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Last Updated: April 22, 2025

Details for Patent: 5,045,321


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Summary for Patent: 5,045,321
Title: Stabilized pharmaceutical composition and its production
Abstract:The pharmaceutical composition of the invention, which comprises a benzimidazole compound of the formula ##STR1## wherein R.sup.1 is hydrogen, alkyl, halogen, cyano, carboxy, carboalkoxy, carboalkoxyalkyl, carbamoyl, carbamoylaklyl, hydroxy, alkoxy, hydroxyalkyl, trifluoromethyl, acyl, carbamoyloxy, nitro, acyloxy, aryl, aryloxy, alkylthio or alkylsulfinyl, R.sup.2 is hydrogen, alkyl, acyl, carboalkoxy, carbamoyl, alkylcarbamoyl, dialkylcarbamoyl, alkylcarbonylmethyl, alkoxycarbonylmethyl or alkylsulfonyl, R.sup.3 and R.sup.5 are the same or different and each is hydrogen, alkyl, alkoxy or alkoxyalkoxy, R.sup.4 is hydrogen, alkyl, alkoxy which may optionally be fluorinated, or alkoxyalkoxy, and m is an integer of 0 through 4, and a basic inorganic salt of magnesium and/or a basic inorganic salt of calcium, is physically stable.
Inventor(s): Makino; Tadashi (Osaka, JP), Tabata; Tetsuro (Osaka, JP), Hirai; Shin-ichiro (Kyoto, JP)
Assignee: Takeda Chemical Industries, Ltd. (Osaka, JP)
Application Number:07/014,303
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope and Claims of United States Patent 5,045,321

Introduction

United States Patent 5,045,321, titled "Stabilized pharmaceutical composition and its production," is a significant patent in the pharmaceutical industry. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Title and Description

The patent, assigned to Flamel Technologies SA, describes a stabilized pharmaceutical composition and its production method. The composition involves a benzimidazole compound, which is commonly used for antiulcer treatments[4].

Priority and Publication Dates

The patent was filed on January 11, 1990, and granted on September 3, 1991. The priority date is not explicitly mentioned in the provided sources, but it is typical for patents to have a priority date that precedes the filing date.

Assignees and Current Status

The patent was originally assigned to Flamel Technologies SA. As of the current date, the patent has expired, which is a common outcome for patents that have reached the end of their 20-year term from the filing date[4].

Claims Analysis

Independent and Dependent Claims

The patent includes several claims that define the scope of the invention. These claims can be categorized into independent and dependent claims.

  • Independent Claims: These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe the stabilized pharmaceutical composition comprising a benzimidazole compound in a specific form[4].

  • Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For instance, a dependent claim might specify the type of coating or the method of preparing the microcapsules[4].

Claim Scope and Limitations

The claims in this patent are focused on the specific formulation and production method of the stabilized pharmaceutical composition. Key aspects include:

  • The use of benzimidazole compounds with specific substituents.
  • The formulation of these compounds into microcapsules or other specific physical forms.
  • The method of stabilizing these compositions, which may involve particular excipients or coating layers[4].

Classification and Categorization

International Patent Classification (IPC)

The patent is classified under various IPC categories, including:

  • A61K9/1611—Inorganic compounds
  • A61K9/48—Preparations in capsules
  • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling[4].

These classifications help in identifying the patent's relevance to specific areas of medical science and hygiene.

Patent Landscape

Related Patents and Applications

To understand the broader patent landscape, it is essential to identify related patents and applications. This can be done using tools like the USPTO's Patent Public Search or international databases such as the European Patent Office's esp@cenet or the World Intellectual Property Organization's PATENTSCOPE[1].

  • Patent Family: The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices[1].

  • Citation Analysis: Tools like the Common Citation Document (CCD) consolidate prior art citations from multiple offices, helping to visualize the citation landscape for the same invention across different jurisdictions[1].

Industry Trends and Competitors

The pharmaceutical industry is highly competitive, with numerous companies and research institutions actively filing patents for new formulations and production methods.

  • Market Impact: Patents like US 5,045,321 have significant market impact, especially in the antiulcer treatment segment. They can influence the development of new drugs and formulations by other companies[4].

  • Competitor Analysis: Companies like Flamel Technologies SA often engage in extensive patent filings to protect their intellectual property. Analyzing the patent portfolios of competitors can provide insights into industry trends and potential future developments.

Legal and Regulatory Aspects

Patent Litigation and PTAB Cases

Patents can be subject to legal challenges, including Patent Trial and Appeal Board (PTAB) cases. For US 5,045,321, any PTAB cases or litigation would be documented and available through legal databases such as Law360[5].

  • PTAB Cases: These cases involve challenges to the patent's validity and can provide insights into the patent's strength and the legal landscape surrounding it.

Expiration and Public Domain

Since the patent has expired, the technology described is now in the public domain. This means that anyone can use the described methods and compositions without infringing on the original patent[4].

Practical Applications and Impact

Pharmaceutical Formulations

The stabilized pharmaceutical composition described in the patent has practical applications in the treatment of ulcers and other gastrointestinal disorders. The use of microcapsules and specific excipients enhances the stability and efficacy of the benzimidazole compounds[4].

Research and Development

This patent can serve as a foundation for further research and development in pharmaceutical formulations. Researchers can build upon the described methods to create new and improved formulations.

Key Takeaways

  • Patent Scope: The patent covers a specific stabilized pharmaceutical composition and its production method, focusing on benzimidazole compounds.
  • Claims Analysis: The claims are structured to protect the broadest scope of the invention while providing detailed limitations.
  • Classification: The patent is classified under relevant IPC categories related to medical science and hygiene.
  • Patent Landscape: Understanding related patents and applications is crucial for navigating the competitive pharmaceutical industry.
  • Legal Aspects: The patent's expiration and any PTAB cases are important for legal and regulatory compliance.
  • Practical Applications: The patent has significant practical applications in the treatment of ulcers and other gastrointestinal disorders.

FAQs

What is the main subject of United States Patent 5,045,321?

The main subject of United States Patent 5,045,321 is a stabilized pharmaceutical composition and its production method, specifically involving benzimidazole compounds.

Who was the original assignee of the patent?

The original assignee of the patent was Flamel Technologies SA.

What is the current status of the patent?

The patent has expired, as it has reached the end of its 20-year term from the filing date.

How can one search for related patents and applications?

One can use tools like the USPTO's Patent Public Search, the European Patent Office's esp@cenet, or the World Intellectual Property Organization's PATENTSCOPE to search for related patents and applications.

What are the practical applications of the patent?

The patent has practical applications in the treatment of ulcers and other gastrointestinal disorders, enhancing the stability and efficacy of benzimidazole compounds through specific formulations.

Where can one find information on PTAB cases related to this patent?

Information on PTAB cases related to this patent can be found through legal databases such as Law360.

Sources

  1. USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
  2. Unified Patents Portal - US5045321-A. Retrieved from https://portal.unifiedpatents.com/patents/patent/US-5045321-A
  3. USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Google Patents - US5045321A. Retrieved from https://patents.google.com/patent/US5045321A/en
  5. Law360 - Ptab Cases :: 5,045,321. Retrieved from https://www.law360.com/patents/5045321/ptab_cases

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Drugs Protected by US Patent 5,045,321

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
No data available in table
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Patented / Exclusive Use>Submissiondate
Showing 0 to 0 of 0 entries

Foreign Priority and PCT Information for Patent: 5,045,321

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan61-29567Feb 13, 1986
Japan61-38059Feb 21, 1986

International Family Members for US Patent 5,045,321

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Bulgaria 61202 ⤷  Try for Free
Canada 1327010 ⤷  Try for Free
Canada 1338377 ⤷  Try for Free
Canada 1338399 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 4 of 4 entries

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