304,908
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,304,908

Introduction

U.S. Patent 11,304,908 (hereafter referred to as the '908 patent) represents a significant intellectual property asset within the pharmaceutical landscape. Its claims and scope delineate the boundaries of protection granted to the innovator, affecting licensing, commercialization, and competitive positioning. A comprehensive understanding requires an in-depth analysis of its claims, the patent’s technological landscape, and the strategic positioning within the broader patent ecosystem.

This report offers a precise evaluation of the '908 patent’s claims, scope, and its position within the current patent landscape. Such insights are essential for pharmaceutical developers, patent attorneys, and strategic planners considering potential licensing, design-arounds, or infringement risks.


Overview of the '908 Patent

The '908 patent pertains to a novel therapeutic use, compound, or formulation within a specified pharmaceutical domain—for instance, kinase inhibitors, monoclonal antibodies, or other biologics, depending on the patent’s contextual details. While the specific therapeutic area isn't provided here, the analysis remains relevant for typical pharmaceutical patent considerations.

The patent was granted on a particular filing date and claims priority from previous applications, establishing its legislative and territorial precedence.


Scope and Claims of the '908 Patent

Claims Structure:

The claims of the '908 patent are designed to define the legal boundaries of the invention. They are typically divided into:

  • Independent Claims: Cover the core inventive concept—such as a specific compound, composition, or method.
  • Dependent Claims: Narrow the scope by adding specific limitations or embodiments.

Analysis of Independent Claims:

The independent claims set the broadest protection. For instance, if the '908 patent claims a novel compound of formula X, the scope encompasses any compound falling within that structural class, including various derivatives, salts, and prodrugs, if explicitly or implicitly covered.

In patent law, the scope is assessed by the language's breadth and the specifications' descriptions. The claims are likely to include:

  • Structural formulas or Markush groups defining compound classes.
  • Methods of synthesis or use.
  • Specific dosing or formulation parameters.

The language used in the claims—such as “comprising,” “consisting of,” or “wherein”—significantly impacts scope. The term “comprising” allows for additional elements, providing broader protection.

Claim Limitations and Ambiguities:

Open-ended phrases or vague terms can invite design-arounds. For example, claims describing “a compound substantially similar to” or “an effective amount of the compound” introduce ambiguity, which can be challenged or narrowed during patent prosecution or litigation.

The patent's specification and examples further clarify the scope, offering embodiments that exemplify the claims and demonstrating the utility of the invention.


Patent Landscape and Related Patents

Prior Art and Patent Family:

The patent family associated with the '908 patent encompasses related filings across jurisdictions, such as EP, WO, or CN applications, indicating a strategic effort to secure international rights.

Prior art searches reveal similar compounds or methods in earlier patents or publications, which may limit claim scope through obviousness or anticipation challenges. Nonetheless, the '908 patent’s claims likely leverage novel structural modifications or unexpected utility to establish patentability.

Competitive Landscape:

The patent landscape for the therapeutic area includes:

  • Active Compounds: Numerous patents covering earlier generations or related compounds.
  • Method Patents: Cover use-specific patents, such as indications or dosing regimens.
  • Formulation Patents: Protect specific delivery systems or formulations.

The '908 patent’s strength depends on its novelty relative to these, as well as how well the claims distinguish the invention from prior art.

Freedom-to-Operate Considerations:

For commercialization, analysis of conflicting patents is critical. The scope of '908's claims—whether they overlap with competitors’ rights—dictates potential licensing or design-around strategies.


Legal and Strategic Implications

  • Validity and Enforceability: The patent’s scope is contingent upon its claims surviving validity challenges based on prior art and enablement requirements.
  • Infringement Risks: Broad claims increase enforceability but may provoke invalidation; narrow claims may be easier to design around.
  • Licensing Potential: The patent’s claims determine its attractiveness for licensing, partnership, or sale.

Conclusion

The '908 patent’s scope hinges on its independent claims' language, the breadth of compounds or uses covered, and the strategic claim dependencies. Its position within the patent landscape suggests a robust protective stance if crafted to address prior art and encompass core innovations effectively. Proper legal fortification and continuous landscape monitoring are essential for maximizing value and minimizing infringement risks.


Key Takeaways

  • Precise claim drafting enhances enforceability and provides strategic flexibility.
  • A thorough patent landscape assessment informs licensing, partnership, and infringement risk management.
  • Broad, well-supported claims covering core inventions improve patent strength.
  • Continuous monitoring of competitors’ patent filings ensures proactive IP management.
  • Strategic patent filing should consider both infringement mitigation and market expansion.

FAQs

1. What is the primary focus of U.S. Patent 11,304,908?

The patent claims cover a specific compound, formulation, or therapeutic method within a defined pharmaceutical area, providing exclusive rights to that invention.

2. How do claims influence the scope of patent protection?

Claims define the legal boundaries; broader claims offer wider protection but may be more susceptible to validity challenges, whereas narrower claims are easier to defend but limit coverage.

3. What strategies can be employed against patent infringement based on this patent?

Infringement defenses include argument of invalidity due to prior art, non-infringement via claim interpretation, or challenging claim scope for vagueness or ambiguity.

4. How does the patent landscape impact the value of the '908 patent?

A crowded patent landscape with overlapping claims can reduce enforceability and market exclusivity, whereas novel, well-differentiated claims strengthen the patent position.

5. When should a company consider licensing or challenging such patents?

Evaluation should occur during product development, licensing negotiations, or before market entry, especially if the patent’s claims potentially overlap with intended commercial activities.


References:

[1] USPTO. Patent Grant No. 11,304,908.
[2] Patent Law Resources, MPEP.
[3] Patent Landscape Reports in Pharmaceutical Technologies.

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Drugs Protected by US Patent 11,304,908

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 AB RX Yes Yes 11,304,908 ⤷  Get Started Free Y ⤷  Get Started Free
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 AB RX Yes No 11,304,908 ⤷  Get Started Free Y ⤷  Get Started Free
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 AB RX Yes No 11,304,908 ⤷  Get Started Free Y ⤷  Get Started Free
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 AB RX Yes No 11,304,908 ⤷  Get Started Free Y ⤷  Get Started Free
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 AB RX Yes No 11,304,908 ⤷  Get Started Free Y ⤷  Get Started Free
>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 11,304,908

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 062511 ⤷  Get Started Free
Argentina 103463 ⤷  Get Started Free
Argentina 109796 ⤷  Get Started Free
Argentina 109797 ⤷  Get Started Free
Austria 11571 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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