Last updated: March 3, 2026
What Is NDC 00591-5347?
NDC 00591-5347 refers to a generic or branded drug listed in the National Drug Code (NDC) system. Based on available databases, this code corresponds to Doxycycline Hyclate Capsule, 100 mg. It is a broad-spectrum tetracycline antibiotic used to treat bacterial infections.
Market Size and Dynamics
Current Market Landscape
- Global Doxycycline Market Value (2022): Estimated at US$1.2 billion.
- US Market Share (2022): Accounts for approximately 45% of global sales.
- Units Sold (2022): Roughly 55 million doses in the US.
- Key Therapeutic Areas: Respiratory tract infections, Lyme disease, sexually transmitted infections, acne, and periodontal diseases.
Competitive Environment
- Leading Brands: Vibramycin (Pfizer), Doryx (Alvogen), and generic versions produced by multiple manufacturers.
- Generics Penetration: 70-80% of prescriptions are for generic formulations, pushing prices down.
- Patent Status: Doxycycline patents expired over a decade ago; market dominated by generics.
Regulatory Factors
- FDA Approvals: Existing approvals cover broad indications, with no recent updates limited to stewardship programs.
- Biosimilar Development: No biosimilar competitors are present as doxycycline is a small molecule.
Pricing Trends and Projections
Current Pricing (Q1 2023)
| Price Component |
Average Price (per capsule) |
Market Notes |
| Brand-name (Vibramycin) |
US$2.50 – US$3.50 |
Despite availability of generics, brand premiums persist in some regions. |
| Generic (bulk purchase) |
US$0.10 – US$0.20 |
Widely available, supplied by multiple manufacturers. |
Historical Price Trajectory
| Year |
Average Price per Capsule |
Remarks |
| 2018 |
US$0.25 |
Slight decline driven by patent expiration. |
| 2020 |
US$0.16 |
Trends toward lower prices amid increased generic competition. |
| 2022 |
US$0.12 |
Steady decline stabilized around US$0.10–US$0.15 range. |
Price Forecast (Next 3 Years)
- 2023–2025: Prices expected to remain stable or decline marginally, scaling between US$0.08 and US$0.15 per capsule, driven by continued generic competition and procurement efficiencies.
- Factors Influencing Prices:
- Supply chain stability, especially porting supplies from manufacturing hubs.
- Regulatory actions affecting manufacturing costs.
- Potential regional market restrictions or policy changes.
- Emerging antimicrobial stewardship efforts, possibly reducing prescription volumes.
Impact of Market Factors on Price
| Factor |
Effect on Price |
Rationale |
| Increased generic competition |
Downward |
More suppliers reduce pricing pressure. |
| Supply chain disruptions |
Upward |
Shortages increase costs and prices. |
| Regulatory restrictions |
Upward |
Stricter policies on antibiotic use may limit demand, reducing prices. |
| Healthcare policies |
Neutral on prices |
Policies focused on stewardship may decrease volume, affecting revenue but not necessarily unit prices. |
Future Market Drivers
- Emerging Infectious Disease Trends: Rising antibiotic resistance may influence the clinical use and demand for doxycycline.
- Stewardship and Resistance Policies: May restrict prescribing, limiting market growth.
- Introduction of Novel Therapies: Competing antibiotics or combination therapies could reduce doxycycline’s market share.
- Pricing Strategies: Large generics manufacturers may further reduce prices to gain or defend market share.
Regulatory and Reimbursement Outlook
- Reimbursement Policies: In the US, Medicare and Medicaid cover doxycycline generics at standard rates, with little variation.
- Price Negotiation Trends: CMS and private insurers increasingly negotiate drug prices, especially for antibiotics, pushing prices lower.
- International Markets: Emerging economies tend to have lower prices, influenced by local policies and procurement practices.
Final Analysis Summary
| Attribute |
Details |
| Market Size (2022) |
US$1.2 billion (global), with 45% US share |
| Units Sold (2022) |
55 million doses in the US |
| Price Trend |
Declining, stabilization at US$0.08–US$0.15 per capsule |
| Key Drivers |
Generic competition, supply chain, policy restrictions |
| Future Price Range (2023–2025) |
US$0.08 – US$0.15 per capsule |
Key Takeaways
- Doxycycline Hyclate capsules are a mature market with high generic penetration.
- Prices have declined significantly over the past five years; further decreases are unlikely.
- Market volume may decline gradually due to antimicrobial stewardship, influencing overall revenue but not unit prices substantially.
- Supply chain stability and regulatory policies remain critical factors influencing future pricing.
- International markets present additional price and volume considerations, often at lower price points.
FAQs
1. What primarily influences doxycycline price changes?
Generic availability, supply chain stability, and antimicrobial stewardship policies.
2. Are new formulations or patents affecting doxycycline?
No; patents expired over ten years ago. New formulations are not under development or approval.
3. How does antimicrobial resistance impact this market?
Rising resistance could reduce demand and influence prescribing practices, affecting volume more than price.
4. What is the outlook for doxycycline in international markets?
Prices are generally lower, with localized regulatory and procurement factors influencing margins.
5. Could biosimilars or new entrants disrupt this market?
No; doxycycline is a small molecule without biosimilars, and no new competitors currently threaten market stability.
References
- MarketsandMarkets. (2022). "Antibiotics Market by Drug Class: Global Forecast to 2026."
- IQVIA. (2022). "US Prescription Data and Market Share Insights."
- U.S. Food and Drug Administration. (2023). "Drug Approvals and Advisory Statements."
- Medscape. (2021). "Antibiotic Resistance Trends and Impact on Prescribing."
- Statista. (2022). "Pharmaceutical Market Data: Antibiotics."
