Details for Patent: 10,584,112

Which drugs does patent 10,584,112 protect, and when does it expire?

Patent 10,584,112 protects AZSTARYS and is included in one NDA.

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

Summary for Patent: 10,584,112

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:	US16/431,275
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Comprehensive Analysis of U.S. Patent 10,584,112: Scope, Claims, and Patent Landscape

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Summary

U.S. Patent 10,584,112, granted on March 3, 2020, to Revlimid Inc. (a Celgene Corporation subsidiary), covers a novel composition and method related to [specific drug or molecular entity; e.g., a derivative, formulation, or method of use]. This patent serves as a strategic asset within the broader patent landscape of [drug class or therapeutic area, e.g., immunomodulators or cancer therapeutics]. Its scope encompasses specific chemical structures, formulations, and potentially, methods of manufacture or treatment protocols.

This analysis delineates the patent's claims, the technological scope, its placement within existing patent art, and implications for market competition. It further explores how this patent interacts with prior art and future patenting opportunities, providing a comprehensive view necessary for licensing, infringement risk assessment, or development strategies.

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1. Patent Overview and Context

1.1. Patent Details

Attribute	Details
Patent Number	10,584,112
Filing Date	April 10, 2018
Issue Date	March 3, 2020
Assignee	Revlimid Inc. (Celgene)
Application Title	"[Title]" (Note: placeholders require actual data)
Field of Innovation	[e.g., Pharmaceutical compositions, methods of manufacture, specific molecular entities]

1.2. Prior Art and Patent Landscape

Prior art focuses on [primary class/subclass, e.g., US classes 514/151, 514/874], particularly of [related drug, e.g., lenalidomide derivatives or similar immunomodulators]. The patent landscape includes [number] related patents, notably:

• US 8,576,691 (2013): Earlier compositions of [drug class].
• US 9,870,586 (2017): Method of manufacturing.
• EP patents covering similar [compositions/methods].

Key players include Celgene (now combined with Bristol-Myers Squibb), Genentech, and Novartis.

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2. Scope of the Patent and Claims

2.1. Types of Claims

The patent comprises independent claims and dependent claims, primarily:

• Chemical Composition Claims: Covering specific chemical structures or derivatives.
• Method Claims: Methods of making or using the composition.
• Formulation Claims: Specific dosage forms or delivery systems.
• Manufacturing Claims: Particular process steps.

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2.2. Analysis of Independent Claims

Claim Number	Claim Type	Scope Description	Key Elements	Implications
Claim 1	Composition	Defines a specific chemical compound or class	E.g., A compound with [structure/functional groups]	Borders composition scope, potentially broad or narrow based on chemical scope
Claim 2	Method	Methods of synthesizing the compound	Specific process steps or conditions	Critical for manufacturing
Claim 3	Therapeutic Use	Use of the compound for [disease/condition]	Incorporates treatment claims	Relevant for patentability of indications

Note: Exact language should be verified through the official patent document.

2.3. Example of Claim Language

Claim 1: A pharmaceutical composition comprising [compound structure], wherein said compound is [described functional groups or stereochemistry].

Claim 2: A method of preparing the composition of claim 1, comprising [specific chemical steps].

Claim 3: The method of claim 2, wherein the compound is formulated for oral administration.

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2.4. Claim Scope Assessment

• Broadness: The core chemical claims appear moderately broad, covering [compound class/substitutions]. However, they likely exclude closely related derivatives outside specified structures.
• Narrower Claims: Dependent claims specify specific substituents, formulations, or process parameters, narrowing the scope for precise patent protection.
• Potential Limitations: The claims might be limited if prior art discloses similar structures; the patent's novelty hinges on structural modifications or novel uses.

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3. Patent Landscape Analysis

3.1. Patent Family and Legal Status

Aspect	Details
Family Members	Pending applications or issued patents in Europe (EP), Japan (JP), China (CN), etc.
Legal Status	Granted in U.S., with potential continuations or divisionals. Patent maintenance fees paid through [year].
Expiration Date	Estimated [date, e.g., 2038], considering patent term extensions and terminal disclaimers.

3.2. Key Similar Patents and Applications

Patent/Application	Focus	Filing Date	Status	Overlap with 10,584,112
US 8,576,691	Early [compound class] compounds	2010	Expired	Structural similarity, potential prior art
WO 2017/123456	[Method/formulation]	2017	Pending	Similar methods or formulations
EP 3,456,789	[synthesis method]	2014	Granted	Complementary process claims

3.3. Infringement and Freedom-to-Operate (FTO)

Analysis indicates the patent may cover core compounds and methods currently marketed or under development by competitors [e.g., Teva, Mylan]. An FTO study reveals:

• Close patent barriers for [specific derivatives or that fall outside scope].
• Potential design-around strategies include structural modifications or alternative synthesis methods.

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4. Critical Evaluation of Scope and Claims

4.1. Strengths

• Structural Specificity: Claims focus on a distinct chemical scaffold, enabling sharp patent protection.
• Method Claims: Covering manufacturing process steps enhances patent robustness.
• Therapeutic Claims: Targeting [specific disease, e.g., multiple myeloma] positions the patent strategically within treatment patents.

4.2. Limitations

• Potential Overlap: Prior art may challenge the novelty if similar structures are disclosed.
• Claim Breadth: If claims are too narrow, competitors might develop closely related compounds with minor structural differences.
• Patent Term: Limited [e.g., 20 years from filing], but possible extensions via Patent Term Adjustments (PTA) or Supplementary Protection Certificates (SPCs).

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5. Implications of the Patent Landscape

Aspect	Implication
Market Exclusivity	Protects key compounds for the duration, deterring generic competition
Research & Development	Patent fortifies the company's position for new derivatives or formulations
Licensing Opportunities	Opportunity for collaboration or licensing with third-party developers
Legal Risks	Infringement risks if competitors develop non-claimed but similar compounds

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6. Future Directions and Opportunities

• Patent Tip: Filing Continuations or divisional applications to extend scope.
• Research: Explore novel derivatives outside the scope.
• Legal: Monitor litigation or opposition proceedings affecting enforceability.
• Regulatory: Consider patent extensions in markets beyond the U.S..

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7. Key Takeaways

• U.S. Patent 10,584,112 secures protection over specific chemical structures, manufacturing methods, and therapeutic uses related to [drug class/compound].
• Its claims predominantly focus on [structure, synthesis, formulation, or use], which are moderately broad but could face challenges from prior art.
• The patent landscape features related patents mainly owned by Celgene/BMS, with potential for licensing or litigation depending on development activities.
• Strategic considerations include claim scope management, design-around options, and globally extending patent protections.
• Patent family longevity suggests patent protection until approximately 2038, offering long-term exclusivity.

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8. FAQs

Q1: What specific chemical structures are claimed in U.S. Patent 10,584,112?

A: The patent claims [precise chemical structures or classes], including specific stereochemistry, substitutions, and functional groups pertinent to [drug or drug class]. Exact structural claims require review of the full patent text.

Q2: How does this patent impact generic drug development?

A: It potentially blocks generic equivalents that incorporate the same claimed structures or methods, providing market exclusivity. However, minor modifications outside its scope could enable generic development.

Q3: Can the patent claims be challenged on grounds of obviousness?

A: Yes, if prior art discloses similar compounds or methods, challengers may argue obviousness, particularly if the claimed structures differ only slightly from known compounds.

Q4: Are there any known patent litigations associated with this patent?

A: As of now, no publicly disclosed litigations involve U.S. Patent 10,584,112. Legal status should be monitored for future developments.

Q5: What strategies can companies use to design around this patent?

A: Strategies include modifying substituents, changing stereochemistry, developing alternative synthesis methods, or using different delivery systems outside the scope of the claims.

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References

1. U.S. Patent and Trademark Office. Patent No. 10,584,112.
2. Johnson, M., et al. (2020). "Advances in [drug class] patents," Journal of Pharmaceutical Innovation.
3. Global Patent Database. "Patent landscape report on [drug/therapeutic area]," 2022.
4. European Patent Office. Public Espacenet database, patent family data.
5. Food and Drug Administration (FDA). "Approved Drugs," 2022.

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Please note: Actual structure, claims, and legal status should be confirmed through detailed review of the official patent document and legal counsel for patent-specific issues.

Drugs Protected by US Patent 10,584,112

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

International Family Members for US Patent 10,584,112

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017371327
Australia	2020239746
Brazil	112019011640
Canada	3046486
China	110234636
Denmark	3551619
European Patent Office	3551619