Last updated: February 20, 2026
What is the drug associated with NDC 50268-0503?
The NDC 50268-0503 corresponds to Rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist approved by the FDA in 2020 for the acute treatment and preventive management of migraines in adults.
What is the current market size for Rimegepant?
The migraine therapeutics market was valued at approximately $4.2 billion in 2022, with CGRP receptor antagonists accounting for roughly 35% of that total, i.e., about $1.47 billion. Rimegepant's sales accounted for approximately $500 million in 2022, reflecting its rapid adoption.
What are key competitors and their market positions?
| Drug |
Approval Year |
Indication |
2022 Sales (USD Million) |
Market Share (%) |
Notes |
| Rimegepant (50268-0503) |
2020 |
Acute and preventive migraine |
500 |
34 |
First oral CGRP for both uses |
| Ubrogepant (MK-1602) |
2019 |
Acute migraine |
200 |
14 |
Prescribed mainly for acute treatment |
| Erenumab (Aimovig) |
2018 |
Preventive migraine |
400 |
27 |
Injectable, high patient retention |
| Fremanezumab (Ajovy) |
2018 |
Preventive migraine |
200 |
14 |
Subcutaneous administration |
The competitive landscape has shifted toward oral options like Rimegepant, driven by convenience.
What is the price trajectory of Rimegepant?
Current Pricing
The wholesale acquisition cost (WAC) for Rimegepant 75 mg tablets is approximately $600 for 30 tablets, translating to about $20 per tablet.
Historical and Projected Pricing Trends:
- 2022: Stable WAC around $600 per 30 tablets.
- 2023-2025: Expected gradual decrease in net prices due to increased competition, generic entry, and payor negotiations. Anticipate a 10-15% reduction over this period.
- Post-2025: Introduction of generics could reduce prices by approximately 50%, based on comparable CGRP inhibitors.
Factors Influencing Price:
- Patent protections until 2030, with potential for extensions.
- Entry of generic manufacturers post-patent expiration.
- Insurance formulary negotiations favoring lower-cost options.
- Enrollment in value-based pricing arrangements.
What are key regulatory and market dynamics?
-
Patent and exclusivity: Rimegepant's composition patent expires in 2030, with a data exclusivity period lasting until 2035.
-
Regulatory approvals: Beyond FDA approval, Rimegepant has received approvals in the EU and Japan, broadening market potential.
-
Market penetration: Growing awareness of CGRP antagonists boosts prescriptions. Physicians prefer oral medications over injectables for preventive therapy.
-
Reimbursement landscape: Coverage policies favor newer oral therapies, increasing market access. Out-of-pocket costs remain a factor.
-
Pipeline developments: Other oral CGRP antagonists are under development, potentially impacting Rimegepant’s market share.
What is the outlook for revenue growth and price?
| Year |
Projected Revenue (USD Million) |
Assumptions |
| 2023 |
550 |
Slight growth driven by increased prescriptions in US and EU. |
| 2024 |
600 |
Market expansion and wider reimbursement coverage. |
| 2025 |
650 |
Continued growth with increased physician adoption. |
| 2026+ |
Decline to 300-400 |
Patent expiry leading to generic competition and significant price reductions. |
Summary
Rimegepant (NDC: 50268-0503) maintains a leading position in the oral migraine treatment market. Market growth is driven by increasing prevalence, physician preference for oral therapy, and expanding regulatory approval. Price projections indicate stability through 2025, followed by significant reductions as generics enter the market in 2030.
Key Takeaways
- Rimegepant dominates the oral CGRP market due to dual-use approval.
- 2023-2025 price stability is expected, with gradual decreases.
- Post-2030, market share and revenue are forecast to decline sharply due to patent expiration.
- Competitive dynamics include new entrants and generics.
- Reimbursement policies and insurance coverage heavily influence net prices.
FAQs
1. When will generic versions of Rimegepant be available?
Post-2030, following patent expiry in 2030, generics are expected to enter the market within 1-2 years, depending on regulatory approval timelines.
2. How does Rimegepant compare prices with injectable CGRP drugs?
Oral Rimegepant's WAC is approximately $20 per tablet, whereas injectable CGRP drugs like Erenumab and Fremanezumab have annual list prices around $6,000-$7,000.
3. What factors could accelerate or delay price reductions?
Market entry of generics, patent litigation outcomes, negotiated insurance discounts, and healthcare policy changes all influence pricing timelines.
4. What is the forecast for Rimegepant’s market share post-2025?
It is projected to decline from around 34% of the CGRP market to less than 10% after 2030 due to generic competition.
5. Are there ongoing formulation or delivery improvements?
Current focus remains on expanding indications and approval in other regions. No significant new formulations announced as of 2023.
References
- FDA. (2020). FDA approves Rimegepant for migraine. Retrieved from [FDA website]
- IQVIA. (2022). Pharmaceutical Market Data.
- EvaluatePharma. (2022). Worldwide Sales Data for Migraine Drugs.
- U.S. Patent Office. (2022). Data on patent status for Rimegepant.
- Bloomberg Industry Data. (2022). Market Share and Pricing Trends.
