Last updated: March 4, 2026
What is NDC 81565-0204?
NDC 81565-0204 corresponds to Rimegepant Oral Powder, marketed as Nurtec ODT by Biohaven Pharmaceuticals. It is approved for acute migraine treatment and preventive therapy in adults.
Market Overview
Regulatory Status
- FDA approval: January 2019 for acute migraine treatment.
- Expanded: August 2020 for preventive migraine therapy.
- Marketed as an orally disintegrating tablet (ODT); no generic versions yet.
Clinical and Market Demand
- Migraines significantly impact 12% of the U.S. population.
- Market size includes approximately 40 million chronic migraine sufferers in the U.S.
- Growing demand driven by preference for non-invasive, fast-acting therapies.
Competitive Landscape
| Drug |
Class |
Approval Year |
Key Features |
Price (Estimated) |
| Nurtec ODT (81565-0204) |
CGRP receptor antagonist |
2019 |
Oral, fast onset, preventive use |
~$78 per 75 mg dose |
| Aimovig |
CGRP antibody |
2018 |
Monthly injections |
~$6,900 annually |
| Ubrevly |
GCRP receptor antagonists |
2022 |
Oral, acute treatment |
~$40 per dose |
Market Penetration
- Nurtec ODT has captured substantial market share among oral migraine therapies.
- Approximately 800,000 prescriptions in 2022.
- Sales revenue in 2022 approximates $630 million.
Price Projections
Current Price Range
- Retail price for Nurtec (per 75 mg ODT): $78–$83.
- Wholesale acquisition cost (WAC): $65–$70.
Projected Future Pricing Trends
| Year |
Price Range (Per Dose) |
Context |
| 2023 |
$75–$85 |
Stable, slight inflation expected due to supply chain factors. |
| 2024 |
$75–$90 |
Anticipated slight increase driven by inflation and demand. |
| 2025 |
$78–$95 |
Potential price adjustment for patent protection or formulation improvements. |
Factors Influencing Price Changes
- Patent exclusivity until at least 2030.
- No generic competition expected before 2028.
- Market expansion into additional indications could sustain or raise prices.
Competitive Price Impact
- Entry of generics typically reduces prices by 30–50% within two years of approval.
- Currently, no generics are in development or pending approval for NDC 81565-0204.
Summary
Nurtec ODT commands a premium price due to its novel delivery method and dual indications. Current retail prices hover around $78 per dose, with WAC lower by approximately $7. Price stability is anticipated through 2024 barring market disruptions. The lack of generic competition keeps prices high, with potential reductions contingent on patent challenges or new entrants.
Key Takeaways
- NDC 81565-0204 (Nurtec ODT) is a leading oral CGRP receptor antagonist for migraine.
- U.S. sales in 2022 reached approximately $630 million, with stable growth projections.
- Price per dose remains around $78 but may rise to $85–$90 by 2024.
- Patent protection extends until at least 2030, delaying generic price competition.
- Market growth remains driven by rising migraine prevalence and preference for oral therapies.
FAQs
1. When is generic competition expected for Nurtec ODT?
Generic versions are unlikely before 2028 due to patent protections and orphan drug exclusivity.
2. How does the price of Nurtec compare to similar treatments?
It is priced higher than oral NSAIDs but lower than injectable CGRP antibodies, reflecting its oral administration and dual use.
3. What factors could influence a change in the drug's price?
Patent expiration, regulatory decisions, market competition, and manufacturing costs.
4. Are there indications for Nurtec beyond migraine?
Currently approved solely for migraine treatment; expanded indications require regulatory approval.
5. What is the potential market impact if a generic enters?
Prices could decrease by 30–50%, leading to significant market share shifts and revenue declines for the brand.
References
[1] Biohaven Pharmaceuticals. (2022). Nurtec ODT prescribing information.
[2] IQVIA. (2022). U.S. prescription data.
[3] FDA. (2019). Approval letter for Nurtec ODT.
[4] EvaluatePharma. (2023). Market forecast reports.
