Last updated: March 9, 2026
What is NDC 61314-0030?
The National Drug Code (NDC) 61314-0030 corresponds to a specific pharmaceutical product, identified as Baxdela (delafloxacin) 300 mg film-coated tablets. Baxdela is an antibiotic used for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The drug was approved by the Food and Drug Administration (FDA) on June 20, 2017, marketed by Melinta Therapeutics.
Market Overview
Market Size and Demand
- Indications: Primarily indicated for ABSSSI and CABP.
- Population: Estimated U.S. adult population with bacterial skin infections and pneumonia, approximately 7-8 million annually.
- Market share: Baxdela entered an antibiotic market with established players like levofloxacin, ciprofloxacin, and doxycycline, but offers a novel fluoroquinolone alternative.
Competitive Landscape
| Drug Name |
Dose |
Marketed By |
FDA Approval |
Retail Price (per 300 mg tablet) |
Estimated Market Share (2022) |
| Baxdela (delafloxacin) |
300 mg oral tablet |
Melinta |
2017 |
$50-$70 |
5-8% |
| Levaquin (levofloxacin) |
Varies (sol., tablets) |
Johnson & Johnson |
1996 |
$25-$40 |
30-40% |
| Cipro (ciprofloxacin) |
Varies |
Bayer |
1987 |
$15-$30 |
20-25% |
Sales Trends
- 2018-2022: Sales plateaued after initial approval, constrained by limited awareness and established competition.
- 2023 Onward: Slight growth expected due to increasing resistance to first-line antibiotics, expanding indications, and formulary placements.
Pricing Trends and Reimbursement
- Wholesale acquisition cost (WAC): Approximately $50-$70 per 300 mg tablet (SSR Health, 2022).
- Average selling price (ASP): Estimated 10-20% higher than WAC, depending on payer contracts.
- Reimbursement: Usually covered by Medicare/Medicaid; reimbursement rates align with ASP minus negotiated discounts.
Price Projections
Factors Influencing Future Prices
- Generic Entry: No generic version available yet, limiting price pressure.
- Market Penetration: Limited but growing market share may facilitate price stability.
- Reinforcement of Clinical Value: Resistance issues and safety profile can sustain premium pricing.
- Insurance Reimbursement Policies: Favoring cost-effective antibiotics may reduce premiums.
Predicted Price Range (2023-2028)
| Year |
Estimated Avg. Price per 300 mg Tablet |
Commentary |
| 2023 |
$50-$70 |
Current levels, stable market share |
| 2024 |
$48-$68 |
Slight downward pressure, market stabilization |
| 2025 |
$45-$65 |
Entry of biosimilars may pressure prices |
| 2026 |
$43-$62 |
Market consolidation, increased competition |
| 2027 |
$40-$60 |
Approaching cost parity with generics |
Market Growth and Revenue Projections
- Global Market: Expected to grow at 3-5% annually, reaching approximately $50 million by 2028.
- U.S. Revenue: $15-$20 million in 2022, with projections to grow to $25-$35 million annually by 2028.
Challenges and Opportunities
Challenges
- Limited pipeline: No major clinical development for expanded indications.
- Resistance potential: Fluoroquinolone resistance could limit use.
- Pricing pressure: Increased availability of generic fluoroquinolones may erode market share.
Opportunities
- Expanded indications: Potential approval for other bacterial infections.
- Combination therapies: Developing fixed-dose combinations to enhance compliance.
- Partnerships: Licensing with hospital systems to increase formulary access.
Key Takeaways
- NDC 61314-0030 (Baxdela 300 mg) remains a niche antibiotic within fluoroquinolones, with limited but steady growth prospects.
- Current average retail prices are $50-$70 per tablet, with stable market dynamics.
- Price projections suggest slight declines over five years, driven by potential generic entry and market competition.
- Revenue growth hinges on expanding indications and increasing hospital formulary acceptance.
- The competitive advantage centers on resistance profiles and safety, which may sustain premium pricing.
FAQs
What factors will most influence Baxdela's future pricing?
Resistance development, generic entry, and policy shifts toward cost-effective antibiotics.
Are there regulatory hurdles that could impact Baxdela sales?
Potential FDA review of expanded indications or safety concerns could impact sales, but no major hurdles are anticipated currently.
How does Baxdela compare to other fluoroquinolones in terms of price?
Baxdela is priced higher per tablet than older fluoroquinolones such as ciprofloxacin and levofloxacin, reflecting its newer status and clinical profile.
Will Baxdela's market share increase substantially?
Market share growth depends on formulary placements, resistance patterns, and clinician adoption. Limited opportunities for expansion exist without new indications.
What strategies could help sustain Baxdela's premium price?
Clinical advantages in safety, expanding approved uses, and securing hospital formulary access are key.
References
- SSR Health. (2022). Drug Pricing Trends Report.
- U.S. Food and Drug Administration (FDA). (2017). Approval documents for Baxdela (delafloxacin).
- IQVIA. (2022). United States Market Indicators.
- Melinta Therapeutics. (2023). Annual Report.
(Note: Prices and projections are estimations based on current market data and may fluctuate with market conditions.)
