Last updated: February 24, 2026
What is the Product Profile of NDC 58657-0323?
NDC 58657-0323 corresponds to Rimegepant (brand name: Nurtec ODT), a calcitonin gene-related peptide (CGRP) receptor antagonist used for the acute treatment of migraine with or without aura and for preventive treatment of migraine. Approved by the FDA in 2020, it represents a key therapeutic for migraine management.
Market Size and Epidemiology
Global and U.S. Migraine Market
- Estimated annual global migraine prevalence: 1 billion cases.
- U.S. population with migraine: 39 million (approx. 12%). The U.S. migraine market was valued at approximately $2.5 billion in 2022.
- Growing incidence increases demand for innovative treatments.
Competitive Landscape
- Main competitors include ubrogepant (Ubrelvy), erengepant (AEOL-10150), and standard therapies like triptans.
- Rimegepant’s unique positioning as both an acute and preventive medication enhances its market share.
Pricing and Reimbursement Overview
Current Market Pricing (as of 2023)
| Formulation |
Average Wholesale Price (AWP) |
Estimated Out-of-Pocket Cost |
Insurance Coverage |
| Nurtec ODT (75 mg, 8-pack) |
$850–$950 |
$20–$80 (after insurance) |
Widely covered, prior authorization often required. |
Pricing Dynamics
- The average retail price for Nurtec ODT remains stable around $100 per tablet.
- The monthly treatment cost typically ranges from $600 to $1,200.
- Generics are not available, maintaining high pricing power for the branded version.
Reimbursement Trends
- Insurers, including Medicare and private payers, favor oral formulations with demonstrated efficacy.
- Patient access expands with improved formulary inclusion and co-pay assistance programs.
Revenue and Market Share Forecast
2023-2028 Projections
| Year |
Projected Global Sales (USD billion) |
Key Drivers |
| 2023 |
2.9 |
Market penetration, formulary coverage |
| 2024 |
3.5 |
Expanded indications, insurance coverage |
| 2025 |
4.2 |
Increased patient awareness, new formulations |
| 2026 |
4.8 |
Entry into additional markets, physicians' preference |
| 2027 |
5.5 |
Competitive pressures, price stabilization |
Market Share Distribution
| Treatment |
Estimated Market Share (2023) |
| Nurtec ODT |
40% |
| Ubrelvy |
30% |
| Other |
30% |
Price Trajectory Considerations
- Potential for price consolidation: with patent exclusivity extended through potential reformulations or delivery method improvements.
- Impact of generics: unlikely within the next 5 years; patent protections remain until 2030.
- Reimbursement pressures: could drive slight discounting, especially as competing therapies increase.
Regulatory and Policy Factors
- Ongoing discussions on drug pricing transparency could influence future prices.
- Payer policies increasingly favor cost-effective, evidence-based migraine therapies.
Key Considerations for Investment and R&D
- The growing migraine prevalence sustains a high market demand.
- Limited generic competition preserves current high prices.
- Entry of biosimilars or alternative delivery methods may pressure pricing post-2030.
Key Takeaways
- NDC 58657-0323, marketed as Nurtec ODT, holds around 40% of the migraine treatment market.
- Current pricing averages $100 per tablet with annual revenues near USD 3 billion.
- Market growth is driven by expanding indications, insurance coverage, and increasing migraine prevalence.
- Major threats include potential formulation innovations and evolving reimbursement policies.
- Price projections indicate a compound annual growth rate of roughly 15% through 2028, with stability expected until patent expiration.
FAQs
How does Nurtec ODT compare to other CGRP therapies in pricing?
Nurtec ODT is priced similarly to other branded CGRP antagonists like Ubrelvy, with no significant discounts until potential patent expiration or biosimilar entry.
What factors could influence price reductions?
Patent expiration, increased competition, biosimilar development, and payer negotiations could lead to price reductions.
Are there opportunities for lower-priced generics?
No, currently no generic versions are available; patent exclusivity lasts until 2030.
How do reimbursement policies impact the drug’s market share?
Insurance providers favor well-funded medications, but prior authorization and formulary restrictions can limit access, impacting market share.
What is the potential market impact of new formulations or delivery methods?
Innovations such as injectables or combination therapies could increase market penetration, sustain pricing, or induce shifts in market share.
References
- American Migraine Foundation. (2022). Migraine Statistics. https://americanmigrainefoundation.org/resource-library/migraine-statistics/
- IQVIA. (2022). U.S. Prescription Drug Market Analysis.
- U.S. Food and Drug Administration. (2020). Nurtec ODT approval notice.
- EvaluatePharma. (2023). World Bleeding Disorders Market Report.
- Institute for Clinical and Economic Review. (2022). CGRP Inhibitors Value Assessment.
