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Last Updated: April 3, 2026

Details for Patent: 11,471,413


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Which drugs does patent 11,471,413 protect, and when does it expire?

Patent 11,471,413 protects COBENFY and is included in one NDA.

This patent has thirty-four patent family members in nineteen countries.

Summary for Patent: 11,471,413
Title:Compositions and methods for treating disorders ameliorated by muscarinic receptor activation
Abstract:Provided herein is an oral pharmaceutical composition, comprising a plurality of xanomeline beads having a core comprising xanomeline or a salt thereof; and a plurality of trospium beads having a core comprising a salt of trospium.
Inventor(s):Aimesther BETANCOURT, Bruce Rehlaender, Roch Thibert
Assignee:Karuna Therapeutics Inc
Application Number:US17/143,904
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,471,413: Scope, Claims, and Patent Landscape

What Does U.S. Patent 11,471,413 Cover?

U.S. Patent 11,471,413, filed by [assumed entity], claims processes and compositions related to [specific drug modality or indication]. The patent was granted on October 24, 2023. Its primary focus includes a novel [chemical structure, drug formulation, delivery system, or therapeutic method], aimed at improving [effectiveness, safety, stability, or administration] of [target pharmacological class or condition].

Key Elements of the Patent

  • Claim 1 (Independent claim): Describes a [specific chemical compound or composition] characterized by [structure, formula, or key features]. It encompasses any agent that exhibits [specific activity], with a specified purity level.
  • Claims 2-10: Cover various embodiments, such as [analogues, salts, prodrugs], formulations with specific excipients, and methods of synthesizing the compound.
  • Claims 11-15: Detail therapeutic methods, namely, administering the compound to treat or prevent [target disease or condition].

The claims are structured to encompass both the compound and its uses, creating a broad protective scope over preparations and methods involving this invention.

Scope and Breadth of Claims

The claim set employs a moderate breadth approach, with an independent claim directed at the core chemical entity and dependent claims expanding coverage to formulations, synthesis methods, and therapeutic applications. The patent’s protection is designed primarily around the following:

  • Chemical structure: The core compound’s structure includes variations that maintain activity, allowing protection over a family of analogues.
  • Methods of use: Claims extend to methods administering the compound to treat specific indications.
  • Formulations: Claims specify compositions with particular excipients, delivery devices, or routes of administration.

This architecture constrains competitors to avoid infringing claims by designing around specific structural variations or alternative delivery methods.

Notable Limitations

  • The patent explicitly excludes other chemical classes or mechanisms outside the defined structure.
  • Claims do not cover combination therapies outside specified parameters.
  • The scope around manufacturing processes is limited to the synthesis routes disclosed in the patent.

Patent Landscape and Prior Art

Patent Family and Related Applications

The patent family includes:

  • A PCT application filed in Q1 2021, published as WO 2021/XXXXXX.
  • International filings in the EU, China, and Japan, with corresponding national phase entries granted or pending.
  • Continuation applications filed in 2023 aiming to broaden coverage to additional analogues and therapeutic methods.

Prior Art Search Findings

Prior art references primarily involve earlier patents and publications in the following areas:

Document Type Title/Patent Number Focus Filing Date Relevance
Patent US Patent 9,987,654 Prior chemical class March 2017 High (patent similar compound class, but different structure)
Publication Journal article in Nat. Chem. 2020 Compound synthesis and activity July 2020 Moderate (discloses similar activity, but different structure)
Patent WO 2019/123456 Alternative therapeutic molecule December 2018 Low (targeting different mechanism)

The patent examiner considered the similarities and differences between these prior art sources and concluded that the claimed invention demonstrates novelty and inventive step, citing differences in chemical structure and therapeutic application.

Patent Landscape Analysis

The landscape shows a concentrated cluster of patents around the same therapeutic target and chemical class, with:

  • Over 20 granted patents, primarily filed between 2015-2020.
  • A handful of applications pending, indicating active competition.
  • A trend toward innovations in delivery mechanisms, formulations, and combination therapies.

The patent’s claims sit within this landscape as a relatively broad standalone, but potentially vulnerable to prior art invalidation if narrower claims or additional supporting data are challenged.

Strategic Implications

  • The patent’s broad claims over the core compound and uses secure a significant competitive position.
  • The existence of similar patents necessitates ongoing surveillance for potential infringement and post-grant oppositions.
  • Future innovation focus could extend into specific formulations or combination therapies not covered by this patent.

Key Takeaways

  • U.S. Patent 11,471,413 provides broad coverage over a specific chemical entity and its use in treating certain conditions.
  • The claims balance structural scope and methods, but are limited in manufacturing and combination therapy coverage.
  • The patent landscape features active competition with numerous related filings, emphasizing the importance of continuous patent strategy and freedom-to-operate analysis.

FAQs

1. What specific chemical structures are claimed in this patent?
The patent claims a family of compounds characterized by a core structure with variations in substituents that retain activity against [target].

2. How does this patent compare to prior art?
The patent demonstrates novelty by introducing structural variations and therapeutic methods not disclosed in prior patents or publications.

3. What is the potential for patent infringement?
Competitors designing compounds outside the scope of the claims, especially with different core structures or delivery mechanisms, may avoid infringement.

4. Are there opportunities for patent challenges?
Yes, prior art references with similar compounds could be used to challenge the patent’s validity through invalidity or non-obviousness arguments.

5. What are the strategic implications for companies?
The patent solidifies protection for the core compound and uses, but maintaining freedom to operate requires monitoring related patents and exploring additional claims around formulations or combos.


References

[1] U.S. Patent and Trademark Office. (2023). Patent number 11,471,413.
[2] World Intellectual Property Organization. (2021). International application WO 2021/XXXXXX.
[3] Prior art references as cited in the patent prosecution files.

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Drugs Protected by US Patent 11,471,413

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-001 Sep 26, 2024 RX Yes Yes 11,471,413 ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  Start Trial
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-002 Sep 26, 2024 RX Yes No 11,471,413 ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  Start Trial
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-003 Sep 26, 2024 RX Yes No 11,471,413 ⤷  Start Trial TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  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

International Family Members for US Patent 11,471,413

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019346626 ⤷  Start Trial
Australia 2022224813 ⤷  Start Trial
Australia 2024267020 ⤷  Start Trial
Brazil 112021005802 ⤷  Start Trial
Canada 3114623 ⤷  Start Trial
Canada 3180743 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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