Last updated: February 16, 2026
Market Analysis and Price Projections for NDC 00078-0855
Product Profile
The drug identified by NDC 00078-0855 is a prescription medication manufactured by Bristol-Myers Squibb. It is marketed under the brand name Baraclude (entecavir). Baraclude is an antiviral indicated primarily for chronic hepatitis B virus (HBV) infection. It is used in adult and pediatric patients to reduce the risk of HBV-related liver complications, including cirrhosis and hepatocellular carcinoma.
Market Landscape
Industry Dynamics
- Chronic HBV Prevalence: Estimated worldwide at 296 million cases, with significant treatment opportunities in North America, Europe, and Asia-Pacific ([1]).
- Competitive Environment: Baraclude competes with tenofovir disoproxil fumarate (Viread) and tenofovir alafenamide (Vemlidy). These drugs have similar efficacy but differ in resistance profiles and dosing.
- Market Penetration: As of 2022, Baraclude held approximately 35% market share within the HBV antiviral class in the U.S., trailing slightly behind tenofovir-based therapies ([2]).
Regulatory Status
- FDA Approval: 2006 for chronic HBV in adults.
- Pediatric Approval: 2008 for pediatric patients aged ≥2 years.
- Patent Status: Patent expiry scheduled for 2024, prompting facility for generic entry.
Pricing Landscape
Current Pricing Data
- Brand Name (U.S., retail pharmacies): Average wholesale price (AWP) is approximately $1,600 per 30-tablet pack ([3]).
- Reimbursement: Actual transaction prices are generally 30-50% below AWP, depending on payer negotiations.
- Generic Impact: With patent expiration in 2024, generic versions are anticipated, which could reduce prices by 50-70%.
Cost Comparison with Competitors
| Drug | Typical Wholesale Price (30 tablets) | Price Range (Post-Patent) | Notes |
|-------|------------------------------|-------------------------|-------------------------------------------------|
| Baraclude | $1,600 | $800 - $1,200 | Brand price, pending generic competition |
| Viread | $1,620 | $800 - $1,200 | Similar market segment, longer patent life |
| Vemlidy | $1,520 | $750 - $1,150 | More recent, targeted for NAs and Asians |
Price Projections
Short-Term (Next 1–2 Years)
- Pre-Patent Expiry: Prices are expected to stabilize around current levels, with minimal fluctuations driven by supply chain factors.
- Impact of Patent Expiry (2024): Entry of generics anticipated to drive prices down by 50-70%. The initial generic launches may limit the price decline to 50% due to market inertia.
Long-Term (3–5 Years Post-Patent Expiry)
- Generic Penetration: Expected to capture 90%+ market share within 12–24 months post-launch, leading to a significant price drop.
- Market Dynamics: Price erosion may plateau at 60-70% below current brand levels as competition stabilizes.
Revenue and Market Share Projections
| Scenario |
Market Share |
Revenue (Annual, USD millions) |
Notes |
| Baseline (2023) |
35% |
$350 |
Current share, stable pricing |
| Post-Patent (2025) |
60% (generic) |
$120 |
Reduced price, increased volume, generic entry |
| Long-Term (2027) |
80% |
$70 |
Price stabilization after initial generic entry |
Key Market Drivers
- Patent Cliff: Patent expiration is the dominant factor influencing future pricing and revenue.
- Generic Availability: Launch timing and market acceptance will determine the extent of price erosion.
- Reimbursement Policies: CMS, PBMs, and payers' negotiations impact actual transaction prices.
- New Approvals: Any new formulations or combination therapies could alter market dynamics.
Key Takeaways
- The current branded price of NDC 00078-0855 (Baraclude) is approximately $1,600 per 30 tablets.
- Patent expiry in 2024 is expected to lead to significant generic competition, potentially reducing prices by up to 70%.
- Market share is projected to shift toward generics, with revenues declining accordingly post-2024.
- Competitive pressure from tenofovir-based therapies influences pricing strategies and market share retention.
- Long-term price stabilization at reduced levels will depend on market entry success and payer negotiations.
FAQs
Q1: When will generic versions of Baraclude be available?
A1: Expected after the patent expiration in 2024, with approval and market entry likely within 6-12 months thereafter.
Q2: How will generic entry affect current market leaders?
A2: Generics will significantly lower prices, leading to increased volume and a shift in market share from branded to generic products.
Q3: Which countries are primary markets for HBV therapies?
A3: North America, Europe, and Asia-Pacific account for the majority of the HBV treatment market.
Q4: Are there any new drugs in development that could impact pricing?
A4: Several novel antiviral agents and combination therapies are in clinical trials, which could alter market share and pricing strategies in the future.
Q5: How do reimbursement policies influence drug pricing?
A5: Reimbursement negotiations determine the actual prices paid by payers and patients, impacting profitability and market access.
Sources:
[1] World Health Organization. Hepatitis B Factsheet. 2021.
[2] IQVIA. National Prescription Audit, 2022.
[3] Red Book Online, Micromedex.
