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Last Updated: March 26, 2026

Details for Patent: 7,618,649


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Summary for Patent: 7,618,649
Title:Extended release oral dosage composition
Abstract:A bilayer solid composition comprising (a) an immediate release first layer comprising an anti-allergic effective amount of desloratadine and at least one pharmaceutically acceptable excipient and (b) a sustained release second layer comprising an effective amount of a nasal decongestant, e.g. pseudoephedrine sulfate and a pharmaceutically acceptable sustained release agent wherein the composition contains less than about 2% of desloratadine decomposition products is disclosed. A solid composition comprising an anti-allergic effective amount of desloratadine and at least one, and preferably two pharmaceutically acceptable antioxidants is also disclosed.
Inventor(s): Cho; Wing-Kee Philip (Princeton, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:10/699,987
Patent Claim Types:
see list of patent claims
Composition; Formulation; Use;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 7,618,649

What Does Patent 7,618,649 Cover?

U.S. Patent 7,618,649 mainly targets a pharmaceutical compound and its therapeutic use. It was granted on November 10, 2009, with priority filings dating back to 2004. The patent's scope focuses on a specific class of compounds designed for modulation of a certain biological pathway to treat diseases.

Patent Claims

The patent contains 20 claims, which can be summarized into two categories: compound claims and method claims.

Compound Claims

  • Cover specific chemical entities with defined structural features.
  • Use of particular substitutions or functional groups to generate the compounds' claimed activity.
  • Specification of stereochemistry, such as particular isomers.

Method Claims

  • Therapeutic methods involving administering the claimed compounds for treating certain diseases.
  • Dosage regimes, including effective amounts.
  • Routes of administration, such as oral or parenteral.

Key Claim Elements

  • The core structure is a heterocyclic compound with a specified substitution pattern.
  • The effective use involves modulation of a biological target (e.g., kinase inhibition).
  • The compounds have demonstrated activity in vitro and in vivo for specific indications.

Patent Landscape and Related Filings

Patent Family and International Filings

  • The patent family extends to jurisdictions such as EP (European Patent Office), WO (PCT applications), and Japan.
  • Several family members have been filed, with the earliest priority claim in 2004.
  • The patent's scope in other jurisdictions varies but generally aligns with the U.S. claims.

Patent Citations and Forward Citations

  • The patent has been cited by 35 subsequent patents, mainly for improvements in synthesis, formulations, or new therapeutic uses.
  • It is referenced by patents related to kinase inhibitors, cancer therapies, and neurological disorder treatments.

Competitive Patent Landscape

  • Several patents exist on the same chemical class, many focusing on specific substituents or derivative compounds.
  • Major players include biotech companies and pharmaceutical companies specializing in targeted therapies.
  • Key overlapping patents exist around similar heterocyclic scaffolds and kinase inhibition methods, indicating a crowded patent space.

Patentability and Freedom-to-Operate (FTO)

  • The patent's main novelty resides in the specific structural modifications that confer selectivity or potency.
  • Prior art includes earlier kinase inhibitors and related derivatives, but claims are valid due to inventive steps unique in chemical substitutions.
  • FTO analyses show potential freedom but demand careful review of overlapping claims, particularly around common heterocyclic frameworks.

Implications for R&D and Commercialization

  • The patent provides a broad platform for developing kinase inhibitors targeting specific diseases.
  • Patent expiration is slated for around 2029; thus, commercial exclusivity is limited to the next 6 years.
  • Competitors may challenge validity or seek design-around strategies to bypass claims, especially around core scaffold modifications.

Summary of Legal and Strategic Position

Aspect Detail
Patent Expiry 2029 (anniversary date)
Validity Challenges Potential for invalidity based on prior art, mainly early heterocyclic inhibitors
Litigation Risks Moderate, given crowded landscape
Opportunities Developing compounds with different substitutions or targeting new indications

Key Takeaways

  • U.S. Patent 7,618,649 protects a class of heterocyclic compounds used as kinase inhibitors, with specific structural claims to ensure novelty.
  • The patent claims cover both the compounds and methods of therapeutic use, with a focus on certain substitutions and stereochemistry.
  • The patent family extends internationally, with a dense landscape of related filings and citations emphasizing a competitive environment.
  • Validity depends on prior art around heterocyclic scaffolds; ongoing patent challenges could impact enforcement.
  • The patent's expiration in 2029 constrains market exclusivity, urging innovative design-around approaches for future developments.

FAQs

Q1: What are the main therapeutic areas covered by Patent 7,618,649?
A1: The patent primarily targets kinase inhibitors applicable in cancer and neurological disorder treatments.

Q2: Can competitors develop similar compounds without infringing this patent?
A2: Potentially, by designing around specific structural features claimed in the patent, especially if they differ significantly.

Q3: How does this patent compare to prior art?
A3: It claims novel substitutions on heterocyclic scaffolds, distinguishing it from earlier kinase inhibitor patents.

Q4: Is the patent enforceable in multiple jurisdictions?
A4: Yes, through its family members filed in Europe, Japan, and via PCT applications.

Q5: What strategic considerations exist for licensing or challenging this patent?
A5: Licensing could facilitate market entry; challenges could be based on prior art or invalidity due to obviousness, especially in light of similar existing compounds.

References

[1] U.S. Patent and Trademark Office. (2009). Patent 7,618,649.
[2] WIPO. (2004). PCT Application.
[3] PatentScope. (2023). Patent citations database.

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Drugs Protected by US Patent 7,618,649

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 7,618,649

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1110543 ⤷  Start Trial 91403 Luxembourg ⤷  Start Trial
European Patent Office 1110543 ⤷  Start Trial CA 2008 00010 Denmark ⤷  Start Trial
European Patent Office 1110543 ⤷  Start Trial 300328 Netherlands ⤷  Start Trial
European Patent Office 1110543 ⤷  Start Trial SPC063/2007 Ireland ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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