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

Last Updated: July 10, 2025

Details for Patent: 8,357,394


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,357,394 protect, and when does it expire?

Patent 8,357,394 protects MOXATAG and is included in one NDA.

This patent has eleven patent family members in six countries.

Summary for Patent: 8,357,394
Title:Compositions and methods for improved efficacy of penicillin-type antibiotics
Abstract:Disclosed are once-a-day penicillin-type antibiotic products comprising at least one modified release dosage form comprising penicillin-type antibiotics and pharmaceutically acceptable carriers, which compositions provide T>MIC90 in the serum for at least 5 hours (preferably for at least five consecutive hours), within a 24-hour dosing interval, for a given bacterial pathogen's MIC90, while providing a total dosage of the penicillin-type antibiotic for a 24-hour dosing interval.
Inventor(s):Henry H. Flanner, Robert J. Guttendorf, Susan P. Clausen, Donald Treacy, Beth A. Burnside
Assignee:Shionogi Inc
Application Number:US11/636,291
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

United States Patent 8,357,394: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,357,394, titled "Compositions and methods for improved efficacy of penicillin-type antibiotics," is a significant patent in the pharmaceutical industry, particularly in the realm of antibiotic formulations. This patent, owned by Pragma Pharmaceuticals LLC, addresses critical aspects of penicillin-type antibiotics, enhancing their efficacy and delivery.

Background and Prior Art

The patent builds upon existing knowledge in the field of antibiotic formulations, particularly focusing on penicillin-type antibiotics like amoxicillin. Prior art in this area includes various formulations and delivery methods aimed at improving the efficacy and bioavailability of these antibiotics[1][4].

Scope of the Patent

Compositions

The patent describes various compositions designed to enhance the efficacy of penicillin-type antibiotics. These include:

  • Immediate Release Formulations: Designed to release the antibiotic quickly, ensuring rapid onset of action.
  • Delayed Release Formulations: These can be pH-sensitive or non-pH sensitive, allowing for controlled release of the antibiotic at specific times or conditions.
  • Sustained Release Formulations: Formulations that release the antibiotic over an extended period, maintaining therapeutic levels for a longer duration[1].

Methods

The patent outlines several methods for preparing these formulations, including:

  • Coating Methods: Using coating agents to control the release of the antibiotic.
  • Formulation Techniques: Involving the use of various excipients, polymers, and other materials to achieve the desired release profile[1].

Claims of the Patent

The patent includes several claims that define the scope of protection:

  • Claim 1: A pharmaceutical composition comprising a penicillin-type antibiotic, a methacrylic acid copolymer, and a polyoxyl 35 castor oil, which provides improved efficacy.
  • Claim 2: A method for preparing a sustained-release formulation of a penicillin-type antibiotic using a specific coating process.
  • Claim 3: A dosage form comprising a delayed-release pellet coated with a pH-sensitive polymer[1].

Key Components and Materials

Polymers and Coating Agents

  • Methacrylic Acid Copolymer: Used in sustained-release formulations to control the release of the antibiotic.
  • Polyoxyl 35 Castor Oil: An emulsifying agent that enhances the bioavailability of the antibiotic.
  • Triethyl Citrate: A plasticizer used in the coating process to improve the flexibility of the coating layer[1].

Excipients and Fillers

  • Talc: Used as an anti-caking agent and filler.
  • Granular Materials: Such as beads or pellets, which are coated with the antibiotic and other materials to achieve the desired release profile[1].

Patent Landscape and Exclusivity

Patent Expiration

The patent is set to expire on December 2026, along with other related patents protecting the same active ingredient. This expiration date is crucial for generic drug manufacturers, as it marks the time when they can legally produce generic versions of the drug[2].

Related Patents

Other patents, such as US8299052 and US8778924, also protect aspects of the same drug, including modified release formulations and methods for improved bacterial eradication. These patents collectively form a robust patent landscape that protects the intellectual property of Pragma Pharmaceuticals LLC until their respective expiration dates[2][4].

Impact on the Pharmaceutical Industry

Innovation and Competition

The patent encourages innovation in antibiotic formulations by providing a framework for improving the efficacy of penicillin-type antibiotics. However, it also limits competition by granting exclusivity to the patent holder until the patent expires[1].

Generic Launch

The expiration of this patent, along with others, will pave the way for generic versions of the drug. This is expected to increase competition and potentially reduce the cost of the medication, making it more accessible to a broader population[2].

Legal and Regulatory Considerations

Maintenance and Legal Activities

The patent's life can be affected by various legal activities such as maintenance fee payments, term extensions, or amendments to the claims. These activities are critical in determining the exact expiration date and the timing of generic launches[2].

International Protection

While the patent provides insights into exclusivity within the United States, it is also protected by patents in multiple countries. Understanding the global patent landscape is essential for strategizing market entry and identifying potential generic entry points[2].

Conclusion

United States Patent 8,357,394 is a pivotal patent in the field of penicillin-type antibiotics, offering significant improvements in efficacy and delivery. Its scope and claims provide a comprehensive framework for pharmaceutical companies to develop and market these antibiotics. As the patent approaches its expiration date, it will be crucial for both the patent holder and potential generic manufacturers to monitor the patent landscape closely.

Key Takeaways

  • The patent covers various formulations and methods to improve the efficacy of penicillin-type antibiotics.
  • Key components include methacrylic acid copolymer, polyoxyl 35 castor oil, and triethyl citrate.
  • The patent is set to expire in December 2026, along with related patents.
  • Expiration will allow for generic versions, increasing competition and potentially reducing costs.
  • Understanding the global patent landscape is crucial for market strategy.

FAQs

What is the main focus of United States Patent 8,357,394?

The main focus of this patent is on compositions and methods to improve the efficacy of penicillin-type antibiotics, including immediate release, delayed release, and sustained release formulations.

What are the key components used in the formulations described in the patent?

The key components include methacrylic acid copolymer, polyoxyl 35 castor oil, and triethyl citrate, among others.

When is the patent set to expire?

The patent is set to expire in December 2026.

How does the patent impact the pharmaceutical industry?

The patent encourages innovation in antibiotic formulations but also limits competition by granting exclusivity to the patent holder until its expiration.

What happens after the patent expires?

After the patent expires, generic versions of the drug can be produced, potentially increasing competition and reducing costs.

Cited Sources:

  1. US8357394B2 - Compositions and methods for improved efficacy of penicillin-type antibiotics - Google Patents
  2. Moxatag patent expiration - Pharsight
  3. Patent Analytics - SLWIP
  4. US8299052B2 - Pharmaceutical compositions and methods for improved bacterial eradication - Google Patents

More… ↓

⤷  Try for Free


Drugs Protected by US Patent 8,357,394

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>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 8,357,394

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006321782 ⤷  Try for Free
Australia 2006351475 ⤷  Try for Free
Canada 2635378 ⤷  Try for Free
Canada 2635606 ⤷  Try for Free
China 101563466 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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. 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.