Last updated: March 13, 2026
What is the Product Verified by NDC 00378-2085?
NDC 00378-2085 corresponds to Axert (almotriptan malate) 6 mg tablets. Axert is a medication used for acute treatment of migraines with or without aura in adults.
Market Size and Demand
Historical Market Data
- Global migraine market projected to reach approximately $4.8 billion by 2025, with a compound annual growth rate (CAGR) of 4.1% (Grand View Research, 2022).
- Americas dominate this market, accounting for approximately 55%, driven by higher diagnosis rates and insurance coverage.
- Demand for triptans like Axert has remained steady but faces pressure from newer therapies and generics.
Key Competitors
- Sumatriptan (brand: Imitrex)
- Rizatriptan (brand: Maxalt)
- Eletriptan (brand: Relpax)
- Lasmiditan (brand: Reyvow), a 5-HT1F receptor agonist, with emerging market share.
Market Position
- Axert holds a smaller share compared to Imitrex and Maxalt, primarily due to later market entry and limited marketing.
- It benefits from existing prescriptions and insurance formularies but faces generic competition.
Patent and Regulatory Timeline
- Original patent expiry: 2014 (patent protections long expired)
- Current market exclusivity: Limited to orphan drug designation and orphan exclusivity, which is not applicable here.
- FDA status: Fully off-patent; generic versions exist.
Pricing Overview
Current Pricing
- Brand-name Axert (6 mg): Approximate wholesale acquisition cost (WAC) is around $35-$45 per tablet.
- Generic almotriptan (6 mg): Available at roughly $10-$15 per tablet.
Reimbursement
- Price to payers varies based on pharmacy benefit managers (PBMs) and insurance plans.
- Typical out-of-pocket costs for patients with insurance range from $10 to $20 per tablet.
Price Trends and Projections
Factors Influencing Future Pricing
- Generic competition continues to push prices downward.
- Market saturation with established triptans limits price increases.
- New delivery formulations: Extended-release or combination products may command higher prices.
- Regulatory developments: No new patent protection or exclusivities are expected for Axert.
Forecast for 2023-2028
| Year |
Estimated Average Retail Price per Tablet |
Key Drivers |
| 2023 |
$12 - $15 |
Increased generic penetration |
| 2024 |
$10 - $14 |
Increased generic availability |
| 2025 |
$10 - $13 |
Market stabilization |
| 2026 |
$9 - $12 |
Competitive pressures |
| 2027 |
$9 - $11 |
Market maturity |
| 2028 |
$8 - $10 |
Price compression from generics |
Market Entry and Competitive Dynamics
- No near-term patent protections.
- Entry of newer therapies (e.g., lasmiditan, ubrogepant) could further compress prices.
- The shift toward non-vasoconstrictive therapies might diminish triptan market share over time.
Recommendations for Stakeholders
- Manufacturers should focus on cost containment to remain competitive.
- Investors should monitor generic market penetration and the emergence of new therapies.
- Payers may leverage price competition to control costs.
Key Takeaways
- Axert (almotriptan) faces substantial generic competition, leading to a consistent downward trend in price.
- Market size remains significant in the migraine treatment space but is becoming more saturated.
- Price projections suggest modest declines over the next five years, with retail prices potentially stabilizing around $8-$10 per tablet.
- Broader trends toward newer, non-vasoconstrictive treatments may further diminish Axert's market share.
FAQs
1. Are there any upcoming patent protections for Axert?
No. The original patents expired in 2014, and no new patents or exclusivities are anticipated.
2. How does Axert pricing compare to other triptans?
Axert's branded prices are comparable or slightly higher than other triptans like sumatriptan. Generics significantly reduce costs.
3. Will new formulations impact Axert’s market?
Potentially. Extended-release or combination formulations could command higher prices but are yet to be launched.
4. What is the primary driver of price decline?
The availability of generic almotriptan limits brand prices and exerts downward pressure overall.
5. How might emerging therapies influence Axert's market?
New drugs like lasmiditan and gepants may reduce demand for traditional triptans, impacting overall market size and pricing.
References
- Grand View Research. (2022). Migraines Market Size & Trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/migraine-therapeutics-market
- IBM Watson Health, Mergent, and IQVIA data, 2023.
- FDA. (2022). Drug Approvals and Labeling. https://www.fda.gov/drugs/development-approval-process-drugs
