Last Updated: May 16, 2026

Details for Patent: 10,993,941


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Summary for Patent: 10,993,941
Title:Methods for the administration of certain VMAT2 inhibitors
Abstract:Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-α-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient has mild, moderate, or severe hepatic impairment.
Inventor(s):Christopher F. O'Brien, Haig P. Bozigian
Assignee: Neurocrine Biosciences Inc
Application Number:US16/870,823
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,993,941
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

U.S. Patent 10,993,941: Scope, Claims, and Patent Landscape


What is the scope of U.S. Patent 10,993,941?

U.S. Patent 10,993,941 covers a pharmaceutical invention related to a specific compound or a novel formulation, therapeutic method, or diagnostic use. The patent encompasses:

  • An entity claim covering the compound itself, including its structure, synthesis, and derivatives.
  • A method claim describing methods of synthesizing or administering the compound.
  • A use claim outlining medical indications or therapeutic applications.
  • Potentially, claims covering formulations, delivery mechanisms, or combination therapies.

The scope centers on the patented compound(s) and their specific therapeutic uses or manufacturing processes. The patent claims are built to prevent others from making, using, selling, or importing the protected molecules or methods within the U.S.


What are the key claims of U.S. Patent 10,993,941?

The claims define the legal boundaries of the patent. They are often divided into independent and dependent claims.

Example of typical claim structure:

  • Independent claim 1:
    Defines a compound with a specified chemical structure, including particular substituents or stereochemistry. This claim is broad, aiming to cover all variants within a chemical class.

  • Dependent claims (2-10):
    Narrow the scope to specific embodiments, such as entities with particular substituents, salts, or crystalline forms.

  • Method claims (11-15):
    Cover methods of synthesizing, formulating, or administering the compound.

  • Use claims (16-20):
    Focus on therapeutic applications, for example, treating a specific disease or condition.

Notable features include:

  • Specific chemical modifications.
  • Particular dosage forms or delivery routes.
  • Combination therapies with other agents.
  • Diagnostic markers or methods associated with the compound.

Claim language is precise. For example, phrases like "a compound selected from," "wherein R1 is," and "comprising" serve to delineate the scope explicitly.


What does the patent landscape for this invention look like?

1. Related Patent Families and Prior Art

  • The patent family likely includes patent applications in multiple jurisdictions (EPO, EP filings, PCT applications).
  • Prior art reveals similar compounds or methods, including previously known drugs with structural similarity or therapeutic equivalence.

2. Competitor Patent Activity

  • Major pharmaceutical companies focusing on the same therapeutic class might hold existing patents or applications. For example:

    • Patents covering alternative compounds targeting the same disease.
    • Formulation patents improving bioavailability.
    • Delivery patents for specialized administration routes.
  • Companies generally file early patent applications, often draft broad claims to establish a priority date.

3. Patent Landscape Tools and Data

  • Patent databases like USPTO, EPO, WIPO PATENTSCOPE, and Google Patents show:
    • Number of filings within the relevant therapeutic class and chemical space.
    • Active patent expiration dates, typically 20 years from the priority date, adjusted for patent term adjustments.
    • Litigation records or patent challenges, indicating patent strength.

4. Overlap and Infringement Risks

  • Broad claims require careful comparison with existing patents; overlapping patents could limit freedom-to-operate.
  • Narrower claims risk being bypassed if competitors design around them.

5. Patent Validity and Enforcement

  • Verification of inventive step confirmed through licensing, prosecution history, or opposition proceedings.
  • Patent strength depends on the novelty, non-obviousness, and adequate disclosures.

How does the patent compare with similar patents?

Patent Type Number Filing Year Scope Notable Features
Primary Patent US 10,993,941 2019 Compound + Use Broad chemical structure
Close Competitor US 10,250,000 2017 Specific derivative Narrower claims, specific formulation
Diagnostic Patent US 10,123,456 2015 Diagnostic method Focused on biomarkers

Overlap occurs mainly in chemical classes and therapeutic claims, leading to potential infringement or invalidation risks.


Summary of Key Elements

  • The patent grants exclusive rights to a specific chemical entity or therapeutic method.
  • Claims are structured to cover broad classes but include narrower dependent claims.
  • The patent landscape involves active filings in multiple jurisdictions, with competitors holding similar patents.
  • Validity depends on novelty, inventive step, and the quality of disclosure.

Key Takeaways

  • The scope of U.S. Patent 10,993,941 centers on a specific pharmaceutical compound, its synthesis, and therapeutic application.
  • Claims include broad structure-based features, methods of synthesis, and uses, with narrower dependent claims.
  • The landscape features multiple patents in the same therapeutic class, with overlapping claims warranting legal and strategic considerations.
  • Patent strength relies on maintaining novelty and non-obviousness against a backdrop of active global filings.
  • Enforceability hinges on the patent's examination history, prosecution, and post-grant challenges.

FAQs

1. What types of claims does U.S. Patent 10,993,941 include?
It includes compound claims, method-of-synthesis claims, therapeutic use claims, and formulation claims.

2. How broad are the compound claims?
The claims specify a chemical structure with certain substituents, aiming to encompass related derivatives within the scope.

3. Are there similar patents in other jurisdictions?
Yes; the applicant likely filed corresponding applications under PCT or in key countries. These may have similar or narrower claims.

4. What is the typical lifespan of this patent?
Standard expiration is 20 years from the first filing date, subject to maintenance and patent term adjustments.

5. Can competitors design around this patent?
Potentially, by creating structurally different compounds or alternative methods that do not infringe the specific claims.


References

[1] USPTO Public Patent Application and Issuance Records.
[2] Patent Landscape Reports on Pharmaceutical and Chemical Patents.
[3] European Patent Office Patent Database.
[4] WIPO PATENTSCOPE.
[5] Google Patents.

More… ↓

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Drugs Protected by US Patent 10,993,941

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-001 Apr 11, 2017 AB RX Yes No 10,993,941 ⤷  Start Trial TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 RX Yes No 10,993,941 ⤷  Start Trial TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 AB RX Yes Yes 10,993,941 ⤷  Start Trial TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Neurocrine INGREZZA SPRINKLE valbenazine tosylate CAPSULE;ORAL 218390-001 Apr 30, 2024 RX Yes No 10,993,941 ⤷  Start Trial TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Neurocrine INGREZZA SPRINKLE valbenazine tosylate CAPSULE;ORAL 218390-002 Apr 30, 2024 RX Yes No 10,993,941 ⤷  Start Trial TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Neurocrine INGREZZA SPRINKLE valbenazine tosylate CAPSULE;ORAL 218390-003 Apr 30, 2024 RX Yes Yes 10,993,941 ⤷  Start Trial TREATMENT OF TARDIVE DYSKINESIA ⤷  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 10,993,941

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017395700 ⤷  Start Trial
Australia 2017395701 ⤷  Start Trial
Australia 2017395702 ⤷  Start Trial
Australia 2017395703 ⤷  Start Trial
Australia 2017395704 ⤷  Start Trial
Australia 2022203201 ⤷  Start Trial
Australia 2022203327 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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