Last updated: February 27, 2026
What is the drug associated with NDC 00078-0379?
NDC 00078-0379 corresponds to a specific formulation of Doxycycline Hyclate, an antibiotic used to treat various bacterial infections. The drug is marketed under several brand names, including Vibramycin and Doryx, primarily for oral administration.
Market Overview
Indications and Therapeutic Area
Doxycycline Hyclate targets bacterial infections such as respiratory tract infections, urinary tract infections, sexually transmitted diseases, and Lyme disease. Its broad-spectrum activity positions it as a widely prescribed antibiotic.
Market Size and Trends
The global antibiotics market was valued at approximately $45 billion in 2022[1]. Doxycycline’s share within this market is significant due to its clinical utility and affordability.
In the U.S., annual prescriptions for doxycycline average around 15 million units per year[2]. Growth is driven by increasing resistance to other antibiotics and expanding use in prophylaxis and treatment.
Competitive Landscape
Major competitors include azithromycin, amoxicillin, and other tetracyclines. Doxycycline benefits from well-established manufacturing, clinician familiarity, and broad-spectrum efficacy.
Regulatory Status
The drug holds FDA approval. Generic versions are readily available, increasing market penetration based on cost-effectiveness.
Price Analysis
Current Market Pricing
For outpatient prescriptions, the average wholesale price (AWP) for doxycycline hyclate (100 mg) ranges as follows:
| Formulation |
Typical AWP per capsule |
Monthly cost (assuming 30 capsules/day) |
| Generic doxycycline hyclate (100 mg) |
$0.50 |
$450 |
| Brand-name Vibramycin |
$2.00 |
$1,800 |
Wholesale acquisition costs (WAC) and retail prices are generally 20–50% lower than AWP.
Price Trends
Over the past five years, the price of generic doxycycline has decreased approximately 15–20% due to increased competition. Brand-name products maintain higher prices but are less prescribed due to cost considerations.
Pricing for Hospital and Institutional Use
Hospital formulary costs for IV doxycycline are higher, around $10 per 100 mg vial, with inpatient daily costs reaching $200–$300 depending on dosing and length of stay.
Price Projections
Short-Term (Next 1–2 Years)
Anticipate stable pricing within the generic market:
- Wholesale prices for generic doxycycline are expected to remain at $0.40–$0.60 per capsule.
- Limited price increases are likely due to ongoing generic competition and manufacturing efficiencies.
Medium-to-Long Term (3–5 Years)
Potential for slight price reductions driven by:
- Further increase in generic market share.
- Manufacturing innovations reducing production costs.
- Regulatory pressures on brand-name pricing.
Projected annual costs for typical prescriptions are expected to range between $400–$600 at retail, with institutional costs remaining steady.
Impact of External Factors
- Antibiotic stewardship efforts and resistance trends may influence prescription volume, affecting overall revenue.
- New formulations, such as extended-release tablets, could garner premium pricing if approved.
Key Factors Affecting Market and Prices
- Patent expirations: Doxycycline hyclate’s primary patents expired decades ago, leading to widespread generics.
- Supply chain dynamics: Raw material availability impacts manufacturing costs.
- Regulatory policies: Price controls or incentives for antibiotic development could influence future costs.
- Market demand fluctuations: Seasonal infections, pandemic-related prescribing patterns, and resistance trends affect volume.
Key Takeaways
- NDC 00078-0379 corresponds to generic doxycycline hyclate.
- The drug holds a significant position within the antibiotics market due to broad efficacy.
- Current retail prices for generic doxycycline remain low, with steady prices projected over the next 2 years.
- Price reductions are unlikely; instead, prices are expected to stabilize or slightly decline as competition persists.
- Market volume may fluctuate with resistance and prescribing habits, influencing overall revenue potential.
FAQs
-
What are the main competitors to doxycycline hyclate?
A: Azithromycin, amoxicillin, and other tetracyclines.
-
Are there any upcoming regulatory changes that could impact prices?
A: No major changes are currently announced but ongoing antibiotic stewardship efforts may limit prescribing volume.
-
How does the cost of brand-name doxycycline compare to generics?
A: Brand-name products typically cost four times more than generics, affecting prescribing habits.
-
What factors influence the supply chain for doxycycline?
A: Raw material availability, manufacturing capacity, and regulatory inspections.
-
Can emerging resistance impact the market for doxycycline?
A: Yes; increasing resistance could reduce clinical utility and prescribing volume, impacting revenues.
References:
[1] Grand View Research. (2022). Antibiotics Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). Prescription Data for Antibiotics.
[3] FDA. (2022). Approved Drug Products Database.
