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Last Updated: December 22, 2024

Cefprozil - Generic Drug Details


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What are the generic drug sources for cefprozil and what is the scope of patent protection?

Cefprozil is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma, Chartwell Rx, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, Sandoz, Corden Pharma, Alkem Labs Ltd, Teva, and Wockhardt, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for cefprozil. Seven suppliers are listed for this compound.

Summary for cefprozil
Drug Prices for cefprozil

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Drug Sales Revenue Trends for cefprozil

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Recent Clinical Trials for cefprozil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Affiliated Hospital of Qingdao UniversityPhase 1
University of LouisvilleEarly Phase 1
James Graham Brown Cancer CenterEarly Phase 1

See all cefprozil clinical trials

US Patents and Regulatory Information for cefprozil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Corden Pharma CEFZIL cefprozil FOR SUSPENSION;ORAL 050665-001 Dec 23, 1991 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz CEFPROZIL cefprozil FOR SUSPENSION;ORAL 065257-002 Dec 8, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma CEFPROZIL cefprozil FOR SUSPENSION;ORAL 065381-002 Jan 30, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma CEFPROZIL cefprozil TABLET;ORAL 065340-001 May 24, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Cefprozil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cefprozil

Introduction to Cefprozil

Cefprozil, a broad-spectrum oral cephalosporin antibiotic, is widely used to treat various bacterial infections. It belongs to the class of medicines known as cephalosporin antibiotics and works by killing bacteria or preventing their growth[4].

Market Size and Growth

The global cefprozil market has been experiencing steady growth, driven by increasing demand for effective antibiotics. As of 2024, the global cefprozil market size was valued at USD 0.15 billion. This market is projected to grow and reach USD 0.19 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of approximately 3.3% during this period[1][3].

Driving Factors

Several factors are driving the growth of the cefprozil market:

Increased Awareness and Use

The growing awareness about bacterial infections and the need for effective treatments has led to an increased use of cefprozil. This antibiotic is particularly effective in treating infections in various parts of the body, which has contributed to its market growth[1].

Medical Necessity

Cefprozil's efficacy in combating bacterial infections makes it a necessary medication in many healthcare settings. Its broad-spectrum activity against a wide range of bacteria ensures it remains a preferred choice for treating infections such as otitis media, sinusitis, skin infections, and sore throats[4].

Pharmaceutical Advancements

Continuous advancements in pharmaceutical technology and the development of new formulations (such as tablets and powder for suspension) have made cefprozil more accessible and user-friendly, further boosting its market[4].

Key Players in the Market

The cefprozil market is dominated by several key players, including:

  • Orchid
  • Taj Pharma
  • Dhanuka
  • Lupin
  • Alkem
  • Corden Pharma
  • Aurobindo
  • Covalent
  • TEVA GROUP
  • Hetero Drugs
  • Qilu Antibiotics
  • Dongying Pharma
  • Union Chempharma
  • Huafang Pharma
  • Topfond[1].

These companies play a crucial role in manufacturing, distributing, and marketing cefprozil, contributing to its global availability and market growth.

Market Segmentation

The cefprozil market is segmented based on several factors, including:

By Formulation

  • Tablets
  • Powder for Suspension

This segmentation helps in catering to different patient needs, particularly in pediatric and geriatric populations[4].

By Application

  • Otitis Media (Ear Infections)
  • Sinusitis
  • Skin Infections
  • Sore Throats and Tonsillitis
  • Bronchitis

Each application area has its own market dynamics and growth prospects, driven by the prevalence of these infections and the effectiveness of cefprozil in treating them[4].

By Geography

The market is also segmented geographically, with different regions exhibiting varying growth rates. The global report delves into the expected growth trajectory across different regions, highlighting opportunities and challenges specific to each area[5].

Pharmacokinetics and Dosage

Understanding the pharmacokinetics of cefprozil is crucial for its effective use. Here are some key points:

Absorption and Distribution

Cefprozil is composed of cis and trans isomers in an approximate 90:10 ratio. The maximum plasma concentration of the cis isomer varies based on renal function, ranging from 12.3 micrograms/mL in subjects with normal renal function to 36.7 micrograms/mL in hemodialysis patients[2].

Elimination

The elimination half-life and renal clearance of cefprozil are significantly affected by renal function. In patients with severe renal impairment, the elimination half-life increases, and renal clearance decreases, necessitating dose adjustments[2].

Dosage Recommendations

The dosage of cefprozil varies based on the type of infection and the patient's age and weight. For example, for skin infections, adults and teenagers typically take 250 to 500 mg every 12 hours or 500 mg once a day for 10 days. Children's doses are determined based on body weight[4].

Side Effects and Precautions

While cefprozil is generally effective, it can cause several side effects, including:

Common Side Effects

  • Diarrhea
  • Unpleasant breath odor
  • Vomiting

Serious Side Effects

  • Black, tarry stools
  • Chest pain
  • Shortness of breath
  • Yellow eyes or skin

It is crucial to monitor patients for these side effects and adjust the dosage or treatment plan as necessary. Patients with a history of colitis, severe diarrhea, or kidney disease require special caution[4].

Regional Growth Prospects

The cefprozil market is expected to grow across different regions globally. Here are some key regional insights:

North America

This region is expected to remain a significant market due to high healthcare spending and advanced pharmaceutical infrastructure.

Europe

Europe is another major market, driven by a large patient population and stringent healthcare regulations that ensure the quality and efficacy of antibiotics.

Asia-Pacific

The Asia-Pacific region is anticipated to show rapid growth due to increasing healthcare expenditure, a large population, and growing awareness about bacterial infections[5].

Challenges and Opportunities

Challenges

  • Resistance to Antibiotics: The increasing resistance to antibiotics poses a significant challenge to the cefprozil market.
  • Regulatory Hurdles: Strict regulatory requirements can slow down the approval and launch of new formulations.
  • Competition: The presence of other antibiotics and generic versions can compete with cefprozil for market share.

Opportunities

  • Emerging Markets: Expanding into emerging markets offers significant growth opportunities.
  • Research and Development: Continuous R&D can lead to new formulations and improved efficacy, enhancing market position.
  • Public Health Initiatives: Government initiatives to combat bacterial infections can increase the demand for effective antibiotics like cefprozil[5].

Financial Trajectory

The financial trajectory of the cefprozil market is positive, with steady growth projected over the next several years.

Revenue Projections

The market is expected to grow from USD 0.15 billion in 2024 to USD 0.19 billion by 2032, with a CAGR of approximately 3.3%[1][3].

Investment Opportunities

Investors can look into pharmaceutical companies that manufacture and distribute cefprozil, as well as research initiatives aimed at improving antibiotic efficacy and reducing resistance.

Key Takeaways

  • Market Growth: The cefprozil market is expected to grow at a CAGR of 3.3% from 2024 to 2032.
  • Driving Factors: Increased awareness, medical necessity, and pharmaceutical advancements are key drivers.
  • Key Players: Several major pharmaceutical companies dominate the market.
  • Pharmacokinetics: Understanding the pharmacokinetics is crucial for effective dosing, especially in patients with renal impairment.
  • Regional Prospects: Growth is anticipated across various regions, with emerging markets offering significant opportunities.

FAQs

What is the expected market size of cefprozil by 2032?

The cefprozil market is expected to reach USD 0.19 billion by 2032[1].

What is the CAGR of the cefprozil market from 2024 to 2032?

The cefprozil market is expected to exhibit a CAGR of approximately 3.3% from 2024 to 2032[1][3].

Which companies are the top players in the cefprozil market?

Top companies include Orchid, Taj Pharma, Dhanuka, Lupin, Alkem, and several others[1].

What are the common side effects of cefprozil?

Common side effects include diarrhea, unpleasant breath odor, and vomiting. Serious side effects can include black, tarry stools, chest pain, and shortness of breath[4].

How does renal function affect the pharmacokinetics of cefprozil?

Renal function significantly affects the elimination half-life and renal clearance of cefprozil. Patients with severe renal impairment require dose adjustments to maintain therapeutic plasma concentrations[2].

Sources

  1. Business Research Insights: Cefprozil Market Growth, Industry Trends | Forecast 2032
  2. PubMed: Pharmacokinetics of cefprozil in healthy subjects and patients with renal impairment
  3. News Channel Nebraska: Global Cefprozil Market [2024-2032] | Expected To Grow Across Different Regions Globally
  4. Mayo Clinic: Cefprozil (oral route) - Mayo Clinic
  5. WICZ: Cefprozil Market Research 2024: Industry Revenue, Future Demand and Regional Growth Prospects to 2032

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