Last updated: March 7, 2026
What is the Drug Identified by NDC 50458-0941?
NDC 50458-0941 corresponds to Baxdela (delafloxacin), an antibiotic used primarily for bacterial skin infections and community-acquired bacterial pneumonia. Approved by the FDA in June 2017, Baxdela is marketed by Melinta Therapeutics. It belongs to the fluoroquinolone class and is administered intravenously and orally.
Current Market Landscape
Indications and Approved Uses
- Bacterial skin and skin structure infections (ABSSSI)
- Community-acquired bacterial pneumonia (CABP)
Competition
Key competitors include:
| Drug Name |
Class |
Indications |
Approval Year |
Market Share (2019-2022) |
| Levofloxacin |
Fluoroquinolone |
ABSSSI, pneumonia |
1996 |
15% |
| Moxifloxacin |
Fluoroquinolone |
Respiratory infections |
1999 |
9% |
| Ciprofloxacin |
Fluoroquinolone |
Various infections |
1987 |
13% |
Market Size (2022)
- Global antibiotic market: Estimated at $45 billion, with fluoroquinolones representing approximately 20% ($9 billion).
- US antibiotic market: Approximate value of $10 billion; fluoroquinolones account for roughly 25%.
Usage Trends
- Antibiotic resistance has increased demand for new agents like Baxdela.
- Prescribing patterns shift toward drugs with favorable safety profiles.
- Growing resistance to older fluoroquinolones boosts interest in delafloxacin.
Price Analysis
Current Pricing
| Formulation |
Price per unit (approximate) |
Notes |
| 200 mg IV vial |
$750 |
Based on wholesale acquisition cost (WAC) |
| 300 mg oral tablet |
$50 |
WAC |
Cost to Healthcare Providers
- IV medication cost compounds with infusion services and monitoring.
- Oral formulations reduce hospitalization costs over time.
Reimbursement Landscape
- Typically reimbursed via Medicare, Medicaid, and private insurance.
- Average reimbursement for Baxdela IV ranges from $600-$800 per dose.
- Formularies favor newer agents with better safety profiles despite higher per-dose costs.
Price Projection Outlook (2023–2028)
Factors Influencing Price Trends
- Market penetration: Limited but growing: Baxter's recent licensing could expand access.
- Resistance patterns: Increased resistance to older fluoroquinolones will sustain demand.
- Competitive dynamics: Introduction of generic versions unlikely before 2030 due to patent protections.
- Regulatory approvals: Pending approvals for additional indications could expand market size.
Projection Scenarios
| Year |
Moderate Growth |
Accelerated Growth |
Possible Price Range (IV) |
Possible Price Range (Oral) |
| 2023 |
$750 |
$750 |
$750 |
$52 |
| 2024 |
$760 |
$770 |
$770 |
$55 |
| 2025 |
$770 |
$800 |
$780 |
$60 |
| 2026 |
$780 |
$830 |
$790 |
$65 |
| 2027 |
$790 |
$860 |
$800 |
$70 |
| 2028 |
$800 |
$890 |
$810 |
$75 |
Note: Prices assume no significant price cuts due to generics, and limited market penetration limits downward pressure.
Strategic Considerations
- Patent protection: Maintains price premiums, expected to expire around 2030.
- Market expansion: Licensing agreements could increase usage in Europe and Asia.
- Safety profile: Its favorable adverse effect profile compared with older fluoroquinolones may sustain higher pricing.
- Pricing pressure: Payers and policymakers' efforts to restrict fluoroquinolone use could impact uptake and pricing.
Key Challenges and Opportunities
- Resistance trends could limit growth but sustain demand for new drugs.
- Potential biosimilar entry post-patent expiry could decrease prices.
- New indications, such as complicated urinary tract infections, in development could broaden market appeal.
Key Takeaways
- Baxdela (delafloxacin) remains a niche antibiotic with a stable but limited market share.
- Current IV pricing averages around $750 per dose; oral forms are substantially cheaper.
- Market growth depends on resistance trends, approval of new indications, and licensing agreements.
- Price projections suggest slight incremental increases through 2028, driven by demand and market expansion.
- Competition, patent expirations, and biosimilar entries pose risks to current pricing power.
FAQs
1. What is the primary therapeutic indication for Baxdela?
It treats bacterial skin infections and community-acquired pneumonia.
2. How does Baxdela compare price-wise to older fluoroquinolones?
It costs approximately 10 times more per dose than generic ciprofloxacin, reflecting its protected patent status and newer safety profile.
3. What factors could lower Baxdela's future price?
Introduction of generics post-patent expiry, biosimilar competition, or downward pricing negotiations by payers.
4. Is Baxdela approved for uses beyond ABSSSI and pneumonia?
As of now, no. Additional indications are in clinical development.
5. How significant is Baxdela's market compared to the overall antibiotic market?
It represents a small fraction, estimated at less than 1% of the global antibiotic market.
References
- FDA. (2017). Baxdela (delafloxacin) prescribing information.
- IQVIA. (2022). Global pharmaceutical market report.
- EvaluatePharma. (2022). Antibiotics market forecast.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement data for antibiotics.
- Melinta Therapeutics. (2023). Company press releases and financial reports.
