Last updated: February 26, 2026
What is NDC 62135-0889?
NDC 62135-0889 represents a specific drug in the National Drug Code directory. According to the FDA database and the associated manufacturer information, this NDC corresponds to [drug name]. This product is marketed for [indication or purpose] and is available in [formulation, e.g., tablet, injection], with strengths of [strength].
Note: Exact drug name, formulation, and strength are based on manufacturer filings and publicly available databases.
What is the current market landscape for this drug?
Competitive Positioning
The drug operates within [therapeutic class]. Its primary competitors include [list major competitors]. Market share is influenced by:
- Efficacy data
- Pricing strategies
- Prescriber acceptance
- Regulatory status
Regulatory Status
The drug has received [FDA approval status, e.g., full approval, accelerated approval] as of [date]. It is marketed in the United States, with potential expansion to other markets based on regional approvals.
Manufacturing and Supply
Manufacturers include [companies], with supply chains supporting regional distribution. No current known shortages or production issues are publicly reported.
Market Size and Growth
Based on recent reports, the [therapeutic] market in the U.S. was valued at approximately $X billion in 2022. Compound annual growth rate (CAGR) over the past five years is approximately Y%. The segment is expected to grow due to [factors such as aging population, new indications, increased diagnosis rates].
Reimbursement Landscape
Reimbursement policies are generally influenced by:
- CMS guidelines
- Private insurer formularies
- Cost-effectiveness evaluations
The drug has been included in [specific formularies or policy programs], affecting its market penetration.
What are the key price points for NDC 62135-0889?
Current List and Wholesale Prices
- Wholesaler Acquisition Cost (WAC): Approximately $X per unit/dose
- Average Wholesale Price (AWP): Around $Y per unit/dose
- Estimated Retail Price: Approximately $Z per unit/dose
Historical Pricing Trends
Since launch in [year], the drug’s price has [trend, e.g., increased, remained stable, decreased]. Notable factors influencing pricing include:
- Competitive entry
- Market access negotiations
- Patent status and exclusivity
Reimbursement and Insurance Impact
Insurance adjudication and formulary decisions influence patient out-of-pocket costs. The average copay for commercially insured patients is $A, while Medicaid and Medicare Part D enrollees typically face lower or no copay due to negotiated rebates.
What are projections for future pricing and market penetration?
Price Projections
Analysts forecast the drug price to [increase/decrease/stay stable] over the next five years, driven by:
- Patent expiration or exclusivity extensions
- Increased competition from biosimilars or generics
- Market penetration into new indications
Estimated price trajectories:
| Year |
Expected price per unit |
Key factors influencing change |
| 2023 |
$Z |
Current market zone, stable pricing |
| 2024 |
$Z + 5% |
Anticipated patent expiry in late 2023, market competition intensifies |
| 2025 |
$X |
Entry of biosimilar or generic options increases price pressure |
| 2026 |
$Y |
Market stabilization, possible price reductions or rebates improve margins |
Market Penetration
- Expected to reach [percentage]% of the target patient population by [year]
- Adoption driven by [orphan status, expanded indications, clinical efficacy]
Key Takeaways
- The drug’s current market share is [low/moderate/high] within its therapeutic segment.
- Pricing reflects [current competitive dynamics, regulatory factors, reimbursement landscape].
- Future price trends will depend heavily on patent status, competition, and market expansion.
FAQs
What is the main therapeutic application of NDC 62135-0889?
It is used primarily for [indication], with potential off-label uses based on ongoing research.
Are there approved biosimilars or generics for this drug?
As of now, no biosimilar or generic equivalents have been approved, maintaining exclusivity and pricing power.
How does patent expiration impact future prices?
Patent expiration typically results in increased competition and significant price reductions due to biosimilars or generics entering the market.
What reimbursement challenges may affect the market?
Reimbursement policies depend on insurer negotiations, formulary placements, and cost-effectiveness evaluations, influencing patient access and profitability.
What factors could accelerate market growth?
Expansion to new indications, regulatory approvals outside the U.S., and increased adoption due to clinical guidelines can boost market share.
References
[1] U.S. Food and Drug Administration. (2023). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] IQVIA. (2023). National Prescription Audit. Market size and growth estimates.
[3] CMS.gov. (2023). Medicare Part D Reimbursements and formularies.
[4] EvaluatePharma. (2023). 2023 World Preview: Key drug pricing and market projections.
[5] Pharma Intelligence. (2023). Competitive landscape analysis for [therapeutic class].
