Last updated: April 1, 2026
What is the Drug Represented by NDC 60429-0823?
NDC 60429-0823 identifies Ubrogepant, marketed as Ubrelvy. It is an oral CGRP receptor antagonist indicated for the acute treatment of migraine with or without aura in adults.
- Approval Date: December 2019 by the FDA.
- Manufacturer: Allergan (acquired by AbbVie in 2020).
- Formulation: 50 mg and 100 mg tablets.
- Dosage: Take as needed; no more than 18 doses per month.
Market Size and Growth Dynamics
The global migraine therapeutics market, valued at approximately $3 billion in 2022, is projected to reach $4.5 billion by 2030. The compound annual growth rate (CAGR) is estimated at 4.3%.
Key Market Drivers
- Increasing prevalence of migraine: affects approximately 15% globally.
- Expansion of CGRP inhibitor use: Ubrogepant is among a new class, driving patent exclusivity.
- Growing awareness and diagnosis rates.
- Competitive landscape: Several CGRP drugs including Aimovig (erenumab) and Emgality (galcanezumab).
Competitive Positioning
| Drug |
Mechanism |
Approval Year |
Notes |
| Ubrogepant |
Oral CGRP receptor antagonist |
2019 |
First oral CGRP antagonist |
| Aimovig |
Monoclonal antibody, CGRP receptor |
2018 |
First CGRP monoclonal approved |
| Emgality |
Monoclonal antibody, CGRP ligand |
2018 |
Subcutaneous injection |
Ubrogepant distinguishes itself through being an oral medication, providing an alternative for patients hesitant toward injectables.
Pricing Trends and Projections
Current Pricing Landscape (2023)
- Average WAC (Wholesale Acquisition Cost): Approximately $800 - $900 per month.
- TAF (Times Average Wholesale Price): Used for insurance negotiations; approximately $750.
- Average Out-of-pocket: Varies from $30 to $50 per prescription with insurance.
Historical Price Movements
- Prices have remained relatively stable since launch.
- Price reductions are rare, as patent exclusivity is expected to last until 2035.
Future Price Projections (2024–2030)
- Price Stability Expectation: Prices are projected to remain within the $750 - $950 range over the next five years.
- Factors Supporting Stability:
- Limited generic competition (patent protections until 2035).
- High demand for oral CGRP options.
- Potential for Price Erosion: Minimal unless biosimilar or generic entrants appear post-patent expiration.
Regulatory and Market Entry Risks
- Patent Challenges: Potential patent litigation or generic challenge could influence pricing post-2035.
- Market Penetration: Prescription volume depends on prescribing habits; acceptance of oral CGRP agents is increasing but has not yet fully displaced older therapies.
- Reimbursement Policies: Insurance coverage will significantly influence patient out-of-pocket costs.
Distribution and Access Policies
Major payers cover Ubrogepant with prior authorization; copay cards and assistance programs lower patient costs. Market access hinges on payer negotiations and physician prescribing trends.
Summary of Key Data Points
| Aspect |
Data |
| Approved indications |
Acute migraine treatment |
| Launch date |
December 2019 |
| Patent expiration |
2035 |
| Current average price |
$800–$900 per month |
| Projected price stability |
2024–2030, within current range |
Key Takeaways
- Ubrogepant remains a high-cost, branded oral migraine drug with stable pricing due to patent protection.
- Market growth driven by increasing migraine prevalence and patient preference for oral medications.
- Price projections suggest stability through at least 2028, with minimal erosion expected until patent expiry.
- Potential future generic or biosimilar entrants post-2035 could significantly impact pricing dynamics.
- Access and reimbursement policies will influence actual patient costs and market penetration.
FAQs
Q1: When is Ubrogepant expected to face generic competition?
A1: Patent protections extend until 2035, delaying generic entry.
Q2: How does Ubrogepant compare in price to other migraine treatments?
A2: It is generally priced higher than older triptans but competitively aligned with other CGRP therapies, especially monoclonal antibodies.
Q3: What factors could influence Ubrogepant’s market share?
A3: Prescribing habits, insurance coverage, and availability of alternative therapies.
Q4: Are there any pricing regulations impacting Ubrogepant?
A4: No specific regulations; pricing is market-driven, with reimbursement influenced by insurer policies.
Q5: What are the main barriers to wider adoption?
A5: Cost considerations, physician familiarity, and patient preference for existing therapies.
Sources
[1] IQVIA, "Global Migraine Therapeutics Market Data," 2022.
[2] U.S. Food and Drug Administration, "Ubrogepant (Ubrelvy) Approval Letter," 2019.
[3] Rite Aid, "Ubrogepant (Ubrelvy) Pricing and Patient Assistance," 2023.
[4] Evaluate Pharma, "2022 Market Forecast," 2022.
[5] U.S. Patent and Trademark Office, "Patent Expiry Data," 2021.
