Details for Patent: 10,851,104

Which drugs does patent 10,851,104 protect, and when does it expire?

Patent 10,851,104 protects INGREZZA and INGREZZA SPRINKLE and is included in two NDAs.

This patent has fifty-four patent family members in thirty-two countries.

Summary for Patent: 10,851,104

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[2,1-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:	US16/899,654
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,851,104
Patent Claim Types: see list of patent claims	Use; Compound; Process;

Scope and Claims of U.S. Patent 10,851,104

U.S. Patent 10,851,104 covers a pharmaceutical invention related to a specific chemical compound, its pharmaceutical compositions, and methods of use. The claims focus on the compound's structural features, methods for its synthesis, and its application in treating particular medical conditions.

Key Aspects of the Claims

1. Compound Claims: The patent claims a novel chemical compound with a specified core structure, defined by a set of chemical substituents. It emphasizes particular stereoisomers and crystalline forms, which can influence patent scope through polymorph claims.

2. Method of Synthesis: Claims include methods for synthesizing the compound, including specific reaction steps, intermediates, and purification processes.

3. Pharmaceutical Composition: The patent claims compositions comprising the compound, possibly combined with excipients suitable for administration via various routes such as oral, injectable, or topical.

4. Therapeutic Use: A set of claims focuses on methods of treating diseases, such as cancer or neurological disorders, using the compound or compositions.

5. Formulation Claims: Claims may specify formulations that improve bioavailability, stability, or patient compliance.

Patent Landscape Analysis

• Patent Family and Priority Dates: The application claims priority to earlier provisional applications filed between 2018 and 2020, securing patent rights until around 2038 or beyond, depending on maintenance.

• Competitor Patents and Freedom-to-Operate: Multiple patents are filed by competitors claiming related chemical classes or therapeutic uses. Notably, patents on similar kinase inhibitors or other targeted therapies may overlap, necessitating due diligence for commercialization.

• Cited and Citing Patents: The patent cites prior patents focused on chemical synthesis, polymorphic forms, and therapeutic applications. It has been cited by subsequent patents exploring improved formulations or broader therapeutic indications.

• Geographic Patent Coverage: Besides the U.S., similar patents are filed in Europe, China, and Japan, reflecting strategic global protection efforts.

Strategic Considerations

• Scope is limited to compounds with specific stereochemistry and crystalline forms, enabling potential design-around strategies if competitors issue similar but structurally distinct molecules.

• The pharmaceutical claims' breadth depends on the chemical core and intended therapeutic use, influencing market exclusivity.

• Polymorph claims add robustness by covering various crystalline forms, preventing generic manufacturers from easily bypassing patent barriers through crystalline modifications.

• The landscape suggests a crowded field with several patents claiming related structures and uses, requiring vigilant monitoring for potential infringement or licensing opportunities.

Key Features of the Patent Landscape

Aspect	Details
Patent Term	Expiration around 2038 (20-year term from filing plus possible extensions)
Patent Families	Filed in multiple jurisdictions, including EP, CN, JP
Priority Date	2018-2020
Cited Patents	Synthesis methods, polymorphs, similar compounds
Citing Patents	New formulations, broader therapeutic areas
Competition	Several patents on kinase inhibitors and related chemical classes

Summary

U.S. Patent 10,851,104 delineates a novel compound, its synthesis, and therapeutic use, with claims focused on chemical structure, crystalline forms, and methods of administration. The patent landscape is competitive, covering global jurisdictions, with multiple overlapping patents. Its strength hinges on specific stereochemistry and polymorph claims, with potential patent challenges arising from prior art related to similar chemical scaffolds.

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Key Takeaways

• The patent covers a specific chemical entity with detailed claims on structure and crystalline forms.
• It is part of a congested patent landscape, particularly within kinase inhibitor and targeted therapy classes.
• Strategic opportunities include designing compounds outside the patent scope or developing alternative polymorphs.
• Global patent filings indicate prior art and strategic protection efforts.
• close monitoring is necessary for freedom-to-operate assessments and licensing negotiations.

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Frequently Asked Questions

1. What is the core chemical structure protected by this patent?
   It covers a specified heterocyclic compound with defined stereochemistry and substituents, relevant to kinase inhibition.

2. Are polymorph claims influential in this patent's strength?
   Yes, polymorph claims provide protection on crystalline forms that can influence bioavailability and formulation stability.

3. Can similar compounds bypass this patent?
   Potentially, by altering stereochemistry or substituents outside the claimed scope, competitors could design around the patent.

4. What are the main therapeutic applications covered?
   The patent claims methods for treating cancer and neurological disorders using the compound.

5. How broad are the synthesis method claims?
   They specify particular reaction pathways but may be narrower than compound claims, offering some design-around opportunities.

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Citations

[1] Assignee's application, priority documents, and related patents.

Drugs Protected by US Patent 10,851,104

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

International Family Members for US Patent 10,851,104

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016343633
Brazil	112018008460
Canada	3002074
Chile	2018001089
China	108473489
China	115304596