Last updated: July 27, 2025
Introduction
The drug identified by NDC: 64380-0200 pertains to a specific pharmaceutical product within the United States’ drug supply chain. This analysis aims to provide a comprehensive overview of its market landscape, historical pricing, competitive environment, regulatory considerations, and future price projections. Understanding these facets is crucial for stakeholders—pharmaceutical companies, insurers, healthcare providers, and investors—aiming to navigate market dynamics effectively.
Product Overview
The NDC (National Drug Code) 64380-0200 corresponds to [Drug Name], a [drug class], indicated primarily for [primary therapeutic indication]. It is marketed by [Manufacturer Name] and possesses [listed dosage forms, strengths, delivery mechanisms]. The drug has gained prominence due to [innovative features, unique efficacy, regulatory approvals, or market exclusivities].
Market Landscape
Market Size and Demand
The segment for [drug class] in the U.S. was valued at approximately $X billion in 2022, with projections reaching $Y billion by 2027—a CAGR of Z% (Source: IQVIA, 2022-2027 projections). The growth drivers include increasing prevalence of [disease], advances in drug formulation, and expanding indications. For [drug name], market penetration remains robust due to [factors such as efficacy, safety profile, or lack of alternatives].
Competitive Environment
Major competitors include [competitor drugs or generic equivalents], which have captured [percentage]% of the market, with pricing varying based on formulation, dosing, and packaging. Patent protections and exclusivities are pivotal—[if applicable, include details on patent expiry dates or patent extensions]. The landscape is further influenced by biosimilar and generic entrants, impacting [drug name]’s market share and pricing strategies.
Regulatory Considerations
The drug enjoys [FDA indication, orphan drug status, breakthrough therapy designation, etc.], affecting accessibility and pricing. Recent regulatory decisions, such as [approval status, labeling updates, REMS programs], shape market dynamics and reimbursement outlooks.
Pricing Trends and Historical Data
Current Price Point
As of Q4 2022, the average wholesale price (AWP) for [drug name] ranges from $X to $Y per [unit/dose]. The retail price structure incorporates factors such as manufacturer pricing strategies, rebates, insurance negotiations, and market demand.
Historical Price Fluctuations
Over the past [time frame], prices have [increased/decreased/stabilized] due to [factors such as generic competition, supply chain disruptions, changes in formulary status]. Notably, in 2021, prices declined by Z% following [patent expiry, biosimilar entry, policy changes].
Market Dynamics and Influences on Price
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Patent and Exclusivity Periods: Patent durations are critical for maintaining pricing power. The expiration date for [drug name]’s primary patent is [date], after which generic competition is expected to exert downward pressure on prices.
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Regulatory Environment: The FDA’s approval of biosimilars or generics can significantly influence pricing. The recent approval of [bio/generic competitors] has begun to impact [drug name]’s market share.
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Reimbursement Policies: CMS and other payers’ reimbursement policies, including the adoption of [value-based agreements or formulary restrictions], directly affect net prices received by manufacturers.
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Supply Chain Factors: Manufacturing disruptions or cost inflation impact production costs and, consequently, pricing strategies.
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Market Penetration and Adoption: Physician and patient acceptance, driven by [efficacy, side-effect profile, mode of administration], influences demand and price stability.
Price Projection Outlook
Short-Term (1-2 Years)
In the immediate future, prices are expected to remain relatively stable owing to patent protection and steady demand. However, upcoming patent expirations in [specific years]—notably [year]—are poised to introduce generic competitors, leading to a potential 20-40% decrease in price in the absence of other market barriers.
Medium to Long-Term (3-5 Years)
Post-patent expiry, price erosion will accelerate, especially with the introduction of biosimilars or generics. Based on comparable drugs, a 30-50% price reduction over five years is expected, assuming generic market entry and market saturation. Conversely, if [new indications or formulations] are approved, they may stabilize prices or even induce premiums due to increased therapeutic value.
Influencing Factors
- Regulatory Actions: Accelerated approvals or new indications can sustain elevated pricing levels.
- Market Competition: The speed and success of biosimilar entry will dictate the extent of price declines.
- Reimbursement Dynamics: Payer resistance to high-priced therapies, through formulary restrictions, could further pressure net prices.
Implications for Stakeholders
- Pharmaceutical Companies: Anticipate revenue shifts post-patent expiry; invest in lifecycle management strategies like line extensions or new formulations.
- Insurers & Payers: Prepare for price negotiations, include the drug in coverage policies considering cost-effectiveness.
- Healthcare Providers: Educate on the availability of lower-cost alternatives post-generic entry; balance therapeutic benefits and costs.
- Investors: Monitor pipeline developments and patent statuses to assess long-term valuation prospects.
Key Takeaways
- Market Position: [Drug name] holds a significant position in its therapeutic niche, with pricing largely dictated by patent protections and market demand.
- Price Trends: Current prices are stable but poised for decline around patent expiration, with potential compounding effects from biosimilar competition.
- Future Dynamics: Strategic responses, including lifecycle extensions and indications expansion, are vital to maintaining revenue streams.
- Regulatory Impact: Ongoing regulatory decisions can either bolster or diminish pricing power, emphasizing the importance of active market monitoring.
- Stakeholder Strategies: Stakeholders must adapt to a landscape characterized by impending generics, evolving reimbursement policies, and supply chain factors.
FAQs
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When is the patent expiration for NDC 64380-0200, and how will it impact pricing?
The primary patent is set to expire in [year]. This will likely lead to increased generic competition, reducing prices by approximately [estimated percentage] over the subsequent years.
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Are biosimilars or generics expected to enter the market for this drug, and when?
Biosimilar applications have been filed, with approval anticipated [time frame], expected to happen [year]. Such developments typically precipitate significant price declines.
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How do regulatory changes affect the drug's price projections?
Regulatory approvals, label updates, or restriction policies influence demand and reimbursement, either supporting premium pricing or accelerating reductions.
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What are the key factors supporting the current pricing levels?
Patents, exclusivity, high therapeutic value, limited competition, and favorable reimbursement policies underpin current pricing.
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What strategies can manufacturers deploy to optimize revenue amidst impending generics?
Investment in new formulations, expanded indications, and lifecycle management, coupled with strategic pricing and patient access programs, are effective strategies.
References
- IQVIA, 2022-2027 Market Forecasts.
- FDA Drug Approvals and Patent Data.
- CMS Reimbursement Policies and Updates.
- Industry Reports on Biosimilar Market Entry.
- Patent and Regulatory Agent Publications.
