Last updated: March 10, 2026
What is the drug identified by NDC 68382-0383?
NDC 68382-0383 corresponds to Rimegepant, marketed under the brand name Nurtec ODT (oral disintegrating tablet). It is a calcitonin gene-related peptide (CGRP) receptor antagonist approved by the FDA in February 2020 for the acute treatment of migraine with or without aura and for preventive treatment of episodic migraines.
Market Overview
Current Market Dynamics
- Indications: Migraine management, targeting a high-prevalence condition affecting approximately 39 million adults in the U.S.
- Market size: U.S. migraine drug market estimated at over $2 billion annually as of 2022.
- Competition:
- Erenumab (Aimovig): CGRP monoclonal antibody, launched in 2018.
- Fremanezumab (Ajovy): Monoclonal antibody, launched in 2018.
- Galcanezumab (Emgality): Monoclonal antibody, launched in 2018.
- Ubrogepant (Ubrelvy): Oral CGRP receptor antagonist, launched in 2019.
Prescription Trends
- Strong initial uptake driven by prescribing guidelines favoring oral options.
- Prescriptions grew 35% year-over-year in 2022, with approximately 4 million prescriptions dispensed.
Pricing Strategy
- Current Average Wholesale Price (AWP): Approximately $37 per tablet.
- Reimbursement models often set net prices 30-50% lower than AWP.
- Patient co-pays in commercial insurance range from $5-20 per month with extended rebates and discounts.
Price Projections
Short Term (2023-2024)
- Current price range: $35-$40 per tablet.
- Market acceptance: Expected stability or slight increase due to expanding indications and patient population.
- Potential discounts and rebates: Could reduce net prices by 20-30%.
Medium Term (2025-2027)
- Market expansion:
- New formulations, including potential once-daily extended-release versions.
- Growing acceptance among physicians and insurance coverage expansion.
- Pricing trajectory:
- Price stabilization around $35 per tablet.
- Possible incremental reductions driven by generic or biosimilar entry, though none currently announced.
Long Term (2028 and beyond)
- Patent expiry: Expected around 2030, given the 2020 approval date and patent protections.
- Patent challenges: Increased entries from biosimilar/copycat products could drive price reduction.
- Market penetration: Saturation may limit price increases; intense competition suggests possible decline to $20-$30 per tablet as generics or biosimilars mature.
Competitive Landscape
| Product |
Market Launch |
Formulation |
Annual Sales (2022) |
Price Range (per tablet) |
Patent Expiry |
| Nurtec ODT (Rimegepant) |
2020 |
Oral disintegrating |
~$600 million |
$35-$40 |
2030 |
| Ubrelvy (Ubrogepant) |
2019 |
Oral |
~$350 million |
$34-$38 |
2028-2030 |
| Aimovig (Erenumab) |
2018 |
Injectable |
~$1 billion |
$575/month (injectable) |
2030 |
| Ajovy (Fremanezumab) |
2018 |
Injectable |
~$600 million |
$575/month |
2030 |
| Emgality (Galcanezumab) |
2018 |
Injectable |
~$620 million |
$575/month |
2030 |
Regulatory and Policy Factors
- Reimbursement policies: Favor oral medications with lower administration costs.
- Patent protections: Most CGRP inhibitors protected until 2030, delaying biosimilar entry.
- Potential for formulary shifts: Insurance coverage favors drugs with proven efficacy and cost-effectiveness, influencing pricing strategies.
Key Takeaways
- Nurtec ODT maintains a strong market position due to its oral formulation and expanding indications.
- Price remains stable around $35-$40 per tablet, with potential reductions due to market saturation and biosimilar competition starting in the late 2020s.
- Long-term pricing will likely decline as generics or biosimilars enter the market, with prices possibly falling below $25 per tablet.
- Market growth depends on approval of new formulations, expanding indications, and reimbursement shifts.
- Competitive landscape remains robust, with monoclonal antibodies maintaining dominance in preventive therapy and oral agents capturing acute treatment segments.
FAQs
1. What factors influence the pricing of Nurtec ODT?
Pricing is influenced by manufacturing costs, market demand, competition, insurance reimbursement policies, and patent protection status.
2. When can biosimilars or generics be expected?
Patent expiry around 2030, with biosimilar competition potentially emerging 1-2 years after patent lapses.
3. How does Nurtec ODT compare price-wise to monoclonal antibody CGRP inhibitors?
Nurtec ODT typically costs about $35-$40 per tablet; monoclonal antibodies cost approximately $575 per month, representing significant cost differences favorable to Nurtec.
4. What is the outlook for market growth?
Market growth remains steady, driven by increased diagnosis, expanded indications, and higher prescribing rates for oral CGRP antagonists.
5. Are there upcoming regulatory changes that could impact pricing?
Potential policy shifts promoting biosimilar entry and value-based reimbursement models could pressure prices downward starting in the late 2020s.
References
- Food and Drug Administration. (2020). Nurtec ODT (rimegepant) approval letter.
- IQVIA. (2022). National prescription data for migraine drugs.
- EvaluatePharma. (2022). Global market insights for migraine treatments.
- Mabs and Biosimilars. (2022). Patent expiration timelines and biosimilar entry.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for branded and generic migraine therapies.
