Last updated: March 1, 2026
What is the Drug with NDC 65162-0557?
NDC 65162-0557 is the code assigned to Galcanezumab (brand name: Emgality). It is an FDA-approved medication used for the preventive treatment of episodic and chronic migraine in adults.
Market Size and Growth Drivers
Current Market Overview
- The migraine treatment market was valued at approximately $4.2 billion in 2022.[1]
- Expected compound annual growth rate (CAGR) between 2023-2028 is 8.5%.[2]
- The increase driven by unmet need for preventive therapies and expanded indications.
Patient Population
- Estimated US adult migraine sufferers: 39 million.[3]
- Candidates for preventive therapy: approximately 70%, around 27 million.[4]
- Emgality targets both episodic (more than 14 headache days/month) and chronic migraine populations.
Competitive Landscape
- Main competitors: erenumab (Aimovig), fremanezumab (Ajovy), eptinezumab (Vyepti).
- Emgality launched in 2018, capturing approximately 20% of the CGRP preventive market.[5]
- Recently, the market saw increased competition from new monoclonal antibodies and oral preventives.
Price and Revenue Performance
Current Pricing
- US wholesale acquisition cost (WAC): ~$875 per dose.[6]
- Typically administered monthly, translating to approximately $10,500 annually per patient.
- Price adjustments due to payer negotiations and rebates widely occur.
Revenue Trends
- 2022 revenue: approximately $600 million.[7]
- Market share has stabilized with gradual growth driven by new patient initiation and expanded indications.
Pricing Trends and Outlook
- The list price is stable; however, actual net prices vary based on insurance discounts.
- Price erosion expected to be limited over the next 3-5 years due to limited substitutes and high unmet need.
Price Projections (2023-2028)
| Year |
Projected Average Price per Dose |
Estimated Annual Revenue (US) |
Rationale |
| 2023 |
$875 |
$600 million |
Current market penetration, stable pricing, and existing competition |
| 2024 |
$865 |
$630 million |
Slight price adjustments, increased patient initiation |
| 2025 |
$855 |
$660 million |
New indications, increased insurance coverage, stable market share |
| 2026 |
$845 |
$700 million |
Market expansion, new formulations or delivery methods possibly introduced |
| 2027 |
$835 |
$730 million |
Potential price negotiations, increased competition from biosimilars or generics in distant future |
| 2028 |
$825 |
$760 million |
Market maturation, sustained demand, limited price erosion |
(Note: These projections assume no dramatic shifts in regulatory or reimbursement policies, and stable market dynamics.)
Regulatory and Policy Impact
- Patent expiry is unlikely within the next five years; exclusivity remains until at least 2026-2028.
- Payer pressure could influence net prices but less likely to affect list prices significantly.
- Access initiatives and expanded indications could increase utilization but may pressure margins.
Key Risks and Opportunities
Risks
- Increased competition from biosimilars or oral CGRP antagonists.
- Policy changes affecting drug reimbursement or coverage.
- Market saturation as more patients are initiated on preventive treatments.
Opportunities
- Expansion into new geographic markets.
- New formulations, such as longer-acting versions.
- Growing awareness and diagnosis rates improve market penetration.
Key Takeaways
- The migraine prevention market remains robust with steady growth driven by unmet needs.
- NDC 65162-0557 (Emgality) maintains a premium pricing structure with stable revenues projected to reach around $760 million by 2028.
- Market share stability relies on expanding indications, patient access, and managing competitive pressures.
- Pricing projections assume no significant regulatory or insurance policy shocks.
FAQs
Q1: What therapeutic class does NDC 65162-0557 belong to?
A1: It is a calcitonin gene-related peptide (CGRP) monoclonal antibody.
Q2: How does Emgality compare price-wise to its competitors?
A2: Its list price (~$875/month) is comparable or slightly higher than other CGRP monoclonals, which range from $695 to $885 per dose.
Q3: What factors could influence future market growth?
A3: Introduction of biosimilars, new oral CGRP antagonists, expanded indications, and increased diagnosis rates.
Q4: Is there potential for price reduction due to competitive pressure?
A4: Possible but limited; high ongoing demand and patent protection restrict substantial discounts.
Q5: What is the outlook for reimbursement and insurance coverage?
A5: Coverage is expected to improve, supporting stable or growing revenue streams, especially with expanded indications.
References
- MarketsandMarkets. (2023). Migraine market forecast.
- Grand View Research. (2022). Migraine therapeutics market size.
- CDC. (2022). Migraine prevalence estimates.
- Pew Charitable Trusts. (2020). Preventive migraine medications.
- IQVIA. (2022). CGRP monoclonal antibody market share.
- RedBook. (2023). Wholesale acquisition costs.
- Company financial reports. (2022). Eli Lilly revenue from Emgality.
