Last updated: February 27, 2026
What is NDC 00187-0006?
NDC 00187-0006 refers to Acthar Gel (repository corticotropin injection), a treatment used for multiple indications, including multiple sclerosis relapses, infantile spasms, and certain inflammatory conditions. It is manufactured by Mallinckrodt Pharmaceuticals.
Market Overview
Market Size and Growth Drivers
- Global Market Size (2022): Estimated at USD 430 million.
- CAGR (2022-2027): Approximately 4.5%.
Key Factors
- Indication Expansion: Approved for additional conditions like rheumatoid arthritis and Behçet's disease.
- Pricing Dynamics: Acthar Gel's high price influences the insulin-like growth factor pathway, limiting generic competition.
- Clinical Utility: Its unique mechanism of action and limited alternatives sustain demand.
Competitive Landscape
- Brand Dominance: No significant generic competition since patent loss in 2018; remaining competitors are limited.
- Market Share: Acthar holds an estimated 90% of the repository corticotropin injection segment.
- Emerging Alternatives: Small molecules and biologics targeting similar inflammatory pathways are under development, but none currently match Acthar's approved indications.
Regulatory Environment
- Patent Status: Key patents expired in 2018, but patent creation tactics (e.g., formulation patents) have prolonged exclusivity.
- Reimbursement Policies: Coverage remains broad, reinforced by the drug’s clinical importance and lack of alternatives.
Price Projections
Current Pricing (2023)
- Average Wholesale Price (AWP): Approximately USD 38,000 per 10 mL vial.
- Annual Treatment Cost: Variability from USD 15,000 to USD 30,000 per patient based on treatment duration and dosing schedules.
Future Trends
- Price Stability or Increase: Due to continued demand and lack of generics, prices are unlikely to decrease.
- Potential for Price Escalation: Given inflation, physician prescribing habits, and treatment durations, prices may increase 2-3% annually.
Factors Influencing Price Changes
| Factor |
Effect on Price |
Rationale |
| Regulatory exclusivity |
Maintains high prices |
Patent protections and formulation patents limit new entrants |
| Market demand |
Supports high pricing |
Limited clinical alternatives sustain demand |
| Manufacturing costs |
Slightly influences pricing |
Commodity prices and regulatory compliance impacts |
| Reimbursement policies |
Affect accessibility and margins |
Reimbursements generally remain stable due to clinical necessity |
Price Comparison with Alternatives
| Drug/Product |
Indications |
Pricing (USD) per treatment course |
Notes |
| NDC 00187-0006 |
Multiple inflammatory conditions |
USD 15,000 – USD 30,000 per course |
No close substitutes, high price point |
| Synthetic Corticosteroids |
Inflammation, autoimmune |
USD 100 – USD 1,000 per course |
Cheaper but less targeted |
| Biologics (e.g., ACTH receptor agents) |
Rare, emerging therapies |
USD 50,000+ annually |
Not yet approved for the same indications |
Investment and R&D Outlook
- Pipeline: Some biologic agents are in early-stage development, focusing on mimicking ACTH effects, but none currently threatened by Acthar's market dominance.
- Regulatory Threats: Patent strategies and formulation modifications likely extend exclusivity until at least 2030.
- Market Entry Barriers: High due to complex manufacturing, clinical trial requirements, and reimbursement hurdles.
Key Takeaways
- NDC 00187-0006 (Acthar Gel) remains a high-price, market-dominant drug with limited competition due to patent protections and clinical necessity.
- The global market is expected to grow modestly, driven by steady demand for its approved indications.
- Price projections suggest stability or moderate increases, with no immediate generic threats likely before 2030.
- Competition from biologics and small molecules remains in early development stages, unlikely to replace Acthar’s market share soon.
FAQs
Q1: How long is Acthar Gel expected to maintain market exclusivity?
A1: Patent protections, formulation patents, and market factors likely extend exclusivity until at least 2030.
Q2: What is the potential for generic competition?
A2: Generics are unlikely before patent expiry or patent challenges, which are not imminent.
Q3: How do current prices compare globally?
A3: Prices are highest in the US, averaging USD 38,000 per vial; other markets typically see lower prices due to price regulation.
Q4: Will emerging biologics impact Acthar’s market share?
A4: Early pipeline candidates lack clinical approval; it remains unlikely that biologics will replace Acthar within the next 5 years.
Q5: What factors could influence future prices?
A5: Reimbursement policies, inflation, manufacturing costs, and market demand could lead to small price increases.
Sources:
- MarketsandMarkets. (2022). Corticotropin Market by Application and Region.
- IQVIA. (2022). US Prescription Market Data.
- FDA. (2022). Drug approvals and patent listings.
- Mallinckrodt Pharmaceuticals. (2023). Acthar Gel product information.
- Medtrack. (2023). Patent expiries and pipeline analysis.
