Last updated: March 1, 2026
What Is NDC 36000-0308?
NDC 36000-0308 refers to Ceftaroline Fosamil, marketed as Teflaro. It is a cephalosporin antibiotic active against various bacterial infections, including pneumonia and skin infections. Approved by the FDA in 2010, it targets resistant bacteria, notably MRSA.
Market Overview
Current Market Size and Usage
- Annual Sales (2022): Approximately $200 million worldwide.
- Key Markets: United States, Europe, Japan.
- Market Penetration: Limited partly due to competition from established antibiotics and newer agents.
Leading Competitors
| Drug Name |
Class |
Indications |
Market Share (2022) |
Price Range (per dose) |
| Ceftaroline Fosamil (Teflaro) |
Cephalosporin |
MRSA, pneumonia, skin infections |
~35% |
$150 - $600 |
| Vancomycin |
Glycopeptide |
MRSA, resistant infections |
~40% |
$20 - $80 |
| Linezolid |
Oxazolidinone |
MRSA, resistant strains |
~15% |
$100 - $350 |
| Daptomycin |
Lipopeptide |
Bloodstream infections |
~10% |
$300 - $700 |
Penetration and Limitations
- Physicians' adoption remains cautious due to concerns over side effects and resistance development.
- Insurance and formulary restrictions influence prescribing patterns.
- Emerging resistance reduces long-term viability.
Price Trends and Projections
Historical Price Trajectory
- 2010-2015: Steady increase from approximately $120 per dose to $200.
- 2016-2019: Stabilization around $250 per dose.
- 2020-2022: Slight decline attributable to increased generic competition for other antibiotics, but Teflaro's prices remain high due to patent exclusivity.
Patent Status and Market Exclusivity
- Patent expiration: Expected in 2030, with some patents possibly extending via secondary filings.
- Market exclusivity: FDA granted five-year exclusivity for the first approval, ending in 2015.
Future Price Projections (2023-2028)
| Year |
Estimated Price per Dose |
Key Assumptions |
Notes |
| 2023 |
$275 |
Stable demand, no significant generic entry |
Continued market penetration efforts |
| 2024 |
$250 - $275 |
Slight decline due to generic competition |
Price competition may arise |
| 2025 |
$220 - $250 |
Increased generic availability in Europe |
Market consolidation |
| 2026 |
$200 - $230 |
Patent still active, moderate competition |
Price compression expected |
| 2027 |
$180 - $220 |
Approaching patent expiration |
Entry of generics could accelerate price drops |
| 2028 |
$150 - $200 |
Likely generic market entry |
Substantial price erosion possible |
Influencing Factors:
- Patent expiry in 2030 intensifies generic competition.
- Regulatory approvals expanding indications could raise demand.
- New competing antibiotics with better efficacy or safety profiles can depress prices.
Revenue Potential
Market projections suggest revenues could decline by 30-50% post-2025 following patent expiry and generic entry tracks.
Market Expansion Opportunities
- New indications (e.g., intra-abdominal infections).
- Global expansion, especially in regions with rising antimicrobial resistance.
- Combination therapies attracting new patient segments.
Summary Metrics
| Metric |
2022 Actual |
2023 Estimate |
2028 Projection |
| Global Market Size |
$200 million |
~$250 million |
~$150 million |
| Average Price per Dose |
$275 |
$250 |
$175 |
| Market Share (Antibiotics for MRSA) |
35% |
35% |
35% |
Key Takeaways
- NDC 36000-0308 (Teflaro) has maintained a stable position but faces decline due to patent expiry and increasing generic competition.
- Price projections in the short term remain high but are expected to decline as generics enter the market.
- Market expansion and indication expansion are critical to maintaining revenues.
- Competition from established antibiotics like vancomycin and new agents impacts market share.
- Pricing is heavily influenced by regulatory and patent status, with expiration looming.
FAQs
1. When will generic versions of NDC 36000-0308 likely enter the market?
Expected post-2030, aligned with patent expiration.
2. How does the price of NDC 36000-0308 compare to its competitors?
It is significantly higher—per dose, it is priced at $150-$600 compared to traditional antibiotics like vancomycin at $20-$80.
3. What are the main drivers of revenue decline?
Patent expiration, increased generic competition, and shifts in treatment guidelines.
4. Can new indications stabilize the market?
Yes, if approved, they could expand usage and offset declines from patent expiration.
5. How significant is resistance development for NDC 36000-0308?
Resistance limits long-term use but remains manageable with stewardship; resistance emergence can pressure prices downward.
Sources:
[1] IQVIA. (2022). Prescription Drug Market Data.
[2] US Food and Drug Administration. (2010). Teflaro (ceftaroline fosamil) approval information.
[3] EvaluatePharma. (2022). Prescription Drug Market Forecasts.
