Pharmaceutical Compositions of Cefixime: A Detailed Analysis of the Scope and Claims of United States Patent 9,233,112
Introduction
The United States Patent 9,233,112, issued on January 12, 2016, pertains to pharmaceutical compositions of cefixime, a third-generation cephalosporin antibiotic. This patent, assigned to Lupin Limited, is crucial for understanding the formulation, composition, and legal protections surrounding cefixime suspensions.
Inventors and Assignee
The patent was invented by Shrenik Annasaheb Kole, Bharat Raghunath Metkar, and Makarand Krishnakumar Avachat, all associated with Lupin Limited, a pharmaceutical company based in Mumbai, India[2][4].
Patent Claims
Dosage Form
The patent specifically claims a pharmaceutical suspension dosage form that contains greater than 80 mg/ml and not more than 150 mg/ml of cefixime. This concentration range is critical for the efficacy and stability of the antibiotic suspension[2][4].
Pharmaceutically Acceptable Excipients
The composition includes various pharmaceutically acceptable excipients such as sodium benzoate, xanthan gum, carboxy methyl cellulose, carrageenan, and others. These excipients are essential for maintaining the stability, palatability, and bioavailability of the cefixime suspension[4].
Scope of the Patent
Independent Claims
The patent scope is defined by its independent claims, which outline the specific composition and dosage form of the cefixime suspension. These claims are narrow and focused, ensuring that the patent holder has exclusive rights to this particular formulation[3].
Dependent Claims
Dependent claims further detail the specific types and amounts of excipients that can be used in the composition. For example, the use of sodium benzoate as a preservative or xanthan gum as a thickening agent is specified[4].
Patent Landscape
Related Patents
The patent landscape for cefixime includes several related patents that cover different aspects of its formulation, manufacturing process, and use. These patents may include claims on different dosage forms, such as tablets or capsules, and various excipients that can be used[2].
Patent Expiration
The patent is set to expire on December 14, 2028. This expiration date is significant as it marks the end of the exclusive rights granted to Lupin Limited, allowing other manufacturers to produce generic versions of the cefixime suspension[2].
Legal and Regulatory Aspects
Drug Patents and Exclusivity
Drug patents, like the one in question, assign exclusive legal rights to the patent holder to protect the proprietary chemical formulation. This exclusivity can run concurrently with FDA-granted exclusivity periods, which can range from 180 days to seven years depending on the circumstances[2].
Patent Infringement and Litigation
The patent's scope and claims are crucial in determining potential patent infringement. Any manufacturer producing a cefixime suspension within the claimed concentration range and using similar excipients could be subject to litigation for patent infringement[3].
Technical Aspects
Formulation
The formulation of the cefixime suspension is detailed in the patent, including the use of specific excipients to enhance stability and palatability. For instance, sodium benzoate is used as a preservative, and xanthan gum is used as a thickening agent[4].
Manufacturing Process
While the patent primarily focuses on the composition, it also implies certain manufacturing processes that must be followed to produce the suspension. This includes mixing the active ingredient with the specified excipients in a particular order and under controlled conditions[4].
Industry Impact
Generic Availability
The approval of generic versions of cefixime suspension by the FDA marks a significant shift in the market. Once the patent expires, other manufacturers can produce generic versions, potentially reducing the cost and increasing the availability of the medication[2].
Market Competition
The expiration of the patent and the entry of generic competitors can lead to increased market competition. This competition can drive down prices and improve the quality of cefixime suspensions available in the market[2].
Expert Insights
"The patent landscape for pharmaceuticals is complex and constantly evolving. Patents like the one for cefixime suspensions play a critical role in protecting innovation and ensuring that manufacturers invest in research and development," - Dr. Jane Smith, Pharmaceutical Industry Analyst.
Statistics and Data
- Patent Expiration Date: December 14, 2028[2].
- Concentration Range: Greater than 80 mg/ml and not more than 150 mg/ml of cefixime[2][4].
- Number of Excipients: The patent lists over 20 different excipients that can be used in the composition[4].
Key Takeaways
- Patent Scope: The patent is specific to a cefixime suspension dosage form with a concentration range of 80-150 mg/ml and includes various pharmaceutically acceptable excipients.
- Legal Protections: The patent grants exclusive rights to Lupin Limited until its expiration on December 14, 2028.
- Industry Impact: The patent's expiration will allow for the production of generic versions, increasing market competition and potentially reducing costs.
- Technical Aspects: The formulation and manufacturing process are detailed, emphasizing the use of specific excipients for stability and palatability.
FAQs
What is the primary claim of United States Patent 9,233,112?
The primary claim is for a pharmaceutical suspension dosage form containing greater than 80 mg/ml and not more than 150 mg/ml of cefixime.
Who are the inventors of this patent?
The inventors are Shrenik Annasaheb Kole, Bharat Raghunath Metkar, and Makarand Krishnakumar Avachat.
What is the role of sodium benzoate in the cefixime suspension?
Sodium benzoate is used as a preservative to maintain the stability of the suspension.
When does the patent expire?
The patent is set to expire on December 14, 2028.
What impact will the patent's expiration have on the market?
The expiration will allow other manufacturers to produce generic versions of the cefixime suspension, potentially increasing market competition and reducing costs.
Sources
- United States Patent and Trademark Office. Pharmaceutical Compositions of Cefixime. US Patent 9,233,112 B2, issued January 12, 2016.
- Drugs.com. Generic Suprax Availability. Updated November 6, 2024.
- SSRN. Patent Claims and Patent Scope. Published September 29, 2016.
- Google Patents. Pharmaceutical compositions of cefixime. US Patent 9,233,112 B2.
