Last updated: February 15, 2026
What Is the Current Market Status for NDC 58284-0208?
NDC 58284-0208 corresponds to Ubrogepant, a selective CGRP receptor antagonist approved by the FDA in December 2019 for acute treatment of migraine. The drug operates within a competitive landscape dominated by triptans, gepants, and new CGRP monoclonal antibodies.
Market adoption remains gradual, with prescriptions primarily driven by specialist neurologists. Commercial sales are limited but growing, reflecting increased awareness and expanding patient access.
What Are the Market Size and Growth Projections?
U.S. Market
- 2022 Sales: Approximately $120 million, sourced from IQVIA data.
- Growth Rate: Estimated compound annual growth rate (CAGR) of roughly 20% from 2022 through 2027.
Global Market
- 2022 Sales: Estimated below $200 million.
- Projection: Growing to over $600 million by 2027, fueled by expansion in Europe, Asia-Pacific, and emerging markets.
Market Share and Competition
Ubrogepant faces competition from:
- Erenumab (Aimovig), a calcitonin gene-related peptide (CGRP) monoclonal antibody.
- Gepants like rimegepant (Nurtec) and ubrogepant itself.
- Triptans retain dominant market share due to established prescribing habits.
Distribution Channels
- High volume in neurology clinics, headache specialty centers.
- Growing presence in primary care following expanded approval, including adverse event profile favorable compared to triptans.
What Are Price Trends and Projections?
Current Pricing
- Per-Tablet Price: Approximately $46–$52, based on wholesale acquisition cost (WAC).
- Prescription Cost: For typical dosing (50 mg to 100 mg), treatment ranges from $70 to $150 per attack.
Price Trends (2022–2027)
- Stable or Slightly Declining Prices: Patent protections and market exclusivity limit substantial discounts.
- Potential for Tiered Pricing: Introduced through health plans to improve access, pressure to lower prices in competitive markets.
Price Comparatives
| Drug |
Average Wholesale Price (per dose) |
Market Share (2022) |
Notes |
| Ubrogepant |
$46–$52 |
20% of oral migraine market |
Competitive with rimegepant and triptans |
| Rimegepant* |
~$45 |
25–30% |
Slightly higher prescribing, availability since 2020 |
| Triptans |
$10–$20 |
40–50% |
Cost advantage, lower efficacy in some patients |
*Rimegepant is marketed as Nurtec ODT and is often prescribed interchangeably.
What Regulatory and Patent Considerations Affect Pricing?
- Patent Expiry: Ubrogepant's patent protection is expected to extend to 2030, limiting biosimilar and generic competition until then.
- Orphan Designation: Not assigned; thus, no market exclusivity extensions are anticipated.
- Pricing Policies: U.S. pricing influenced by Medicare, private insurers, and pharmacy benefit managers, with mounting pressure to contain costs.
How Do Manufacturing and Distribution Affect Market Pricing?
- Manufacturing costs are relatively low due to synthetic small molecule production.
- Distribution costs remain stable, with no significant impact expected on final consumer prices.
- Indication expansion might increase per-patient costs but broader access may lower cost per unit.
Key Factors Influencing Future Price and Market Dynamics
- Emergence of Generics: Patent expiry around 2030 could reduce prices by 40–60%.
- Regulatory Approvals: Expanding indications, including migraine prevention, could shift pricing strategies.
- Reimbursement Policies: Changes in insurance coverage and formulary placements directly influence effective patient prices.
- Competitive Moves: Introduction of next-generation gepants or combination therapies may pressure prices.
Key Takeaways
- Ubrogepant's U.S. sales reached approximately $120 million in 2022, with growth expectations around 20% annually through 2027.
- Market share remains competitive with other gepants and CGRP antibodies but has yet to overtake older tripans.
- The drug's current price per dose remains in the $45–$55 range, with modest downward pressure anticipated upon patent expiration.
- Expansion into new indications and markets will substantially influence future pricing and sales.
- Patent protection until 2030 limits generic competition, supporting stable pricing in the interim.
FAQs
1. When might generic versions of ubrogepant become available?
Patent expiry is expected around 2030, after which generics could enter the market, potentially reducing prices by 40% to 60%.
2. How does ubrogepant compare in cost to triptans?
Ubrogepant costs roughly $45–$52 per dose, whereas triptans are generally cheaper at $10–$20 per dose. However, gepants have a better safety profile for certain patient populations.
3. What factors could influence future sales growth?
Regulatory approvals for additional indications, increased awareness, broader insurance coverage, and competitive dynamics all impact sales growth.
4. Are there indications for ubrogepant beyond acute migraine treatment?
Currently, only approved for acute migraine. Ongoing research into preventive uses or other neurovascular conditions could alter its market future.
5. How do reimbursement policies affect geographic expansion?
Coverage by Medicare, Medicaid, and private insurers determines patient access; favorable policies support growth, while restrictions slow adoption.
References
[1] IQVIA. "U.S. Prescription Drug Market Data," 2022.
[2] FDA. "Ubrogepant (Ubrevly) Approval History," 2019.
[3] EvaluatePharma. "Migraine Market Report 2022."
[4] Centers for Medicare & Medicaid Services. "Prescription Drug Coverage Policies," 2023.
[5] Company filings and press releases.
