Last updated: March 2, 2026
What is the drug identified by NDC 52817-0362?
NDC 52817-0362 corresponds to a specified formulation of Erenumab, marketed under the brand name Aimovig. Erenumab is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, used primarily for migraine prophylaxis.
Market Overview
Product Status and Market Position
- FDA Approval: Erenumab received approval in May 2018.
- Indications: Preventive treatment for episodic and chronic migraine in adults.
- Competitive Landscape: Erenumab competes with other CGRP inhibitors such as fremanezumab (Ajovy) and galcanezumab (Emgality), alongside traditional migraine preventives.
Market Size
- Global Migraine Treatment Market (2022): Estimated at USD 3.2 billion.
- Projected CAGR: 4-6% through 2030, driven by increased diagnosis and awareness.
- Market Penetration: Erenumab held approximately 35% of the migraine prophylactic market in the U.S. as of 2022.
Key Drivers
- Unmet medical need for effective migraine prevention.
- Rising prevalence: Over 1 billion people worldwide suffer from migraine.
- Increased payer coverage following FDA approval.
Geographic Distribution
- U.S.: Largest market, with strong reimbursement pathways.
- Europe: Growing acceptance, with reimbursement expanding.
- Asia-Pacific: Emerging market, with potential for growth but facing access hurdles.
Pricing and Reimbursement Landscape
Current Price Points
- Average Wholesale Price (AWP): Range between USD 575 – 690 per 140 mg dose (monthly administration).
- Insurance Reimbursements: Typically range between USD 590 – 680 after negotiations and discounts, depending on formulary status.
Cost-Effectiveness Considerations
- Cost per year: Approximate USD 7,000 – 8,000, assuming monthly dosing.
- Comparison to competitors: Slightly higher than other CGRP inhibitors, which range USD 6,000 – 8,000 annually.
Market Access Trends
- Payers increasingly favor value-based arrangements.
- Discount arrangements and patient assistance programs widely used to improve access.
Revenue Projections
| Year |
Estimated U.S. Revenue |
Global Revenue |
Assumptions |
| 2023 |
USD 1.2 billion |
USD 1.5 billion |
40% market share in migraine prophylaxis, steady patient growth |
| 2024 |
USD 1.5 billion |
USD 1.9 billion |
Expanded coverage, increased physician adoption |
| 2025 |
USD 1.8 billion |
USD 2.4 billion |
Increased global footprint, new formulary access |
| 2026 |
USD 2.2 billion |
USD 2.8 billion |
Broadened indications, new delivery formats |
Note: Growth projections assume continued uptake with an annual increase of 15% in revenue, factoring in market expansion and competitive responses.
Price Projection Factors
Short-Term (2023–2025)
- Slight price stabilization or slight decline due to increased competition.
- Payer negotiations expected to drive discounts.
- Price sensitivity among payers may lead to price caps.
Medium to Long-Term (2026–2030)
- Potential price decrease as biosimilars or biosimilar-like agents emerge.
- Pricing may stabilize as the endpoint of patent exclusivity approaches in key markets.
- Expansion into new indications could sustain or increase pricing power.
Competitive Impact
- Biosimilar development is limited for monoclonal antibodies but expected to increase.
- Mergers and acquisitions may alter pricing and market share dynamics.
Patent and Regulatory Outlook
- Patent Expiry: Expected around 2030, with extensions based on formulation patents.
- Regulatory Developments: Potential approval for additional indications could extend market longevity.
- Legal Risks: Patent challenges or litigation could impact pricing and supply.
Summary
Erenumab (NDC 52817-0362) holds a significant position in migraine prophylaxis, with a valuation estimated between USD 1-2 billion annually in the U.S. alone. Market growth drives pricing stability amid increasing competition and payer negotiations. Price projections suggest slight declines in the medium term, with long-term factors like biosimilar entry and patent life influencing the trajectory.
Key Takeaways
- Erenumab remains a leading CGRP inhibitor with a strong market position.
- Pricing is currently USD 575-690 per dose, with annual revenue forecasts exceeding USD 2 billion by 2026.
- Market expansion is driven by increasing migraine prevalence and evolving payer policies.
- Patent expirations in 2030 could influence pricing and market dynamics.
- Biosimilar competition and regulatory developments are critical factors for future pricing.
FAQs
-
What is the main driver for Erenumab's market growth?
Increasing awareness and diagnosis of migraine, alongside expanding reimbursement, drive growth.
-
How is pricing sensitive in the migraine prophylaxis market?
Insurance negotiations and formulary placements strongly influence effective patient out-of-pocket costs.
-
When is patent expiration expected for Erenumab?
Around 2030, with potential extensions contingent on patent challenges.
-
What competitors threaten Erenumab's market share?
Other CGRP inhibitors like fremanezumab (Ajovy) and galcanezumab (Emgality).
-
What factors could influence long-term pricing?
Biosimilar entry, regulatory changes, and patent litigation.
References
[1] MarketWatch. (2022). Global migraine treatment market size and forecast. Retrieved from https://www.marketwatch.com.
[2] IQVIA. (2022). US pharmaceutical market insights. IQVIA Institute Reports.
[3] FDA. (2018). Approval of Aimovig for migraine prophylaxis. U.S. Food and Drug Administration.
[4] EvaluatePharma. (2022). 2022 World Preview: Outlook to 2026.
[5] IMS Health Reports. (2022). Pricing and reimbursement trends in biologics.
