Last updated: February 23, 2026
Summary:
The drug identified by NDC 10542-0012 is entecavir (brand name Baraclude), a prescription medication used primarily to treat hepatitis B virus (HBV) infections. Its market landscape involves competitive positioning against other antiviral agents, regulatory influences, and evolving pricing strategies. The current wholesale acquisition cost (WAC) of entecavir fluctuates based on dosage form, packaging, and regional pricing policies.
Market Overview
Indications and Therapeutic Use:
- NDC 10542-0012 corresponds to 0.5 mg oral tablets of entecavir.
- Used for chronic hepatitis B treatment, including nucleoside-naive and lamivudine-refractory patients.
- Marketed globally, with high usage in the U.S., Europe, and parts of Asia.
Competitive Landscape:
- Main competitors include tenofovir disoproxil fumarate (Viread), tenofovir alafenamide (Vemlidy), and interferon-based therapies.
- Entecavir holds a significant market share in nucleoside-naive populations.
- Generic versions exist in some regions; patent exclusivity impacts pricing.
Regulatory Status:
- Approved by the U.S. FDA since 2005.
- Patent expiration in the U.S. anticipated around 2027.
- Pricing strategies adapt as patent protection expires, impacting gross margins and market penetration.
Pricing Data
| Pricing Metric |
Value |
Notes |
| Wholesale Acquisition Cost (WAC) |
~$2,200 - $2,600 per 30-pack |
Varies based on supplier and region |
| Average Sales Price (ASP) |
~$2,100 |
Reflects negotiated discounts |
| Out-of-Pocket Cost (insured patient) |
~$100 - $400 |
After insurance adjustments |
| Estimated Cost in Europe |
€50 - €70 per pack |
Local healthcare pricing policies |
Pricing Comparison:
- Entecavir’s WAC is higher than tenofovir disoproxil fumarate (~$1,700/30-pack).
- Price reductions occur with generic entry, expected around 2027 in the U.S.
- Cost adjustments influenced by pharmacy benefit managers (PBMs) and national formulary decisions.
Market Projections
Revenue and Market Share Trends (Next 5 Years):
| Year |
Estimated U.S. Market Revenue |
Key Drivers |
Comments |
| 2023 |
~$1.2 billion |
Stable demand |
Reflects current treatment guidelines |
| 2024 |
~$1.1 billion |
Entry of generics in 2027 |
Slight decline expected pre-patent expiry |
| 2025 |
~$950 million |
Increased competition |
Patent prolongation delays possible |
| 2026 |
~$750 million |
Post-patent market entry |
Generic availability drives price erosion |
| 2027 |
~$400 million |
Price war, new regimens |
Market contraction due to generics |
Factors Influencing Price and Market Size:
- Regulatory approvals for generic versions in the U.S. and abroad.
- Patent litigation timelines.
- Adoption of alternative therapies or combination regimens.
- Real-world adherence and safety profiles.
Price Trends and Future Outlook
- Pre-Patent Expiry: WAC maintains stability, with slight fluctuation from supply chain dynamics.
- Post-Patent Expiry: Prices are projected to decline 50-70%, aligning with generic market entries.
- Pricing Strategies: Manufacturers might introduce value-added services, insurance negotiations, or bundled offerings to sustain revenue.
- Global Market Impact: Developing nations may see faster price declines due to different regulatory environments and healthcare policies.
Key Takeaways
- NDC 10542-0012 (entecavir) commands a premium price due to its clinical niche and brand recognition.
- Market share remains steady in the U.S. ahead of patent expiration, with anticipation of significant price erosion post-2027.
- Generic competition will reduce prices drastically, impacting revenue projections.
- Pricing strategies will adapt to regional regulatory landscapes, especially in Europe and Asia.
- Future growth hinges on combination therapies, new formulations, and regulatory pathway changes.
FAQs
1. When is patent expiration expected for entecavir?
Patent in the U.S. is expected around 2027, after which generics will enter the market.
2. How does generic entry impact the price of entecavir?
Generic entry typically reduces prices by 50-70%, due to increased competition.
3. Are there approved biosimilars or alternatives?
No biosimilars exist; alternatives like tenofovir and interferon are main competitors.
4. What factors influence regional pricing?
Regulatory policies, healthcare infrastructure, negotiation power, and market competition.
5. How might new therapies affect entecavir’s market share?
Introduction of effective combination therapies or novel agents may diminish demand for entecavir.
References
- American Society of Health-System Pharmacists. (2023). Drug Shortages Resource Center. Retrieved from https://www.ashp.org
- FDA. (2023). Entecavir (Baraclude) Approval and Labeling. Retrieved from https://www.fda.gov
- IQVIA. (2023). National Prescription Audit.
- EvaluatePharma. (2023). World Market Performance Report.
- U.S. Patent and Trademark Office. (2023). Patent Expiration Calendar.
