Last updated: February 25, 2026
What is NDC 00378-5246?
NDC 00378-5246 is a specific formulation of a pharmaceutical product regulated by the Food and Drug Administration (FDA). The NDC code identifies the drug's manufacturer, product, strength, dosage form, and packaging. Based on available data, this NDC corresponds to Doxycycline Hyclate Capsules, 100 mg.
Market Overview
Indications and Usage
Doxycycline Hyclate is a broad-spectrum tetracycline antibiotic used primarily to treat bacterial infections such as respiratory tract infections, urinary tract infections, Lyme disease, cholera, and anthrax. It also features in dermatology and certain sexually transmitted infections.
Competitive Landscape
The antibiotic market, especially doxycycline formulations, is highly competitive:
- Generic saturation: Numerous manufacturers produce doxycycline capsules.
- Branded products: Limited, mainly for specific formulations or packaging.
- Supply chain dynamics: Organic and inorganic factors impact availability.
Regulatory Environment
The drug is generally recognized as safe (GRAS) within the scope of approved indications. Post-market surveillance focuses on antimicrobial resistance concerns and supply stability.
Recent Market Data
- 2022 global doxycycline market: Estimated USD 646 million, projected to grow at CAGR of 4.2% over 2023–2028 [1].
- U.S. doxycycline sales: USD 200 million in 2022, with a significant share from generic manufacturers.
Price Trends and Projections
Current Pricing
- Wholesale acquisition cost (WAC): Approximately USD 0.30 per capsule for 100 mg strength.
- Average retail price: USD 0.50–0.70 per capsule, dependent on pharmacy and insurance coverage.
- Generic market pricing: Competitive pressure tends to keep prices stable or declining.
Factors Influencing Pricing Dynamics
- Market Entry of Generics: Increased number of manufacturers reduces prices.
- Supply Chain Stability: Doxycycline production has historically faced shortages due to raw material constraints.
- Antimicrobial Stewardship: Policies restricting antibiotics can affect demand.
- Pricing Policies: Medicare and Medicaid negotiation dynamics impact reimbursement and retail prices.
Price Projections (2023–2028)
| Year |
Estimated WAC Price (USD) per capsule |
Key Factors |
| 2023 |
USD 0.30 |
Existing competition maintains low prices |
| 2024 |
USD 0.27 |
Increased generic competition and supply chain stabilization |
| 2025 |
USD 0.25 |
Potential generic price erosion, continued market saturation |
| 2026 |
USD 0.23 |
Slight cost reduction as manufacturing efficiencies improve |
| 2027 |
USD 0.22 |
Market stabilization at low price points |
| 2028 |
USD 0.21 |
Possible further price drops due to increased manufacturing capacity |
Clinical and Market Considerations Impacting Price
- Antibiotic resistance: Growing concerns may limit broad use.
- Regulatory updates: New restrictions or approvals may alter demand.
- Emergent alternatives: New antibiotics could displace doxycycline, impacting prices.
Summarized Key Data Points
- Market size (2022): USD 646 million globally.
- U.S. sales (2022): USD 200 million.
- Price (2023) WAC**: Approx. USD 0.30 per capsule.
- Projected trend: Gradual decline to USD 0.21–0.23 per capsule by 2028.
Summary
Doxycycline capsules (NDC 00378-5246) occupy a mature, highly competitive market characterized by declining prices driven by generic competition. Industry dynamics suggest prices will continue to decrease gradually. Supply chain stability and antimicrobial stewardship initiatives are critical external factors influencing future market stability and pricing.
Key Takeaways
- The market for doxycycline is saturated, with stable or declining prices.
- Current WAC stands around USD 0.30 per capsule, with retail prices slightly higher.
- Price projections anticipate a decline to approximately USD 0.21–0.23 per capsule by 2028.
- Market growth remains moderate due to patent expirations and competition.
- Supply chain disruptions and antimicrobial stewardship policies remain critical risk factors.
FAQs
1. How does the presence of generics impact doxycycline prices?
Generic competition drives prices downward, with multiple manufacturers offering similar formulations, reducing profit margins and controlling pricing.
2. What external factors could influence future doxycycline prices?
Supply chain disruptions, antimicrobial resistance concerns, regulatory restrictions, and the emergence of new antibiotics can alter prices and demand.
3. Are shortages a concern for this drug?
Yes. Doxycycline production has experienced shortages due to raw material availability, which could temporarily inflate prices or limit supply.
4. Does the pricing vary significantly between different markets?
Yes. U.S. retail prices are higher than wholesale, and international market prices vary based on regulatory policies, competition, and healthcare systems.
5. How might new regulations impact this drug’s market?
Stringent antimicrobial stewardship policies or new approvals for alternative treatments could reduce demand, decreasing prices further.
References
[1] Grand View Research. (2022). Doxycycline Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/
