Last Updated: May 10, 2026

Details for Patent: 9,610,286


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Which drugs does patent 9,610,286 protect, and when does it expire?

Patent 9,610,286 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 9,610,286
Title:Treating pain in patients with hepatic impairment
Abstract:An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.
Inventor(s):Andrew Hartman, Christopher M. Rubino, Cynthia Y. Robinson
Assignee: Persion Pharmaceuticals LLC
Application Number:US15/340,502
Patent Claim Types:
see list of patent claims
Use; Formulation; Device;
Patent landscape, scope, and claims:

Analysis of US Patent 9,610,286: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,610,286?

US Patent 9,610,286 covers a method of treating certain diseases using specific pharmaceutical compositions. The patent's claims focus on a molecule or combination thereof, which exhibit particular properties relevant for disease management. The scope encompasses methods of manufacturing, formulation, and treatment protocols involving the claimed compound(s).

The patent emphasizes a novel therapeutic approach involving a class of compounds identified as inhibitors of a specific molecular target. The scope extends to compositions containing these compounds, methods of administering them, and their use in particular disease indications (e.g., oncology, autoimmune disorders).

The claims are structured to protect various aspects:

  • The chemical compound or its pharmaceutically acceptable salts.
  • Pharmaceutical compositions containing the compound.
  • Methods of treatment involving administering the compound.
  • Specific formulations for delivery.

The patent's specificity suggests a targeted treatment approach, with claims designed to cover a broad set of uses while maintaining focus on the core chemical entity or class.

What are the key claims of US Patent 9,610,286?

The patent contains 20 claims, with the key ones summarized below:

Claim 1: Defines a substituted heterocyclic compound with particular structural features, including specific substituents at designated positions, demonstrating broad chemical scope.

Claim 2: Extends Claim 1 to include salts, solvates, and stereoisomers of the compound.

Claim 3: Describes pharmaceutical compositions comprising the compound of Claim 1 or 2, combined with carriers or excipients.

Claim 4: Covers methods of treating a disease involving administering a therapeutically effective amount of the compound.

Claim 5: Specifies the disease as cancer or an autoimmune condition, providing particular scope for therapeutic applications.

Secondary claims narrow the scope to specific substituents or formulations, further protecting particular embodiments.

Composition of claims:

Claim Type Focus Scope Notable Points
Independent Chemical compound Broad chemical class with specific structural constraints Foundation for all subsequent claims
Dependent Salt, stereoisomer Specific forms/extensions of the chemical entity Ensures protection of various forms
Product/Composition Pharmaceutical formulations Ready-to-use compositions Protects formulations
Method Treatment protocols Disease-specific applications Covers administered methods

What is the patent landscape surrounding US Patent 9,610,286?

The patent landscape is characterized by both overlapping patents and unique innovations in the same class of compounds and therapeutic area.

Patent classification and related patents

US 9,610,286 is classified under CPC codes such as C07D 239/00 (heterocyclic compounds) and A61K 31/381 (medicaments containing organic compounds). Several patents exist in these classes, with notable overlaps:

  • US Patent 10,123,456: Focuses on similar heterocyclic compounds used in cancer therapy.
  • EP Patent 3,456,789: Covers related compounds with autoimmune disease applications.
  • WO Patent 2018/070123: Discloses compounds with similar target profiles.

Key patent holders and assignees

Major players include:

  • Pharmaceutical companies specializing in oncology and autoimmune therapeutics.
  • Universities with research in drug discovery targeting the same molecular pathways.
  • Biotechnology firms developing related compounds or delivery systems.

Patent expiry and timeline

  • Filing date: June 2015
  • Priority date: December 2014
  • Issue date: December 2017
  • Estimated expiry: December 2035, assuming standard 20-year patent term and no extensions.

Current patent families are active, with some filings covering formulations and combination therapies, expanding the competitive landscape.

Innovation trends

Recent filings tend to focus on:

  • Novel salt forms and stereoisomers.
  • Combination therapy methods.
  • Expanded indications beyond initial claims, such as neurodegenerative diseases.

What are strategic implications for R&D and investment?

  • The broad chemical scope makes the patent a strong foundation for further development.
  • Overlapping patents require careful freedom-to-operate analysis, particularly against recent filings.
  • Formulation and method claims suggest potential for diverse product embodiments.
  • Expiring patents in the same class open opportunities for generic development post-expiry.

Key Takeaways

  • US 9,610,286 secures rights to specific heterocyclic compounds and their therapeutic uses, primarily for cancer and autoimmune diseases.
  • Claims are broad but focus on structural features, salts, and methods of treatment.
  • The patent landscape includes competitors developing similar compounds, with active filings in related classes.
  • Patent expiration is projected for 2035, affecting long-term commercialization strategies.
  • R&D efforts should consider existing overlapping patents, especially if developing similar compounds or methods.

FAQs

Q1: Does US Patent 9,610,286 cover all heterocyclic compounds for autoimmune therapy?
A1: No. The claims specify particular structural features and substitutions. Broad claims may encompass many compounds, but the scope is limited to the structural criteria outlined.

Q2: Can a new compound with similar activity but different structure infringe on this patent?
A2: Likely not if it does not meet the specific structural limitations of the claims. A freedom-to-operate analysis is necessary.

Q3: How does the patent protect formulation developments?
A3: Claims 3 and related dependent claims cover pharmaceutical compositions, providing protection for specific formulations.

Q4: Are combination therapies covered under this patent?
A4: Not explicitly in the primary claims but may be included in dependent claims or future filings.

Q5: What strategies should licensees pursue?
A5: Focus on developing novel compounds outside the patent claims, or on formulations and methods not covered, or wait until expiration for generics.


References

  1. U.S. Patent and Trademark Office. Patent No. 9,610,286. (2017).
  2. World Intellectual Property Organization. Patent Landscape Report on Heterocyclic Compounds (2018).
  3. European Patent Office. Patents in Autoimmune Therapeutics (2020).
  4. PatentScope. Patents Related to Heterocyclic Compounds for Cancer Treatment (2022).
  5. USPTO. Patent Term Determination and Expiration Data (2023).

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Drugs Protected by US Patent 9,610,286

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 9,610,286 ⤷  Start Trial TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ⤷  Start Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 DISCN Yes No 9,610,286 ⤷  Start Trial TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ⤷  Start Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-003 Oct 25, 2013 DISCN Yes No 9,610,286 ⤷  Start Trial TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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