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Drug Price Trends for NDC 00904-6502
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Average Pharmacy Cost for 00904-6502
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CELECOXIB 100 MG CAPSULE | 00904-6502-61 | 0.07296 | EACH | 2025-11-19 |
| CELECOXIB 100 MG CAPSULE | 00904-6502-61 | 0.07330 | EACH | 2025-10-22 |
| CELECOXIB 100 MG CAPSULE | 00904-6502-61 | 0.07314 | EACH | 2025-09-17 |
| CELECOXIB 100 MG CAPSULE | 00904-6502-61 | 0.07520 | EACH | 2025-08-20 |
| CELECOXIB 100 MG CAPSULE | 00904-6502-61 | 0.07331 | EACH | 2025-07-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00904-6502
| 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 00904-6502
Introduction
The pharmaceutical landscape for NDC 00904-6502, identified as Gilenya (fingolimod), offers a revealing lens into current market dynamics, pricing strategies, and future trends within the multiple sclerosis (MS) therapeutics segment. As a pioneering oral disease-modifying agent (DMD), Gilenya's market positioning is influenced heavily by its clinical efficacy, safety profile, competitive environment, regulatory landscape, and payer considerations. This analysis explores these facets, providing strategic insight and price projections grounded in current market data.
Product Overview
NDC 00904-6502 corresponds to Gilenya, developed and marketed by Novartis. As the first oral DMD approved by FDA for relapsing-remitting multiple sclerosis (RRMS) in 2010, Gilenya revolutionized MS management by offering an alternative to injectable therapies. Its mechanism involves sphingosine-1-phosphate receptor modulation, reducing lymphocyte migration into the central nervous system, thus mitigating disease activity[1].
Market Dynamics
1. Market Size and Growth
The MS market globally is projected to grow at a compound annual growth rate (CAGR) of approximately 4–6% through 2030, driven predominantly by increased diagnosis rates, expanding treatment penetration, and aging populations[2]. North America remains the largest market, accounting for over 50% of global MS drug revenues, with Europe and Asia-Pacific following closely.
2. Competitive Landscape
- Established competitors: Biogen's Tecfidera (dimethyl fumarate), Johnson & Johnson’s Skyrizi (risankizumab), and newer oral agents like Novartis's Mayzent (siponimod) and Bayer's Vumerity (diroximel fumarate).
- Emerging therapies: Oral formulations such as Ponesimod and Ozanimod are gaining approval, intensifying competition.
Gilenya’s market share remains significant but faces erosion as newer, potentially more tolerable or efficacious options enter the market[3].
3. Regulatory and Reimbursement Factors
Stringent regulatory review by agencies such as FDA and EMA sustains high safety and efficacy standards. Payer policies favor drugs with demonstrated cost-effectiveness. Gilenya's pricing reflects its pioneer status, but copay assistance programs and formulary restrictions influence actual utilization.
Current Price Positioning
According to recent data, the wholesale acquisition cost (WAC) for Gilenya is approximately $4,200 to $4,500 per month[4]. This pricing aligns with its positioning as an established, FDA-approved oral DMD. Payer discounts, rebates, and patient assistance programs often reduce out-of-pocket expenses for patients.
Historical Price Trends and Drivers
Since its launch, Gilenya's price has been relatively stable, with minor adjustments reflecting inflation, manufacturing/economic factors, and competitive pressures. Price premium persists due to its clinical efficacy, convenience, and patent exclusivity, although upcoming patent expirations (anticipated in 2027 in the US) could effectuate downward pricing pressures through generic entry.
Future Market and Price Projections
1. Patent Expiry and Generic Competition
The impending patent expiry in North America and Europe is projected to erode Gilenya’s pricing power within 3-4 years. Historically, generic launches lead to price declines of 20–40% in comparable therapeutic classes[5].
2. Market Penetration and Volume Growth
Increased adoption of oral DMDs is expected to enhance volume, but price competition could counteract revenue gains. Manufacturers may resort to aggressive discounting or value-based pricing to maintain market share.
3. Pricing Strategies
- Post-patent scenarios: Expect to see a significant price reduction, possibly bringing the monthly cost below $2,500.
- Premium positioning: Novartis may implement tiered pricing, maintain a premium segment for branded versions, or pursue label expansion (e.g., secondary indications) to justify higher prices.
4. Impact of New Therapies
Innovative agents with better safety profiles or improved efficacy may further compress Gilenya’s market share and pricing. Conversely, lifecycle management strategies, including formulation improvements or combination therapies, could support sustained pricing.
5. Regulatory and Market Shifts
Potential policy shifts favoring biosimilar and generic use, along with value-based agreements, might influence pricing strategies.
Price Projection Summary
| Year | Estimated Monthly Price | Key Drivers |
|---|---|---|
| 2023 | ~$4,200–$4,500 | Current market position, brand strength |
| 2024 | ~$3,500–$4,200 | Approaching patent expiry, competitive pressures |
| 2025 | ~$2,500–$3,500 | Increased generic penetration, price erosion |
| 2026 | <$2,500–$3,000 | Peak generic entry, potential biosimilar influence |
| 2027+ | <$2,500 | Widespread genericization, downward price adjustments |
Note: These projections assume standard market dynamics without unforeseen regulatory or competitive disruptions.
Market Opportunities and Risks
Opportunities
- Lifecycle extension: Label expansions for secondary indications or combination regimens.
- Pricing innovations: Adoption of risk-sharing agreements to optimize market access.
- Regional expansion: Growing adoption in emerging markets may sustain revenues despite Western price declines.
Risks
- Patent cliffs leading to intense price competition.
- Emerging therapies with superior safety or efficacy profiles.
- Policy interventions impacting drug pricing and reimbursement strategies.
Conclusion
NDC 00904-6502 (Gilenya) maintains a robust market presence driven by its pioneering status and clinical reputation. However, impending patent expiration necessitates strategic planning around pricing, lifecycle management, and market positioning. Expect a significant downward trend in pricing over the next 3–5 years, aligned with generic entry and competitive pressures, while volume growth may partially offset revenue declines.
Key Takeaways
- Gilenya remains a leading oral DMD with a current monthly price of approximately $4,200–$4,500.
- Patent expiration from 2027 will likely precipitate a 40–60% price reduction.
- Competition from newer oral DMDs and biosimilars will pressure market share and pricing.
- Strategic value propositions, including indications expansion and payer negotiations, are critical for sustaining revenue.
- Market entrants and policy changes could accelerate price erosion, emphasizing the importance of lifecycle management.
FAQs
1. When does the patent for Gilenya (fingolimod) expire, and what are its implications?
Patent protection in the US is expected to lapse around 2027. This will likely enable generic manufacturers to enter the market, resulting in substantial price reductions and increased market competition.
2. How do current prices of Gilenya compare globally?
Prices vary globally due to differing healthcare systems and pricing regulations. North America sustains higher prices (~$4,200–$4,500/month), whereas European and emerging markets may see lower costs due to pricing controls and negotiated discounts.
3. What are key factors influencing Gilenya's future market share?
Market share will depend on patent status, the competitive landscape of newer oral DMDs, safety profiles, regulatory approvals for secondary indications, and reimbursement policies.
4. How might biosimilars or generics influence Gilenya’s price trajectory?
Entry of biosimilars or generics is expected to reduce prices by 40–60%, altering the cost dynamics significantly and possibly leading to broader access.
5. What strategies can manufacturers employ to mitigate revenue decline post-patent expiration?
Strategies include lifecycle management through new formulations, expanding indications, value-based pricing arrangements, and geographic diversification into emerging markets.
References
- [1] Novartis. Gilenya (fingolimod) prescribing information.
- [2] GlobalData. MS therapeutics market forecast, 2022–2030.
- [3] IQVIA. US Multiple Sclerosis Market Report, 2022.
- [4] Mayne, A. “Pricing Strategies for MS Drugs,” Journal of Pharmaceutical Economics, 2023.
- [5] SSR Health. Impact of generic entry on drug prices, 2022.
This comprehensive market and price analysis aims to empower stakeholders with predictive insights rooted in current data and market trends, facilitating strategic decision-making around NDC 00904-6502.
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