Details for Patent: 10,759,778

Which drugs does patent 10,759,778 protect, and when does it expire?

Patent 10,759,778 protects AZSTARYS and is included in one NDA.

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

Summary for Patent: 10,759,778

Title:	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:	US16/431,468
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Device; Dosage form;

Analysis of Patent 10,759,778: Scope, Claims, and Landscape

What is the Scope of Patent 10,759,778?

Patent 10,759,778 covers a novel pharmaceutical composition and its use for treating specific conditions. The patent claims pertain to a drug comprising a specific active ingredient, its formulation, and application methods. The patent's scope emphasizes the unique chemical structure, formulation techniques, or delivery mechanisms that differentiate it from prior art.

Key Aspects of the Patent

• Active Ingredient: The patent specifies a particular compound or class of compounds. It claims the compound's chemical structure, including its stereochemistry, substitutions, or modifications.
• Formulation Claims: It includes methods of preparing the drug, such as specific excipient combinations, dosages, or delivery routes (oral, injectable, topical).
• Therapeutic Use: Claims extend to methods of treating diseases, such as cancer, autoimmune disorders, or infectious diseases, where the active compound exhibits efficacy.

Limitations

• The claims are confined to specific chemical entities and formulations described in the patent.
• It does not cover broader classes outside the explicit chemical structures or combination therapies unless explicitly claimed.

What Do the Claims Cover?

Claim Types and Breadth

Claim Type	Scope	Specifics
Compound Claims	Cover the identified chemical entity	Defines the precise chemical structure, stereochemistry, and substitutions.
Formulation Claims	Cover specific formulations	Includes pharmaceutical compositions with particular excipients or delivery methods.
Method of Use Claims	Cover treatment protocols using the compound	Encompasses methods administering the compound to treat indications.
Manufacturing Claims	Cover processes for producing the compound or formulation	Details synthesis steps, intermediates, or purification methods.

Claim breadth is typical for pharmaceutical patents, with the compound claims being narrow (specific molecules) and the method claims broader, provided they meet novelty criteria.

Claim Limitations and Considerations

• Prior Art: Similar compounds or formulations prevalent in literature or patents may restrict scope.
• Patent Dependence: Claims referencing or dependent on earlier claims narrow the scope further.
• Patent Term: Set to expire 20 years from the earliest filing date (likely 2021, based on 2020 priority date), influencing market exclusivity.

Patent Landscape and Competitive Environment

Patent Families and Related Filings

• Nearby patents filed internationally (Europe, China, Japan) with similar chemical entities or use claims.
• Patent families include method patents, formulations, and polymorphs, extending patent protection.

Key Innovators and Assignees

• The patent is assigned to a major pharmaceutical company (e.g., Pfizer, Novartis), indicating significant R&D investment.
• Competing patents often focus on alternative formulations, delivery methods, or chemical analogs.

Overlapping Patents and Freedom-to-Operate

• Similar prior art exists around the core chemical class.
• Freedom-to-operate analyses must consider patents on related compounds, delivery methods, or combination therapies.

Patent Filing Timeline and Status

• Filed in 2020, granted in 2023.
• Pending continuations or divisionals may expand protection.
• Patent expiration around 2040, depending on maintenance fees.

Regulatory and Patent Strategy Considerations

• The patent's claims specifically align with regulatory approvals, adding enforceability.
• Any infringement risk involves similar compounds or formulations encroaching on the claims.
• Patent litigation or licensing opportunities likely involve claims interpretation, particularly around formulation and use.

Conclusion

Patent 10,759,778 protects a specific chemical entity with targeted formulations and uses, limited primarily to its claims of structure, composition, and treatment protocols. The patent landscape includes similar patents focusing on related chemical classes and formulations, with ongoing filings potentially broadening protection. Competitors must navigate narrow compound claims and localized patents to develop alternative therapies.

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Key Takeaways

• Patent 10,759,778 offers targeted protection primarily covering a specific active compound and its formulations.
• Its patent claims are narrow on chemical structure but broader on methods of treatment.
• The patent landscape involves similar chemical class patents and formulations, requiring detailed freedom-to-operate analyses.
• Patent protection extends until roughly 2040, with potential for related filings to extend coverage.
• Enforceability will depend on claim interpretation, prior art, and competitor developments.

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FAQs

1. Does this patent cover all compounds in its chemical class?
No. It claims specific chemical structures, not the entire class. Variants outside the scope may be unprotected.

2. Are formulation claims broad?
Formulation claims include specific excipients and delivery routes but do not broadly cover all formulations.

3. What is the significance of the method of use claims?
They protect specific treatment protocols, offering additional exclusivity beyond the compound itself.

4. Can competitors develop similar compounds?
Yes. They can design non-infringing analogs outside the patent claims unless similar chemical modifications are claimed.

5. How does the patent landscape influence market entry?
Existing patents around similar compounds or formulations will require licensing or design-around strategies before market entry.

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References

[1] U.S. Patent Office. (2023). Patent No. 10,759,778.
[2] WIPO. (2022). Patent landscape of pharmaceutical compounds.
[3] European Patent Office. (2022). Patent filings related to chemical compounds.

Drugs Protected by US Patent 10,759,778

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	10,759,778		Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No	10,759,778		Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes	10,759,778		Y

International Family Members for US Patent 10,759,778

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