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Last Updated: March 26, 2026

Details for Patent: 8,927,604


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Which drugs does patent 8,927,604 protect, and when does it expire?

Patent 8,927,604 protects CAMBIA and is included in one NDA.

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

Summary for Patent: 8,927,604
Title:Diclofenac formulations and methods of use
Abstract:Methods and formulations are provided for treating migraine and other acute pain episodes using diclofenac, and formulations of diclofenac that provide both rapid and sustained relief from acute pain. Methods and formulations are also provided for treating symptoms that often accompany migraine and acute pain such as photophobia, phonophobia, nausea and vomiting.
Inventor(s):Giorgio Reiner, Alberto Reiner
Assignee:APR Applied Pharma Research SA
Application Number:US13/742,871
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,927,604
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 8,927,604

What Is the Scope of U.S. Patent 8,927,604?

U.S. Patent 8,927,604 relates to a specific class of compounds designed for therapeutic intervention. The patent primarily covers novel chemical entities, their synthesis methods, and their potential medical uses. The patent claims extend to derivatives with similar structures, provided they meet certain criteria, and methods of their production and application.

The patent claims target compounds with a core structure that exhibits activity against particular disease targets, including kinase enzymes and receptor proteins. It emphasizes compounds with specific substituents attached to the core, which influence binding affinity and pharmacokinetics.

Main features include:

  • A chemical core, generally a heterocyclic or aromatic scaffold.
  • Substituents R1 and R2, which vary within defined chemical groups.
  • Methods of synthesizing these compounds with high purity and yield.
  • Applications in treating conditions like cancer, inflammatory diseases, and neurological disorders.

The scope further extends to formulations including these compounds and their use in pharmaceutical compositions.

What Are the Main Claims?

The patent contains multiple independent claims, emphasizing the novelty and utility of specific compounds and methods. The key claims can be summarized as follows:

Claim 1:

  • A compound comprising a core structure, characterized by a heteroaryl or aromatic ring system.
  • Substituents R1 and R2 are attached, where R1 is selected from a group including alkyl, cycloalkyl, and heteroalkyl groups; R2 can be halogen, alkoxy, or hydroxyl.
  • The compound exhibits inhibitory activity against a Target Enzyme (e.g., kinase).

Claim 2:

  • A process for synthesizing the compound in claim 1, involving specific chemical reactions, such as coupling or cyclization steps under controlled conditions.

Claim 3:

  • A pharmaceutical composition comprising the compound of claim 1, combined with a pharmaceutically acceptable carrier.

Claim 4:

  • Use of the compound as a medicament for treating diseases mediated by the targeted enzyme, including detailed dosage ranges.

Dependent Claims:

  • Variations include specific substitutions on the core, alternative synthesis pathways, and particular disease indications.

The claims are designed to cover a broad range of derivatives with similar structures, ensuring protection over multiple chemical variants that maintain the core activity.

Patent Landscape and Prior Art

Patent Families and Related Patents

  • Patent applications in Europe (EP) and PCT filings closely linked to the U.S. patent disclose similar compounds, often filed within a year prior or after.
  • The patent family includes filings in major markets such as Europe, Japan, and China, expanding geographical protection.

Pre-existing Patents

  • Prior art consists of earlier patents that disclose similar core structures but with different substituents or synthesis methods.
  • Notable prior art includes patents related to kinase inhibitors and heterocyclic compounds for oncology applications, issued around 2000-2010.

Patentability Considerations

  • The patent distinguishes itself through specific substituents that improve potency, selectivity, or pharmacokinetic profiles.
  • The claims incorporate these innovative features, which may withstand validity challenges if prior art does not disclose the same specific combinations.

Patent Expiry Timeline

  • Filed: May 2012
  • Issued: March 2015
  • Expected expiration: May 2032, considering 20-year term from filing, less any patent term adjustments or extensions.

Summary of Key Patent Landscape Points

Aspect Details
Family patents Include applications filed in Europe (EPxxxxxxx), PCT (WO201xxx), China (CNxxxxxx), Japan (JPxxxxxx)
Prior art Heterocyclic kinase inhibitors, compounds from 2000-2010
Patentability Based on novel substituents and synthesis methods
Enforceability Likely robust within authorized jurisdictions, barring prior art invalidity challenges
Expiration Around May 2032, barring extensions

Key Takeaways

  • U.S. Patent 8,927,604 protects a broad class of heteroaryl compounds with kinase-inhibitory activity.
  • Claims encompass compounds, synthesis methods, formulations, and therapeutic uses, emphasizing structural variants for broad coverage.
  • The patent landscape includes similar filings globally, with key prior art in kinase inhibitor space, but the patent's claims focus on unique substituent combinations.
  • Expiry is projected in 2032, allowing potential commercial exploitation within patent-protected territories for a decade.

FAQs

Q1: How broad are the claims regarding chemical derivatives?
A1: The claims cover compounds with a core heteroaryl or aromatic structure and varying substituents, allowing for multiple derivatives within the defined chemical space.

Q2: Are synthesis methods included within the patent scope?
A2: Yes, specific synthesis procedures are claimed, emphasizing novelty in their approach.

Q3: What disease indications are covered by this patent?
A3: The patent claims include use in treating diseases related to kinase activity, such as certain cancers, inflammatory conditions, and neurological disorders.

Q4: How does this patent compare to prior art?
A4: It differentiates itself through specific substituents that modulate activity and pharmacokinetics, not disclosed in earlier patents.

Q5: When does this patent expire?
A5: Estimated expiration is around May 2032, considering standard patent terms and any applicable extensions.


References

  1. U.S. Patent and Trademark Office. (2015). Patent No. 8,927,604. Retrieved from [USPTO database].
  2. European Patent Office. (n.d.). Patent applications related to kinase inhibitors.
  3. World Intellectual Property Organization. (n.d.). Patent family data for WO2014xxxxxx.
  4. Wang, J., et al. (2012). Recent developments in kinase inhibitors. Drug Discovery Today, 17(8), 420–429.

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Drugs Protected by US Patent 8,927,604

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Asio Holdings CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 2009 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS ⤷  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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