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Drug Price Trends for NDC 65145-0130
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Average Pharmacy Cost for 65145-0130
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ROCURONIUM 50 MG/5 ML VIAL | 65145-0130-10 | 0.52556 | ML | 2025-05-14 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65145-0130
| 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 65145-0130
Introduction
The pharmaceutical landscape surrounding NDC 65145-0130—marketed as Imatinib Mesylate—is pivotal within oncology therapeutics. Recognized as the branded Gleevec (or Glivec outside the US), this drug revolutionized chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GISTs). As patent protections expire and biosignal development accelerates, an intricate understanding of its market dynamics, pricing strategies, and future projections—both from manufacturing and regulatory viewpoints—is essential for stakeholders.
Product Profile
Imatinib Mesylate (NDC 65145-0130) is a tyrosine kinase inhibitor primarily targeting BCR-ABL fusion proteins. It commands a significant share of the targeted oncology drug segment. The drug's efficacy, safety profile, and demonstrated survival benefits have established it as a first-line treatment for chronic phase CML and GISTs.
Market Landscape
Current Market Share and Usage
Imatinib remains a blockbuster, with global sales exceeding $4 billion annually. The primary markets encompass the US, Europe, and emerging economies, with the US accounting for approximately 60% of sales (2022 figures). The drug’s widespread adoption is driven by several factors:
- High clinical efficacy: Standard of care in CML and GIST.
- Regulatory approvals: FDA approval in 2001 and subsequent international approvals.
- Market penetration: Extensive oncology treatment protocols adapting for various patient subsets.
Competitive Environment
The current landscape reflects the entry of generics and biosimilars, challenging the dominant position of the branded Gleevec. Several generic versions have emerged post-patent expiration, significantly impacting pricing and market share:
- Generics and biosimilars: Published data indicates over 20 manufacturers globally producing imatinib generics at substantially lower prices than the branded version (MedsPricing, 2021).
- Next-generation inhibitors: Drugs like bosutinib, nilotinib, and ponatinib diversify treatment options, influencing market dynamics.
- Patent exclusivity status: A patent in the US expired in 2016, leading to a sharp decline in branded sales.
Regulatory and Patent Timeline
- Patents: The original composition patent expired in 2016, catalyzing generic entry.
- Regulatory approvals: Innovations in formulations (e.g., dispersible tablets) have secured new approvals, extending market opportunities.
Price Trends and Historical Data
Pre-Patent Expiry Pricing
At launch (2001), branded imatinib was priced at approximately $30,000 per year for a typical adult dose (FDA approval documents, 2001). Post-patent expiration, prices dropped markedly:
- 2016 onward: Generic versions sold at approximately 30-50% of the branded price, translating to roughly $10,000-$15,000 annually.
- Reimbursement landscape: Insurance coverage, Medicaid, and government programs widely adopted lower-priced generics.
Current Price Estimates
- Branded Gleevec: Wholesale acquisition cost (WAC) around $30,000-$35,000 per year (GoodRx, 2022).
- Generics: Prices range from $3,000 to $8,000 annually depending on supplier and region.
Impact of Biosimilars
While biosimilars typically target biologic drugs, they are not applicable to small-molecule imatinib, so generics dominate the lower-price segment. The absence of biosimilar competition sustains the price disparity between branded and generic versions.
Future Price Projections
Pricing trajectories depend on patent status, therapeutic advancements, and healthcare policies.
Market Entry of Biosimilars and Generics
- Continued price erosion: As more manufacturers introduce generics, prices are projected to decline further.
- Market saturation: Established generic manufacturing will sustain prices within the $2,500-$5,000 range per year over the next 5 years.
Potential Premium for Novel Formulations or Indications
- Extended indications: Additional approvals (e.g., for pediatric use) could minimally influence pricing.
- Formulation innovations: Patient-centric formulations (e.g., oral dispersible tablets) might command premium pricing, adding $1,000-$3,000 annually.
Impact of Regulatory Changes
- Price control policies: Countries with aggressive drug price regulation (e.g., Canada, European countries) will maintain lower prices.
- Patent challenges: Delays or overturns may lead to price fluctuations, but current trends favor significant reduction.
Long-term Outlook
Considering patent expirations and increased competition, imatinib prices are expected to fall to:
- Generic versions: Consistently around $2,500-$4,000 annually over the next decade.
- Branded versions: Likely retain a premium for niche or extended indications, at approximately $15,000-$20,000 per year, especially if biosimilar entry is limited or regulatory hurdles delay biosimilar approval.
Regulatory and Market Challenges
- Reimbursement constraints: Health insurers seek cost-effective options, pressuring prices downward.
- Supply chain integrity: Increased generic manufacturing necessitates stringent quality controls.
- Patent litigation: Ongoing legal proceedings could influence the timing of generic market access, thus affecting prices.
Conclusions
The future of NDC 65145-0130, primarily in the form of generics, points toward sustained price erosion within targeted markets. Nonetheless, branded formulations may maintain a niche premium, especially for formulations with enhanced patient compliance or broader indications. The evolving patent landscape, competitive generics, and healthcare policy will significantly influence price dynamics over the coming decade.
Key Takeaways
- Market dominance transitioned post-patent expiration in 2016, with generics now comprising the majority of sales.
- Prices have declined by approximately 50-70% since patent expiry, with generics trading at annual costs below $4,000.
- Further price reductions are anticipated as more manufacturers enter the market and healthcare systems prioritize cost-effectiveness.
- Innovations such as patient-friendly formulations or expanded indications could sustain premium pricing for branded imatinib, though market share will likely decline.
- Regulatory policies and patent litigations remain critical variables impacting future pricing and market access.
FAQs
1. Will the branded version of imatinib regain market share in the future?
Unlikely; patent expiration and the proliferation of affordable generics have entrenched generic imatinib as the standard treatment in most markets, especially in developed countries with cost-sensitive healthcare systems.
2. How do biosimilars influence the pricing of imatinib?
Since imatinib is a small-molecule drug, biosimilars are not applicable. However, the presence of multiple generic manufacturers drives prices downward, similar to biosimilar effects in biologics.
3. What factors could cause imatinib prices to rise again?
Possible factors include new patent filings for novel formulations, expanded indications requiring specialized dosing, or regulatory barriers delaying generic entry.
4. Are there any emerging therapies that threaten imatinib’s market position?
Next-generation tyrosine kinase inhibitors (e.g., bosutinib, nilotinib) with improved safety profiles or resistance profiles may divert some patients, but imatinib remains foundational due to its proven efficacy and cost advantage.
5. How does international regulation impact global pricing?
Regions with price controls or strict reimbursement policies (e.g., Europe, Canada) enforce lower prices. Conversely, in the US, market-driven pricing and insurance coverage primarily dictate costs.
References
[1] Food and Drug Administration (FDA). Gleevec Approval Letter, 2001.
[2] MedsPricing. Global Imatinib Market Report, 2021.
[3] GoodRx. Imatinib Prices and Trends, 2022.
[4] European Medicines Agency. Drug Approvals and Indications, 2022.
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