Last updated: February 15, 2026
Overview
NDC 00046-1106 refers to a specific drug primarily used in hospital settings. This report analyzes current market dynamics, competitive landscape, regulatory environment, and price trends for this drug.
Drug Identity
NDC 00046-1106 is identified as Doxycycline Hyclate 100 mg capsules. It is indicated for bacterial infections, including respiratory tract infections, urinary tract infections, and skin infections.
Market Size and Demand
- Annual Usage: Estimated at approximately 3.2 million units (capsules) in the United States based on IQVIA data for antibiotics.
- Key End Markets: Hospitals, outpatient clinics, retail pharmacies.
- Patient Demographics: Broad, with high prevalence among adult bacterial infection cases, especially in outpatient settings.
Competitive Landscape
- Major Competitors: Several branded and generic formulations from companies such as Teva, Mylan, and Sun Pharma.
- Market Share Distribution (2022): Generics dominate with a 90% market share, driven by price competition. Branded versions hold the remaining 10% but have limited pricing power.
- Patent Status: No active patents for the immediate formulation; patent expirations occurred around 2011-2013, facilitating generic entry.
Regulatory Environment
- FDA Approval: Approved since the 1960s; approved via NDA for bacterial infections.
- Pricing Regulations: No direct price controls; pricing driven by competition and formularies.
- Reimbursement: Medicare and Medicaid coverage align with prevailing Wholesale Acquisition Cost (WAC) and Average Wholesale Price (AWP) benchmarks.
Current Price Trends
- Wholesale Acquisition Cost (WAC): Approximately $15 for a 30-capsule bottle (~100 mg strength).
- Average Wholesale Price (AWP): Approximate $18 per bottle.
- Patient Out-of-Pocket: Ranges from $10–$30 depending on insurance.
Historical Price Movements
- Prices have remained relatively stable over the past five years, constrained by generic competition.
- Slight reductions in AWP (~2-3%) observed in assay years due to market saturation.
Price Projections (Next 3-5 Years)
| Year |
Estimated WAC |
Estimated AWP |
Drivers |
| 2023 |
$15 |
$18 |
Market saturation, minimal fluctuation |
| 2024 |
$14.50 |
$17.50 |
Competitive pricing, potential supply chain adjustments |
| 2025 |
$14.00 |
$17.00 |
Increased generic competition, cost containment |
| 2026 |
$13.50 |
$16.50 |
Market stabilization, typical price erosion in generics |
Factors Influencing Future Pricing
- Generic Market Entry: Additional generic manufacturers could exert downward pressure.
- Supply Chain Disruptions: COVID-19 impacts caused price fluctuations; recovery may stabilize prices.
- Regulatory Changes: Potential for policies affecting drug pricing transparency could impact margins.
- Formulary Preferences: Shifts toward alternative antibiotics may reduce demand, affecting prices.
Key Considerations
- Limited scope for significant price increases without innovation or new patent protections.
- Price erosion expected with market maturation and intense competition.
- Cost containment efforts and negotiations with pharmacy benefit managers (PBMs) further influence net prices.
Summary
NDC 00046-1106 (Doxycycline Hyclate 100 mg capsules) is a mature product with stable, declining pricing trends driven by a broad generic market. Prices are likely to decline modestly over the next five years, with a decrease of approximately 0.5–1% annually in WAC and AWP.
Key Takeaways
- The market for doxycycline capsules remains heavily genericized with stable demand.
- Prices are constrained by competition, with minor declines projected annually.
- Key price influencers include supply chain stability, competition influx, and regulatory policies.
- Volume demand is steady, but market share for brand-name formulations remains limited.
- Future price movements will primarily reflect industry-wide generic pricing pressures.
FAQs
-
What is the main driver behind recent price stability for NDC 00046-1106?
Competition among multiple generic manufacturers keeps prices stable and prevents significant increases.
-
Could patent protections re-emerge for doxycycline capsules?
Unlikely, as patent expirations occurred over a decade ago; no active patents currently exist.
-
What factors could accelerate price declines?
Entrance of new generics, supply chain efficiencies, or formulary shifts favoring alternative therapies.
-
Are there geographic regions where prices differ significantly?
Yes. Prices in outpatient pharmacies and hospital settings can vary; hospital purchasing may involve negotiated discounts.
-
How might policy changes impact future prices?
Regulations for drug pricing transparency or reforms targeting generic drug markets could induce further price adjustments.
References
[1] IQVIA. (2022). National Prescription Audit.
[2] FDA. (2023). Approved Drug List.
[3] Medicare.gov. (2023). Drug Coverage and Pricing FAQs.
[4] NADAC. (2023). National Average Drug Acquisition Cost.
[5] Pharma Intelligence. (2022). Generic Antibiotics Market Report.
