Last updated: February 23, 2026
What is NDC 23155-0763?
NDC 23155-0763 corresponds to Baxdela (delafloxacin), an antibiotic developed by Melinta Therapeutics for the treatment of bacterial infections, including skin infections and respiratory conditions. It received FDA approval in June 2017.
Current Market Context
Indications and Usage
- Approved for: Acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
- Market penetration: Limited compared to established antibiotics; primarily used in hospital settings and specific outpatient cases.
Competition Landscape
Key competitors include:
- Levofloxacin (Levaquin)
- Moxifloxacin (Avelox)
- Ciprofloxacin (Cipro)
- Other newer agents such as omadacycline and delafloxacin's close analogs.
Regulatory and Market Factors
- Pricing and reimbursement: Limited publicly available pricing; hospital formulary inclusion is a central driver.
- Pharmacovigilance: Demonstrated safety profile similar to other fluoroquinolones; safety concerns around tendinopathy exist but are manageable.
Price Benchmarks
Current Pricing (Estimate, 2023)
| Parameter |
Range |
Notes |
| Acquisition cost per vial |
$350 - $500 |
Based on wholesale acquisition cost (WAC) estimates. |
| Average treatment course |
7-14 days |
1-2 vials daily, depending on infection severity. |
| Average cost per treatment course |
$2,450 - $14,000 |
For a full course, with 1 vial/day. |
Cost Comparison
| Drug |
Cost per Day |
Treatment Duration |
Estimated Total Cost |
| Baxdela (delafloxacin) |
$350 - $500 |
7-14 days |
$2,450 - $7,000 (7 days); up to $14,000 (14 days) |
| Levaquin (levofloxacin) |
~$10 |
7-14 days |
~$70 - $140 |
| Avelox (moxifloxacin) |
~$20 |
7-14 days |
~$140 - $280 |
Note: Baxdela's higher cost reflects its patent protection and intravenous formulation. Oral bioavailability is high, allowing switch to oral dosing.
Market Projections
Short-term (1-3 years)
- Slow market penetration due to conservative adoption, mainly in hospital-based infectious disease protocols.
- Estimated peak annual sales: $50 - $100 million by 2025, primarily in the U.S.
- Price sensitivity among payers may lead to discounts, potentially reducing revenue.
Long-term (4-10 years)
- Growth driven by expanded indications, resistance to other fluoroquinolones, and potential global expansion.
- Competitive pressures from generics and biosimilars will influence pricing.
- Estimated peak sales figure: $150 - $250 million, assuming successful market expansion and formulary inclusion.
Pricing Trends and Policy Influences
- Price erosion likely as patents expire and generics enter the market.
- Payer negotiations may lead to discounts, especially in outpatient settings.
- Development of resistance may limit future market size, necessitating new formulations or indications.
Analytical Summary
| Aspect |
Details |
| Market size estimate (2023) |
$30 - $50 million, mainly the U.S. |
| Key growth drivers |
Resistance to older fluoroquinolones, hospital use, expanding indications |
| Key risks |
Price competition, patent expiration, safety concerns |
Key Takeaways
- NDC 23155-0763 (Baxdela) commands premium pricing due to its brand status and intravenous formulations.
- Market potential remains moderate, with a possible 3-fold increase over current sales in the next decade.
- Long-term success depends on expanding indications and global sales, amid competitive pressures from generic fluoroquinolones.
- Payer negotiations and evolving resistance patterns will shape future pricing and adoption.
FAQs
-
What factors influence Baxdela's price over the next five years?
Patent expiration, competition from generics, and payer negotiations will decrease prices.
-
How does Baxdela compare cost-wise to other fluoroquinolones?
Baxdela costs substantially more per course ($2,450–$14,000) than older agents like levofloxacin (~$70–$140).
-
What is the key driver of Baxdela's market growth?
Resistance to existing fluoroquinolones and its unique safety profile support increased adoption.
-
Are there opportunities to expand Baxdela’s indications?
Yes, potential exists for treatment of other bacterial infections, contingent on clinical trial success.
-
How will global markets impact Baxdela's future revenue?
Entry into European and other international markets depends on regulatory approvals and local pricing policies, potentially doubling the market size.
References
[1] Food and Drug Administration (FDA). (2017). FDA approval announcement for Delafloxacin. Retrieved from https://www.fda.gov
[2] Melinta Therapeutics. (2022). Baxdela (delafloxacin) prescribing information. Retrieved from https://www.melinta.com
[3] IQVIA. (2023). Market data and pricing estimates for antibiotics.
[4] U.S. Centers for Medicare & Medicaid Services. (2023). Reimbursement policies for injectable antibiotics.
[5] Dr. Reddy’s, et al. (2022). Global Fluoroquinolone Market Report.
