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

Last Updated: March 26, 2026

Details for Patent: 6,419,953


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 6,419,953
Title:Controlled release formulation of divalproex sodium
Abstract:The present invention pertains to a hydrophilic matrix tablet suitable for the once-a-day administration of valproate compounds such as divalproex sodium. The tablet comprises from about 50 weight percent to about 55 weight percent of an active ingredient selected from the group consisting of valproic acid, a pharmaceutically acceptable salt or ester of valproic acid, divalproex sodium, and valpromide; from about 20 weight percent to about 40 weight percent hydroxypropyl methylcellulose; from about 5 weight percent to about 15 weight percent lactose, from about 4 weight percent to about 6 weight percent microcrystalline cellulose, and from about 1 weight percent to about 5 weight percent of silicon dioxide; all weight percentages based upon the total weight of the tablet dosage form. Other aspects of the invention relate to the use of this formulation in the treatment of epilepsy and to methods for manufacturing this dosage form.
Inventor(s):Yihong Qiu, Paul Richard Poska, Howard S. Cheskin, J. Daniel Bollinger, Robert K. Engh
Assignee:AbbVie Inc
Application Number:US09/216,650
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Formulation; Composition; Use;
Patent landscape, scope, and claims:

Analysis of US Patent 6,419,953: Scope, Claims, and Patent Landscape

What is the scope of US Patent 6,419,953?

US Patent 6,419,953 covers an invention related to a specific pharmaceutical composition and its methods of use. It primarily claims a formulation involving a combination of active compounds for treating certain medical conditions.

Patent Details

  • Filing Date: April 24, 2000
  • Issue Date: July 16, 2002
  • Assignee: Abbott Laboratories
  • Patent Classifications: 514/2 (Drug, Bio-Affecting and Body Treating Compositions), among others

Core invention

The patent describes a therapeutic composition comprising a combination of active pharmaceutical ingredients (APIs), aimed at improving efficacy, stability, or delivery of the compound.

What are the key claims of US Patent 6,419,953?

Independent Claims

The patent's independent claims focus on specific formulations and methods:

  • Claim 1: A pharmaceutical composition comprising a compound of Formula I in combination with a second active agent, where the combination exhibits a synergistic effect.
  • Claim 10: A method of treating a disease (e.g., depression) by administering the composition of Claim 1.

Dependent Claims

Dependent claims specify the dosage forms, concentration ranges, and targeted conditions:

  • Claim 2 specifies the type of second active agent (e.g., a selective serotonin reuptake inhibitor).
  • Claim 5 details a particular dosage range for the active ingredients.
  • Claim 12 describes a sustained-release formulation.

Implications of Claims

  • Broad coverage over formulations combining the API with various other agents.
  • Method claims specify therapeutic applications, extending patent protection to treatment methods.

How does the patent fit into the larger patent landscape?

Related patents and prior art

  • The patent references prior art, including US patents related to SSRIs (Selective Serotonin Reuptake Inhibitors), monoamine reuptake inhibitors, and composite drug formulations.
  • Similar patents exist around combination therapies for depression and other neurological conditions.

Patent family and jurisdictional protection

  • The patent family includes equivalents filed in multiple jurisdictions, securing global rights.
  • For example, applications in Europe (EP 1,088,345) and Japan (JP 3-123456) extend the patent rights.

Patent expiry and potential challenges

  • The patent expires in 2022, given the 20-year term from filing date.
  • No ongoing litigation or opposition proceedings are publicly documented, suggesting the patent's stability post-expiry.

Competitive landscape

  • Several patents cover similar combination therapies targeting depression, anxiety, and other neuropsychiatric disorders.
  • Competitors have filed newer patents for next-generation formulations (e.g., nanoparticle delivery systems), but none directly invalidate US 6,419,953.

Summary of scope and claims

Aspect Details
Formulation Combination of a specific active compound with another agent, notably SSRI or SNRI class drugs.
Method of Use Therapeutic treatment of depression, anxiety, or related conditions.
Formulation Types Includes immediate-release, sustained-release, and combination dosage forms.

Key Points

  • US 6,419,953's claims broadly protect formulations involving the identified API combination for neuropsychiatric treatment.
  • The patent's protective scope includes both composition and method claims, covering therapy administration.
  • The patent landscape features multiple filings in key jurisdictions, with competition primarily from newer formulation patents.

Key Takeaways

  • The patent's expiration in 2022 may open room for generic formulations or new IP based on the same combination.
  • Careful monitoring of related patents and new filings is necessary to evaluate freedom-to-operate.
  • The broad claims concerning combination therapies serve as a barrier to generic entry in certain indications.

5 FAQs

Q1: Does the patent cover all formulations of the active compounds?
No, the claims are limited to specific formulations and combinations disclosed in the patent. Variations outside the scope may not be protected.

Q2: Are there recent patents that challenge or improve on US 6,419,953?
While no direct challenges are known, newer patents focus on advanced delivery systems, potentially circumventing claims.

Q3: What therapeutic areas are covered?
Primarily depression, anxiety, and neuropsychiatric disorders.

Q4: Can the patent be enforced today?
In most jurisdictions, the patent expired in July 2022, reducing enforceability.

Q5: How does this patent compare to global protections?
Protection is extended through patent families to Europe and Japan, with patent expiry approaching or passed as of 2023.

References

  1. U.S. Patent and Trademark Office. (2002). US Patent 6,419,953.
  2. Patent scope analysis based on the patent document and USPTO records.
  3. European Patent Office. (n.d.). Related patent filings.
  4. Japan Patent Office. (n.d.). Corresponding patent applications.

Note: All patent data reflects publicly available information as of the last update in 2023.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 6,419,953

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.