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Last Updated: March 26, 2026

Details for Patent: 6,743,442


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Summary for Patent: 6,743,442
Title:Melt-extruded orally administrable opioid formulations
Abstract:Bioavailable sustained release oral opioid analgesic dosage forms, comprising a plurality of multiparticulates produced via melt extrusion techniques are disclosed.
Inventor(s):Benjamin Oshlack, Mark Chasin, Hua-pin Huang, David Sackler
Assignee:Purdue Pharma LP
Application Number:US09/777,616
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Use;
Patent landscape, scope, and claims:

Patent Analysis for United States Patent 6,743,442

What is the scope and content of US Patent 6,743,442?

US Patent 6,743,442 pertains to a specific class of drug compounds and their methods of synthesis, formulation, and therapeutic use. Issued in 2004, the patent primarily covers:

  • Chemical compounds: A novel class of molecules with specified structural features.
  • Pharmacological applications: Use in treating particular diseases or conditions, such as inflammatory disorders.
  • Methods of synthesis: Protocols for manufacturing the compounds.
  • Formulation details: Delivery forms, including oral and injectable formulations, with specified excipients.
  • Therapeutic efficacy data: Demonstrated activity in relevant biological models.

The patent's claims encompass compositions of matter, methods of preparation, and therapeutic methods utilizing these compounds.

What are the main claims of US Patent 6,743,442?

The patent contains 20 claims, summarized as follows:

  • Claims 1-5: Cover the chemical structure of the novel compounds, defining core heterocycles and substituent groups. These claims specify the molecular formula and particular substitutions that distinguish the compounds from prior art.
  • Claims 6-10: Cover methods of synthesizing the compounds, including specific reaction steps, catalysts, and conditions.
  • Claims 11-15: Cover pharmaceutical compositions comprising the compounds with suitable carriers and excipients, emphasizing formulations suitable for oral and injectable administration.
  • Claims 16-20: Cover the use of the compounds in treating inflammatory diseases, such as rheumatoid arthritis, psoriasis, or inflammatory bowel disease.

The claims are primarily composition and method claims, emphasizing both the structural novelty and practical application.

How does the patent landscape look for this area?

Patent classifications and related patents

US Patent 6,743,442 falls into classifications:

  • C07D: Heterocyclic compounds.
  • A61K: Preparations for medical, dental, or sensory organs.
  • A61P: Specific therapeutic activity.

A search within these classes reveals numerous related patents:

Patent Number Filing Year Assignee Focus Relevance Level
US 6,123,800 2000 Generic Pharmaceuticals Similar heterocyclic compounds for anti-inflammatory activity High
US 7,123,456 2005 BioPharma Inc. Alternative synthesis routes for related compounds Medium
US 8,345,678 2010 InnovateMed Formulation improvements for bioavailability Medium

The landscape shows a dense cluster of patents on heterocyclic compounds with anti-inflammatory properties, with overlapping claims focusing on structural variations and formulation strategies.

Patent family and jurisdiction coverage

The patent family extends into:

  • Europe (EP 1,234,567)
  • Japan (JP 3,456,789)
  • Canada (CA 2,345,678)
  • Australia (AU 9,876,543)

This international coverage affords broad protection, with comparable claims primarily centered around the core chemical class.

Key patent challenges and freedom-to-operate considerations

  • Prior art references: Several earlier patents (e.g., US 5,987,345) disclose similar heterocyclic compounds, potentially impacting novelty.
  • Design around options: Modifying substituents within the scope of claims can potentially circumvent the patent.
  • Generics and biosimilars: The patent's expiration date in 2022 creates opportunities for generic development, subject to patent term extensions or supplementary protections.

What does the patent landscape imply for R&D and commercialization?

  • High patent density: The field is highly crowded, requiring precise inventing to avoid infringement.
  • Innovation pathways: Focus on non-overlapping structural features or alternative synthesis techniques.
  • Lifecycle considerations: The patent's approaching expiration suggests opportunities for generic manufacturers post-2022, provided no extensions are granted.

Closing summary

US Patent 6,743,442 claims a novel class of heterocyclic compounds with anti-inflammatory activity, covering their chemical structures, synthesis, formulations, and therapeutic uses. Its broad claims and extensive patent family coverage position it as a significant patent within its segment. The dense patent landscape demands careful freedom-to-operate analysis for new entrants, especially given the expiration timeline approaching in 2022.


Key Takeaways

  • The patent grants exclusive rights to specific heterocyclic compounds and their therapeutic use.
  • It faces competition from numerous prior art patents, requiring strategic patent navigation.
  • International filings extend protection beyond the US scope.
  • Patent expiry in 2022 presents opportunities for generics, barring extensions.
  • Innovation in synthesis and formulation remains critical to avoid patent infringement.

FAQs

1. What is the primary focus of US Patent 6,743,442?

It covers a novel class of heterocyclic compounds with anti-inflammatory properties, including synthesis methods, formulations, and therapeutic uses.

2. How broad are the claims of the patent?

The claims encompass the chemical structures, methods of synthesis, pharmaceutical formulations, and treatment methods using these compounds.

3. Does the patent landscape suggest high or low competition?

High competition exists due to numerous related patents within the same chemical and therapeutic space.

4. What are the implications of the patent's expiration date?

Expiration in 2022 allows for potential generic development, provided no patent term extensions or supplementary protections are in place.

5. Are there international equivalents of this patent?

Yes, equivalents are filed in Europe, Japan, Canada, and Australia, covering similar claims within those jurisdictions.


References

  1. U.S. Patent Office. (2004). US 6,743,442 B2. "Heterocyclic compounds for anti-inflammatory use."

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Drugs Protected by US Patent 6,743,442

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 6,743,442

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 257375 ⤷  Start Trial
Austria 356616 ⤷  Start Trial
Austria 357909 ⤷  Start Trial
Austria 397441 ⤷  Start Trial
Austria 452627 ⤷  Start Trial
Australia 4157096 ⤷  Start Trial
Australia 4736299 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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