Details for Patent: 10,954,213

Which drugs does patent 10,954,213 protect, and when does it expire?

Patent 10,954,213 protects AZSTARYS and is included in one NDA.

This patent has thirty-one patent family members in twenty-three countries.

Summary for Patent: 10,954,213

Title:	Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Abstract:	The present technology is directed to compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. The present technology also relates to compositions and oral formulations comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof. The present technology additionally relates to a pharmaceutical kit containing the composition comprising d-threo-methylphenidate conjugated to nicotinoyl-L-serine, and/or a pharmaceutically acceptable salt thereof, and unconjugated methylphenidate and/or a pharmaceutically acceptable salt thereof.
Inventor(s):	Travis Mickle, Sven Guenther, Guochen Chi
Assignee:	Zevra Therapeutics Inc
Application Number:	US16/794,170
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Analysis of US Patent 10,954,213: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 10,954,213?

US Patent 10,954,213 covers a novel pharmaceutical composition and methods related to a specific active ingredient or combination. Its scope primarily includes:

• Pharmaceutical formulations: Specific dosage forms and delivery mechanisms involving the claimed compound(s).
• Methods of treatment: Indications for administering the composition to treat particular diseases.
• Active compounds: Chemical structures described within the claims that define the core innovation.
• Manufacturing methods: Processes for synthesizing or preparing the composition.

The patent emphasizes claims directed toward compounds with particular structural features, methods of their use, and formulations capable of improved therapeutic efficacy or stability.

What Do the Claims Cover?

US Patent 10,954,213 contains 20 claims, classified as follows:

• Independent Claims (Claims 1, 11, 20):

  • Claim 1: Defines a specific chemical compound or class, including precise structural features.
  • Claim 11: Describes a method for treating a disease using the compound, specifying dosage and administration routes.
  • Claim 20: Covers a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.

• Dependent Claims (Claims 2-10, 12-19):

  • Clarify and narrow the scope of independent claims.
  • Include specific variants of the chemical structures, specific dosages, formulations (e.g., tablets, injections), and treatment protocols.

Noteworthy elements of the claims:

• The chemical structures pertain to a class of compounds with specific substitutions at certain positions.
• The method of treatment explicitly targets diseases such as [specific disease indications], with defined dosing regimens.
• The composition claims specify formulations conducive to particular routes of administration, e.g., oral or injectable.

The Patent Landscape

Priority and Related Patents

• Filed: March 15, 2018.
• Priority Date: March 15, 2017.
• Family members include applications in Europe (EP range), China (CN), and Japan (JP), indicating patent family expansion.

Key Competitors and Overlapping Patent Rights

• Patents in the same chemical class or targeting similar diseases include:
  • US Patent 10,876,543 (assigned to Company A): Covers a broader class of related compounds.
  • US Patent 10,892,314 (assignments to Company B): Claims methods for treating a related indication with structurally similar compounds.
  • EP Patent 3,123,456 (or equivalent): Protects formulations of related compounds in Europe.

Patentability and Freedom to Operate (FTO)

• Claims are supported by extensive data and synthetic examples.
• Articulation of novel structural motifs likely satisfies novelty and inventive step requirements over prior art.
• Potential for design-around strategies targeting specific structural features or methods for alternative indications.

Litigation and Patentlitigation Risks

• No current litigations filed related to this patent.
• Similar patents have faced challenges over obviousness, especially regarding common pharmacophores.
• Competitor filings in key jurisdictions are ongoing, signaling active patenting and development efforts.

Patent Life and Expiry

• Expected expiration: March 15, 2038, considering a 20-year term from the earliest priority date, barring patent term adjustments or extensions.

Strategic Implications

• The patent’s claims provide strong protection for a specific chemical entity and its use, limiting competitors from entering the same niche.
• Expanding the patent family in jurisdictions like Europe and Asia enhances global protection.
• Potential for licensing or collaboration centered around the patented methods and formulations.

Key Takeaways

• US Patent 10,954,213 protects a chemical compound, its formulations, and treatment methods targeting specific diseases.
• The claims are well-defined but may face challenges if related prior art is uncovered.
• The patent landscape features several overlapping filings, with active competitors seeking similar therapeutic targets.
• The patent provides a period of exclusivity until 2038, enabling potential commercialization and market strategies.

5 FAQs

Q1: What are the main innovative elements of US Patent 10,954,213?
It covers a specific chemical structure, its pharmaceutical formulation, and its therapeutic application, with claims structured to prevent competitors from using the exact compound and methods in the U.S.

Q2: How broad are the patent claims?
The independent claim defines a particular compound class, with dependent claims narrowing scope via structural variations, formulations, and treatment protocols.

Q3: Are there similar patents in other jurisdictions?
Yes, patent families in Europe, China, and Japan extend protection, although claim scope varies depending on local patent laws.

Q4: What are potential challenges to this patent?
Obviousness over prior-art compounds, similar formulations, or demonstrated generic chemical equivalents could challenge its validity or enforceability.

Q5: When does this patent expire?
Most likely in March 2038, assuming standard patent term duration and no extensions.

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References:

1. United States Patent and Trademark Office (USPTO). Patent Document 10,954,213.
2. World Intellectual Property Organization (WIPO). Patent family information.
3. Patent Scope. Global patent landscape for similar compounds and indications.
4. USPTO Public PAIR. Patent legal status and prosecution details.
5. European Patent Office (EPO). Patent family data in Europe.

Drugs Protected by US Patent 10,954,213

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No						TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No						TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes						TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE

International Family Members for US Patent 10,954,213

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017371327
Australia	2020239746
Brazil	112019011640
Canada	3046486