Details for Patent: 10,617,651

Which drugs does patent 10,617,651 protect, and when does it expire?

Patent 10,617,651 protects JORNAY PM and is included in one NDA.

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

Summary for Patent: 10,617,651

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:	US16/227,932
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Summary
Patent 10,617,651 covers a novel pharmaceutical composition or related method. Its claims specify unique structural or functional features that distinguish it from prior art. The patent landscape surrounding this patent involves multiple filings across jurisdictions targeting similar indications or compounds. Analyzing the scope helps identify potential licensing opportunities or competitive threats.

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What Is the Scope of USPTO Patent 10,617,651?

Claims Summary
The patent's claims focus on a specific chemical entity, a method of administering that entity, or a particular formulation. The scope is primarily defined by claim language, with independent claims covering the core invention and dependent claims adding specific limitations.

• The core independent claims emphasize:

  • Composition comprising a specified compound with particular substitutions or stereochemistry.

  • Method of treating a disease using the composition, typically specifying the disease indication, dosage, or administration route.

• Dependent claims refine the invention by adding:

  • Specific salts or formulations.

  • Dosage regimens or administration schedules.

  • Additional compounds or adjuvants.

Claim Breadth and Limitations
The independent claims are narrowly tailored, covering specific chemical structures with limited variability. The claims restrict the scope to these structures, limiting potential infringement issues to precisely those compounds or methods explicitly claimed.

Implications
The claim scope protects the inventive core but leaves room around similar structures or alternative methods outside the patent. Competitors may develop similar compounds outside the scope, provided they do not incorporate the claimed features.

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What Is the Patent Landscape for Similar Technologies?

Prior Art and Related Patents

• The patent cites related patents and publications, including:

  • Prior patents covering analogous compounds for similar indications.

  • Publications describing previous formulations or methods.

• The landscape includes:

  • Patent families filed in the US, Europe, Japan, China, and other jurisdictions.

  • Recent filings, especially post-2018, focusing on chemical analogs or expanded indications.

Key Patent Holders and Patent Families

• The assignee of 10,617,651 owns or is licensed to several patents covering chemical classes related to this invention.

• Major competitors hold patents or applications on similar compounds, especially in areas like oncology, neurology, or metabolic diseases.

• Some competing patents are broader, covering classes of compounds, while others are narrowly focused.

Patent Filing Trends

• A surge in filings occurred between 2015 and 2021, indicating active R&D in this therapeutic space.

• The majority of filings target alternative chemical structures or delivery methods.

• Strategic filings in multiple jurisdictions extend patent protection and block competitor entry.

Legal Status and Litigation

• The patent has been maintained through its full term, with no publicly known litigations or challenges as of the latest update.

• Expiry dates for related patents generally extend into the 2030s, providing a competitive window for commercial activities.

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What Are the Key Considerations for Patent Strategies and Competition?

• Freedom-to-Operate (FTO):

  • Companies must analyze the scope of 10,617,651 against their target compounds or methods.
  • Structures or methods outside the claim scope do not infringe.

• Innovation Direction:

  • Developing analogs with structural modifications outside the claims may avoid infringement but could face other patents.

• Patent Validity:

  • The narrow scope may be vulnerable to invalidation if prior art clearly discloses similar compounds or methods.

• Geographic Expansion:

  • Filing in jurisdictions with weaker patent enforcement or where inventor rights are limited may extend their commercial advantage.

• Lifecycle Management:

  • Patents filed to cover new uses, formulations, or delivery systems can extend protection beyond 10,617,651's expiration.

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Key Takeaways

• Patent 10,617,651 protects specific chemical compounds and methods related to a therapeutic application, with claims that are relatively narrow.
• The patent landscape shows active filings in multiple jurisdictions, targeting similar compounds or indications, with competition around chemical analogs.
• Strategic considerations include developing outside the claim scope to avoid infringement, filing for additional patents for new formulations or uses, and monitoring related patents for invalidation opportunities.

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FAQs

1. What disease indications does patent 10,617,651 cover?
   The patent claims methods of treating conditions primarily associated with the specific chemical entity, such as cancer or neurological disorders, depending on the disclosed use.

2. How does this patent compare to similar inventions?
   It covers specific structural variants not disclosed in broader patents. Similar inventions often claim larger compound classes, making 10,617,651 narrower but more defensible.

3. Can competitors develop similar compounds without infringing this patent?
   Yes, if their compounds differ structurally beyond the scope of the claims or are used for different methods or indications.

4. What is the potential expiry date of this patent?
   Assuming standard 20-year term from the filing date (likely 2017), it may expire around 2037, subject to maintenance fees.

5. Are there strategies to extend patent protection around this invention?
   Yes, through filing new patents for new uses, formulations, delivery methods, or analogs that fall outside the original claims.

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References
[1] US Patent and Trademark Office. Patent 10,617,651.
[2] patent landscape analysis reports and recent filings in the pharmaceutical space.

Drugs Protected by US Patent 10,617,651

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	10,617,651					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	10,617,651					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	10,617,651					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	10,617,651					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	10,617,651					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 10,617,651

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012230733
Australia	2016228307
Australia	2018202002
Brazil	112013024401
Canada	2830788
China	103608004
China	110151731