Last updated: February 27, 2026
What is the drug identified by NDC 62011-0323?
NDC 62011-0323 corresponds to Releterm (Ruxolitinib) 15 mg tablets, manufactured by Incyte Corporation. Ruxolitinib is an oral Janus kinase (JAK) inhibitor indicated primarily for the treatment of myelofibrosis, polycythemia vera, and certain cases of graft-versus-host disease.
Market landscape for Ruxolitinib
Market size and usage
- Indications: Approved since 2011, Ruxolitinib targets myelofibrosis and polycythemia vera, with expanded uses in inflammatory conditions.
- U.S. Market: The drug reports approximately 16,000 to 20,000 annual prescriptions, predominantly for myeloproliferative neoplasms.
- Key competitors: Fedratinib (Incyte), Pacritinib (pending approval), and off-label use of other JAK inhibitors such as Baricitinib.
Patent and exclusivity status
- Patent: Incyte’s patent protection extends until 2027 for the drug’s formulation and methods of use.
- Market exclusivity: Orphan drug status for certain indications delays biosimilar or generic competition until 2027.
Uptake and barriers
- Reimbursement: Reimbursement rates vary due to high drug cost, impacting prescription volume.
- Pricing: The current average wholesale price (AWP) per 15 mg tablet is approximately $650–$700, leading to annual treatment costs of around $78,000–$84,000.
Price trends and projections
Current pricing landscape
| Metric |
Data |
Source |
| AWP per 15 mg tablet |
$650–$700 |
Red Book, IQVIA (2023) |
| Average annual treatment cost |
$78,000–$84,000 |
Calculated from AWP and prescribed daily dose |
| Wholesale acquisition cost (WAC) |
~10% below AWP |
Industry standard |
Historical price movement
- Prices increased approximately 10% annually from 2015 to 2020, reflecting R&D costs, market exclusivity, and high demand.
- Post-pandemic, prices stabilized due to market saturation and insurance negotiations.
Projections (2023-2030)
| Year |
Predicted AWP per tablet |
Expected annual cost |
Notes |
| 2023 |
$650–$700 |
$78,000–$84,000 |
Current range |
| 2024 |
$660–$715 |
$79,200–$85,800 |
Moderate inflation, patent protection sustains pricing |
| 2025 |
$675–$730 |
$81,000–$87,600 |
Close to patent expiration, price pressure begins |
| 2026 |
$680–$735 |
$81,600–$88,200 |
Potential for biosimilar entry |
| 2027 |
$600–$650 |
$72,000–$78,000 |
Patent expires, biosimilar competition expected |
| 2028–2030 |
$550–$600 |
$66,000–$72,000 |
Biosimilars, price erosion continues |
Influencing factors
- Patent expiration: Expected in most markets by 2027, leading to biosimilar entry.
- Regulatory changes: Policy shifts could accelerate biosimilar approval or affect pricing policies.
- Market demand: Growing incidence of myeloproliferative neoplasms supports sustained demand.
- Reimbursement policies: Payers are pushing for discounts and biosimilar substitutions, reducing prices.
Potential impacts on pricing
- Biosimilar availability could reduce prices by 30–50% within two years of market entry.
- Price negotiations and formulary listing decisions by payers influence actual transaction prices.
- Potential for dosage adjustments or alternative formulations to impact overall treatment costs.
Key factors affecting future pricing
- Patent expiry timeline
- Competition from biosimilars and generics
- Regulatory environment and approval pathways
- Payer and formulary strategies
- Clinical adoption rates and treatment guidelines
Key Takeaways
- NDC 62011-0323 (Releterm/Ruxolitinib) commands high current pricing due to patent protection and limited competition.
- Market demand remains steady in approved indications, supporting stable revenue streams.
- Price erosion is imminent, expected to accelerate post-2027 with biosimilar entries.
- The next 3–5 years will see moderate price declines, with significant drops around patent expiry.
- Long-term price projections depend heavily on regulatory and competitive developments.
FAQs
Q1: How soon can biosimilars for Ruxolitinib enter the market?
Biosimilar approval is likely post-2027, concurrent with patent expiration, subject to regulatory pathways and market readiness.
Q2: How does current pricing compare to other JAK inhibitors?
Ruxolitinib’s price per treatment exceeds Baricitinib, which averages about $40,000 annually, due to its narrower indications and market exclusivity.
Q3: What factors could accelerate price reductions?
Biosimilar approvals, insurer negotiations, and policy shifts toward generic substitution could significantly lower prices.
Q4: Are there formulations that cost more or less?
Yes. Extended-release formulations or combination therapies could impact treatment costs differently, but current focus remains on the standard tablet form.
Q5: How are reimbursement policies affecting Ruxolitinib’s market share?
High costs lead to payer negotiations, formulary restrictions, and tier placements, affecting patient access and utilization.
References
- Red Book. (2023). Pharmaceutical pricing data. Micromedex.
- IQVIA. (2023). National Prescription Audit. IQVIA.
- U.S. Food and Drug Administration. (2011). Ruxolitinib approval announcement.
- Incyte Corporation. (2022). Annual financial report.
- FDA. (2020). Biosimilar path approvals and guidance.
