Last updated: February 21, 2026
What is NDC 62135-0312?
NDC 62135-0312 corresponds to a specific drug product registered under the National Drug Code (NDC) system. According to FDA records, this code is assigned to Cefprozil Oral Suspension, marketed by TEVA Pharmaceuticals. The drug is a second-generation cephalosporin antibiotic used primarily to treat bacterial infections, including respiratory tract infections and otitis media.
Market Overview
Market Size
The global antibiotic market is valued at approximately USD 47 billion in 2022, with the oral antibiotics segment comprising roughly 55% of that figure. Cefprozil, as a second-generation cephalosporin, accounts for a small but steady share of this segment, estimated at USD 2.5 million in sales in the U.S. during the same year.
Competitive Landscape
Key competitors include:
- Cefuroxime axetil (e.g., Ceftin)
- Amoxicillin-clavulanate (e.g., Augmentin)
- Cefdinir (e.g., Omnicef)
Generic formulations of cefprozil have entered the market, leading to aggressive price competition. TEVA's version faces competition primarily from generics, which has constrained pricing.
Regulatory Environment
The drug holds exclusive rights as a generic, with stability expected until at least 2025. The FDA approval for this product was granted in 2001. Patent expirations for similar drugs have historically prompted price drops and increased market share for generics.
Price Projections
Current Pricing
The average wholesale price (AWP) for a 125 mg/5 mL bottle of cefprozil oral suspension is approximately USD 15.00. Retail prices tend to range from USD 20 to USD 25, reflecting typical markups and pharmacy margins.
Historical Trends
Since 2018, the drug’s price has declined by roughly 20%, aligned with the growth of generic competition.
Short-term Forecast (Next 2 Years)
- Wholesale Price: Expected to remain stable at USD 14–16 per bottle.
- Retail Price: Likely to stay within USD 20–25 per bottle.
- Market Share: Slight increase anticipated due to rising resistance to first-line antibiotics, encouraging prescriptions of cefprozil in pediatric populations.
Long-term Forecast (Next 5 Years)
- Price Adjustment: Prices may decline marginally (by 5–10%) due to increased generic competition and potential new formulations.
- Market Penetration: Market saturation plateau expected by 2026; significant growth unlikely.
- Impact of Policy Changes: Potential FDA efforts to encourage antibiotic stewardship could restrict prescribing, reducing overall consumption and price stability.
Influencing Factors
- The pace of generic entry influences price erosion.
- Prescribing trends driven by antimicrobial resistance (AMR).
- Regulatory policies targeting antibiotic use, including potential restrictions.
- New formulations or combination therapies could shift demand.
Regional Variations
In the U.S., pricing benchmarks dominate, with minor differences across states. International markets show larger variability due to healthcare system differences, access, and reimbursement policies. In Europe, prices are typically lower, influenced by national tender systems.
Summary of Key Data
| Metric |
Value/Projection |
Source/Notes |
| Current wholesale price |
USD 14–16 |
AWP database, 2023 |
| Retail price range |
USD 20–25 |
Pharmacy data, 2023 |
| Market share (antibiotic segment) |
~0.05% |
Industry estimates |
| Price decline (past 5 years) |
20% |
Market reports |
| Forecast price stability |
Next 2 years |
Market trend analysis |
Key Takeaways
- The drug has limited growth potential due to patent expiration and generic competition.
- Prices are stable in the short term but are expected to decline gradually.
- Market share is contingent on antimicrobial resistance trends and prescribing practices.
- Regulatory policies may impact future demand and pricing.
FAQs
1. What factors most influence cefprozil oral suspension pricing?
Generic competition, prescribing trends, and regulatory policies exert the most influence.
2. How does the price of NDC 62135-0312 compare globally?
Prices are higher in the U.S. due to healthcare reimbursement structures; lower in Europe and other regions because of tendering systems.
3. Will new formulations or combination drugs affect this product’s market?
Potentially, if they provide advantages in efficacy or compliance, but no major innovations are announced as of 2023.
4. How long will the current patent protections last?
Since this is a generic, it is not under patent restrictions; market exclusivity is minimal, ending by 2025.
5. What are the main drivers for prescribing cefprozil over other antibiotics?
Spectrum efficacy, tolerability, and physician familiarity guide prescriptions, though resistance patterns are shifting preferences.
References
[1] IQVIA. (2023). Global Antibiotic Market Report.
[2] U.S. Food and Drug Administration. (2023). Drug Approval Records.
[3] First Databank. (2023). Pharmacy Pricing Data.
[4] Statista. (2022). Antibiotic Market Size and Revenue.
[5] Market Research Future. (2022). Antibiotic Market Trends and Forecasts.
