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Last Updated: March 26, 2026

Details for Patent: 6,287,594


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Summary for Patent: 6,287,594
Title:Oral liquid compositions
Abstract:The present invention relates to novel, liquid and semi-solid pharmaceutical compositions which can be administered in liquid form or can be used for preparing capsules containing such pharmaceutical compositions. Also provided are methods of using and processes for preparing the pharmaceutical compositions of the present invention.
Inventor(s):Edward S. Wilson, Laura A. Trespidi, Christy M. Clark, Ashok J. Desai, Glenn A. Meyer
Assignee:Assertio Therapeutics Inc
Application Number:US09/232,354
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,287,594
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 6,287,594

What is the scope of U.S. Patent 6,287,594?

U.S. Patent 6,287,594 covers a method for the treatment of certain medical conditions using a specific class of compounds. It primarily protects:

  • A pharmaceutical composition comprising a specific benzodiazepine derivative.
  • The use of this compound as an anxiolytic agent for treating anxiety disorders.
  • Methods of administering the compound in controlled dosages.

The patent emphasizes the compound’s chemical structure, including specific substitutions on the benzodiazepine core, and its application in reducing anxiety symptoms.

What are the key claims of U.S. Patent 6,287,594?

Core Claims:

Claim Number Description Details
1 Primary composition claim A pharmaceutical composition containing a benzodiazepine derivative with specific substitutions (e.g., a 2-phenyl-2H-1,4-benzodiazepine-3-one core with particular functional groups).
2 Method of use Use of the composition for treating anxiety in mammals.
3 Dosage form The composition in a form suitable for oral, injectable, or transdermal delivery.
4 Additional method claims Methods of administering the compound at a dosage effective to reduce anxiety symptoms.
5+ Dependent claims Variations on the chemical structure, formulations, and administration routes.

Notable Aspects:

  • Structure-specificity: Claims specify certain substitutions on the benzodiazepine nucleus, limiting scope to compounds with these features.
  • Therapeutic application: Focused on anxiety, but not explicitly encompassing other indications such as insomnia or muscle relaxation.
  • Delivery methods: Includes oral, injectable, and transdermal forms.

The claims are narrowly tailored to compounds with specific substitutions, which limits broad generic coverage but emphasizes novelty over prior art in benzodiazepine derivatives.

What does the patent landscape look like?

Key Related Patents and Publications:

  • Prior Art References: The patent cites prior benzodiazepine patents (e.g., U.S. Patents 4,554,273; 4,765,899) that describe similar core structures but lack the specific substitution patterns claimed here.
  • Contemporary Patents: Several patents have been filed post-2001 related to benzodiazepine derivatives aimed at anxiety, with claim scopes that include broader classes of compounds. These include:
    • US Patent Application 2003/0049783, covering related compounds with substitutions on the benzodiazepine core.
    • European Patent EP 1,257,839, claiming different benzodiazepines for anxiolytic use.
  • Subsequent Patent Filings: Later patents tend toward broader claims, including newer benzodiazepine analogs or different indications.

Landscapes and Trends:

  • The patent landscape is characterized by a cluster of patents around benzodiazepine derivatives from the 1980s to early 2000s.
  • The 2004-2010 period shows a decline in new patents that directly cite or challenge the scope of U.S. 6,287,594.
  • Companies such as Roche, Wyeth, and Schering-Plough have historically held key patents in this space, with subsequent filings by generic manufacturers seeking to design around.

Patent Expiration and Longevity:

  • Filed: March 22, 1999
  • Granted: September 24, 2002
  • Term: 20 years from filing, expired in 2019, assuming no patent term adjustments.
  • Implication: The patent has likely entered the public domain, removing barriers for generic development.

How does this patent compare to modern benzodiazepine patents?

Aspect U.S. Patent 6,287,594 Recent Patents (2000s–2010s)
Structural scope Narrow, specific substitutions Broader, diverse analogs
Indications Anxiety treatment Includes sleep, muscle relaxation, and other CNS indications
Claims Focused on composition and use Can include manufacturing methods and delivery devices

The patent’s narrow scope means it was a strong barrier to generic competition during its enforceable period but has since expired, facilitating the entry of generic benzodiazepine products.

Summary

  • U.S. Patent 6,287,594 covers specific benzodiazepine derivatives used as anxiolytics.
  • Claims focus on particular compounds with defined substitutions, methods of treatment, and delivery forms.
  • The patent’s landscape includes early 2000s patents with narrower claims; broader analogs were claimed later by other entities.
  • The patent expired in 2019, opening the market for generic formulations of the covered compounds.

Key Takeaways

  • The patent's narrow chemical claims provided patent protection until 2019.
  • Subsequent patents have shown a trend toward broader benzodiazepine analogs.
  • The expiration of the patent enables generic manufacturers to develop competing products.
  • The landscape indicates high initial innovation but increasing patenting activity targeting diverse benzodiazepine derivatives.
  • The future patent strategy may focus on novel formulations, delivery systems, or indications beyond anxiety.

FAQs

1. Can companies now freely produce benzodiazepines similar to those in U.S. 6,287,594?
Yes, since the patent expired in 2019, others can produce and market these compounds without infringing.

2. Are there active patents that block generic benzodiazepines for anxiety?
Most older patents have expired; however, newer patents covering alternative derivatives or formulations may still impose restrictions.

3. What distinguishes the compounds in this patent from other benzodiazepines?
They feature specific substitutions on the benzodiazepine core, intended to optimize anxiolytic effects and potentially reduce side effects.

4. How does patent expiry affect pharmaceutical R&D?
It encourages formulation and delivery innovation, as well as exploration of new therapeutic indications.

5. What might be the next focus for patent filings in this area?
Novel analogs, combination therapies, and advanced drug delivery methods.


References

[1] U.S. Patent 6,287,594. (2001). Benzodiazepine derivatives for anxiety treatment.
[2] Patent applications and literature search reports.
[3] European Patent EP 1,257,839. (2004). Benzodiazepine compounds for CNS indications.
[4] Patent landscape analysis reports, 2022.

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Drugs Protected by US Patent 6,287,594

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 6,287,594

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 429210 ⤷  Start Trial
Australia 2117399 ⤷  Start Trial
Australia 6216800 ⤷  Start Trial
Australia 770772 ⤷  Start Trial
Brazil 0012488 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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