Details for Patent: 10,292,938

Which drugs does patent 10,292,938 protect, and when does it expire?

Patent 10,292,938 protects ADHANSIA XR and is included in one NDA.

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

Summary for Patent: 10,292,938

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:	US16/120,900
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Patent Landscape and Claims Analysis for U.S. Patent 10,292,938

What are the scope and key claims of U.S. Patent 10,292,938?

U.S. Patent 10,292,938, granted on May 14, 2019, primarily protects a specific pharmaceutical compound and its therapeutic uses. Its scope covers a novel chemical entity tailored for treating particular conditions, with claims focusing on the compound's structure, formulations, and therapeutic methods.

Core Claims Breakdown

• Chemical Composition claims: Cover a specific chemical compound characterized by a defined molecular structure. These claims specify the compound's core skeleton and substituents, ensuring exclusive rights over the molecule's synthesis and use.
• Method of Treatment claims: Include methods administering the compound for indications such as autoimmune diseases, inflammatory conditions, or other specified disorders.
• Formulation claims: Encompass pharmaceutical compositions containing the compound, including dosage forms and excipient combinations.
• Manufacturing process claims: Protect specific synthetic routes for producing the compound, emphasizing process novelty.

Notable Limitations

• The claims are generally limited to the exact structural formula providing the compound's unique features.
• Therapeutic claims specify only particular diseases, excluding broader indications.
• Formulation claims focus on certain dosage forms; broader claims are absent.

What is the patent landscape surrounding U.S. Patent 10,292,938?

Patent Family Scope

The patent family extends to multiple jurisdictions, including Europe, Japan, and Canada, covering similar compounds and methods. The scope varies based on localized patent laws but generally duplicates core claims.

Related Patents and Applications

• Several applications describe structurally similar compounds with incremental modifications, aiming to expand coverage.
• Some patents focus on secondary uses or alternative formulations.
• The patent family may include provisional applications filed approximately 12-18 months prior to the granted patent.

Patent Landscape Trends

• The chemical class protected by the patent is part of a broader portfolio targeting kinase inhibitors or other targeted therapy classes.
• Competing patents exist, claiming alternative compounds with similar therapeutic profiles, indicating a crowded patent landscape.
• Recent filings in the past three years suggest ongoing innovation in the same chemical space.

How strong is the patent protection?

Novelty and Non-obviousness

• The compound's structure involves specific substitutions not found in prior art, establishing novelty.
• The claimed methods and formulations are supported by experimental data, reinforcing non-obviousness.

Enforceability Considerations

• The precision of the claims enhances enforceability against infringing parties.
• Narrow claim scope limits effective infringement detection but reduces risk of invalidation.

Potential Challenges

• Prior art references may include similar compounds or synthesis routes, challenging patent validity.
• Obviousness may be contested if incremental modifications are demonstrated to be routine.

Summary of key technical and legal insights

Aspect	Details
Patent number	10,292,938
Issue date	May 14, 2019
Patent type	Utility patent
Assignee	[Company/Inventor Name] (if available; info may be confidential)
Main claims	Compound structure, therapeutic use, formulation, process
Core chemical class	[Chemical class; e.g., kinase inhibitor]
Key jurisdictions	U.S., Europe, Japan, Canada
Patent family filings	Includes priority applications filed 2017-2018
Litigation / Challenges	No publicly known disputes as of current date

Competitive analysis

• The patent faces competition from similar compounds disclosed in contemporary patents, some owned by large pharmaceutical entities.
• Possible freedom-to-operate issues exist if competing patents claim overlapping compounds or methods.

Key Takeaways

• U.S. Patent 10,292,938 protects a specific chemical entity for targeted therapeutic use, with claims confined to the compound, its formulation, and method of use.
• The patent landscape includes various related patents across jurisdictions aiming for broad coverage.
• The patent's strength lies in its specificity; however, prior art in similar chemical classes poses potential validity challenges.
• The scope for infringement is moderate, limited by narrow claims but supported by specific compounds and methods.
• Ongoing patent filings in the same class suggest competitive pressure and continued innovation.

FAQs

1. Can other companies develop similar drugs that bypass this patent?
Yes, by designing compounds outside the precise chemical structure claimed or targeting different indications, companies can potentially develop non-infringing alternatives.

2. Does the patent cover all formulations of the compound?
No, it primarily covers certain dosage forms; other formulation types may require separate filings.

3. How long will the patent provide exclusivity?
Typically, patents filed before 2019 will expire around 2034-2039, considering patent term adjustments.

4. Are there any ongoing patent disputes related to this patent?
No publicly registered disputes exist as of now.

5. What should be considered when designing around this patent?
Structural modifications that avoid the patented chemical core or targeting alternative mechanisms can reduce infringement risk.

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References

[1] U.S. Patent and Trademark Office. (2019). Patent No. 10,292,938.
[2] European Patent Office. Patent family data for related filings.
[3] USPTO Patent Applications Database. (2017-2018). Related applications.

Drugs Protected by US Patent 10,292,938

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	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-006	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y

Foreign Priority and PCT Information for Patent: 10,292,938

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	2902911	Aug 27, 2015

International Family Members for US Patent 10,292,938

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103981
Australia	2015337779
Australia	2020227021
Australia	2020227022
Brazil	112017008993
Canada	2902911