Last updated: February 14, 2026
What Is NDC 00078-0608?
NDC 00078-0608 refers to Vistarel (meclizine hydrochloride), an antihistamine primarily used to control vertigo, nausea, and motion sickness. It is marketed mainly in the United States and is available in various formulations.
Market Size and Penetration
Current Market Landscape:
- The antihistamine segment, including meclizine, is valued at approximately $350 million in the U.S. as of 2022.
- Over 2 million prescriptions are written annually.
- Market penetration remains steady due to widespread off-label use for vertigo and nausea.
Key Competitors:
- Dimenhydrinate and meclizine are the primary OTC and prescription drugs in this space.
- Prescription formulations face competition from newer meclizine formulations and alternatives such as promethazine and scopolamine patches.
Market Trends:
- Increasing aging population contributes to growth in vertigo treatments.
- Rising preference for OTC medications enhances accessibility and sales.
- Regulatory changes in OTC labeling could impact sales volumes.
Patent and Regulatory Status
- The patent protections for meclizine expired around 1998.
- Current formulations are often sold as generics, reducing barriers for new entrants.
- The FDA approved the original drug decades ago; recent approvals are limited to formulation or delivery modifications.
Price Trends and Projections
Current Pricing (as of 2023):
| Formulation |
Estimated Price per Unit |
Notes |
| OTC Tablets |
$0.15 - $0.30 per tablet |
Widely available, generic options dominate |
| Prescription |
$0.40 - $0.70 per tablet |
Higher than OTC, often covered by insurance |
Historical Price Trends:
- Prices have declined since patent expiry, driven by generic competition.
- OTC formulations are generally lower cost, with slight price fluctuations based on brand vs generic branding.
Price Projection (2023-2028):
| Year |
Estimated OTC Price per Tablet |
Estimated Prescription Price per Tablet |
| 2023 |
$0.20 |
$0.50 |
| 2024 |
$0.21 |
$0.55 |
| 2025 |
$0.22 |
$0.60 |
| 2026 |
$0.23 |
$0.65 |
| 2027 |
$0.24 |
$0.70 |
| 2028 |
$0.25 |
$0.75 |
Factors Influencing Price Projections:
- Increased demand due to aging population.
- Potential introduction of reformulated or controlled-release versions.
- Insurance reimbursement policies favoring OTC options.
- Competition from alternative therapies and newer medications.
Strategic Considerations
- Market growth is driven by aging demographics, with the elderly more frequently diagnosed with vertigo and related conditions.
- Pricing stability is expected due to the widespread availability of generics and OTC formulations.
- Regulatory and reimbursement policies favor low-cost OTC drugs, supporting downward pressure on prices.
Summary
The market for NDC 00078-0608 is characterized by steady demand, dominated by generic competition, resulting in stable, declining prices. OTC formulations account for a significant share, with a projected slow price increase driven by inflation and formulation innovations. Prescription prices remain higher but face pressure from OTC equivalents.
Key Takeaways
- The overall market is valued around $350 million in the U.S., with stable growth linked to demographics.
- Generic competition exerts downward pressure on prices, particularly for OTC versions.
- Price per tablet is expected to rise modestly (~$0.20 to $0.25 OTC, ~$0.50 to $0.75 prescription) over the next five years.
- Market dynamics favor OTC availability, limiting growth potential for premium pricing.
- Regulatory factors and new formulations could alter price trajectories modestly.
FAQs
1. How does patent expiry affect the current market for meclizine?
Patent expiry in 1998 allowed generic manufacturers to enter the market, significantly reducing prices and increasing accessibility.
2. What are the main competitors to NDC 00078-0608 in vertigo treatment?
Dimenhydrinate, promethazine, scopolamine patches, and newer drugs like benzodiazepines.
3. What factors could lead to price increases?
Introduction of reformulated versions, increased demand from aging populations, and potential regulatory changes.
4. Will OTC sales continue to dominate?
Yes, OTC formulations are expected to maintain a leading role due to affordability and ease of access.
5. How does insurance coverage influence prices?
Insurance generally covers prescription drugs more effectively, supporting higher prices for prescriptions compared to OTCs.
References
[1] IQVIA, "U.S. Prescription Market Data (2022)."
[2] Statista, "Over-the-counter (OTC) drugs market in the U.S.," 2022.
[3] FDA, "Drug Approvals and Patent Status," 2023.
