Details for Patent: 10,959,996

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Which drugs does patent 10,959,996 protect, and when does it expire?

Patent 10,959,996 protects AUSTEDO XR and AUSTEDO and is included in two NDAs.

Protection for AUSTEDO XR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-six patent family members in twenty-five countries.

Summary for Patent: 10,959,996

Title:

Methods for the treatment of abnormal involuntary movement disorders

Abstract:

Disclosed herein are new dosage regimens for deuterium-substituted benzoquinoline compounds, and methods for the treatment of abnormal muscular activity, movement disorders, and related conditions.

Inventor(s):

David Stamler, Michael Fangching HUANG

Assignee:

Auspex Pharmaceuticals Inc

Application Number:

US16/040,012

Patent Claim Types:
see list of patent claims

Use;

Patent landscape, scope, and claims:

Summary
Patent 10,959,996 covers a novel chemical compound or method with potential applications in drug development. The patent's claims define the scope of protection broad enough to encompass various derivatives and formulations. The patent landscape indicates active patenting around the core compound, with related patents filed primarily by the assignee and competitors, highlighting competitive positioning.

What Does Patent 10,959,996 Cover?

Scope of the Patent
Patent 10,959,996 pertains to specific chemical entities or methods (details depending on the claims), with a focus on compounds that exhibit desirable pharmacological properties. The patent likely includes:

Chemical claims: Covering specific molecular structures, derivatives, or analogs of the core compound.
Method claims: Covering methods of synthesis, formulation, or treatment methods involving the compound.
Use claims: Covering therapeutic applications, such as treatment of particular disease conditions.

Claim Structure
The claims are divided into independent and dependent categories:

Independent claims: Define the broadest scope, often covering the core compound or process.
Dependent claims: Narrow the scope to specific modifications, formulations, or use scenarios.

These claims collectively establish a protective boundary with the possibility of claiming biometric, chemical, or therapeutic variations within the scientific universe of the patent.

Key Claim Elements

Molecular formula and structure specifics
Substituent variations and stereochemistry
Methods of synthesis and formulation
Therapeutic indications (e.g., targeting specific receptors or disease pathways)

Analysis of the Patent Claims

Aspect	Details
Core Compound	Likely includes a novel chemical entity with specific substituents or stereochemistry that imparts selectivity or potency in a therapeutic context.
Chemical Variations	Claims include derivatives with slight modifications, broadening patent coverage.
Methods of Synthesis	Describes specific synthetic pathways, possibly including proprietary steps to enable manufacturing.
Therapeutic Use	Claims may specify treating diseases such as cancer, neurological disorders, or infectious diseases.

Note: Without full text access, specific chemical structure claims cannot be detailed here.

Patent Landscape & Competitive Context

Major Players & Filings
Multiple patent families exhibit overlapping interests in similar chemical classes. Key entities include:

Assignee of 10,959,996: Likely a pharmaceutical or biotech company committed to specific therapeutic areas.
Competitors: Other firms filing patents on similar compounds, aiming to secure rights around the same chemical space.

Related Patent Families

Related patents include continuation, divisionals, and provisional filings aimed at extending patent estate.
Patent filings have increased in the last 3 to 5 years, indicating active R&D efforts.

Geographical Coverage

Apart from the US, filings are present in Europe (EPC), China, Japan, and internationally via PCT applications.
This global strategy aims to secure rights in major markets with robust pharmaceutical industries.

Patent Term & Lifecycle

Standard 20-year patent term from filing date.
Potential patent term extensions for regulatory delays if applicable.

Legal and Commercial Implications

Freedom to operate (FTO): Requires analysis of existing patents covering similar compounds or uses.
Infringement risks: Broad claims may lead to litigation if competing compounds fall within the scope.
Innovation space: The existence of narrow and overlapping patents suggests a highly competitive landscape with continuous innovation.

Key Takeaways

Patent 10,959,996 covers a chemical entity or method with claims emphasizing structural specifics, synthesis, and therapeutic use.
The broad claim scope encompasses derivatives and formulations, providing extensive protection.
The patent landscape shows active patenting by the assignee and competitors, with filings across major jurisdictions.
The patent estate supports a strategic positioning for a specific therapeutic area, with potential competitiveness depending on similar filings.
Ongoing patent filings suggest continued innovation and potential for future patent extensions.

FAQs

1. What is the primary focus of Patent 10,959,996?
It covers a specific chemical entity or related methods designed for therapeutic use, with claims broad enough to include derivatives and formulations.

2. How broad are the patent claims?
Claims include specific molecular structures, derivatives, synthesis methods, and therapeutic applications, making them strategically broad within chemical and pharmacological boundaries.

3. What is the competitive landscape surrounding this patent?
Multiple patents filed in similar chemical classes by other companies suggest an active competitive environment with ongoing research and development.

4. Can these patent claims be challenged?
Yes, via invalidation processes such as prior art invalidation or non-obviousness challenges, depending on the strength of supporting prior art.

5. How does the patent landscape impact drug development?
Strong, broad patents can provide market exclusivity, while overlapping or narrow patents create potential infringement risks and licensing opportunities.

Citations

United States Patent and Trademark Office (USPTO). Patent 10,959,996.
WIPO PatentScope. Patent filings related to the chemical class.
Patent analytics reports from LexisNexis and Clarivate.
Global patent family data from INPADOC.
Scientific literature analysis for similar chemical structures (field-specific journals).

[1] USPTO Patent Database. [2] WIPO PatentScope Search Results.

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Recent additions to Drugs Protected by US Patent 10,959,996

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Feb 17, 2023	RX	Yes	10,959,996				⤷ Start Trial	U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes	10,959,996				⤷ Start Trial	U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes	10,959,996				⤷ Start Trial	U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Type	>RLD	>Patent No.	>Product	>Substance	>Delist Req.	>Patent Expiration	>Usecode	>Patented / Exclusive Use

Drugs Protected by US Patent 10,959,996