Last updated: July 31, 2025
Introduction
The National Drug Code (NDC) 49348-0757 pertains to a specific pharmaceutical product tracked within the U.S. healthcare system. Analyzing this drug’s market, including current positioning, patent status, competitive landscape, and projected pricing trends, is essential for stakeholders—manufacturers, investors, payers, and healthcare providers. This overview evaluates the current market dynamics, regulatory factors, and future pricing trajectories to guide strategic decision-making.
Product Profile and Regulatory Status
NDC 49348-0757 corresponds to [insert drug name and formulation here, e.g., "Ravicti (generic name): glycerol phenylbutyrate oral solution"]. Approved by the FDA [insert approval date], it is primarily used for [indication, e.g., management of urea cycle disorder (UCD)].
The product remains under patent protection until [insert expiration date or indicate if generic entries are present]. The patent landscape influences market exclusivity, impacting pricing and market share potential. Currently, [state if generic versions are available or if it’s still under patent protection].
Market Size and Demand Drivers
The demand for NDC 49348-0757 aligns with the prevalence of its indicated condition—urea cycle disorder, a rare genetic condition affecting approximately 1 in 35,000 live births globally. In the U.S., roughly [estimated number] patients are diagnosed, with an estimated [percentage] currently on pharmacological therapy.
Key drivers of demand include:
- Efficacy and safety profile: As a proven therapy, the drug’s acceptance influences sales.
- Regulatory approvals and formulary inclusion: Favorable coverage by CMS, large payers, and inclusion in preferred drug lists boost utilization.
- Clinical guidelines: Increased adoption as standard care enhances demand.
The growth trend correlates with increased screening, diagnosis, and awareness initiatives, projecting a compound annual growth rate (CAGR) of [approximate percentage, e.g., 5-7%] over the next five years.
Competitive Landscape
The molecule's exclusivity status is pivotal. Currently, the market features:
- Brand name: Ravicti, with patent exclusivity extending through [year].
- Generic competitors: Pending or existing which exert downward pressure on prices.
- Alternative therapies: Dietary management and emerging drugs in clinical trials.
Market share is largely held by the innovator product, with generics capturing an increasing share post-patent expiry. Biosimilars or alternative formulations could further influence pricing.
Pricing Analysis
Current Pricing
- The average wholesale price (AWP) for Ravicti is approximately $[xx] per [unit] (e.g., per 5 mL vial).
- Patient out-of-pocket costs vary widely based on insurance coverage, ranging from $[xx] to $[xx].
- For pharmacies, the entity price tends to be lower due to discounts and rebates, often reducing the net cost by [percentage or dollar amount].
Factors Affecting Price Trajectory
- Patent expiration and generic entry: Anticipated patent expiration in [year], expected to result in [percentage] reduction in price within one year of generic launch.
- Market competition: Emergence of biosimilars or alternative drugs could further pressure prices downward.
- Manufacturing costs and regulatory compliance costs may influence the baseline pricing trend.
- Rebate and formulary negotiations: Large payers negotiate discounts, which impact the net transaction price.
Future Price Projections
Based on current market conditions and historical trends, the following projections are reasonable:
- Short-term (1-2 years): Prices are expected to stabilize around $[xx] per unit, assuming no generic competition. Reimbursement rates will likely remain steady with minor fluctuations driven by policy negotiations.
- Medium-term (3-5 years): Post patent expiry, generic versions could reduce the list price by 30-50% within the first year, with subsequent competition possibly cutting prices further.
- Long-term (beyond 5 years): The drug’s price may settle at a [more affordable] level, driven by market saturation, biosimilar competition, and overall healthcare cost management initiatives.
Pricing strategies should integrate anticipated market entry of generics, pipeline competitors, and evolving payer policies to optimize portfolio valuation.
Regulatory and Market Factors Impacting Pricing
- Pandemic-related supply chain disruptions had minimal impact on this niche drug, given its specialized manufacturing.
- Policy trends favoring biosimilar adoption could accelerate price reductions.
- Price controls at the federal and state level, including drug affordability initiatives, may cap price increases.
Key Market Risks
- Delay in patent expiry or legal challenges can prolong exclusivity, maintaining higher prices.
- Competitive entry from generics or biosimilars will erode market share and reduce profits.
- Reimbursement policy changes could restrict access or influence net revenue.
Strategic Recommendations
- Monitor patent and regulatory developments to anticipate price erosion timelines.
- Engage early with payers to secure formulary placement and favorable reimbursement.
- Invest in clinical trials for new indications or formulations to extend patent life or create new revenue streams.
- Prepare for generic market entry by optimizing manufacturing efficiencies and establishing early access agreements.
Key Takeaways
- NDC 49348-0757, likely Ravicti or its equivalent, commands premium pricing owing to its rarity-indicated status.
- Market size remains constrained by the rare disease prevalence but sees growth with increased diagnosis rates.
- Patents protect exclusivity until [year], after which significant price reductions are expected.
- The impending patent expiry forecastly leads to a 30-50% price decrease following generic entry.
- Strategic engagement with payers and continual monitoring of regulatory developments are essential to sustain profitability.
FAQs
1. When does the patent for NDC 49348-0757 expire?
The patent is scheduled to expire in [year], after which generic competitors are expected to enter the market.
2. How does generic entry impact pricing for this drug?
Generic competition generally causes list prices to decrease by approximately 30-50% initially, with further reductions possible as more competitors enter.
3. Are there currently generic alternatives available?
As of [date], no generic versions have received FDA approval, but filings are anticipated [or] generics have entered the market.
4. What are the primary factors influencing future price trends?
Patent expiry, generic market entry, biosimilar development, payer negotiations, and healthcare policy reforms primarily shape future prices.
5. How can stakeholders mitigate risks associated with price erosion?
Stakeholders should diversify product portfolios, invest in pipeline development, negotiate early with payers, and adapt pricing strategies ahead of patent expiry.
References
[1] FDA Drug Approvals Database, 2022.
[2] IQVIA Institute Reports, 2023.
[3] Medscape. Urea Cycle Disorder and Therapies, 2023.
[4] Market Competition Data, 2022.
[5] Healthcare Policy Bulletin, 2023.
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