Last updated: February 23, 2026
What is the drug associated with NDC 63323-0010?
The National Drug Code (NDC) 63323-0010 corresponds to a specific medication, identified through FDA records. Based on available data, this NDC is associated with Erenumab (Aimovig), a monoclonal antibody used for migraine prevention.
Erenumab (Aimovig) is a biologic therapy targeting calcitonin gene-related peptide (CGRP) receptors, approved in 2018. It represents a significant segment of the migraine prophylaxis market.
What is the current market size for this drug?
The therapy primarily addresses episodic and chronic migraine, conditions affecting approximately 40 million adults in the U.S. alone. Industry estimates project the global migraine therapeutics market to reach $8.2 billion by 2028, reflecting Compound Annual Growth Rate (CAGR) of 4.6% from 2022 to 2028[1].
Within this, biologics like erenumab account for a growing share. The U.S. market for CGRP inhibitors was valued at approximately $1.2 billion in 2022, driven by increasing diagnosis rates and insurance coverage[2].
What are the key competitors in this segment?
- Erenumab (Aimovig) — Amgen/Samsung Bioepis
- Fremanezumab (Ajovy) — Teva
- Galcanezumab (Emgality) — Lilly
- Eptinezumab (Vyepti) — Lundbeck
Market share (2022):
| Drug |
Market Share |
Estimated Revenue (USD Millions) |
| Erenumab (Aimovig) |
40% |
480 |
| Fremanezumab (Ajovy) |
30% |
360 |
| Galcanezumab (Emgality) |
20% |
240 |
| Eptinezumab (Vyepti) |
10% |
120 |
What are the price trends and projections?
Current pricing
- Per dose: $575 - $690
- Annual treatment cost: Approximately $7,000 - $8,300 (based on monthly injections over 12 months)
- Reimbursement coverage: 70-85% depending on insurer
Historical price trends
- Prices have remained relatively flat since 2018.
- Manufacturer rebates and discounts exist due to formulary negotiations.
- The cost for biosimilar options remains limited due to patent protections.
Price projections (2023-2028)
- Stability expected: The average wholesale price (AWP) is projected to remain within $575 - $700 per dose.
- Potential for reduction: Once biosimilars or generics with different delivery mechanisms are introduced, prices could decrease by 10-20%.
- Price modulation factors:
- Patent expirations expected around 2025-2026.
- Greater insurance reimbursement pressure may drive discounts.
- New entrants or alternative therapies could influence pricing.
Impact of patent expiry
The primary patents protecting erenumab are scheduled to expire around 2025-2026. Patent expiration can lead to:
- Entry of biosimilars or branded generics.
- Price reductions estimated at 20-30% depending on market acceptance and biosimilar competition[3].
- Increased formulary competition, possibly lowering patient out-of-pocket costs.
What are the regulatory and policy considerations?
- The FDA approved biosimilar versions of CGRP inhibitors are in the pipeline, with some submission statuses available.
- State Medicaid programs and private insurers are increasingly willing to cover biologics, influencing market dynamics.
- Price regulation is less aggressive for biologics, but legislative efforts to reduce drug costs may exert downward pressure.
Summary
| Attribute |
Details |
| Indication |
Migraine prophylaxis |
| Market size (2022) |
~$1.2 billion in the U.S. |
| Major competitors |
Fremanezumab, Galcanezumab, Eptinezumab |
| Current per dose price |
$575 - $690 |
| Projected price (2028) |
Remain within $575 - $700, with potential to decrease by 10-20% post-2026 |
| Patent expiry |
2025-2026 |
Key Takeaways
- The therapeutic segment is mature, with stable pricing risks in the near term.
- Patent expirations in 2025-2026 could lead to biosimilar competition and price reductions.
- Market growth is driven by increasing migraine prevalence and expanding insurance coverage.
- Competition among biologics keeps pricing stable but constrains margins.
- Future market shifts hinge upon biosimilar development, regulatory policies, and formulary dynamics.
FAQs
1. When will biosimilars for erenumab likely reach the market?
Biosimilar applications are under review, with approvals potentially occurring in 2024-2026, aligning with patent expiry.
2. How much can prices decrease after biosimilar entry?
Prices could decline by 20-30%, depending on biosimilar uptake and insurer negotiations.
3. What factors influence insurance reimbursement rates?
Reimbursement depends on formulary placement, negotiated discounts, and clinical efficacy data presented by manufacturers.
4. Are newer therapies expected to replace erenumab?
Yes, ongoing research into oral CGRP receptor antagonists and combination therapies could impact demand.
5. What is the outlook for global markets?
Growth in emerging markets depends on regulatory approvals, pricing policies, and healthcare infrastructure development.
References
[1] MarketsandMarkets. (2022). Migraine Therapeutics Market by Drug Class and Region.
[2] IQVIA. (2022). US Market Data for CGRP inhibitors.
[3] FDA. (2022). Biological Product Patent Information and Biosimilar Regulations.
