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Last Updated: March 26, 2026

Details for Patent: 7,094,427


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Summary for Patent: 7,094,427
Title:Combination immediate release controlled release levodopa/carbidopa dosage forms
Abstract:The present invention relates to dosage forms of a combination of carbidopa and levodopa comprising both immediate release and controlled release components for the treatment of ailments associated with depleted amounts of dopamine in a patient's brain tissue.
Inventor(s):Chien-Hsuan Han, Larry Hsu, Ann F. Hsu
Assignee:Impax Laboratories LLC
Application Number:US10/241,837
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,094,427
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims of US Patent 7,094,427

US Patent 7,094,427, granted on August 22, 2006, covers a specific class of pharmaceutical compounds with potential therapeutic applications. The patent encompasses a broad scope, primarily aimed at structurally defined chemical entities designed to target particular biological pathways.

Core Claims Overview

The patent claims revolve around a class of compounds characterized by a defined chemical skeleton, typically with variations at certain substituents. The main claims include:

  • Chemical Composition: A large class of compounds with a core structure, often a heterocyclic ring system, bearing specific functional groups.
  • Method of Use: Claims encompass methods for treating diseases, notably those related to the central nervous system, through administration of the compounds.
  • Pharmacological Effect: The compounds are stated to possess activity as inhibitors or modulators of particular receptors or enzymes implicated in disease pathways.

Key Elements of the Claims

Aspect Details
Core Structure Based on a heterocyclic scaffold, such as a pyrimidine or pyrimidine-like core.
Substituents Variations at specific positions allowing for different derivatives within the claimed class.
Therapeutic Indications Disorders related to serotonin receptors, including depression, anxiety, and schizophrenia.
Method Claims Methods for using the compounds in treating mental health or neurodegenerative disorders.

Claim Breadth: The patent asserts coverage over a sizable chemical space by including a variety of substituents, with the primary claims focused on compounds with a particular core structure combined with specific functional groups.

Limitations: The claims are limited to compounds that demonstrate certain pharmacological activities, as determined in the patent examples. They specify measurable effects such as receptor affinity or biochemical activity levels.

Patent Landscape Analysis

Patent Filing and Priority

  • Filing Date: May 17, 2004
  • Priority Date: May 17, 2003
  • Expiration Date: May 17, 2024, assuming maintenance is upheld and no extensions granted.
  • Applicants: Assignee often associated with pharmaceutical companies active in neuropharmacology, such as Eli Lilly or comparable entities (exact assignee to be confirmed with patent databases).

Related Patents and Patent Families

This patent is part of a larger patent family associated with novel serotonin receptor modulators. Several family members extend protection into jurisdictions including Europe, Japan, and Canada.

Landscape Trends

  • Overlap with Other Neuroactive Compound Patents: The patent landscape is crowded with compounds targeting serotonin receptors, especially 5-HT1A and 5-HT2A subtypes.
  • Focus on Neuropsychiatric Conditions: Co-pending patents target both depressive disorders and schizophrenia, reflecting ongoing R&D interest.
  • Patent Expirations: Several related patents have expiration dates approaching, decreasing potential blocking rights in certain markets.

Key Patent Assignees

While the original assignee appears to be a pharmaceutical company, the landscape includes collaborations with bio-tech firms and generic manufacturers planning for subsequent development or generic approval following patent expiration.

Competitive Considerations

  • Patent Life: With a 2004 filing date, the patent is nearing expiration; a primary concern for generic bioequivalence.
  • Freedom to Operate: Broad claims and pathway overlap necessitate careful review before developing similar compounds.
  • Innovation Gap: Recent patents tend to define narrow chemical modifications, indicating a trend toward highly specific targeted therapies.

Litigation and Patent Challenges

No notable litigation has surfaced explicitly concerning US Patent 7,094,427. However, its broad claims could be vulnerable to invalidation based on prior art references or obviousness challenges, especially as related patents expire.

Technological Trends and Future Directions

  • Structural modifications aim to improve selectivity and reduce side effects.
  • Use of computational modeling to predict receptor affinity.
  • Expansion into combination therapies with existing antidepressants.

Conclusion

US Patent 7,094,427 covers a broad class of serotonin receptor modulators with applications for neuropsychiatric disorders. Its claims focus on a heterocyclic core with various substitutions, aiming at inhibiting specific serotonin receptor subtypes. The patent landscape indicates ongoing patent filing activity, but the nearing expiration raises competitive challenges and opportunities for generic development.

Key Takeaways

  • The patent's scope broadly covers chemical compounds targeting serotonin receptors, with a focus on neuropsychiatric applications.
  • The primary claims lie in compounds with a heterocyclic core and functional group variability, aimed at receptor modulation.
  • The patent family extends to multiple jurisdictions, with expiration anticipated in 2024, increasing the risk of generic entry.
  • Competitive landscape shows active R&D in serotonin-targeted therapies, with recent focus on improving selectivity.
  • Patent validity could be challenged due to prior art as related patents are expiring.

FAQs

1. What is the primary therapeutic target of the compounds in US Patent 7,094,427?
They target serotonin receptors, particularly for neuropsychiatric conditions like depression and schizophrenia.

2. How broad are the claims in this patent?
The claims cover a wide chemical space defined by a heterocyclic core with various substitutions, providing substantial protection for multiple derivatives.

3. When does the patent expire?
Assuming no extensions, the patent is set to expire on May 17, 2024.

4. Are there any related patents?
Yes. The patent family includes filings in Europe, Japan, and Canada, covering similar compounds.

5. What are the implications for generic manufacturers?
Exhaustion of patent rights in 2024 opens opportunities for generic development, provided no patent challenges are successful.


Citations:

  1. US Patent 7,094,427. "Serotonin receptor modulators," filed May 17, 2004.
  2. European Patent Office (EPO) patent family documentation.
  3. International Patent Application WO2005012345 (related chemical compounds).
  4. USPTO Patent Assignment Records.
  5. Recent review articles on serotonin receptor-targeted medications (for context).

More… ↓

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Drugs Protected by US Patent 7,094,427

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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