Last updated: March 9, 2026
What is the Drug NDC 59651-0839?
NDC 59651-0839 corresponds to a specific drug product approved by the FDA. Based on the NDC directory, this code identifies a prescription medication with a particular formulation, dosage, and manufacturer. (Exact drug name and details can vary; confirmed through official databases.)
Market Overview
Therapeutic Area and Competition
The drug belongs to the [specific therapeutic class]. It competes with [number] other products approved for the same indication.
- Key Competitors:
- Drug A: Market share of approximately X% (2022)
- Drug B: Market share of approximately Y% (2022)
- Biosimilars or generics may be available, impacting pricing dynamics.
Market Size and Growth
- Estimated global market size for the therapeutic class: $X billion (2022)
- Compound annual growth rate (CAGR): X% (2021-2026)
- U.S. market share: X% of total global sales
Regulatory Status
- Approved by FDA since [approval date].
- Patent expiration: [date or year], influencing generic entry.
- Possible exclusivity periods: [e.g., orphan, pediatric, data exclusivity].
Price Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): $X per unit (e.g., per tablet, vial)
- Average selling price (ASP): $Y per unit, based on national databases.
- Retail price: Ranges from $Z to $Z + A% across different channels.
Pricing Drivers
- Manufacturing costs: Influenced by formulation complexity, raw material prices.
- Price of competitors: Similar drugs priced within $X-$Y range.
- Reimbursement policies: CMS, private insurers influence final prices.
Cost Trends and Impact
- Patent protections sustain higher prices during exclusivity.
- Biosimilar and generic entries forecasted for [year], likely reducing prices by X% over the subsequent Y years.
Price Projections (2023-2028)
| Year |
Projected WAC |
Projected ASP |
Comments |
| 2023 |
$X |
$Y |
Stable, pending patent protections |
| 2024 |
$X * 0.98 |
$Y * 0.97 |
Patent expiry approaching, increased competition |
| 2025 |
$X * 0.95 |
$Y * 0.93 |
Entry of biosimilars or generics begins |
| 2026 |
$X * 0.90 |
$Y * 0.88 |
Increased market penetration of generics |
| 2027 |
$X * 0.85 |
$Y * 0.80 |
Market consolidation, discounts on established brands |
Note: These projections assume typical patent cliff effects and generic entry timelines.
Market Dynamics
- Regulatory influences: Accelerated approvals for biosimilars could hasten price reductions.
- Reimbursement: Insurers favor generics, decreasing brand drug sales volume and price.
- Market penetration: Adoption rates driven by clinical efficacy, side effect profiles, and formulary placement.
Key Factors Affecting Future Price
- Patent status: Patent expiration scheduled for [date].
- Generic/biosimilar competition: Entry expected in [year], with corresponding price declines.
- Market penetration: High adoption can sustain prices longer if clinical demand remains strong.
- Pricing regulations: New policies may either cap prices or expand formularies.
Key Takeaways
- NDC 59651-0839 operates within a competitive, rapidly evolving therapeutic landscape.
- Current prices range around $X-Y per unit, constrained by competitive dynamics and reimbursement factors.
- Patent expiry and biosimilar entry forecast a price decline of approximately [percentage] over five years.
- Market size and growth remain robust, but pricing is increasingly influenced by regulatory and competitive pressures.
FAQs
1. When will generic versions of NDC 59651-0839 become available?
Approximate timeline is within [X] years of patent expiry, typically 8-12 years post-approval.
2. How do biosimilar entries affect the drug’s pricing?
Biosimilar competition generally reduces prices by 20-40% within 1-3 years of market entry.
3. What factors could delay price declines?
Prolonged patent protection, manufacturing complexities, limited biosimilar approval, or formulary restrictions.
4. How does reimbursement impact the final patient cost?
Reimbursement rates set by insurers and government programs directly affect copayments, influencing patient affordability.
5. Are there upcoming regulatory changes that could influence prices?
Potential changes include patent extension policies, importation laws, or price negotiation structures, depending on legislative developments.
References
- U.S. Food and Drug Administration. (2023). [Drug database reference].
- IQVIA. (2022). National Prescription Audit.
- DRG Content. (2023). Drug pricing and formulary data.
- FDA. (2022). Patent and exclusivity status for relevant drugs.
- HealthInsurance.org. (2023). Reimbursement trends.
Note: Accurate identification of the drug, current market conditions, and specific dates depend on accessing proprietary sources or direct manufacturer data.
