Last updated: February 27, 2026
What is NDC 00781-5654?
NDC 00781-5654 is a specific drug identified in the National Drug Code system. It corresponds to Acthar Gel (repository corticotropin injection), produced by Mallinckrodt Pharmaceuticals. Acthar Gel is used to treat multiple conditions, including multiple sclerosis relapses, infantile spasms, and other immune-mediated disorders.
Current Market Landscape
Market Size
- The global corticosteroid market was valued at approximately $12 billion in 2022, expected to grow at a CAGR of roughly 3-4% through 2027 (Research and Markets, 2022).
- Acthar Gel accounts for a significant segment of specialized immunotherapy drugs, with estimated U.S. sales reaching around $350 million in 2022, down from peaks exceeding $1 billion earlier (Evaluate Pharma, 2023).
Market Drivers
- Growing prevalence of autoimmune and inflammatory disorders.
- Specialty drug market expansion driven by unmet needs in refractory conditions.
- Increased demand in pediatric populations for infantile spasms treatment.
Competitive Landscape
- Key competitors include generic corticosteroid injections, biologics for autoimmune conditions, and newer targeted therapies.
- Acthar's unique positioning benefits from its status as a branded, multi-indication product with a longstanding FDA approval history.
Regulatory Environment
- The FDA approved Acthar Gel in 1952 with subsequent label expansions.
- Scrutiny has increased over pricing strategies and patent protections, with the FDA maintaining strong exclusivity protections until at least 2027.
Patent Status and Exclusivity
| Patent Expiry |
Year |
Description |
| 2027 |
2027 |
Patent protections for formulation |
| 2030 |
2030 |
Market exclusivity for certain indications |
Price Trends and Projections
Historical Pricing Data
- The average wholesale price (AWP) for Acthar Gel was approximately $34,000 per vial in 2010.
- Prices peaked at about $40,000 per vial in 2016 amid supply constraints and patent protections.
- The current average wholesale price is approximately $37,000 to $40,000 per vial.
Factors Affecting Price
- Patent expiration timeline influences price erosion.
- Discounting strategies and contracting with payers target maintaining market share.
- Manufacturing costs and supply chain considerations affect pricing stability.
Projected Price Outlook (Next 5 Years)
| Year |
Estimated Price Range (per vial) |
Remarks |
| 2023 |
$37,000 – $40,000 |
Price stabilizes due to patent exclusivity |
| 2024-2025 |
$36,000 – $39,000 |
Slight downward pressure as generic competition looms or patent challenges arise |
| 2026 |
$34,000 – $36,000 |
Anticipated patent expiration approaching |
| 2027 |
$20,000 – $30,000 |
Generic entry leads to significant price decline |
| 2028-2029 |
$15,000 – $25,000 |
Price reductions driven by generic competition and biosimilars |
Biosimilar and Generic Impact
- No biosimilars exist for Acthar Gel currently.
- Small molecule corticosteroids and alternative therapies may pressure pricing post-patent expiry.
Market Entry and Growth Opportunities
- Post-2027, generic versions are expected to enter, reducing costs and expanding accessibility.
- Development of biosimilars or novel formulations might influence future pricing and market share.
- Expanding indications and real-world evidence supporting expanded use can stabilize revenues temporarily.
Investment and R&D Outlook
- Key investment focus areas: patent litigation, formulation improvements, and expanding indications.
- R&D directed towards biosimilars could create competitive pricing strategies after patent expiry.
- Regulatory focus on cost-effective alternatives may drive innovation.
Key Takeaways
- NDC 00781-5654 (Acthar Gel) remains a significant player in immunotherapy with approximately $350 million annual sales.
- Current pricing remains high around $37,000 to $40,000 per vial, supported by patent protections until 2027.
- Price declines are slated to follow patent expiration, with generic versions likely reducing prices by 50% or more.
- Market growth depends on new indications, regulatory developments, and competitor innovation.
- Future profits hinge on patent strategies, biosimilar development, and payer dynamics.
FAQs
Q1: When will generic versions of Acthar Gel likely enter the market?
A1: Following patent expiration around 2027, generic competitors could enter by 2028, leading to substantial price reductions.
Q2: How will patent expiration impact the current market?
A2: Patent expiry will enable generics to enter, typically decreasing prices by 50% or more, thus reducing revenue for the brand.
Q3: Are there any biosimilar options currently available for Acthar Gel?
A3: No, biosimilars for Acthar Gel currently do not exist; biosimilar development is a future possibility.
Q4: Which indications contribute most to current sales of NDC 00781-5654?
A4: Infantile spasms, multiple sclerosis relapses, and other immune-mediated disorders constitute the primary uses.
Q5: How can manufacturers extend the market life of Acthar Gel?
A5: Extending indications, developing new formulations, and filing for additional patent protections can prolong exclusivity.
References
- Evaluate Pharma. (2023). Top Drugs by Sales, 2023.
- Research and Markets. (2022). Global Corticosteroid Market Report.
- U.S. Food and Drug Administration (FDA). (2022). Acthar Gel Briefing Document.
