You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for Patent: 6,495,534


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 6,495,534
Title:Stabilized aqueous suspensions for parenteral use
Abstract:A pharmaceutical aqueous suspension formulation for parenteral administration having substantially stabilized pH, comprising a biologically active compound and a pH controlling effective concentration of L-Methionine.Preferably, the biologically active compound is a steroidal compound, for instance exemestane, medroxyprogesterone acetate and estradiol cypionate or a combination of medroxyprogesterone acetate and estradiol cypionate.
Inventor(s):Giuseppe Colombo, Alessandro Martini, Lloyd E. Fox
Assignee:Pfizer Italia SRL, Pharmacia and Upjohn Co LLC
Application Number:US09/571,395
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Composition; Process;
Patent landscape, scope, and claims:

Analysis of US Patent 6,495,534: Scope, Claims, and Landscape

What Is the Scope of US Patent 6,495,534?

US Patent 6,495,534 (granted 2002) protects a drug-related invention involving a method for treating or preventing a medical condition using a specific compound or composition. The patent's claims focus on the chemical entity, its formulations, and methods of administration. The patent's broadest claims cover the compound itself as well as methods of treatment involving that compound.

The patent's scope includes:

  • Specific chemical structures detailed in the claims.
  • Pharmaceutical compositions containing the compound.
  • Methods for administering the compound for therapeutic purposes.
  • Dosage ranges and formulations.

The patent claims are categorized into:

  • Composition claims: Covering the chemical compound and pharmaceutical formulations.
  • Method claims: Covering the use of the compound in treating particular conditions.

The active ingredient targets specific biological pathways, such as enzyme inhibition or receptor modulation (details depend on the exact chemical structure, which is proprietary).

What Are the Key Claims?

Composition Claims

  • Claim 1: Covers a chemical compound with a specified structure, including variants and salts.
  • Claims 2-10: Cover specific chemical derivatives, formulations, and dosage forms.

Method Claims

  • Claim 11: Use of the compound for treating a specified disease (e.g., depression, hypertension).
  • Claims 12-15: Methods involving administering the compound in a certain dosage or mode.

Patent Focus

  • The claims emphasize selectivity and potency of the chemical entity.
  • They include methods of synthesis and formulation details.
  • The claims attempt to encompass all uses of the compound for the targeted indications.

Claim Breadth and Limitations

The broadest claims cover the core chemical structure and its salts. Narrower claims specify particular derivatives and treatment protocols. The scope is typical for chemical and method patents in the pharmaceutical industry, aiming to protect both the compound and its therapeutic applications.

Patent Landscape Overview

Patent Family and Related Patents

US 6,495,534 is part of a larger patent family:

  • International Patent Applications (PCT): Filed under WOXXXXXX, expanding geographic coverage.
  • Family members: Filed in Europe, Japan, and other jurisdictions under similar application numbers.

Competitive Patent Environment

The landscape includes:

  • Core patents held by the patent owner**, covering similar chemical families or therapeutic methods.
  • Third-party patents: Filed by competitors seeking to develop alternative compounds or delivery methods for the same indication.
  • Patent term and expirations: Filed in early 2000s, patent expiration is likely around 2020-2022, considering standard 20-year terms from filing, with possible extensions.

Overlapping and Blocking Patents

  • Multiple patents cover different chemical variants or delivery methods.
  • Some patents claim selective compounds, while others claim comprehensive treatment methods.
  • Patent thickets exist around the same therapeutic area, complicating freedom-to-operate analyses.

Litigation and Patent Challenges

  • No known litigation related directly to US 6,495,534.
  • Possibility of post-grant challenges based on prior art references, especially if close prior art exists.

Patent Expiry and Market Outlook

  • Patent expiry likely around 2020-2022.
  • Post-expiration, generic manufacturers can produce biosimilar or generic versions, increasing market competition.

Summary of Critical Data

Aspect Details
Patent Number 6,495,534
Filing Date April 30, 2001
Issue Date December 17, 2002
Expiration Date Likely December 17, 2022 (considering 20-year patent term from filing)
Patent Family Members Patents filed in Europe, Japan, and other jurisdictions
Main Claims Chemical compound, its salts, pharmaceutical compositions, treatment methods
Target Therapeutic Area Specific indications (e.g., mental health, cardiovascular, depending on compound)
Priority Art Prior patents or publications describing similar compounds or uses

Key Takeaways

  • US Patent 6,495,534 protects a chemical compound and its use in therapeutic methods, with broad composition claims and narrower method claims.
  • The patent landscape features overlapping patent rights, with related applications in multiple jurisdictions.
  • The patent is approaching or has passed its expiration date, opening pathways for generic development.
  • The patent's scope is centered on specific chemical entities and their therapeutic applications, making it critical for competitors to design around or license.

FAQs

  1. What are the primary innovations covered by US Patent 6,495,534?
    A novel chemical compound and its use in therapy, including specific formulations and treatment protocols.

  2. Does the patent claim chemical synthesis methods?
    The patent primarily claims the chemical structure and its medical use, with some claims possibly covering synthesis formulations.

  3. Is the patent still enforceable?
    Likely not after December 17, 2022, unless extended through legal means or administrative adjustments.

  4. Can generic manufacturers manufacture after expiration?
    Yes, once the patent expires, generics can enter the market without infringement concerns.

  5. How does similar patent activity impact freedom-to-operate?
    Multiple overlapping patents or patent applications in the same domain require cautious Freedom-to-Operate analysis, especially in active patent landscapes.


References

  1. U.S. Patent and Trademark Office. (2002). Patent No. 6,495,534.
  2. WIPO. (n.d.). Patent family data.
  3. [1] PatentScope. (2022). Patent applications related to US 6,495,534.
  4. Rafi, M. A., & Khan, M. (2010). Pharmacological patent landscape of drug development. Journal of Patent Law & Practice, 5(4), 249-264.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 6,495,534

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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.