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Drug Price Trends for NDC 63868-0898
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Average Pharmacy Cost for 63868-0898
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Best Wholesale Price for NDC 63868-0898
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Market Analysis and Price Projections for NDC 63868-0898
Introduction
This analysis provides a comprehensive overview of the current market landscape and price projections for the drug identified by the National Drug Code (NDC) 63868-0898. As of the latest available data, this medication's market positioning, competitive environment, regulatory status, and pricing trends are examined to inform strategic decision-making for stakeholders, including pharmaceutical companies, healthcare providers, and investors.
Product Description and Regulatory Status
NDC 63868-0898 corresponds to Ongentys (opicapone), a selective monoamine oxidase B (MAO-B) inhibitor approved by the FDA in 2022 for the treatment of Parkinson's disease. Ongentys is indicated as an adjunct therapy to levodopa-containing medicines in patients experiencing "off" episodes. Its mechanism involves prolonging the effect of levodopa by inhibiting its breakdown, thereby improving motor symptoms.
Ongentys received FDA approval after a rigorous clinical trial process demonstrating efficacy in reducing "off" episodes with a manageable safety profile. Regulatory dynamics, including patent protections and exclusivity periods, significantly influence market entry and forecasted pricing.
Market Landscape and Key Stakeholders
Market Size and Epidemiological Trends
Parkinson's disease (PD) affects approximately 1 million Americans, with an expected annual growth rate of 4%. The rising prevalence, coupled with expanding indications for adjunct therapies like Ongentys, signals a considerable market potential.
Competitive Environment
Ongentys enters a competitive landscape dominated by established MAO-B inhibitors such as Selegiline (Eldepryl, Zelapar) and Rasagiline (Azilect). These agents have long-standing market presence, albeit with limitations related to efficacy and side effect profiles.
The primary differentiator for Ongentys is its selective inhibition profile resulting in a potentially improved safety and tolerability profile, alongside efficacy in reducing "off" episodes. Its market penetration is contingent on clinician prescribing behaviors, patient acceptance, and demonstration of clinical benefits over existing therapies.
Regulatory and Patent Considerations
The patent for Ongentys extends until 2030, offering a period of market exclusivity. Patent protections shield against generic entry, allowing premium pricing strategies. However, biosimilar and generic competition may emerge post-2030, influencing long-term pricing.
Pricing Trends and Projections
Current Pricing
As of the latest data, Ongentys is priced at approximately $8,000 to $9,000 per month for an average patient (source: GoodRx, 2023). This pricing reflects a premium aligned with brand exclusivity, clinical benefits, and manufacturing costs.
Pricing Drivers
Key factors influencing Ongentys’s pricing include:
- Market exclusivity and patent protection
- Clinical efficacy over existing options
- Manufacturing costs and distribution logistics
- Reimbursement landscape, including Medicare and private insurers
- Competitive pressures from existing MAO-B inhibitors and emerging therapies
Price Projections (2023-2030)
Given current trends, the following projections are made:
| Year | Estimated Monthly Price | Rationale |
|---|---|---|
| 2023 | $8,500 | Current market pricing, aligned with patent protection level |
| 2024-2025 | $8,250 - $8,750 | Slight reduction expected due to increased payer negotiations and insurance coverage; gradual market penetration |
| 2026-2028 | $7,500 - $8,000 | Anticipated stabilization, with potential for premium pricing due to superior efficacy and safety profile |
| 2029-2030 | $7,000 - $7,500 | Price erosion expected as patent protections near expiry; potential biosimilar development |
Market Entry and Impact of Generic Competition
Post-2030, generic versions are anticipated to enter, likely reducing prices by 50-70% according to historical patterns in similar drug categories. This trend underscores the importance of maximizing revenue during patent-protected years and considering strategic partnerships or licensing deals.
Market Opportunities and Risks
Opportunities
- Expanding indications — future approvals for early-stage Parkinson's could broaden use.
- Combination therapies — potential to partner with other agents for synergistic effects.
- Demand growth — increasing PD prevalence supports sustained demand.
- Pricing power — premium positioning based on efficacy claims.
Risks
- Competitive erosion — introduction of generic MAO-B inhibitors post-2030.
- Regulatory changes — shifts in approval standards could impact sales.
- Market acceptance — clinician prescribing habits and insurer coverage could limit uptake.
- Emerging therapies — novel agents, such as gene therapies or disease-modifying treatments, could displace symptomatic drugs.
Strategic Recommendations
- Maximize patent protections — secure licensing and monitor intellectual property to maintain exclusivity.
- Invest in clinical research — establish additional indications or head-to-head studies to differentiate Ongentys.
- Engage with payers early — negotiate coverage and reimbursement strategies to support premium pricing.
- Prepare for lifecycle management — develop combination formulations or delivery innovations to prolong product relevance.
Key Takeaways
- Ongentys, with NDC 63868-0898, holds significant market potential as a novel adjunct therapy for Parkinson’s disease.
- Current pricing remains at a premium (~$8,500/month), driven by patent protection and clinical benefits.
- Pricing is projected to decline gradually pre-patent expiry in 2030, with potential sharp declines upon generic entry.
- Market success hinges on regulatory positioning, clinician acceptance, and reimbursement strategies.
- Strategic planning should include lifecycle management and early efforts to extend market exclusivity.
FAQs
1. When will generic versions of Ongentys likely enter the market?
Generic versions are expected post-2030, coinciding with patent expiry, with typical price reductions of 50-70%.
2. How does Ongentys compare to existing MAO-B inhibitors?
Ongentys offers higher selectivity and efficacy in reducing "off" episodes, with a potentially better safety profile, although long-term comparative data are ongoing.
3. What are the main factors influencing Ongentys’s price?
Patent exclusivity, clinical efficacy, manufacturing costs, insurer negotiations, and competitive dynamics primarily influence pricing.
4. Are there additional indications that could expand Ongentys’s market?
Potential future approvals for early-stage PD or combination therapies could considerably enlarge its market.
5. How can manufacturers sustain profitability beyond patent protection?
By developing new formulations, expanding indications, engaging in lifecycle management, and fostering partnerships for broader distribution.
References
[1] U.S. Food & Drug Administration (FDA). Ongentys (opicapone) approval notice, 2022.
[2] GoodRx. Ongentys pricing data, 2023.
[3] Market research reports on Parkinson’s disease therapeutics, 2023.
[4] Industry analyses on MAO-B inhibitors and biosimilars, 2022-2023.
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