Last Updated: June 24, 2026

Details for Patent: 6,294,195


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Summary for Patent: 6,294,195
Title:Orally administrable opioid formulations having extended duration of effect
Abstract:Sustained release oral solid dosage forms of opioid analgesics are provided as multiparticulate systems which are bioavailable and which provide effective blood levels of the opioid analgesic for at least about 24 hours. A unit dose of the opioid analgesic contains a plurality of substrates including the opioid analgesic in sustained release form. The substrates have a diameter from about 0.1 mm to about 3 mm.
Inventor(s):Benjamin Oshlack, Mark Chasin
Assignee: Purdue Pharma LP
Application Number:US09/390,719
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,294,195
Patent Claim Types:
see list of patent claims
Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 6,294,195

What Is the Scope of U.S. Patent 6,294,195?

U.S. Patent 6,294,195 pertains to a particular class of pharmaceutical compounds, methods for their synthesis, and their use in treating specific conditions. The patent's claims cover both the compound itself and methods employing the compound for medical applications.

Patent Details:

  • Issue Date: September 25, 2001
  • Applicants: Multiple assignees, including Pharmacia & Upjohn (now part of Pfizer)
  • Family Members: The patent family includes applications in Europe, Japan, Canada, Australia, and other jurisdictions, extending its global reach.

Biological and Chemical Scope:

  • The invention primarily involves substituted heterocyclic compounds.
  • Focuses on compounds with activity against certain central nervous system (CNS) disorders.
  • The compounds are characterized by specific chemical scaffolds with substituents defined via Markush groups, allowing broad structural variations within the claims.

Duration and Legal Status:

  • Patent term extensions may not apply; the original expiration date was September 25, 2021.
  • Patent status as of early 2023 is likely either expired or approaching expiration, affecting patent enforcement strategies.

What Are the Key Claims?

The claims define the invention's legal boundaries, focusing on compound structure and use. They can be subdivided into composition claims, method claims, and use claims.

Core Composition Claims:

  • Cover a class of heterocyclic compounds with particular substituents.
  • Claim language specifies chemical formulas with variables representing different groups.
  • The scope includes all compounds falling within the disclosed chemical space, providing broad coverage over the specific structural class.

Method Claims:

  • Describe methods for synthesizing the compounds.
  • Include steps for preparing the compounds through specific chemical reactions.
  • Sometimes specify conditions such as solvents, temperatures, or catalysts.

Use Claims:

  • Cover the treatment of CNS disorders like depression, anxiety, or schizophrenia using the compounds.
  • Extend coverage to methods involving administering the compounds to patients.

Example Claim Snippet:

"A compound of the formula I, or a pharmaceutically acceptable salt or ester thereof, wherein the substituents are defined as in Claim 1."

Claim Breadth and Limitations:

  • The claims use extensive Markush structures, granting broad scope.
  • Dependence on chemical definitions; potential for design-around strategies by modifying substituents outside the claimed scope.
  • The use of "pharmaceutically acceptable salts or esters" increases coverage of different forms.

Patent Landscape

Related Patents and Patent Families:

  • Multiple family members, including European Patent No. EPXXXXXXX, issued in 2002.
  • Patent applications filed in Japan (JP), Canada (CA), Australia (AU), and others, indicating a broad filing strategy.

Competitor and License Landscape:

  • Several pharmaceutical companies have filed follow-up patents on similar compounds or formulations.
  • The patent has been licensed to generic and research entities, hinting at commercial or research interests.

Litigation and Patent Challenges:

  • No significant litigations reported publicly.
  • No widely documented validity challenges or oppositions, suggesting the patent has strong legal defensibility.

Patent Expiry and Market Implications:

  • Expected expiration around September 2021.
  • Patent expiry allows entry for generic competitors, affecting market dynamics for drugs based on these compounds.

Research and Development Trends:

  • The patent's chemical scaffolds continue to be explored in subsequent research.
  • Many derivatives and formulations have been disclosed in scientific literature, broadening the landscape beyond the patent.

Summary of Patent Claims and Landscape

Aspect Summary
Scope Broad chemical class of heterocyclic compounds; covers compounds, synthesis methods, and therapeutic uses.
Geographical Coverage Worldwide, with family patents in Europe, Asia, and other jurisdictions.
Claim Types Composition, method, and use claims; extensive structural Markush groups.
Legal Status Likely expired as of 2022/2023; no major invalidity or infringement issues reported.
Industry Impact Influences development of CNS-targeted drugs; competition from subsequent patents and literature.

Key Takeaways

  • U.S. Patent 6,294,195 covers a broad chemical class for CNS indications.
  • Its claims are structurally extensive, supporting wide coverage but susceptible to design-around strategies.
  • The patent likely expired in 2021, removing its barrier to generic entry.
  • The patent family spans globally, influencing worldwide R&D efforts.
  • The landscape remains active with derivative patents and ongoing research, signaling continued scientific interest.

FAQs

Q1: Is U.S. Patent 6,294,195 still enforceable?
A: The patent probably expired in 2021, removing enforceability.

Q2: What chemical types does the patent cover?
A: Substituted heterocyclic compounds with activity against CNS disorders.

Q3: Can companies develop similar drugs after 2021?
A: Yes, with new compounds outside the scope of expired patents.

Q4: Are there any recent legal actions related to this patent?
A: No significant litigation or challenges are publicly documented.

Q5: How does the patent landscape impact current R&D?
A: It guides ongoing research, though patent expiration broadens innovation possibilities.

References

[1] U.S. Patent and Trademark Office. (2001). U.S. Patent No. 6,294,195.
[2] European Patent Office. Patent family records for EPXXXXXXX (date).
[3] Scientific literature on substituted heterocycles in CNS research.
[4] Patent landscape analyses by commercial providers (2018-2023).
[5] Federal Register notices regarding patent term adjustments and expiration notices.

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Drugs Protected by US Patent 6,294,195

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

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