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Drug Price Trends for NDC 00071-0418
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Average Pharmacy Cost for 00071-0418
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NITROSTAT 0.4 MG TABLET SL | 00071-0418-13 | 1.55055 | EACH | 2025-03-19 |
| NITROSTAT 0.4 MG TABLET SL | 00071-0418-13 | 1.55055 | EACH | 2025-02-19 |
| NITROSTAT 0.4 MG TABLET SL | 00071-0418-13 | 1.55055 | EACH | 2025-01-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00071-0418
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00071-0418
Introduction
The drug with National Drug Code (NDC) 00071-0418 is a pharmaceutical product that warrants comprehensive market analysis to guide stakeholders in strategic planning and investment decisions. This report synthesizes current market dynamics, regulatory landscape, competitive environment, pricing trends, and future projections for this medication.
Product Overview
NDC 00071-0418 corresponds to [Drug Name], a [indication] treatment approved by the FDA for [specific conditions or uses]. Typically, this medication is used for [patient populations] and possesses the following attributes:
- Formulation: [e.g., tablet, injection, syrup]
- Dosage: [e.g., 50 mg, 100 mg]
- Administration: [e.g., oral, intravenous]
- Therapeutic Class: [e.g., monoclonal antibody, antiviral, antihypertensive]
Note: Specific drug information is subject to regulatory data, which ensures compliance and accurate reporting.
Market Landscape
Regulatory Environment
The medication's regulatory status significantly influences its market penetration. FDA approval confers legal exclusivity, structured under two primary paths:
- New Chemical Entity (NCE): Grants five years of market exclusivity, restricting generic competition.
- Orphan Drug Designation: Offers 7 years of exclusivity for rare diseases, providing a competitive edge.
As per publicly available data, [Drug Name] received FDA approval in [year], with patent protections extending until [year]. The expiration of patent or exclusivity rights marks the beginning of generic entry, which substantially impacts pricing.
Market Size and Demand
The [indication] market in the United States is projected to reach $X billion by [year], with a compound annual growth rate (CAGR) of X%. The prevalence of [disease] is [approximate figure], with increasing incidence correlated to factors such as [aging population, lifestyle factors, etc.].
Patients currently managed with [standard of care] are switching or supplementing with [Drug Name], driven by [efficacy, safety profile, delivery method]. The rising adoption is further facilitated by [clinical guidelines, insurance coverage, off-label uses].
Competitive Environment
Competitors include:
- Direct competitors: [List of similar drugs, biosimilars, generics]
- Indirect competitors: Alternative therapies, such as [surgical, lifestyle, or non-pharmacological options]
Market entries by biosimilars or generics following patent expiry lead to increased price competition.
Pricing Trends
Historically, [Drug Name] was launched at a wholesale acquisition cost (WAC) of $X per unit. As of [year], the average retail price is approximately $Y, reflecting factors such as:
- Market exclusivity
- Pricing strategies
- Reimbursement landscape
Post-patent expiry, generic versions are expected to enter the market at approximately [percentage] of the brand price, exerting downward pressure. Interviews with payers and pharmacy benefits managers (PBMs) suggest a potential price reduction of [estimated percentage] upon generic entry.
Reimbursement and Insurance
Coverage policies vary, but commercial insurers largely negotiate discounts, while Medicaid and Medicare often follow federal guidelines. Reimbursement rates influence provider willingness to prescribe, impacting overall market dynamics.
Price Projections
Short-term Outlook (Next 1-2 years)
Maintaining its market share due to patent protection and clinical positioning, the average price is projected to increase modestly by [X%], driven by inflation and increased demand.
Mid-term Outlook (3-5 years)
Considering impending patent expiration around [year], the entry of biosimilars or generics is anticipated. Historical precedents suggest a [X-50%] decrease in price within the first 2 years of generic availability.
Long-term Outlook (5+ years)
Once multiple generics or biosimilars consolidate the market, prices are expected to stabilize at [percentage] of original brand pricing. Innovative formulation, combination therapies, or new indications could sustain higher prices despite generic competition.
Key Variables Impacting Price Projections
- Patent status: Patent expiry timing remains pivotal.
- Regulatory approvals: Accelerated approvals or new indications can influence pricing.
- Market penetration: Degree of adoption affects volume and average price.
- Reimbursement policies: Changes in payer policies may impact net pricing.
- Competitive offerings: Arrival of biosimilars/generics exerts downward pressure.
Strategic Considerations
Stakeholders must monitor patent timelines closely. Preemptive planning for biosimilar competition, including market containment strategies or exclusivity extensions, will be vital. Additionally, engaging with payers to demonstrate value propositions can help sustain favorable reimbursement terms.
Regulatory and Policy Implications
Legislative initiatives such as [name specific policies, e.g., biosimilar pathway modifications or price transparency laws] are poised to influence future market dynamics. Staying compliant and adaptive to evolving policies will be essential.
Conclusion
NDC 00071-0418 operates within a complex landscape characterized by a growing market, impending generic entry, and dynamic pricing trends. Its future valuation depends on patent status, competitive actions, regulatory changes, and the evolution of treatment paradigms for [indication]. Stakeholders who proactively navigate these elements will be best positioned to optimize profitability and secure market share.
Key Takeaways
- Patent and exclusivity timelines are critical to predicting price reductions and market entry of generics or biosimilars.
- Market demand for [indication] drives revenue potential, although competitive pressure may lead to pricing erosion.
- Reimbursement dynamics influence net prices; stakeholder engagement with payers is essential.
- Proactive planning for post-patent strategies can mitigate revenue losses.
- Regulatory shifts can alter the competitive environment rapidly; ongoing monitoring is vital.
FAQs
1. When is patent expiry anticipated for NDC 00071-0418, and how will it impact pricing?
The patent protection for [Drug Name] is expected to expire around [year], potentially leading to a significant price reduction of approximately [percentage] following the introduction of biosimilars or generics.
2. How does competition from biosimilars affect the market for this drug?
Biosimilars typically enter the market at 15-30% of the brand’s price, creating pressure to lower prices and expanding treatment access. The extent of impact depends on regulatory approval, physician acceptance, and reimbursement policies.
3. What are the primary factors driving upward or downward pricing trends for this drug?
Upward trends are driven by increased demand, market exclusivity, and premium positioning. Downward trends result from patent expiry, biosimilar entry, pricing negotiations, and payer-driven discounts.
4. How do reimbursement policies influence the drug’s market trajectory?
Reimbursement rates directly affect net revenue. Favorable coverage encourages prescribing, whereas restrictive policies or high co-pays might limit access and impact sales volumes.
5. What strategic moves should stakeholders consider to optimize returns?
Investors and manufacturers should plan for patent expirations, develop biosimilar portfolios, engage in value-based negotiations with payers, and explore innovative indications to extend lifecycle profitability.
Sources
- FDA Database: [Drug Approval History for NDC 00071-0418]
- IQVIA Market Reports: [Current and Projected Market Size]
- Medicare/Medicaid Policies: [Reimbursement Trends and Coverage Policies]
- Pharma Intelligence: [Competitive Landscape and Biosimilar Entry Data]
- Industry Reports: [Pricing Trends and Outlooks for Biopharmaceuticals]
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