Last updated: February 22, 2026
What is NDC 51672-4091?
NDC 51672-4091 is a medication marketed under the brand name Stenoptic (generic: Omadacycline). It is an antibiotic approved by the FDA for the treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Approved in October 2018, Omadacycline is a once-daily, IV-to-oral broad-spectrum antibiotic belonging to the tetracycline class.
Market Landscape
Current Market Size and Demand
The antibacterial drugs market was valued at approximately USD 40 billion in 2022, with antibiotics representing a significant segment. The specific market for drugs treating CABP and ABSSSI was around USD 15 billion globally in 2022, projecting a CAGR of 4% through 2030 (Grand View Research, 2022).
Omadacycline's market share remains limited due to competition from established antibiotics like levofloxacin, amoxicillin-clavulanate, doxycycline, and newer agents such as omadacycline's own class rivals.
Competition Analysis
| Drug Name |
Class |
Indications |
Market Position |
| Omadacycline (NDC 51672-4091) |
Tetracycline derivative |
CABP, ABSSSI |
Niche, emerging |
| Levofloxacin |
Fluoroquinolone |
CABP, urinary tract infections, others |
Dominant global sales |
| Doxycycline |
Tetracycline |
Multiple infections, SSTIs |
Low-cost, widespread use |
| Moxifloxacin |
Fluoroquinolone |
Respiratory tract infections |
Strong competition |
Prescriber Adoption and Geographic Penetration
Presence in hospital formularies is limited due to relatively high drug acquisition costs and existing preferred options. Major markets include the US, EU, and select Asian countries.
Pricing Overview and Projections
Current Pricing
| Formulation |
Approximate Wholesale Acquisition Cost (WAC) |
Price in 2023 |
| IV (per 250 mg vial) |
USD 250 - USD 300 |
USD 270 (avg) |
| Oral tablets (per 300 mg) |
USD 150 - USD 200 |
USD 170 (avg) |
The pricing for Omadacycline remains higher than many generic antibiotics due to limited competition, novel status, and patent protections.
Price Trends and Outlook (2023-2030)
- Short-term: Expect price stability due to patent exclusivity and limited generics.
- Mid-term (2025-2027): Potential for slight reductions as patent expiry approaches, but unlikely to fall below USD 150 per oral dose or USD 200 per vial without biosimilar entry.
- Long-term (post-2028): Price erosion may accelerate if biosimilar or generic versions enter the market, possibly reducing costs by 20-50%.
Factors Influencing Future Price Dynamics
- Patent exclusivity ending (expected 2033 for original formulation).
- Expansion into new indications, potentially increasing revenue.
- Adoption in hospitals and outpatient settings.
- Changes in insurance reimbursement policies.
Revenue Projections
Based on current utilization rates, including indications and prescriber adoption, revenue estimates are as follows:
| Year |
Presumed US Market Penetration |
Estimated US Revenue |
Assumptions |
| 2023 |
5% of targeted infections |
USD 200 million |
Early adoption, limited formulary inclusion |
| 2025 |
15% penetration |
USD 600 million |
Increased formulary sorting, expanded indications |
| 2030 |
25% penetration |
USD 1.2 billion |
Broader adoption, potential global expansion |
These figures assume continued FDA approvals and no significant generic competition.
Regulatory and Policy Impact
- Patent extension strategies could prolong exclusivity.
- CMS reimbursement policies affect hospital adoption.
- Increasing antimicrobial resistance may expand demand, but regulatory scrutiny could tighten.
Key Takeaways
- NDC 51672-4091 (Omadacycline) is an emerging antibiotic with a niche market focus.
- Current pricing remains high relative to older antibiotics; likely stable until patent expiration.
- Market growth hinges on prescriber adoption, formulary coverage, and resistance patterns.
- Price erosion anticipated post-2028, dependent on biosimilar and generic entry.
- Revenue potential remains significant through 2030 with broader indication approvals.
FAQs
1. What factors could significantly impact Omadacycline’s price in the next five years?
Patent expiration, biosimilar entry, changes in treatment guidelines, and insurance reimbursement policies.
2. How does Omadacycline compare cost-wise with similar antibiotics?
It costs approximately 2-3 times more per dose than older generic antibiotics like doxycycline or levofloxacin.
3. What are the prospects for expanding Omadacycline's indications?
Pending FDA or EMA approval, including potential uses in intra-abdominal infections or complicated urinary tract infections.
4. Can Omadacycline’s market share increase rapidly?
Market share growth depends on prescriber acceptance, formulary placement, and resistance patterns; it’s currently limited.
5. Which markets are most attractive for Omadacycline’s future expansion?
US hospitals, EU outpatient clinics, and select Asian healthcare markets.
References
-
Grand View Research. (2022). Antibiotics Market Size, Share & Trends Analysis Report. Retrieved from Grand View Research
-
US Food and Drug Administration. (2018). Omadacycline NDA approval letter. Retrieved from FDA
-
IQVIA. (2023). National Prescription Data. Insights on antibacterial prescribing trends.
