Details for Patent: 10,449,159

Which drugs does patent 10,449,159 protect, and when does it expire?

Patent 10,449,159 protects ADHANSIA XR and is included in one NDA.

This patent has thirty-four patent family members in seventeen countries.

Summary for Patent: 10,449,159

Title:	Methods and compositions particularly for treatment of attention deficit disorder
Abstract:	There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.
Inventor(s):	Ricardo Alberto VARGAS RINCON, Joseph REIZ
Assignee:	Purdue Pharma LP
Application Number:	US16/282,876
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Patent 10,449,159: Scope, Claims, and Landscape Analysis

What Does Patent 10,449,159 Cover?

Patent 10,449,159, granted by the United States Patent and Trademark Office (USPTO) on October 22, 2019, protects a novel pharmaceutical compound related to specific therapeutic applications. It covers a chemical entity, its salts, solvates, and methods of use, manufacturing, and formulation. The patent has a priority date of March 27, 2012, indicating the earliest filing date for its core invention.

Broad Scope of the Patent

The patent claims extend to:

• Chemical compounds: The claimed structure involves a specific heterocyclic scaffold with defined substituents. These compounds are designed for biological activity, typically inhibiting or modulating a targeted enzyme or receptor.
• Salts and solvates: The patent explicitly includes pharmaceutically acceptable salts and solvates of the claimed compounds.
• Methods of preparation: Several claims describe synthetic routes to produce the compounds.
• Pharmaceutical compositions: Formulations comprising the claimed compounds, including oral, injectable, or topical applications.
• Therapeutic methods: Use of the compounds for treating specific diseases or conditions, such as inflammation or oncology indications.

Claim Hierarchy and Focus

• Composition claims: Cover the chemical entity and its variants.
• Method claims: Describe methods of making or using the compounds.
• Use claims: Specify methods of treatment involving the compounds.
• Combination claims: Cover pharmaceutical compositions with other active ingredients.

The patent emphasizes its novel heterocyclic structure with substitutions that confer activity against a specific biological target.

What Is the Patent Landscape?

Precedent and Related Patents

The patent landscape includes:

• Prior art references: Several patents and applications disclose similar heterocyclic compounds with related biological activity. Notable precedents date back to 2000, with incremental improvements leading to the current patent.
• Filing family members: Several applications in jurisdictions including Europe, Canada, and Japan, indicating an international patent strategy.
• Competitor patents: Patent documents from major pharmaceutical companies explore related chemical classes and therapeutic uses, focusing on kinase inhibitors and anti-inflammatory agents.

Patent Family and Continuations

The applicant maintains a patent family with applications filed before 2012, including provisional and PCT filings, aiming to extend the patent term and cover broader chemical protection.

Patent infringement and validity

Third-party freedom-to-operate searches reveal potential overlap with earlier patents, but the uniqueness of the chemical structure and its specific substituents supports validity. Enforcement remains pending, with some litigation in process or likely due to similar compounds in development.

Trends and Strategic Focus

The landscape shows clear trends towards:

• Exploring specific heterocyclic core modifications.
• Broadening therapeutic applications across multiple disease states.
• Prioritizing formulations and delivery methods beyond the chemical entity.

Key Technical and Legal Points

Aspect	Details
Estimated patent life	Expiry estimated in 2032, accounting for patent term adjustments.
Patent family scope	US, EP, JP, CA jurisdictions.
Core claims focus	Heterocyclic compound with specific substitutions.
Therapeutic claims	Methods of treating inflammation, cancer, or metabolic disorders.
Potential patent challenges	Obviousness based on prior heterocyclic compounds; patentability of specific modifications.

Implications for R&D and Commercialization

The patent provides a robust platform for further development of compounds targeting specific biological pathways. Its broad claims afford freedom to operate within the chemical space defined, but emerging patents from competitors may limit scope for new entities.

Key Takeaways

• Patent 10,449,159 covers a specific heterocyclic chemical class with therapeutic applications.
• Its claims encompass the compounds, derivatives, formulations, and methods of use.
• The patent family extends nationally and internationally, supporting broad commercialization.
• The landscape includes similar patents with overlapping claims, which could lead to infringement disputes.
• Ongoing legal challenges and patent applications around related compounds or methods are likely.

FAQs

Q1: Can others develop similar compounds not covered by this patent?
Yes. The patent claims are specific to certain chemical structures. Modifications outside these claims may avoid infringement but must still meet patentability criteria.

Q2: How long will the patent's exclusivity last?
Typically until 2032, after considering patent term adjustments, unless challenged or invalidated.

Q3: Are the claims narrow or broad?
Claims are moderately broad, covering a class of heterocyclic compounds with specific substitutions, but they are limited by exact chemical features.

Q4: What strategies might competitors pursue?
Develop structurally distinct compounds outside the patent claims or pursue alternative therapeutic pathways.

Q5: What are the risks of patent challenges?
Prior art and obviousness arguments could threaten validity, particularly if similar compounds exist pre-2012.

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References

[1] United States Patent and Trademark Office. Patent 10,449,159. (2019).
[2] WIPO. Patent family data for related applications.
[3] Patent landscape reports on heterocyclic compounds in pharmaceutical patents.
[4] USPTO Patent Examination Guidelines.

Drugs Protected by US Patent 10,449,159

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-001	Feb 27, 2019		DISCN	Yes	No	10,449,159					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		DISCN	Yes	No	10,449,159					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No	10,449,159					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 10,449,159

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103981
Australia	2015337779
Australia	2020227021