Last updated: March 13, 2026
What is NDC 00904-6537?
NDC 00904-6537 corresponds to Emgality (galcanezumab-gnlm), a monoclonal antibody developed by Eli Lilly for the treatment of migraine prevention. Approved by the FDA in September 2018, Emgality targets calcitonin gene-related peptide (CGRP) pathways involved in migraine pathology.
Market Overview
Indications and Patient Population
- Approved for episodic and chronic migraine in adults.
- Estimated prevalence: 39 million adults in the U.S. suffer from migraine, with approximately 20% eligible for prophylactic therapy.
- Market penetration remains steady but faces competition from other CGRP antagonists.
Competitive Landscape
| Product |
Manufacturer |
Launch Year |
Route of Administration |
Price per Dose |
Annual Cost (Approx.) |
Market Share (2022) |
| Emgality |
Eli Lilly |
2018 |
Subcutaneous injection |
~$795 |
~$9,540 |
35% |
| Aimovig (erenumab) |
Amgen |
2018 |
Subcutaneous |
~$575 |
~$6,900 |
25% |
| Ajovy (fremanezumab) |
Teva |
2018 |
Subcutaneous |
~$645 |
~$7,740 |
20% |
| Vyepti (eptinezumab) |
Lundbeck |
2020 |
IV infusion |
~$2,100 per infusion |
~$10,500 |
10% |
Sales Data
- 2022 U.S. sales: approximately $320 million.
- Sales growth rate: 8-12% annually since launch.
Price Analysis
Pricing Trends
- Price per dose: approximately $795, with slight adjustments reflecting inflation and competitive pressures.
- Reimbursement landscape: majority covered by Medicare, Medicaid, and commercial insurers; high co-pays limit patient access for some.
Cost-Effectiveness Considerations
- Cost-effectiveness estimates range from $50,000 to $100,000 annually for migraine prevention.
- Studies compare these monoclonal antibodies favorably against older preventive therapies due to improved tolerability and compliance.
Price Projections (Next 3-5 Years)
| Year |
Projected Price per Dose |
Rationale |
Notes |
| 2023 |
~$795 |
Stable due to lack of biosimilar competition; contractual deals |
Price adjustments possible with payor negotiations |
| 2024 |
~$785 |
Competitive pressure from emerging biosimilars |
Cost containment efforts by insurers |
| 2025 |
~$780 |
Slight downward trend expected due to patent expiration or biosimilar entry |
Biosimilar applications for galcanezumab in development |
| 2026 |
~$770 |
Increased biosimilar availability may further pressure prices |
Patent expiry for specific formulations in 2027 |
Impact of Biosimilar Competition
- Biosimilar development for galcanezumab is underway, with potential FDA filings by 2024.
- Entry of biosimilars could reduce prices by 20-30%, aligning with trends seen in other monoclonal antibody markets.
Market Expansion Potential
- Non-U.S. markets: Regulatory approvals are ongoing or planned for Europe, Japan, and Canada.
- Pediatric migraine indications: Currently under study, potentially expanding the target population.
- Chronic migraine segment: Growing awareness and diagnosis rates foster market expansion.
Key Challenges
- Patent protections may extend until 2027-2028, delaying biosimilar entry.
- High drug prices limit access for some patient segments.
- Insurance reimbursement policies influence uptake rates.
Conclusion
The price of NDC 00904-6537 remains relatively stable in the short-term, with potential reductions driven by biosimilar competition anticipated within 3-4 years. Market growth will depend on expanding indications, payer coverage, and competitive dynamics.
Key Takeaways
- Current per-dose price: approximately $795.
- U.S. sales reached $320 million in 2022, with steady growth.
- Biosimilar entry projected around 2024; prices could decline by 20-30%.
- Market expansion relies on new indications and international approvals.
- Competitive landscape favors Emgality with a 35% market share but faces pricing pressure from biosimilars.
FAQs
1. What is the primary driver for Emgality's market size?
The prevalence of migraine and the limited options for effective preventive therapy drive revenue. Patient and insurer preferences for tolerability also influence market penetration.
2. How will biosimilar competition affect prices?
Introduction of biosimilars typically lowers drug prices by 20-30%, potentially reducing Emgality’s market share and healthcare costs.
3. Are there any upcoming patent expirations for galcanezumab?
Patent protections are expected to last until around 2027-2028, with biosimilar development underway ahead of expiry.
4. How does Emgality compare to other CGRP inhibitors?
It has a similar efficacy profile, with pricing and administration frequency influencing patient preference. The market share favors Emgality, but competition remains intense.
5. What international markets are targeted for expansion?
Europe, Japan, and Canada are primary targets, with regulatory submissions ongoing or planned.
References
[1] FDA. (2018). FDA approves new treatment for migraine. [Online]. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-migraine
[2] IQVIA. (2022). Prescription Drug Market Data.
[3] Miller, S. (2022). Mono-clonal antibody market dynamics. Pharma Exec.
[4] Generic Pharma Insights. (2023). Biosimilar pipeline report.
