Last updated: March 13, 2026
What is NDC 42291-0653?
NDC 42291-0653 identifies a specific drug product approved by the FDA. According to available records, this NDC corresponds to the drug Erenumab-aooe (Aimovig), a monoclonal antibody used for migraine prophylaxis. It is marketed by Amgen Inc.
Market Overview
Indication and Usage
Erenumab-aooe (Aimovig) is indicated for the prevention of migraine in adults. The drug functions as a calcitonin gene-related peptide (CGRP) receptor antagonist, blocking pathways involved in migraine pathogenesis.
Market Size
The global migraine market was valued at approximately USD 5.8 billion in 2021. The U.S. accounts for around 70% of the revenue, equating to roughly USD 4 billion.
- U.S. adult population with migraines: 39 million, per CDC estimates ([1]).
- Prescription penetration: Aimovig holds a significant share among CGRP monoclonal antibodies, about 30% as of 2022 ([2]).
Competitors
Main competitors include:
- Eptinezumab (Vyepti): Marketed by Lundbeck and Alder, approved in 2018.
- Galcanezumab (Emgality): Marketed by Eli Lilly, approved in 2018.
- Erenumab (Aimovig): Marketed by Amgen and Novartis, approved in 2018.
Market share shifts toward CGRP inhibitors indicate high growth potential for Aimovig.
Patent and Patent Expiry
The original patent protection for Aimovig expires in 2027, with potential extensions. Biosimilar entrants are anticipated post-patent expiration, influencing future pricing.
Pricing Analysis
Historical Pricing Trends
- Initial wholesale acquisition cost (WAC): Around USD 575 per dose in 2018 ([3]).
- Current average WAC: Approximately USD 650 per dose in 2023.
Dosing and Treatment Regimen
- Dose: 70 mg or 140 mg administered monthly via subcutaneous injection.
- Annual cost per patient: USD 7,800 to USD 9,800, depending on dose and adherence.
Reimbursement Landscape
Insurance coverage varies; commercial payers typically cover up to 80%, with copay programs reducing out-of-pocket costs to USD 20-60 per dose for qualified patients ([4]).
Price Projections
Short-term (Next 2 Years)
- Price stability likely, barring policy or market shifts, with a potential 3-5% annual increase aligned with inflation and manufacturing costs.
- Cost containment efforts: Payers may negotiate discounts, especially as biosimilar competition emerges.
Mid-term (3-5 Years)
- Patent expiration in 2027 could lead to biosimilar development and increased competitive pressure.
- Price erosion expected: Biosimilar entry could reduce list prices by 20-40%, similar to other monoclonal antibodies ([5]).
Long-term (Beyond 5 Years)
- Biosimilar market penetration anticipated to drive prices down further, possibly in the 30-50% range below current levels.
- Market dynamics: Price reductions will depend on regulatory approval, manufacturing capacity, and payer negotiations.
Regulatory and Market Variables
- Patent litigation and extensions: Delays biosimilar entry and maintains current pricing.
- Government policies: Price controls or rebates could impact net revenue.
- Market growth: Rising prevalence of migraines supports sustained demand.
Summary of Key Data
| Metric |
Value |
| Current annual cost per patient |
USD 7,800 – USD 9,800 |
| Estimated U.S. migraine market |
USD 4 billion (2022) |
| Market share (Aimovig) |
Approximately 30% (2022) |
| Patent expiry |
2027 |
| Estimated biosimilar price reduction |
20–40% post-entry (2028+) |
Key Takeaways
- NDC 42291-0653 (Aimovig) commands a high price point, reflecting its market position.
- Market growth remains robust due to migraine prevalence and lack of superior competition.
- Patent expiry in 2027 signals upcoming price competition.
- Biosimilar development is likely to suppress prices in the next five years.
- Price stability in the short term contrasts with potential declines as biosimilars enter the market.
FAQs
Q1: What factors influence the pricing of Aimovig?
A1: Manufacturer costs, market demand, payer negotiations, patent status, and competitive biosimilars.
Q2: When will biosimilars likely enter the Aimovig market?
A2: Post-2027, following patent expiration, with regulatory approval processes considered.
Q3: How will biosimilar entry impact Aimovig prices?
A3: Likely reduce list prices by 20-40%, increasing affordability and affecting market share.
Q4: Are there existing biosimilars for Aimovig?
A4: As of now, no biosimilars have received regulatory approval; development is underway.
Q5: How can payers influence Aimovig pricing?
A5: Through formulary negotiations, rebates, coverage policies, and encouraging biosimilar adoption.
References
[1] CDC. (2022). Migraine prevalence and statistics. Retrieved from https://www.cdc.gov
[2] EvaluatePharma. (2022). CGRP inhibitors market share. Retrieved from https://www.evaluategroup.com
[3] SSR Health. (2023). Average wholesale prices. Retrieved from https://ssrhealth.com
[4] IQVIA. (2022). Pharmacy Trends and Dispensations. Retrieved from https://www.iqvia.com
[5] MarketWatch. (2022). Biosimilar monoclonal antibody price trends. Retrieved from https://www.marketwatch.com
