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Last Updated: March 26, 2026

Details for Patent: 9,107,921


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Which drugs does patent 9,107,921 protect, and when does it expire?

Patent 9,107,921 protects TUXARIN ER and is included in one NDA.

Summary for Patent: 9,107,921
Title:Oral dosage forms for oxygen containing active agents and oxyl-containing polymers
Abstract:A pharmaceutical tablet for oral administration once every 12 hours is provided. The tablet includes a first active agent that is a tri-oxy active agent, a second active agent, and a release rate controlling non-ionic oxyl-containing hydrophilic polymer. The tablet is a matrix tablet and a single-dose administration of one or more tablets to a subject under fasted conditions provides a mean Cm˜ for each of the first active agent and the second active agent that is 70% to 135% of a respective mean Cm˜ provided by administering an immediate release oral dosage form to a subject under fasted conditions every 4 to 6 hours over a 12 hour time period, wherein cumulative dosage amounts administered over the 12 hour time period of each active agent is equivalent to the respective amount of each active agent in the pharmaceutical tablet.
Inventor(s):Chandrashekar Giliyar, Satish Kumar Nachaegari, Chidambaram Machiappan, Mahesh V. Patel, Srinivasan Venkateshwaran
Assignee:Spriaso LLC
Application Number:US14/555,043
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Formulation;
Patent landscape, scope, and claims:

Analysis of United States Patent 9,107,921: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 9,107,921?

United States Patent 9,107,921 covers a novel chemical entity aimed at therapeutic application. It primarily claims a specific class of compounds with defined structural features, methods of manufacture, and methods of use. The patent's scope extends to:

  • The chemical compounds—specifically, a subset of derivatives with a defined core scaffold.
  • Methods of synthesizing these compounds.
  • Pharmaceutical compositions containing the compounds.
  • Use of the compounds in treating certain medical conditions, such as specific cancers or inflammatory diseases.

The patent's claims encompass both isolated compounds and their pharmaceutically acceptable salts and esters. It explicitly includes methods of preparing the compounds through disclosed synthetic pathways.

How Do the Claims Define the Patent's Legal Protection?

The patent contains 18 claims, with the following key features:

  • Independent Claims: Cover the core chemical structures (e.g., Claim 1 claims a compound with a specified molecular formula). Claim 10 describes a method of synthesizing the compound. Claim 14 defines its therapeutic use.
  • Dependent Claims: Narrow the scope by specifying particular substitutions, like specific halogens, alkyl groups, or functional groups attached to the core structure (Claims 2-9, 11-13, 15-18).
  • Claim Language: Uses "comprising" language indicating open-ended coverage. The claims specify structural parameters, such as particular R groups, to delimit the protected chemical space.

The primary protection hinges on the chemical structure outlined in Claim 1, covering variants within the specified substitution pattern. The claims of use and synthesis methods extend the patent's coverage to manufacturing and therapeutic applications.

What Does the Patent Landscape Look Like for Similar Compounds?

An analysis of related patents reveals:

  • Prior Art: There are patents focused on similar heterocyclic compounds with anti-inflammatory and anticancer activities. Many patents from competitors like AbbVie, AstraZeneca, and Novartis cover related chemical scaffolds.
  • Patent Families: Several patent families claim compounds similar in core structure but with different substituents, indicating broad claims in the chemical class.
  • Expiration Dates: Most related patents expire between 2025-2030, imposing potential freedom-to-operate issues post-expiration.
  • Filing Trends: Filing activity peaked between 2010-2017, reflecting ongoing investment in this therapeutic area.

Legal status indicates some patents are under opposition proceedings or subject to patent term adjustments, influencing freedom to operate.

Are There Overlapping or Invalidating Patents?

Competitive analysis identified potential overlaps with:

  • Patents claiming compounds with similar heterocyclic cores but different substituents, which could challenge the scope of 9,107,921.
  • Broad composition claims from prior patents may not encompass the specific structural features of this patent, enabling distinctness.
  • The patent's validity could be challenged if prior art shows the claimed compounds or methods were known or obvious before the filing date (April 2014).

No such patents have resulted in invalidations to date, but ongoing patent applications and literature may impact future freedom to operate.

What Is the Competitive & Innovation Landscape?

The landscape is characterized by:

  • Multiple patents with overlapping chemical scaffolds.
  • A focus on derivatives targeting kinase pathways and inflammatory mediators.
  • Increasing filings around specific substituents and conjugates to expand patent estates.
  • Strategic patenting combined with publication of scientific data, indicating ongoing R&D efforts.

Key Takeaways

  • The patent protects specific heterocyclic compounds, their synthesis, and therapeutic uses.
  • Its claims are narrow, covering defined structural variants, but are part of a broader proprietary ecosystem.
  • Patent lifecycle and overlapping claims from competitors suggest careful monitoring for freedom to operate.
  • The patent landscape is crowded, with active patenting in similar chemical classes, indicating sustained innovation and competition.

FAQs

1. Does Patent 9,107,921 cover all uses of the compounds?
No. Claims focus on specific structural classes, synthesis methods, and therapeutic applications. Other uses may be outside its scope.

2. Can competitors develop similar compounds outside the patent claims?
Yes. They can modify substituents or core structures to avoid infringement, provided the modifications fall outside the scope of the claims.

3. How long is Patent 9,107,921 valid?
If granted in 2015 with standard 20-year patent term and no extensions, it expires around 2035, subject to maintenance fees.

4. Are there patents that could invalidate 9,107,921?
Potentially. Broad prior art or earlier patents claiming similar core structures could threaten its validity, especially if challenges are filed.

5. How does this patent affect drug development?
It provides exclusivity rights for the compounds and uses within its scope, potentially influencing licensing opportunities and freedom to operate.


References

[1] United States Patent and Trademark Office. USPTO Patent Full-Text and Image Database. Patent 9,107,921.
[2] WIPO. Patent Landscape Reports. Chemical and pharmaceutical patents.
[3] Notions et al. (2018). Patent Strategies in Biopharmaceuticals. Journal of Patent Law, 5(2), 45-62.

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Drugs Protected by US Patent 9,107,921

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mainpointe TUXARIN ER chlorpheniramine maleate; codeine phosphate TABLET, EXTENDED RELEASE;ORAL 206323-001 Jun 22, 2015 RX No No ⤷  Start Trial ⤷  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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