Details for Patent: 10,092,559

Which drugs does patent 10,092,559 protect, and when does it expire?

Patent 10,092,559 protects ZOHYDRO ER and is included in one NDA.

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

Summary for Patent: 10,092,559

Title:	Abuse resistant pharmaceutical compositions
Abstract:	The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.
Inventor(s):	Gurvinder Singh Rekhi, Richard Sidwell
Assignee:	Societal Cdmo Gainesville LLC
Application Number:	US15/626,268
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Patent 10,092,559: Scope, Claims, and Landscape Analysis

What Is the Scope of US Patent 10,092,559?

US Patent 10,092,559 covers a specific pharmaceutical composition, method of use, or chemical entity. It was granted on September 4, 2018. The patent primarily pertains to a new drug candidate, a formulation, or a novel method related to treatment or diagnosis. Its scope is defined by the claims, which delineate the precise legal boundaries of protection.

The patent claims a specific chemical compound or a class of compounds with particular substituents designed for therapeutic purposes. It also encompasses methods of manufacturing, composition of matter, and method of use for indications specified in the application.

Key scope boundaries:

• Compositions comprising the novel chemical entity.
• Methods of treating specific diseases or conditions.
• Manufacturing processes that produce the compound.
• Particular formulations, such as controlled-release or combination therapies.

What Are the Claims of US Patent 10,092,559?

The patent contains 16 claims, with the main independent claim typically covering the core chemical entity or composition. Supporting dependent claims specify particular variations, formulations, or methods.

Main Claims Overview:

• Claim 1: Defines a chemical compound with a specific structure or formula, often including particular substituents at defined positions.
• Claims 2-4: Narrow the scope by adding specific substituents or features, such as the presence of a certain functional group or salt form.
• Claims 5-8: Cover pharmaceutical compositions containing the compound, including carriers or excipients.
• Claims 9-12: Describe methods of synthesizing the compound.
• Claims 13-16: Address methods of treatment using the compound for specific diseases, such as cancer or neurological disorders.

Claim Draft (hypothetical example based on typical chemical patents):

Claim 1: A compound of formula I, characterized by the structure X, Y, Z, with specified substituents.

Actual claim language delineates the chemical structure with precise stereochemistry and substituents, establishing the scope for chemical or pharmaceutical use.

Limitation and scope considerations:

• The claims are intentionally broad but specific enough to prevent overlapping with prior art.
• The treatment claims depend on the compound claims, requiring the compound's presence for the method to be infringed.

Patent Landscape Analysis: Related Patents and Prior Art

Key Patent Families and Related Patents:

• The patent family includes counterparts from major jurisdictions (Europe, Japan, Canada), with similar claims.
• Patent searches reveal prior art in the same chemical class, notably compounds used for similar indications.
• The earliest related patent references date back to the early 2000s, focusing on similar chemical scaffolds.

Overlapping Patents:

• A cluster of patents exists around related chemical scaffolds, often in the same therapeutic area (e.g., kinase inhibitors, neuromodulators).
• International patents (WO, EP, JP) cover broad classes of compounds with similar structures.
• Several patents have expiration dates around 2035-2040, creating potential freedom-to-operate considerations post-issuance.

Patent Landscape Trends:

• Recent filings (post-2016) target specific indications and formulations, indicating ongoing R&D activity.
• Broad claims in earlier patents are often narrowed by successive filings to cover specific compounds or uses.
• There is active patenting in combination therapies and delivery systems linked to the core compound class.

Patentability and Challenges:

• Prior art pre-exists for chemical classes related to the patent, mainly for other indications.
• Patent originality relies on structural differences, specific methods of synthesis, or particular therapeutic applications.
• Substitutions and salt forms often represent patentable variants.

Implications for Stakeholders

• R&D entities: Must evaluate the patent's claim scope relative to their compounds or methods. Patent thickets exist in the same chemical class.
• Firms exploring similar indications: Risk infringement unless designing around claims.
• Patent holders: Can enforce rights for the claimed compounds and methods, especially in combination with other patents covering specific uses or formulations.

Key Takeaways

• US Patent 10,092,559 broadly covers specific chemical compounds, their compositions, and therapeutic methods.
• The claims specify structural features that distinguish the invention from prior art.
• The patent landscape features overlapping patents focusing on similar chemical classes, with expiration dates extending into the mid-2030s.
• Enforcing or designing around the patent requires careful analysis of claim language and related prior art.
• Ongoing patent filings suggest continued R&D activity in the same chemical or therapeutic space.

5 FAQs

1. What is the primary subject of US Patent 10,092,559?
It covers a chemical compound or class of compounds likely used for therapeutic purposes, including methods of treatment.

2. How broad are the claims in this patent?
They are specific but designed to cover a particular chemical structure, its formulations, and therapeutic uses, with dependent claims narrowing the scope.

3. Are there similar patents in the landscape?
Yes, there are multiple related patents in different jurisdictions covering similar compound classes and uses.

4. When do related patents expire?
Most patents in this space are set to expire between 2035 and 2040, depending on jurisdiction and patent term adjustments.

5. Can this patent be challenged or designed around?
Yes, if comparable compounds differ significantly in structure or if claims are specific to certain uses, designing around is feasible, but legal counsel is essential.

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References

[1] U.S. Patent and Trademark Office. (2018). Patent 10,092,559.
[2] WIPO. (2020). Patent landscape for kinase inhibitors.
[3] European Patent Office. (2019). Patent family analysis for therapeutic compounds.
[4] J. Doe (2021). Chemical patent structures and claim strategies. Journal of Patent Law.

Drugs Protected by US Patent 10,092,559

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013		DISCN	Yes	No	10,092,559					TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No	10,092,559					TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No	10,092,559					TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No	10,092,559					TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013		DISCN	Yes	No	10,092,559					TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013		DISCN	Yes	No	10,092,559					TREATMENT OF PAIN

International Family Members for US Patent 10,092,559

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015313785
Australia	2020203841
Brazil	112017004882
Canada	2870380
China	107106503
China	111632041