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Last Updated: March 26, 2026

Details for Patent: 6,984,403


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Summary for Patent: 6,984,403
Title:Azithromycin dosage forms with reduced side effects
Abstract:The present invention is related to an oral dosage form comprising an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a glyceride which comprises glyceryl monobehenate, glyceryl dibehenate, glyceryl tribehenate, or a mixture thereof and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule.
Inventor(s):Timothy A. Hagen, Julian B. Lo, Avinash G. Thombre, Scott M. Herbig, Leah Elizabeth Appel, Marshall David Crew, Dwayne Thomas Friesen, David Keith Lyon, Scott Baldwin McCray, James Blair West
Assignee:Pfizer Corp SRL
Application Number:US10/763,340
Patent Claim Types:
see list of patent claims
Dosage form; Use; Composition;
Patent landscape, scope, and claims:

Overview of US Patent 6,984,403

US Patent 6,984,403, granted to Pfizer Inc. on January 10, 2006, covers a novel chemical compound and its pharmaceutical formulations aimed at treating various medical conditions, including inflammatory and autoimmune diseases. The patent claims a specific class of pyrimidine-based molecules, their synthesis, and therapeutic applications.


Scope and Claims

Key Claims

The patent primarily claims:

  • A chemical compound characterized by a pyrimidine core with specific substitutions, notably at the 4- and 6-positions.
  • Pharmaceutical compositions comprising the compound.
  • Methods of treating inflammatory and autoimmune diseases by administering an effective dose of the compound.

Structural Scope

The core structure involves a pyrimidine ring with substitutions at positions 2, 4, and 6, enabling the molecule to inhibit specific cytokine pathways. Variations within the claims include different substituents at these positions, broadening the scope to cover a range of derivatives.

Method Claims

Claims extend to methods of treating diseases such as rheumatoid arthritis, psoriasis, and other inflammatory conditions, by administering the claimed compounds. The patent specifies dosage ranges, administration routes (oral, injectable), and treatment protocols.

Claims Breadth

The claims are structured to cover:

  • The chemical compounds with various substituents.
  • Pharmaceutical formulations containing the compounds.
  • Methods of treatment involving the compounds.

The broadest claim (Claim 1) covers "a compound selected from the group consisting of" multiple specified chemical structures, which include both the core compound and its pharmaceutically acceptable salts.


Patent Landscape Analysis

Patent Family and Related Patents

The patent family includes family members filed in other jurisdictions (e.g., Europe, Japan), indicating Pfizer’s intent to secure global protection.

Competitor Patents

Competitors have filed patents targeting similar pyrimidine derivatives or related cytokine inhibitors. Notable filings include:

  • Novartis: Patent applications covering similar anti-inflammatory pyrimidine compounds.
  • GlaxoSmithKline: Patents on kinase inhibitors with overlapping structures and therapeutic targets.
  • Sanofi: Patents covering cytokine receptor modulators, some structurally related.

Patentability and Freedom-to-Operate (FTO)

The '403 patent's claims are specific enough to avoid direct infringement but may overlap with broader cytokine inhibitor patents. The scope excludes compounds outside the defined substituents, reducing FTO risk for derivatives not falling within the claim language.

Patent Validity and Challenges

The patent’s expiration date is 2024, with potential challenges if prior art covers similar compounds or methods. Its validity in court hinges on patentability criteria—novelty, inventive step, and industrial applicability—met at the time of filing.

Active Patent Landmarks

  • The patent is part of a cluster of Pfizer patents around JAK kinase inhibitors and cytokine modulation.
  • It overlaps with subsequent patents addressing specific disease indications (e.g., psoriasis, rheumatoid arthritis).

Market Implication and Strategic Value

The patent’s expiration in 2024 leaves room for generic development. Companies may seek to design around the claims by structurally distinct molecules or develop new indications covered by successor patents.

The patent's scope provides broad protection over pyrimidine derivatives targeting cytokine pathways, crucial in autoimmune therapy, affecting generic entry and R&D pipelines.


Key Takeaways

  • US Patent 6,984,403 covers pyrimidine compounds with anti-inflammatory activity, including specific substitutions tailored for cytokine pathway inhibition.
  • Claims encompass compound structures, pharmaceutical compositions, and treatment methods for autoimmune diseases.
  • The patent's family extends patent rights globally; it faces competition from similar compounds patented by rivals.
  • The patent expires in 2024 but remains influential in compound and method patenting strategies for cytokine inhibitors.
  • Open for challenge based on prior art; design-around options exist by modifying claims' structural scope.

FAQs

1. What is the primary therapeutic application claimed in US Patent 6,984,403?
Treatment of inflammatory and autoimmune diseases via pyrimidine derivatives.

2. How broad are the claims in this patent?
They cover specific chemical compounds with substitutions and their use, including various derivatives within the defined structural scope.

3. Are there similar patents from other companies?
Yes. Novartis, GSK, and Sanofi hold patents overlapping in structure and therapeutic targets, creating a complex patent landscape.

4. What is the patent’s current legal status?
It is active until 2024, with potential for challenge or invalidation if prior art evidence is presented.

5. How can competitors navigate around this patent?
By designing structurally distinct compounds outside the scope of claims or developing new therapeutic methods not covered.


References

[1] USPTO Patent Database. US Patent 6,984,403.
[2] Patent family filings in Europe and Japan.
[3] Pfizer's patent portfolio filings focusing on cytokine inhibitors.
[4] Industry analysis on autoimmune drug patent strategies.
[5] Court cases involving patent validity in pharmaceutical patents.

More… ↓

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Drugs Protected by US Patent 6,984,403

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 6,984,403

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 2218 ⤷  Start Trial
Argentina 045630 ⤷  Start Trial
Austria 407663 ⤷  Start Trial
Australia 2004216676 ⤷  Start Trial
Brazil PI0403935 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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