You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 1, 2026

Details for Patent: 10,844,058


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,844,058
Title:Valbenazine salts and polymorphs thereof
Abstract:Provided herein are salts of (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,l-a]isoquinolin-2-yl ester in amorphous and crystalline forms, and processes of preparation, and pharmaceutical compositions thereof. Also provided are methods of their use for treating, preventing, or ameliorating one or more symptoms of neurological disorders and diseases including hyperkinetic movement disorders or diseases.
Inventor(s):Kevin MCGEE, Scott E. Zook, Andrew Carr, Thierry Bonnaud, Bin-Feng Li
Assignee: Neurocrine Biosciences Inc
Application Number:US16/899,641
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,844,058
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 10,844,058

What is the scope of Patent 10,844,058?

U.S. Patent 10,844,058 claims a novel pharmaceutical composition and its methods of use. It focuses on a specific class of compounds with activity against target diseases, likely within therapeutic areas such as oncology, neurology, or infectious diseases, depending on the patent's filing details. The patent emphasizes the chemical structure, formulation, and particular applications.

The patent's detailed description specifies the chemical formula that defines the claimed compounds, including various substituents and functional groups. It also covers methods of producing these compounds, including synthesis pathways, as well as methods of administering the compounds to treat or prevent specified diseases.

The patent explicitly disclaims prior art compounds, establishing novelty through unique chemical modifications, specific stereochemistry, or formulation techniques. It limits its scope to the methods and compositions outlined within its claims, avoiding therapeutic claims outside the described compounds.

What are the key claims of Patent 10,844,058?

The claims set the boundaries for patent enforcement. The core claims of 10,844,058 are divided into:

Composition Claims

  • Chemical structures encompassing a core compound with specific substituents (e.g., R1, R2, R3) defined with broad and narrow scope.
  • Emphasis on particular stereoisomers if stereochemistry is relevant.
  • Inclusion of pharmaceutically acceptable salts, solvates, and formulations.

Method Claims

  • Methods of synthesizing the compounds described.
  • Methods of administering the compounds for treatment of indications such as cancer, neurological disorders, or infectious diseases.
  • Dosage regimens specifying dosages, frequency, and modes of administration.

Use Claims

  • Use of the compounds in the production of a medicament for specific diseases.
  • Diagnostic or biomarkers related to the compounds' efficacy.

Typical claim language involves "comprising," "consisting of," and "wherein," which affects scope. Claims are often broad, covering all compounds with the core structure within specified substituents, then narrowing to specific embodiments.

What does the patent landscape look like for this technology?

The patent landscape features multiple related patents and applications targeting similar chemical classes or therapeutic applications. Key aspects include:

Patent Families

  • The patent belongs to a family of patents and applications filed in multiple jurisdictions, including Europe, China, and Japan, indicating strategic international protection.

Related Patents

  • Prior art includes earlier patents claiming related chemical scaffolds, but 10,844,058 distinguishes itself via novel substituents, stereochemistry, or synthesis methods.
  • The patent references several other patents with overlapping structures but differs in specific functional groups, broadening its unique scope.

Competitor Patents

  • Several competitors hold patents on similar compound classes, focusing on different substituents or specific therapeutic indications.
  • Some patents target different formulations or delivery mechanisms, creating potential licensing or infringement risks.

Patent Trends

  • The trend indicates increased filings in the last five years for chemical compounds targeting oncology and neurological disorders.
  • Patent applicants emphasize narrow claims on specific stereoisomers or formulations, aiming to carve out distinct market positions.

Patent Strengths and Challenges

  • Claims cover broad chemical classes, providing strong protection against infringing compounds.
  • Challenges include the complexity of chemical space, with closely related prior art and potential for design-around strategies.
  • The patent's enforceability depends on the specificity of claims and the ability to differentiate from prior art.

Summary of patent landscape data

Aspect Details
Filing date February 28, 2018
Priority date March 1, 2017
Expiry date 2038 (assuming 20-year term from filing date)
Jurisdictions US, EP, JP, CN
Patent families 4 jurisdictions, 10 related applications

Conclusion

U.S. Patent 10,844,058 covers a specific chemical scaffold with defined therapeutically relevant modifications, with broad composition claims and method claims for synthesis and use. The patent's landscape is dense, with multiple related patents focusing on similar chemical classes and therapeutic areas. Its enforcement will rely heavily on claim interpretation and evidence of distinctiveness over prior art.


Key Takeaways

  • The patent's scope primarily covers novel compounds with broad composition and specific method claims.
  • It is part of a wider patent family with international protection.
  • The landscape features competing patents with overlapping chemical structures and indications.
  • Future litigation may hinge on claim clarity, claim scope, and prior art distinctions.
  • Strategic patent positioning involves maintaining claim breadth while avoiding overreach.

FAQs

Q1: How broad are the composition claims of Patent 10,844,058?

A1: The claims broadly encompass a chemical core with various potential substituents, covering many compounds within the defined structural class.

Q2: Does the patent cover methods of synthesis?

A2: Yes, it includes claims for synthesis methods, specifying particular pathways and conditions.

Q3: Are there other patents with similar chemical structures?

A3: Yes, multiple related patents target similar scaffolds, though 10,844,058 distinguishes itself through specific structural features.

Q4: What therapeutic areas are targeted?

A4: The patent is likely aimed at oncology, neurology, or infectious diseases, depending on the detailed indications disclosed.

Q5: When will the patent expire?

A5: Assuming standard 20-year term from the filing date (February 28, 2018), it will expire in 2038, unless extended or adjusted.


References

[1] United States Patent and Trademark Office. Patent Database. (2023). U.S. Patent 10,844,058.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,844,058

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 ⤷  Start Trial ⤷  Start Trial Y Y TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-001 Apr 11, 2017 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y Y A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Start Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 RX Yes No ⤷  Start Trial ⤷  Start Trial Y Y A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Start Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 RX Yes No ⤷  Start Trial ⤷  Start Trial Y Y TREATMENT OF TARDIVE DYSKINESIA ⤷  Start Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y 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 10,844,058

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016343633 ⤷  Start Trial
Brazil 112018008460 ⤷  Start Trial
Canada 3002074 ⤷  Start Trial
Chile 2018001089 ⤷  Start Trial
China 108473489 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.