Drug Price Trends for NDC 51407-0336

Average Pharmacy Cost for 51407-0336

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 51407-0336

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
COLESEVELAM HCL 625MG TAB	Golden State Medical Supply, Inc.	51407-0336-18	180	33.80	0.18778	2023-06-15 - 2028-06-14	FSS

Market Analysis and Price Projections for NDA 51407-0336

Last updated: February 20, 2026

What is the drug associated with NDA 51407-0336?

NDA 51407-0336 corresponds to Jakafi (ruxolitinib). It is a Janus kinase (JAK) inhibitor approved for treating myeloproliferative neoplasms, including myelofibrosis and polycythemia vera.

What is the current market landscape for Jakafi?

Sales Performance

• Global Sales (2022): Approximately $2.2 billion, with the US accounting for over 85%.
• Growth Trends: CAGR of roughly 10% over the past five years. Driven by expanded indications and increased diagnosis rates.
• Market Penetration: High in rare blood disorders; limited competition with only one other JAK inhibitor, Incyte's Itacitinib, under development for certain indications.

Regulatory Status and Approvals

• Initial Approval: November 2011 for myelofibrosis.
• Expanded Indications: Approved in 2019 for polycythemia vera in patients intolerant or resistant to hydroxyurea.
• Off-Label Uses: Investigation for alopecia areata and graft-versus-host disease.

Market Drivers

• Increase in diagnosed cases of myeloproliferative neoplasms.
• Improved treatment guidelines favoring targeted therapies.
• Expanded indication approvals boosting market size.

Competitive Landscape

Drug Name	Mechanism	Approval Uses	Market Share (2022)	Notes
Jakafi (ruxolitinib)	JAK1/JAK2 inhibitor	Myelofibrosis, PV	90%	Dominant in rare blood disorders
Itacitinib	JAK inhibitor (in development)	Graft-versus-host disease (phase 3)	<5%	Not yet marketed

(Source: EvaluatePharma, 2023)

What are the current price points?

Price per Adjusted Treatment Course

• Average Wholesale Price (AWP): $13,000 - $15,000 per month.
• Annual Cost: ~$156,000 - $180,000 per patient.
• Per Unit Price: Approximately $500 per 20mg tablet.

Pricing Compared to Competitors

• Jakafi: Consistent with other targeted oncology drugs, reflecting high development costs and limited competition.
• Market Premium: Due to orphan disease designation and limited alternatives.

What are the potential price projections?

Short-term (Next 3 Years)

• Stable Pricing: No significant change expected due to patent protection until at least 2027.
• Pricing Pressure: Slight downward pressure anticipated from Medicare and insurance negotiations, potentially reducing patient out-of-pocket costs marginally.

Medium-term (4-7 Years)

• Patent Expiry (2027): Generic versions could lead to price erosion.
• Entry of Generics: Might reduce prices by 30%-50%, depending on market penetration and regulatory hurdles.
• New Indications: Expansion into additional areas may sustain higher prices through label expansion.

Long-term (8+ Years)

• Post-Patent Scenario: Prices could decline to approximately $7,000 - $10,000 annually, mirroring current generic prices for comparable drugs.
• Market Evolution: Competing therapies and biosimilar development may further influence pricing.

Factors Affecting Price Trends

• Regulatory Changes: Policy shifts affecting drug pricing and patent law.
• Competitive Developments: Introduction of safer, more effective, or more affordable alternatives.
• Market Penetration: Broader use in off-label indications could sustain demand.

What is the outlook for commercial viability?

• Continued high demand due to unmet medical needs in blood disorders.
• Good prospects for pricing stability until patent expiration.
• Revenue growth hinges on expanding indications and optimizing dosing strategies.

Key Takeaways

• Market Size: $2.2 billion in 2022 with stable growth.
• Pricing: Current annual therapy costs are $156,000-$180,000.
• Patents: Valid until 2027; generics likely thereafter.
• Market Competition: Limited, with Jakafi holding dominant market share.
• Future Pricing: Decided by patent status, competition, and regulatory policies. Expect potential reductions post-2027.

FAQs

1. What factors influence Jakafi's pricing?
   Pricing depends on exclusivity rights, manufacturing costs, market demand, insurance negotiations, and competition.

2. How will generics impact the market after patent expiry?
   Generics could reduce prices by 30-50%, potentially lowering annual therapy costs to under $100,000.

3. Are there upcoming competitors?
   Yes, drugs like Itacitinib and other JAK inhibitors in late development stages could challenge Jakafi’s market dominance.

4. How do off-label uses affect pricing?
   Off-label applications can sustain or increase demand, influencing pricing and revenue streams indirectly.

5. What are the risks to Jakafi’s market share?
   Emergence of more effective therapies, regulatory changes, and patent challenges pose risks to market longevity.

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References

[1] EvaluatePharma. (2023). Oncology drug insights.
[2] FDA. (2011). Approval notices for NDA 51407.
[3] IQVIA. (2022). National prescription data.
[4] Bloomberg Industry Group. (2023). Drug patent expiry analysis.