Last updated: February 13, 2026
What is NDC 00003-3764?
NDC 00003-3764 refers to Acthar Gel (repository corticotropin injection), produced by Mallinckrodt Pharmaceuticals. It is an FDA-approved biologic used primarily for multiple sclerosis attacks, infantile spasms, and other inflammatory conditions. The drug's unique status as a repository corticotropin makes it a distinctive product with limited direct competition.
Market Size and Demand Drivers
Historical Sales Data:
- In 2022, Acthar Gel generated approximately $366 million in U.S. net sales.
- Peak sales were around $445 million in 2014, indicating past high demand.
- Sales declined from 2014 to 2019 but stabilized post-2020, aided by expanded indications and formulary access.
Market Drivers:
- Extends beyond its initial indications to rare autoimmune and inflammatory diseases.
- Prescribing patterns influenced by guidelines favoring corticosteroid-sparing options.
- Rheumatologists, neurologists, and pediatric neurologists are primary prescribers.
Market Challenges:
- High price point: Historically around $38,000 per vial.
- Competition from biosimilars and alternative therapies in certain indications.
- Negative concerns regarding safety profiles and label restrictions.
Competitive Landscape
Direct Competition:
- Limited biosimilar options due to the complexity of biologic manufacturing.
- Alternative treatments include high-dose corticosteroids, IVIG, and monoclonal antibodies like rituximab.
Market Position:
- Maintains a high price owing to formulary protections, brand loyalty, and orphan drug status.
- Bioscience companies exploring biosimilars face technical and patent barriers, delaying entry.
Pricing Trends and Projections
Current Price Point:
- Average list price of Acthar Gel remains approximately $38,000 per vial.
- Managed care discounts and rebates typically reduce net prices by 20-30%.
Historical Price Trends:
- Price increased by approximately 20% from 2010 to 2015.
- Stability has persisted over the last three years, with minimal increases.
Projection Timeline (2023-2028):
| Year |
Estimated Price per Vial |
Key Assumptions & Factors |
| 2023 |
$38,000 |
Stabilized pricing due to formulary protections, limited competition. |
| 2024 |
$38,000 |
No major biosimilar entry; price controls in place. |
| 2025 |
$38,500 |
Slight increase to account for inflation and increased manufacturing costs. |
| 2026 |
$39,000 |
Continued stabilization with minor increases. |
| 2027 |
$39,500 |
Potential pressure from biosimilar developments, mitigated by patent protections. |
| 2028 |
$40,000 |
Slight growth, contingent on regulatory and patent status. |
Implications:
- Revenue projections hinge on volume stability and price maintenance.
- The drug's orphan status and lack of biosimilar competition support price resilience.
- Volume decreases could occur if newer therapies gain favor, counteracting price stability.
Market Risks and Opportunities
Risks:
- Biosimilar approval and market entry could erode pricing and market share.
- Regulatory restrictions or label updates could reduce prescribing.
- Alternative therapies with improved safety profiles might replace Acthar in some indications.
Opportunities:
- Expansion into new rare disease areas.
- Use in pediatric populations under regulatory support.
- Value-focused marketing emphasizing unique clinical benefits.
Key Takeaways
- NDC 00003-3764 (Acthar Gel) remains a high-value biologic with stable pricing due to limited biosimilar competition.
- Sales volume is vulnerable to shifts in prescribing patterns and the emergence of alternative therapies.
- Price projections suggest marginal growth through 2028, primarily driven by inflation and manufacturing costs.
- Future market dynamics depend heavily on patent status, regulatory environment, and competitive biosimilar developments.
FAQs
1. How does Acthar Gel's pricing compare to similar biologics?
It remains significantly higher than typical biologic therapies, with list prices exceeding $38,000 per vial, supported by limited competition and its orphan drug designation.
2. What factors could lead to price declines?
Biosimilar approvals and market entry, regulatory label changes, or significant shifts in prescribing preferences.
3. How much of the retail price is retained as net revenue after discounts?
Managed care discounts and rebates reduce the net price by approximately 20-30%.
4. Are there upcoming patent expirations affecting pricing?
Patent expirations are anticipated around the mid-2020s; however, patent extensions and litigation may delay biosimilar entry.
5. What new indications could influence demand?
Expanded use in pediatric autoimmune disorders or rare inflammatory conditions could sustain or increase sales volume.
References
[1] IQVIA, "Pharmaceutical Market & Sales Data," 2022.
[2] FDA Approval Records for Acthar Gel, 2013.
[3] Centers for Medicare & Medicaid Services, "Drug Spending and Pricing Trends," 2022.
[4] Analyst Reports on Biologic Patent Protections, 2021.
