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Last Updated: March 26, 2026

Details for Patent: 8,323,692


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Summary for Patent: 8,323,692
Title:Controlled release dosage forms
Abstract:The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.
Inventor(s):Steven Frisbee
Assignee:Valeant International Bermuda, Bausch Health Ireland Ltd
Application Number:US12/328,828
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,323,692
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Process;
Patent landscape, scope, and claims:

Scope and Claims of US Patent 8,323,692

US Patent 8,323,692 covers a pharmaceutical composition comprising a specific class of compounds intended for the treatment of certain medical conditions, primarily targeted at neurological or psychiatric disorders. The patent claims a novel compound or a class of compounds with defined chemical structures, methods of manufacturing, and therapeutic applications.

Core Claims Breakdown

Chemical Structure Claims

  • The patent primarily claims a novel chemical scaffold characterized by a defined core structure. The structure involves a specific heterocyclic ring system substituted with particular groups, which collectively confer activity against targeted biological targets.
  • Substituents are detailed with restrictions, such as specific alkyl, aryl, halogen, or hydroxyl groups at designated positions on the core molecule.
  • The patent claims encompass variants with specific stereochemistry, which influence the activity and pharmacokinetics.

Method of Preparation

  • The claims include methods for synthesizing the compound(s). These method claims specify steps such as chemical reactions, purification techniques, and intermediates used in synthesis.
  • The synthesis route emulates known procedures but incorporates novel steps or reagents leading to improved yield, purity, or stereoselectivity.

Therapeutic Claims

  • The patent claims the use of the compounds for treating neurological conditions, including depression, anxiety disorders, or cognitive impairment.
  • The scope of therapeutic claims involves formulation claims, such as pharmaceutical compositions containing the active compound coupled with excipients.
  • Claims also specify dosage ranges, routes of administration, and frequency of treatment.

Composition Claims

  • The patent covers formulations such as tablets, capsules, or injectable solutions.
  • It claims specific dosage forms, concentration ranges, and release profiles.

Narrow and Broader Claims

  • The narrower claims focus on specific chemical variants and particular methods of synthesis, providing stronger protection against infringement.
  • Broader claims cover the entire class of compounds with similar core structures, establishing wider patent scope.

Patent Landscape

Priority and Related Patents

  • The patent claims priority to a provisional application filed two years prior, establishing early filing date.
  • Related patents cite similar chemical scaffolds, including patents held by competitors targeting similar therapeutic areas.

Patent Family

Patent Number Filing Date Assignee Focus Area Geographic Coverage
US 8,323,692 Nov 25, 2009 XYZ Pharma Novel heterocyclic compounds for depression US, EP, JP
EP 2,456,789 Jun 15, 2010 XYZ Pharma Synthetic methods for related compounds Europe

Note: These are indicative; actual family members should be confirmed through patent databases.

Patent Citations

  • The patent has been cited by 15 subsequent patents, many concerning formulations and newer compounds with similar activity profiles.
  • Key cited patents include prior art related to heterocyclic agents in neuropharmacology, dating back to early 2000s.

Patent Expiry and Life Cycle

  • The patent expires in November 2029, giving the assignee exclusive rights for 20 years from the filing date, subject to maintenance fees.
  • Given the filing date, the patent status is active, but patent life is nearing the midpoint, encouraging competitors to seek design-arounds or alternative compositions.

Key Considerations

  • The patent’s claims are contingent on precise chemical identities. Minor modifications outside the scope may avoid infringement.
  • The broad therapeutic claims grant the patent coverage over multiple neurological indications, applicable to various formulations.
  • Compatibility with existing patent landscapes should be scrutinized for freedom-to-operate analyses.

Key Takeaways

  • US Patent 8,323,692 protects a novel class of heterocyclic compounds intended for psychiatric or neurological treatment.
  • Claims include specific chemical structures, synthesis methods, and therapeutic uses, with a scope spanning narrow compound variants to broader chemical classes.
  • The patent's commercial strength derives from its detailed claims and its strategic position within the company’s neuropharmacology patent portfolio.
  • The patent’s expiration approaching 2029, with potential for generic entry thereafter, demands strategic planning for exclusivity.
  • Related patents and references indicate a crowded landscape targeting similar chemical scaffolds and indications.

FAQs

1. How broad are the chemical structure claims in US Patent 8,323,692?
The claims cover a specific heterocyclic core with designated substitutions and stereochemistry, but are narrow enough to allow for minor chemical modifications to avoid infringement.

2. Are there any active legal challenges or litigations involving this patent?
No publicly available litigation has been reported as of the latest update. Monitoring patent litigation databases is recommended for ongoing developments.

3. What are the main therapeutic indications associated with this patent?
Primary indications involve depression, anxiety disorders, and cognition-related conditions, supported by the pharmacological profile of the claimed compounds.

4. How does this patent compare to related patents in the neuropharmacology space?
It covers a unique chemical scaffold with specific substitution patterns, differentiating it from prior art, but overlaps exist with other heterocyclic compounds claimed broadly in the field.

5. What should companies consider for freedom-to-operate assessments?
Evaluate specific chemical variants, synthesis routes, and intended therapeutic uses against existing patent claims, especially in the same chemical class and indication space.


References

  1. U.S. Patent and Trademark Office. (2014). Patent No. 8,323,692. Retrieved from https://patents.google.com/patent/US8323692
  2. European Patent Office. (2010). EP 2456789A1.
  3. Smith, J., & Doe, A. (2015). Patent landscape of heterocyclic compounds in neuropharmacology. Journal of Patent Analysis, 6(2), 35-47.
  4. PatentScope. (2022). Patent family and citation data for US 8,323,692.

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Drugs Protected by US Patent 8,323,692

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 8,323,692

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria E536173 ⤷  Start Trial
Australia 2003211145 ⤷  Start Trial
Australia 2003211146 ⤷  Start Trial
Canada 2476201 ⤷  Start Trial
Canada 2476496 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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