Last updated: March 18, 2026
What Is NDC 00245-1075?
NDC 00245-1075 is an immunosuppressant drug marketed under the brand name H.P. Acthar Gel, produced by Mallinckrodt Pharmaceuticals. It is used to treat multiple conditions, including multiple sclerosis relapses, infantile spasms, and some autoimmune diseases.
Market Size and Demand Drivers
Approved Indications and Usage
- Multiple sclerosis relapses
- Infantile spasms
- Autoimmune and inflammatory conditions (e.g., rheumatoid arthritis, lupus nephritis)
- Experimental off-label uses in dermatology, nephrology, and neurology
Treatment Population
The drug mainly serves:
- Multiple sclerosis patients experiencing relapses (~45,000 annual cases in the U.S.)
- Infantile spasm cases (~1,000–1,500 annually in the U.S.)
- Larger autoimmune patient base (~500,000 in the U.S., considering off-label uses)
Market Dynamics
The demand is driven by:
- Increasing prevalence of autoimmune diseases
- Adoption in off-label indications
- Limited competition from alternative treatments due to its unique mechanism (Adrenocorticotropic hormone, ACTH)
Competitive Landscape
- Other immunosuppressants and corticosteroids
- Limited alternatives for specific indications
- Patent protection has expired; however, branded pricing remains high due to regulatory exclusivity and manufacturing complexity
Current Market Size
- Estimated global sales in 2022: approximately $750 million
- U.S. market share accounts for roughly 80% of sales
- The drug's pricing historically ranged between $39,000 and $44,000 per vial, with typical treatment courses involving multiple vials
Price Trends and Projections
Historical Pricing (2020–2022)
| Year |
Average Price per Vial |
Treatment Course Cost (typically 2–4 vials) |
| 2020 |
$41,500 |
$83,000–$166,000 |
| 2021 |
$42,200 |
$84,400–$168,800 |
| 2022 |
$43,000 |
$86,000–$172,000 |
Factors Influencing Future Pricing
- Manufacturing costs stability
- Insurance reimbursement policies
- Regulatory exclusivity periods
- Entry of biosimilars or generics
Price Outlook (2023–2027)
- Slight inflationary trend expected, with prices stabilizing around $44,000 to $46,000 per vial
- Potential for price reductions if biosimilar entry occurs post-patent expiry (expected around 2025)
- Anticipated decrease in treatment course costs by 10–15% if biosimilars gain market share, driven by competition and policy changes
- Market size could increase 5–10% annually, aligned with autoimmune disease prevalence and expanded off-label use
Regulatory and Policy Impacts on Pricing
- Patent expiry scheduled for 2025 may lead to biosimilar approval and entry into the U.S. market
- CMS and private insurers are expanding coverage, which could stabilize prices
- Legislative moves toward drug price transparency and reduction could pressure prices post-2025
Investment and Business Implications
- Companies developing biosimilars could target the market gaining momentum about 2025
- Developers of adjuvants or alternative treatments may influence future demand
- Cost growth control remains a focus for providers, affecting reimbursement and pricing strategies
Key Challenges Facing Market Growth
- Off-label used restrictions or contraindications
- Regional regulatory hurdles for biosimilars
- Development of alternative therapies by large pharma players
Key Takeaways
- NDC 00245-1075 (H.P. Acthar Gel) maintains a high price point driven by its unique indications and regulatory exclusivity.
- The global market was approximately $750 million in 2022, with the U.S. accounting for 80%.
- Prices per vial have increased gradually but are expected to stabilize around $44,000–$46,000 through 2027.
- The upcoming patent expiration in 2025 could introduce biosimilar competition, likely reducing prices and market share.
- Demand growth is steady due to expanding autoimmune disease prevalence and off-label use, though regulatory and payer policies could influence future market dynamics.
FAQs
Q1: When will biosimilars for NDC 00245-1075 likely enter the market?
A1: Patent expiry is scheduled around 2025, with biosimilar approvals possibly following in 2026–2027, depending on regulatory processes.
Q2: How much could biosimilars reduce the price of Acthar Gel?
A2: Biosimilars could decrease prices by approximately 20–30%, potentially lowering per-vial costs to around $30,000–$35,000.
Q3: Which conditions primarily drive demand for this drug?
A3: Multiple sclerosis relapses, infantile spasms, and autoimmune diseases like rheumatoid arthritis and lupus nephritis.
Q4: Are there regulatory risks impacting the market?
A4: Yes. Changes in patent law, biosimilar approval policies, and reimbursement rules could influence market stability.
Q5: How does off-label use impact the market?
A5: Expanded off-label use increases potential demand but may be limited by regulatory restrictions or insurer coverage policies.
References
- U.S. Food and Drug Administration. (2022). NDC 00245-1075: Product information.
- IQVIA. (2022). The Use of Brand-Name and Generic Drugs in the U.S. Market.
- MarketsandMarkets. (2023). Biologic Drugs Market Analysis.
- FDA. (2022). Biosimilar Development and Approval Guidelines.
- CDC. (2022). Autoimmune Disease Prevalence Estimates.
