Last updated: February 27, 2026
What is NDC 51407-0438?
NDC 51407-0438 refers to Opzelura (ruxolitinib) cream, indicated primarily for treatment of atopic dermatitis. Approved by the FDA in September 2021, it was the first topical Janus kinase (JAK) inhibitor approved for this use.
Market Overview
Market Size and Demand
- Prevalence of atopic dermatitis: Affects approximately 10-20% of children and 2-3% of adults in the U.S.
- Market Opportunity: The chronic nature of atopic dermatitis creates sustained demand. In 2022, U.S. sales were estimated at $200 million, with projections reaching $450 million by 2027, based on CAGR of approximately 17%.
Competitive Landscape
| Brand Name |
Active Ingredient |
Approval Year |
Key Market Position |
| Opzelura |
Ruxolitinib cream |
2021 |
First topical JAK inhibitor for moderate-to-severe atopic dermatitis |
| Eucrisa (crisaborole) |
Crisaborole ointment |
2017 |
Non-steroidal topical for mild-to-moderate atopic dermatitis |
| Dupixent (dupilumab) |
Monoclonal antibody |
2017 |
Systemic biologic targeting IL-4 receptor; high efficacy but administered via injection |
Opzelura faces competition primarily from Eucrisa and systemic therapies like Dupixent, which holds a significant share due to broader indications.
Pricing Analysis
Current Pricing
- Average wholesale price (AWP): Estimated at $4,200 per 60g tube.
- Average retail price: Approximately $4,500 to $5,200 per tube, depending on pharmacy and patient insurance coverage.
Price Comparisons
| Product |
Price per Tube |
Indication |
Delivery Method |
| Opzelura (51407-0438) |
~$4,500 |
Atopic dermatitis (topical) |
Cream |
| Eucrisa (crisaborole) |
~$1,200 |
Mild-to-moderate atopic dermatitis |
Cream |
| Dupixent (dupilumab) |
~$4,100 (per injection) |
Moderate-to-severe atopic dermatitis |
Injection (biweekly) |
Reimbursement Considerations
Insurance reimbursement varies. For commercial plans, copay assistance programs are common. The high list price reflects limited, though growing, coverage penetration.
Price Projections
Short-Term (Next 1-2 Years)
- Pricing is likely to remain stable around $4,500 per tube, assuming no generic competition due to patent protections.
- Manufacturers may implement payor discounts and rebate programs.
Medium-Term (3-5 Years)
- Introduction of biosimilar or generic formulations could reduce prices by 20-50%.
- Expansion of indications (e.g., psoriasis) could increase sales volume, stabilizing revenue despite potential price erosion.
- As of 2023, patent exclusivity persists until at least 2030, limiting immediate generic entry.
Long-Term (5+ Years)
- Patent expiry and biosimilar entry anticipated post-2030 could lower prices substantially.
- Market saturation and increased competition from oral JAK inhibitors may influence premium pricing.
External Factors Impacting Price
- Patent litigation outcomes.
- Regulatory changes affecting biosimilar approval pathways.
- Payer negotiations impacting net prices.
Market Entry Barriers and Opportunities
- Barriers: Patent protection until at least 2030, high development and marketing costs, limited initial indications.
- Opportunities: Expanding indications, combination therapies, and geographic expansion.
Conclusion
NDC 51407-0438 (Opzelura) commands a high premium price driven by its innovative mechanism and limited competition. Short-term prices are expected to stabilize at current levels. Price decline projections depend on patent status, biosimilar development, and in-market competition. Market growth hinges on expanding indications and broader insurance coverage.
Key Takeaways
- The drug's current wholesale price is approximately $4,200-$4,500 per tube.
- The market is projected to grow at a CAGR of 17% through 2027, reaching around $450 million in U.S. sales.
- Patent protection delays generic entry until at least 2030, maintaining high pricing.
- Competition from systemic biologics and emerging biosimilars will influence long-term pricing.
- Insurance coverage and rebate programs significantly impact net pricing and patient access.
FAQs
-
When is patent expiration expected for NDC 51407-0438?
Patent protections are expected to last until at least 2030, delaying biosimilar competition.
-
Are biosimilars planned for Opzelura?
As of now, no biosimilars are approved. Biosimilar development is possible but has not been announced.
-
What factors can influence the retail price?
Insurance reimbursements, rebate agreements, and patient copayment programs directly impact retail prices.
-
How does Opzelura compare price-wise to systemic treatments?
It is priced similarly to biologics like Dupixent but is topical, offering a less invasive option.
-
What is the outlook for new formulations?
There are no announced new formulations. Focus remains on expanding indications and geographic reach.
References
- U.S. Food and Drug Administration. (2021). FDA approves first topical JAK inhibitor for atopic dermatitis.
- IQVIA. (2023). U.S. Prescription Drug Market Analysis.
- Refinitiv. (2023). Drug Price Benchmarks and Reimbursement Data.
- Published clinical trial data and FDA approval documents.
