Last updated: February 14, 2026
What is the drug associated with NDC 59212-0003?
The National Drug Code (NDC) 59212-0003 corresponds to Emgality (galcanezumab-gnlm), a monoclonal antibody developed by Eli Lilly. It is approved for preventing migraine, episodic cluster headaches, and certain pediatric conditions.
Market landscape overview
Indications and Approved Uses:
- Prevention of migraine in adult patients (FDA approval 2018)
- Treatment of episodic cluster headaches (FDA approval 2019)
- Pediatric indications for migraine prevention (FDA approval 2023)
Market size:
- Migraine affects approximately 12% of US adults, with an estimated 38 million sufferers.
- Clusters headaches impact about 0.1% of the population.
- The global migraine preventive therapy market was valued at USD 2.2 billion in 2020, projected to reach USD 4.1 billion by 2028 (CAGR 8%).
Competitive landscape:
- Key competitors include erenumab (Aimovig), fremanezumab (Ajovy), anderenumab (Emgality's direct competition).
- Technologically, it’s a CGRP (calcitonin gene-related peptide) receptor antagonist monoclonal antibody.
- The average price of similar CGRP inhibitors varies between USD 6,900 and USD 8,500 per year, depending on dosing and geographic region.
Pricing history and trends
- Initial wholesale acquisition cost (WAC) at launch (2018): approximately USD 6,900 per year.
- Price adjustments: inflation-based increases in 2020 and 2022, maintaining a price range of USD 6,800–USD 7,500.
- Commercial discounts and formularies typically reduce net prices by 20–30%.
Current market trends
- Price stability: The drug’s price has shown limited fluctuation, reflecting a stable competitive position.
- Reimbursement: Coverage by major insurers and Medicare reduces out-of-pocket costs significantly.
- Biosimilar entry: No biosimilars available, maintaining monopoly pricing.
- New market segments: Pediatric indication expanded the target patient pool, potentially increasing volume but not affecting list price.
Price projection assumptions
Factors affecting future pricing:
- Regulatory changes: Greater price regulation or value-based pricing models could pressure list prices downward.
- Market penetration: Increased adoption in pediatric populations could increase volume but stabilize or slightly reduce unit prices.
- Competitive actions: Entry of biosimilars or alternative therapies would place upward pressure on prices of existing drugs.
- Reimbursement policies: Changes in insurer policies or government negotiation strategies could influence net prices.
Projected price range (2023–2027)
| Year |
List Price (USD) |
Market Factors |
Comments |
| 2023 |
7,500 |
Stable competition, no biosimilars |
Slight price stabilization |
| 2024 |
7,400 |
Inflation adjustments |
Slight downward pressure due to market saturation |
| 2025 |
7,200 |
Potential regulatory reforms |
Possible price negotiations or discounts |
| 2026 |
7,100 |
Increasing pediatric use |
Slight decline in list price, volume increase |
| 2027 |
7,000 |
Biosimilar pressures possible |
Continued stabilization or slight decrease |
Key takeaways
- The drug holds a dominant position in the CGRP inhibitor class with no biosimilars, supporting price stability.
- The US market continues to set the pricing trend, with outpatient reimbursement policies influencing net prices.
- The introduction of biosimilars or new therapies could challenge current pricing, but none are imminent.
- Expansion into pediatric populations may increase total volume without significantly impacting list prices.
FAQs
1. Will the drug's price increase significantly in the next five years?
Likely not. Price increases are expected to be limited to inflation adjustments, with potential stability or slight decreases due to market saturation and regulatory pressures.
2. How does the drug’s price compare to its competitors?
It is within the typical range for CGRP monoclonal antibodies—USD 6,900–USD 8,500 annually—placing it in the mid-to-high end of the market.
3. What impact could biosimilar entry have on prices?
Entry of biosimilars could reduce prices of branded drugs by 20–40%, depending on market dynamics and regulatory approval timelines.
4. Are there regional pricing differences?
Yes. In international markets, pricing varies due to local healthcare policies, reimbursement frameworks, and negotiation power.
5. What are the main factors influencing future pricing?
Regulatory environment, label expansion, competitive biosimilar entry, and insurer negotiations are key factors shaping future prices.
Sources:
- FDA. "Galcanezumab-gnlm (Emgality) Approval." 2018.
- MarketWatch. "Migraine Drugs Market Size & Forecast." 2020–2028.
- IQVIA. "Biomedical Market Trends." 2023.
- EvaluatePharma. "Pharmaceutical Pricing Trends." 2022.
- Centers for Medicare & Medicaid Services (CMS). "Drug Reimbursement Policies." 2020.
