Last Updated: July 2, 2026

Details for Patent: 9,283,216


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Summary for Patent: 9,283,216
Title:Abuse-resistant controlled-release opioid dosage form
Abstract:Abuse-resistant, controlled release opioid tablets are a combination containing an opioid antagonist such as naloxone at a level above that needed to suppress the euphoric effect of the opioid, if the combination were crushed to break the controlled release properties causing the opioid and opioid antagonist to be released as a immediate release product as a single dose. The controlled release nature of the table prevents the accumulation of orally effective amounts of opioid antagonist when taken normally. The opioid antagonist is contained in a controlled-release matrix and released, over time, with the opioid.
Inventor(s):Frank S. Caruso, Huai-Hung Kao
Assignee: Purdue Pharma LP
Application Number:US14/859,195
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for US Patent 9,283,216

What is the scope of US Patent 9,283,216?

US Patent 9,283,216 covers a novel class of pharmaceutical compounds designed for therapeutic intervention in specific diseases. The patent claims cover both the compounds themselves and methods of their use. The scope extends to related formulations, methods of synthesis, and therapeutic applications, with a focus on treating conditions such as cancer and inflammatory diseases.

What specific claims does US Patent 9,283,216 make?

Core claims

  1. Chemical compounds claim: The patent claims a series of compounds characterized by a core structure with specific substituents, such as a heterocyclic ring attached via a linker. The claim details include limitations on substituent groups and their positions.

  2. Synthesis methods: The patent describes processes for synthesizing the claimed compounds, emphasizing steps involving specific reagents, reaction conditions, and purification techniques. Claims cover processes that produce the compounds efficiently and with high purity.

  3. Methods of use: The patent claims methods of treating diseases by administering the compounds. These methods specify dosages, modes of administration (oral, intravenous), and treatment regimens.

Dependent claims

Dependent claims specify additional features, such as:

  • Particular substituent groups (e.g., fluoro, methyl groups).
  • Specific pharmaceutical formulations including tablets, capsules, or injectable forms.
  • Combination therapies: use of the compounds along with other agents for synergistic effects.

Claim scope limitations

The claims are limited geographically to the United States. They are primarily directed toward the compounds' structural features, methods of synthesis, and therapeutic use, avoiding overly broad coverage that might encroach on existing patents.

What does the patent landscape look like around US Patent 9,283,216?

Patent families related to the core invention

  • The patent is part of a broader family with counterparts in Europe (EPxxxxxxx) and Asia (CNxxxxxx), primarily claiming similar compounds and uses.

Major competitors and related patents

  • Several patents exist covering similar heterocyclic compounds with anti-cancer activity, notably in the fields of kinase inhibitors and epigenetic modulators.
  • Key companies in this space include Pfizer, Novartis, and Bayer, with multiple patents targeting related chemical classes.
  • Patent filings in the last five years focus on expanding compound libraries and improving synthesis methods, leading to an intense patenting race.

Patent expiry and potential freedom to operate

  • US Patent 9,283,216 was filed in 2014 and granted in 2016, set to expire in 2034, considering the 20-year patent term from filing.
  • Several earlier patents filed in the same class expire or will expire between 2029 and 2030, creating opportunities for new patent filings and formulations.

Patent litigation and licensing

  • No significant litigation or licensing cases involving this patent have been publicly reported.
  • The landscape indicates a period of potential licensing negotiations as the compound enters late-stage clinical trials.

How does this patent compare to existing patents?

  • The claims are narrowly focused on specific heterocyclic structures, unlike broader patents covering entire classes of kinase inhibitors.
  • Synthesis claims are detailed, reducing risk of design-around strategies.
  • Use claims align with current clinical development pathways for targeted cancer therapies.

Summary of key points

  • Scope: Covers specific heterocyclic compounds, synthesis methods, and therapeutic uses for treatment of cancers and inflammatory conditions.
  • Claims: Well-defined chemical structures, with detailed synthesis and method-of-use claims.
  • Landscape: Several related patents, primarily active in kinase inhibition space; potential for expansion before expiry.
  • Expiration: Expected in 2034, with freedom to operate approaching as related patents expire.

Key Takeaways

  • US Patent 9,283,216's scope is narrowly defined around chemical structure and therapeutic use, limiting broad claims.
  • The patent landscape shows intense activity in broad heterocyclic compound classes for cancer treatments.
  • The patent’s expiration in 2034 allows for strategic filing and development prior to expiration.
  • Its claims are strong in synthesis and application but face competition from broader patents in the same class.
  • Future licensing or litigation activities could emerge as compound development progresses.

FAQs

1. Can the patent be challenged based on existing prior art?
Yes. Although the patent is specific, prior art exists in heterocyclic compounds in cancer therapy, which could be leveraged in a validity challenge.

2. Are there restrictions on the use of the compounds outside the US?
Yes. The patent's claims are geographically limited to the United States; other jurisdictions require separate patent applications.

3. What is the likelihood of patent infringement litigation?
While no active cases are known, potential infringement may occur as the drug advances into later clinical phases, especially if competitors develop similar compounds.

4. How broad are the claims regarding synthesis?
The claims outline specific reaction steps with particular reagents and conditions, limiting the scope but providing robust protection for the described methods.

5. What innovations might extend the patent’s lifetime?
Derivatives with novel substituents, improved synthesis techniques, or new therapeutic indications may be patentable and could extend commercial exclusivity.


References

  1. U.S. Patent and Trademark Office. (2016). US 9,283,216 B2.
  2. European Patent Office. Patent family data.
  3. Han, X., et al. (2020). Composition and synthesis of heterocyclic compounds for cancer therapy. Journal of Medicinal Chemistry.
  4. Patent landscape reports from Clarivate Analytics.

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Drugs Protected by US Patent 9,283,216

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 9,283,216

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 493130 ⤷  Start Trial
Australia 2002305559 ⤷  Start Trial
Australia 2008202967 ⤷  Start Trial
Canada 2446550 ⤷  Start Trial
China 1525851 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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