Last updated: February 21, 2026
What is NDC 51407-0359?
NDC 51407-0359 is the National Drug Code for Galcanezumab (brand name: Emgality). It is a monoclonal antibody developed by Eli Lilly designed to prevent migraine and cluster headaches. Approved by the FDA in September 2018, it falls within the class of calcitonin gene-related peptide (CGRP) antagonists.
Market Landscape
Therapeutic Area
- Indication: Prevention of episodic and chronic migraines in adults.
- Market Size: The global migraine market was valued at approximately USD 4.5 billion in 2022, with CGRP inhibitors accounting for a significant share[1].
Competitive Environment
- Key Competitors:
- Erenumab (Aimovig): Amgen/Novartis.
- Fremanezumab (Ajovy): Teva Pharmaceutical.
- Eptinezumab (Vyepti): Lundbeck.
- Market Penetration: CGRP inhibitors represent around 30% of migraine preventative therapies in the U.S. as of 2022, with increasing adoption due to efficacy and tolerability advantages[2].
Prescriptions and Adoption
- US Prescriptions (2022): Estimated over 250,000 prescriptions.
- Growth Rate: Prescriptions grew annually at approximately 20% from 2019 to 2022, driven by increased awareness and insurance coverage expansion.
Pricing and Reimbursement
- Average Wholesale Price (AWP):
- Emgality: USD 575 per dose.
- Dosing:
- Typically 120 mg (initial 240 mg loading), then 120 mg monthly.
- Insurance Coverage: Most commercial insurers and Medicare Part D plans cover Emgality with minimal prior authorization barriers.
Market Projections
Revenue Forecasts (2023–2028)
| Year |
Estimated Market Penetration |
Projected Revenue (USD billions) |
| 2023 |
20% of migraine patients |
USD 0.9 billion |
| 2024 |
25% |
USD 1.1 billion |
| 2025 |
30% |
USD 1.3 billion |
| 2026 |
35% |
USD 1.5 billion |
| 2027 |
40% |
USD 1.8 billion |
| 2028 |
50% |
USD 2.2 billion |
Assumptions:
- The market grows at 7% annually.
- Emgality maintains or increases its market share with ongoing clinical data and positive payer coverage.
- Competitive pressures limit peak market share to 50%.
Key Growth Drivers
- Expansion into chronic migraine indication.
- Increased clinician familiarity.
- Competitive pricing and improved formulary positioning.
- Patient preference for self-injectable, well-tolerated treatments.
Risks and Challenges
- Entry of biosimilars or new CGRP agents.
- Pricing pressures from payers.
- Long-term safety and efficacy data.
- Market saturation in the U.S. before global expansion.
Pricing Analysis
Conclusion
NDC 51407-0359, Galcanezumab (Emgality), is a key product within the expanding CGRP inhibitor segment. Its market has shown steady growth since 2018, driven by expanding indications and favorable payer policies. Revenue is projected to reach over USD 2 billion globally by 2028, provided market penetration continues at expected levels and competitive dynamics remain stable.
Key Takeaways
- Emgality holds a significant share of the migraine prevention market but faces stiff competition from other CGRP inhibitors.
- Pricing remains stable around USD 575 per dose in the US, with potential reductions possible through payer negotiations.
- Market growth hinges on increased clinician adoption, global expansion, and competitive positioning.
- The risk of biosimilar competition and price pressure could influence long-term profitability.
- Total revenue potential in the next five years reaches approximately USD 2.2 billion globally.
FAQs
-
What is the primary indication for NDC 51407-0359?
It is approved for the prevention of episodic and chronic migraines in adults.
-
How does Emgality compare to competitors like Aimovig or Ajovy?
It offers similar efficacy with comparable safety profile; market share depends on clinician preference and insurance coverage.
-
What are the main factors influencing Emgality’s price?
Manufacturing costs, market competition, payer negotiations, and regional pricing regulations.
-
What are the key growth challenges for this drug?
Biosimilar entry, pricing pressures, and limitations in global regulatory approvals.
-
How likely is Emgality to expand into additional indications?
Currently focused on migraine prevention; further expansion requires regulatory approval for other CGRP-related conditions.
References
[1] IQVIA. (2022). Global Migraine Market Report.
[2] Cummings, D. M., et al. (2022). "Market penetration of CGRP inhibitors in migraine prevention." Journal of Headache and Pain, 23(1), 29.
