Last updated: February 24, 2026
What Is NDC 59651-0314?
The NDC 59651-0314 corresponds to Rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist used primarily for migraine treatment. Rimegepant is marketed under the brand name "Nurtec ODT" by Biohaven Pharmaceuticals and approved by the FDA in 2020.
Market Landscape
Market Size and Adoption
- Target Population: Approximately 39 million Americans experience episodic migraines, with 4 million suffering chronic migraines (Source: Migraine Research Foundation, 2021).
- Market Penetration: Since its approval, Nurtec ODT captured a significant share of the acute migraine treatment market, driven by its oral formulation and fast onset.
Competition
| Drug Name |
Class |
FDA Approval Year |
Market Position |
| Nurtec ODT |
CGRP receptor antagonist |
2020 |
Leading oral CGRP drug |
| Ubreyv (Ubrogepant) |
CGRP receptor antagonist |
2019 |
Competition in same class |
| Aimovig (Erenumab) |
Monoclonal antibody |
2018 |
Preventive treatment |
Distribution Channels
- Prescription-based sales predominantly through specialty pharmacies.
- Managed care contracts heavily influence pricing and reimbursement strategies.
Price Projections
Current Pricing Landscape
| Price Metric |
Estimated Price |
Notes |
| Wholesale Acquisition Cost (WAC) |
~$720 for 8-dose pack |
As per drug pricing sources (SVP, 2022) |
| Average Wholesale Price (AWP) |
~$865 |
Slightly above WAC, typical for negotiated discounts |
| Retail Price |
~$750–800 |
After discounts and rebates |
Short-Term Market Dynamics (Next 1-2 Years)
- Pricing Stability: WAC is expected to remain stable due to limited direct competition; however, rebates and discounts may erode list prices.
- Reimbursement Trends: Insurance coverage favors branded drugs like Nurtec ODT, although biosimilar/copycat CGRP inhibitors could pressure pricing long term.
- Volume Growth: Moderate growth anticipated, driven by increased adoption in both episodic and chronic migraine cases. Estimated volume increase of 10–15% annually.
Long-Term Price Trends (3-5 Years)
- Price Erosion: Potential 5–10% reduction in net prices due to formulary negotiations and rebates.
- Market Expansion: As indications broaden and additional formulations (injectables, generics) enter, prices may decline further.
- Generic Entry: No generic currently available; patent expiry rumored around 2028, possibly leading to a significant price drop.
Revenue Projections
| Metric |
2023 Estimate |
2025 Estimate |
2027 Estimate |
| US Sales |
~$480 million |
~$700 million |
~$1 billion |
| Global Sales |
~$550 million |
~$800 million |
~$1.2 billion |
Note: Projected based on current market penetration, growth rates, and pricing strategies.
Regulatory and Patent Landscape
- Patent Status: Patent protection until 2028, with potential for supplementary patent filings extending exclusivity.
- Regulatory Risks: Approval of competing CGRP antagonists or delivery reformulations could impact market share.
Key Risks and Opportunities
- Risks: Entry of generic competitors, downward pressure from rebated net prices, shifts in insurance coverage.
- Opportunities: Expansion in migraine indications, new formulations, combination therapies, and international market penetration.
Key Takeaways
- NDC 59651-0314 (Rimegepant/Nurtec ODT) operates in a competitive CGRP migraine treatment market with a dominant position since 2020.
- List prices hover around $720–$865 per pack, with net prices likely lower due to rebates.
- The market is projected to reach $700 million–$1 billion in US sales by 2025, with steady volume growth.
- Patent exclusivity lasts until 2028, after which price erosion may accelerate with generic entry.
- Market dynamics depend heavily on reimbursement policies, competitor activity, and expansion of indications.
FAQs
1. What factors influence the price of Nurtec ODT?
Reimbursement negotiations, rebate agreements, formulary placements, and competitive dynamics significantly influence net prices.
2. When are generics expected to enter the market?
Patent expiry is projected around 2028, with generic versions likely appearing shortly thereafter.
3. How does Nurtec ODT compare with other CGRP inhibitors?
Nurtec ODT is an oral treatment, offering convenience over injectable monoclonal antibodies but faces competition from other oral CGRP antagonists and injectables.
4. What is the international market outlook?
Limited data exist, but expansion hinges on regulatory approvals and market access strategies in Europe, Asia, and other regions.
5. How are insurance companies affecting drug pricing?
Insurance coverage often favors formulations with the most cost-effective net prices, influencing discounts, rebates, and formulary preferences.
References
[1] Migraine Research Foundation. (2021). Migraine prevalence data.
[2] SVP. (2022). Drug pricing report.
[3] U.S. Food and Drug Administration. (2020). FDA approval documents for Nurtec ODT.
