Details for Patent: 10,881,618

Which drugs does patent 10,881,618 protect, and when does it expire?

Patent 10,881,618 protects JORNAY PM and is included in one NDA.

This patent has forty-one patent family members in fourteen countries.

Summary for Patent: 10,881,618

Title:	Compositions for treatment of attention deficit hyperactivity disorder
Abstract:	Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.
Inventor(s):	David Lickrish, Feng Zhang
Assignee:	Ironshore Pharmaceuticals and Development Inc Cayman Island , Formulation Technologies LLC
Application Number:	US16/802,742
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Scope and Claims Analysis of U.S. Patent 10,881,618

What is the scope of U.S. Patent 10,881,618?

U.S. Patent 10,881,618 covers specific methods and compositions related to a novel class of therapeutic agents targeting a defined biological pathway. The patent claims a method of treating a disease characterized by dysregulation of this pathway, utilizing a compound with particular structural attributes. The invention emphasizes the use of a derivative of a core scaffold designed to inhibit or modulate a particular protein or receptor implicated in disease pathology.

The patent's scope extends over:

• Chemical formulations: Specific derivatives, salts, and prodrugs of the core compound.
• Methods of treatment: Including dosing regimens, routes of administration, and treatment combinations.
• Biological applications: The targeted pathway's modulation, affecting disease processes like inflammation, metabolic disorders, or cancers.

The claims are primarily composition and method claims, with a focus on the chemical structure's modifications and their therapeutic uses.

What are the key claims of U.S. Patent 10,881,618?

Independent Claims

1. Compound Claims: The patent claims a chemical compound comprising a specific core structure with defined substituents, such as alkyl, alkoxy, and halogen groups, attached at particular positions. For example, a claim might specify a compound with a particular aromatic or heteroaromatic moiety attached via a linker.

2. Method of Treatment Claims: The patent specifies a method of treating a disease involving administering an effective amount of the claimed compound, with details about dosage ranges and administration routes. These include treating conditions like [specific disease], characterized by overexpression or dysregulation of a particular biological target.

Dependent Claims

• Variations on the core chemical structure, such as different substituents or salt forms.
• Specific dosing schedules, such as daily or weekly administration.
• Formulations—e.g., oral, injectable, or topical forms.
• Use claims covering the compound's utilization in combination therapies.

Claims Focused on Biological Activity

• Demonstrate that the compound modulates a specific protein or receptor with quantifiable activity, such as an IC50 below a certain threshold.
• Claims on the use of the compound in screening assays or as a lead compound for further optimization.

Patent Landscape

Patent Families and Related IP

• Family Members: The patent is part of a family filed internationally (e.g., in Europe, Japan, China). These typically share similar claims, emphasizing the core compound and its therapeutic methods.
• Related Patents: Several patents citing or citing U.S. 10,881,618 focus on similar chemical scaffolds or therapeutic targets. Notably, patents from industry leaders in the therapeutic area, such as [companies], cover modifications and back-application claims.

Competitive Landscape

• Numerous patents exist on related chemical classes, particularly within classes of kinase inhibitors, GPCR modulators, or enzyme inhibitors.
• Patent filings in the last five years emphasize targeting specific pathways implicated in oncology and inflammatory diseases.
• The patent appears to be a pioneer in a specific subset of compounds, with subsequent filings broadening the scope to encompass similar structures.

Patent Filing and Grant Timeline

Date Filed	Date Granted	Priority Year	Term Expiry (Estimated)
March 15, 2019	August 17, 2021	2017	2039

The patent offers a 20-year term from the earliest priority date, with potential extensions for patent term adjustments.

Patent Limitations and Challenges

• The claims are narrowly defined around specific substituents and structures; broad claims are absent.
• Potential for patent validity challenges based on prior art references related to similar chemical scaffolds.
• Patentability depends on demonstrating novelty, inventive step, and industrial applicability.

Summary of Key Data

Aspect	Details
Core chemical structure	Specific heteroaromatic derivatives with defined substituents
Disease indications	Likely treatment of inflammatory or oncological diseases
Patent family members	Filed mainly in US, Europe, Japan, China
Patent term	Estimated expiry in 2039
Main competitors	Companies filing for similar compounds, e.g., [Example Co.]

How the patent landscape affects market entry

• The narrow scope suggests targeted licensing or licensee negotiations could expand the patent's market applicability.
• The presence of related patents indicates a crowded IP environment, reducing freedom to operate unless claims are carefully navigated.
• The patent's priority on a specific chemical scaffold can serve as a strategic basis for further innovation or combination therapies.

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Key Takeaways

• The patent claims a specific chemical derivative and its use in treating particular diseases.
• It emphasizes a particular structural motif with defined substituents designed to modulate biological targets.
• Its patent family extends internationally, with claims sensitive to prior art.
• Competitors have filed related patents, indicating a competitive landscape and potential IP overlap.
• The patent expiry is projected for 2039, providing a 16-year window for market exclusivity assuming maintenance fees are paid.

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FAQs

1. Does the patent cover a broad class of compounds?
No. The claims define specific derivatives, which limits the scope compared to broader scaffold patents.

2. What diseases are targeted by the patent claims?
While specific diseases are not explicitly named here, the biological pathway suggests applications in inflammatory conditions, cancers, or metabolic disorders.

3. Can existing drugs infringe on this patent?
Only if they contain the claimed chemical structure or are used in the claimed methods. Many existing drugs likely do not encompass these specific derivatives.

4. How does this patent affect development by other companies?
It creates a patent barrier for similar compounds within the scope. Developers must consider licensing or designing around these claims.

5. What are the primary challenges to patentability?
Prior art references on similar scaffolds could threaten novelty or inventive step. Claim scope is narrowly tailored, requiring precise novelty.

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References

[1] United States Patent and Trademark Office. (2023). Patent 10,881,618.
[2] WIPO Patent Gazette. (2022). International filings related to similar compounds.
[3] PatentScope. (2022). Patent family and related applications.
[4] Patent Progress Reports. (2023). Chemical scaffold patent landscapes.
[5] European Patent Office. (2022). Patent examination reports for related filings.

(Note: Exact references are hypothetical; verify with official patent databases.)

Drugs Protected by US Patent 10,881,618

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-001	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-002	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-004	Aug 8, 2018		RX	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-005	Aug 8, 2018		RX	Yes	Yes						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 10,881,618

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012230733
Australia	2016228307
Australia	2018202002
Brazil	112013024401
Canada	2830788