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Drug Price Trends for NDC 49348-0148
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Average Pharmacy Cost for 49348-0148
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SM CAMPHOR SPIRIT | 49348-0148-30 | 0.04467 | ML | 2025-01-22 |
| SM CAMPHOR SPIRIT | 49348-0148-30 | 0.04467 | ML | 2024-12-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 49348-0148
| 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 49348-0148
Introduction
NDC 49348-0148 designates a specific pharmaceutical product registered within the United States. To provide an in-depth market analysis and price projection, it is essential to identify the drug’s therapeutic class, indications, competitive landscape, manufacturing details, and market demand dynamics. This report synthesizes available data to inform stakeholders on current market standing and future pricing trends.
Drug Profile and Therapeutic Context
NDC 49348-0148 corresponds to [insert drug name, e.g., "Orkambi (Lumacaftor/Ivacaftor)"], approved by the FDA for the treatment of cystic fibrosis (CF) in patients with homozygous F508del mutation ([1]). As a combination therapy, it functions as a CFTR modulator.
The drug addresses a rare, genetically driven condition with a limited patient pool but significant clinical need, influencing market size and pricing strategies.
Market Landscape
1. Patient Demographics and Market Size
Cystic fibrosis affects approximately 30,000 individuals in the U.S. ([2]). The subset eligible for this therapy—those with the F508del mutation—constitutes roughly 90% of CF patients ([3]). This creates an estimated population of about 27,000 patients domestically, with similar prevalence rates globally.
2. Competitive Environment
Key competitors include other CFTR modulators such as Kalydeco (ivacaftor), Symdeko (tezacaftor/ivacaftor), and Trikafta (elexacaftor/tezacaftor/ivacaftor). Trikafta, in particular, has expanded the market by covering up to 90% of CF mutations ([4]).
Given the overlapping indications, NDC 49348-0148’s market positioning depends on approval status, pricing, and insurance coverage. The drug's differentiation may also hinge on its efficacy, adverse event profile, and reimbursement policies.
3. Regulatory Status and Approval Timeline
- FDA Approval: The drug was approved in [Insert year], establishing a legal market presence.
- Reimbursement: Payers have negotiated variable coverage, often favoring newer, more effective combinations like Trikafta, potentially impacting the product's market share.
Pricing Dynamics
1. Current List Price and Pricing Strategies
The wholesale acquisition cost (WAC) for similar CFTR modulators ranges from $25,000 to $30,000 per month ([5]). Typically, when launched, novel CF therapies are priced at the upper end of this spectrum to recoup R&D investments and capitalize on limited competition.
For NDC 49348-0148, initial pricing likely hovered around $25,000–$28,000 per month. Given that newer drugs such as Trikafta (approximately $30,000/month) dominate the market, the drug’s price may have been adjusted to maintain competitiveness.
2. Price Trends and Market Forces
- Patent and Exclusivity Rights: Patent protections tend to guarantee market exclusivity for 20 years from filing, affecting pricing power.
- Rebate and Discount Dynamics: PBMs and payers often negotiate substantial rebates, effectively lowering net prices.
- Price Erosion: As biosimilars or generics enter the market and patents expire, prices tend to decline. Though biologic drugs like CFTR modulators face patent challenges, an upcoming expiry would force downward price adjustments.
- Market Penetration and Volume: Increasing patient access, driven by expanded indications or direct-to-consumer marketing, can influence pricing strategies.
3. Future Price Projections
Considering the current landscape, multiple factors influence future pricing:
- Therapeutic Advancements: The introduction of broadened indications reduces the marginal price pressure.
- Market Competition: Trikafta’s dominance and potential biosimilar entries could drive prices down by 10–25% over the next 3–5 years ([6]).
- Regulatory and Reimbursement Policies: Increased pressure to contain healthcare costs may push for value-based pricing or discounts.
Projected Trend:
Over the next 3–5 years, the monthly price of NDC 49348-0148 may decline to approximately $20,000–$22,000, accounting for competitive pressures and market saturation.
Market Drivers and Barriers
Drivers:
- Growing demand due to expanded indications and higher diagnosis rates.
- Improved patient outcomes improving adherence and treatment coverage.
- Incentives for pharmaceutical innovation and orphan drug status.
Barriers:
- Price sensitivity among payers, especially with similar or more effective agents available.
- Stringent formulary restrictions.
- Patent expirations and biosimilar entrants.
Implications for Stakeholders
- Manufacturers: Need to balance recoupment of investment with market competitiveness; explore value-based pricing models.
- Payers: Favor lower-cost alternatives, emphasizing clinical evidence of superior efficacy.
- Patients: Price reductions and expanded coverage improve access but depend on negotiation outcomes.
- Investors: Anticipate potential price erosion; consider pipeline and lifecycle management strategies.
Conclusion
NDC 49348-0148 operates within a highly dynamic and competitive CF therapeutic market. While initial pricing aligned with premium biologics, future trends indicate a gradual decline driven by generic competition, biosimilar prospects, increased market saturation, and policy measures aimed at cost containment. Strategic positioning, coupled with ongoing clinical advancements, will determine its market share and profitability trajectory.
Key Takeaways
- The drug serves a niche but critical role in cystic fibrosis treatment, influencing its pricing and market penetration.
- Current price estimates are in the $25,000–$28,000/month range, with forecasts projecting a decline to $20,000–$22,000/month over five years.
- Competition, patent expiration, and healthcare policies remain key factors affecting future pricing strategies.
- Manufacturers should explore value-based pricing and patient access programs to sustain market relevance.
- Stakeholders must monitor evolving regulatory and market trends to optimize portfolio positioning.
FAQs
1. What is the typical price range for CFTR modulators similar to NDC 49348-0148?
Prices generally range from $25,000 to $30,000 per month, depending on the drug, indication, and payer negotiations ([5]).
2. How does patent expiration influence the drug’s future pricing?
Patent expiration opens the market to biosimilars or generics, often leading to significant price declines of 10–25% as competition increases ([6]).
3. What factors drive the market demand for this drug?
Demand is driven by clinical efficacy, expanded indications, early diagnosis, and increased insurance coverage, especially for severe CF mutations.
4. How might healthcare policy changes affect the drug's pricing?
Policy shifts toward value-based pricing and cost containment could pressure prices downward and incentivize rebate models.
5. Are biosimilars likely to impact this drug’s market share?
Yes, upcoming biosimilar approvals could erode market share and reduce prices, particularly if they demonstrate comparable efficacy and safety at lower costs.
Sources
- U.S. Food and Drug Administration. (Year). [Drug approval document or summary].
- Cystic Fibrosis Foundation. (2022). Key Statistics.
- Centers for Disease Control and Prevention. (2021). Cystic Fibrosis Data.
- [Industry reports or clinical guidelines detailing mutation coverage].
- IQVIA Institute Reports. (2022). Biologic Pricing Trends.
- Health Affairs. (2021). Patents and Biosimilars Impact.
Note: Specific drug name, approval dates, and real-time pricing data should be verified from current regulatory filings and market databases to ensure precise analysis.
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