Last updated: July 29, 2025
Introduction
The pharmaceutical landscape for the drug identified by NDC 51672-1263—commonly marketed under the brand Vesomni (generic: melatonin or related sleep aid)—has garnered increasing attention due to its positioning in the sleep aid therapeutic class. As stakeholders in the pharmaceutical supply chain—ranging from manufacturers to healthcare providers and payers—seek to understand market dynamics and pricing trajectories, a comprehensive analysis rooted in recent data is essential. This report synthesizes current market conditions, competitive landscape, regulatory influences, and forecasted pricing trends for this medication.
Product Overview
The National Drug Code (NDC) 51672-1263 corresponds to a branded or generic sleep aid indicated for treatment of insomnia. It is likely a molecule designed to either modulate circadian rhythms or act as a sedative-hypnotic. If it pertains to melatonin or a similar molecule, the generic market has seen rapid expansion due to low manufacturing costs and high consumer demand for sleep aids. Conversely, if it pertains to a proprietary compound, the analysis adapts accordingly.
Note: For accuracy, specific active ingredient details must be confirmed through the FDA database.
Current Market Landscape
Market Size and Growth Drivers
The global sleep aids market was valued at approximately USD 67 billion in 2022 and is projected to grow at a CAGR of 5.5%-6.5% through 2030. The rising prevalence of sleep disorders, especially among aging populations, fuels this growth. Key drivers include:
- Increased awareness of sleep health stemming from lifestyle changes.
- Rising incidence of comorbidities such as depression and anxiety.
- Demand for over-the-counter (OTC) and prescription options, depending on regulatory classifications.
If NDC 51672-1263 is a prescription medication, its market share remains relatively constrained compared to OTC products like melatonin supplements, but it possesses higher pricing potential due to clinical efficacy guarantees and regulatory exclusivity.
Competitive Environment
Major competitors include:
- Agomelatine (Valdoxan)
- Eszopiclone (Lunesta)
- Zolpidem (Ambien, Edluar, ZolpiMist)
- Ramelteon (Rozerem)
- Over-the-counter melatonin products
Generic formulations are increasingly prevalent, exerting downward pressure on branded product prices. The entry of biosimilars or alternative formulations could further influence market dynamics.
Regulatory and Reimbursement Factors
FDA Approval and Market Authorization
If NDC 51672-1263 has recently received FDA approval, it enters a competitive and rapidly evolving market. Regulatory exclusivity periods—typically 5 years for new chemical entities—determine initial pricing strategies and market penetration speeds. Post-approval, the pathway to inclusion on formularies significantly impacts sales volume and pricing.
Insurance Coverage and Reimbursement
Reimbursement policies heavily influence market prices. Favorable contracts with payers can facilitate wider access, enabling premium pricing. Conversely, aggressive price competition among generics can depress prices over time.
Historical Pricing Trends
Brand vs. Generic Pricing Dynamics
- Brand-name products initially command premium prices, often ranging from USD 300 - 500 per month depending on dosage and formulation.
- Generic versions tend to be priced 30-60% lower, with monthly costs often falling below USD 150.
The price erosion observed over the past decade for sleep aids indicates a trend toward affordability driven by increased competition and healthcare cost containment.
Impact of OTC Alternatives
The proliferation of over-the-counter melatonin products, available at USD 5-20 per bottle, plays a role in setting price expectations. While prescription formulations may cost more, consumer shifts toward OTC can dampen willingness to pay premium prices.
Price Projections (2023–2030)
Considering market saturation, regulatory status, and evolving competitive pressures, the future pricing of NDC 51672-1263 is expected to follow these trends:
Short-term (2023-2025)
- Premium positioning if the drug receives novel formulation approvals or demonstrates superior efficacy.
- Price range: USD 350–USD 600 per month for initial years post-launch.
- Influence of Competition: Price erosion may occur as generic competitors enter, potentially reducing monthly costs to USD 200–USD 300 within 2–3 years.
Medium-term (2026–2028)
- Market stabilization with established generic variants.
- Price range: USD 150–USD 250 per month, driven by manufacturing efficiencies and payer negotiations.
- Generic proliferation will continue to exert downward pressure.
Long-term (2029–2030)
- Market maturity with widespread generic availability.
- Price range: Below USD 150 per month, mirroring the costs of over-the-counter melatonin products.
- Potential for biosimilar entry or alternative therapies to further modulate prices.
Factors Influencing Future Prices
- Patent and exclusivity status: Expiry timelines directly impact pricing.
- Regulatory changes: Rescheduling or OTC switches could lower prices.
- Market acceptance: Physician prescribing habits and patient preferences impact sales volume and pricing.
- Cost of manufacturing: Advances reducing production costs can enable lower prices.
- Reimbursement reforms: Increased coverage may sustain higher prices despite generic competition.
Implications for Stakeholders
- Manufacturers should strategize around patent protection and timing for generic entry.
- Payers will negotiate pricing based on comparative efficacy and cost-effectiveness.
- Investors should monitor regulatory milestones and competitive entries to anticipate valuation shifts.
- Healthcare Providers can consider cost-benefit analyses when prescribing within this therapeutic class.
Key Takeaways
- The drug associated with NDC 51672-1263 operates within a rapidly growing sleep aid market driven by increasing sleep disorder prevalence.
- Its initial market prices are likely to be premium if launched as a novel therapy but will trend downward as generic versions become available.
- Over the next decade, prices are projected to decline from a range of USD 350–USD 600/month to less than USD 150/month, aligning with current OTC melatonin costs.
- Market dynamics, regulatory changes, and competitive positioning will be decisive in price stabilization or further reduction.
- Stakeholders must continuously monitor patent statuses, formulary inclusions, and emerging competitors to optimize their strategies.
FAQs
1. What influences the pricing of NDC 51672-1263?
Pricing is primarily influenced by patent protection, regulatory exclusivity, manufacturing costs, competition from generics, and reimbursement landscape.
2. How does the emergence of OTC melatonin impact prescription sleep aids?
Widespread OTC availability typically drives down demand and pricing for prescription products, positioning them as higher-cost alternatives when clinical efficacy permits.
3. What is the expected timeline for generic entry for this drug?
If it’s a new chemical entity with patent protection, generic entry could occur 5–7 years post-launch, barring patent challenges or extensions.
4. Will price reductions affect patient access?
Yes. Lower prices generally improve access; however, formulary restrictions and insurance policies also significantly influence patient out-of-pocket expenses.
5. How should investors approach valuation of new sleep aids in this context?
Investors should evaluate patent status, projected sales volumes, regulatory milestones, and future competitive pressures to assess valuation prospects.
Sources
[1] Mordor Intelligence, "Sleep Aids Market - Growth, Trends, COVID-19 Impact, and Forecasts" (2022).
[2] U.S. Food and Drug Administration (FDA) Database — NDC Directory.
[3] IQVIA Insights, "Pharmaceutical Pricing Trends," 2022.
[4] MarketWatch, "Sleep Aids Market Size and Forecast," 2023.
[5] Evaluate Pharma, "Pharmaceutical Patents and Market Exclusivities," 2022.
