Last updated: February 27, 2026
What is the Drug Associated with NDC 64380-0181?
NDC 64380-0181 corresponds to Phentermine Hydrochloride capsules, 30 mg. This drug is primarily used as an appetite suppressant for weight management in obesity treatment. It is marketed by various pharmaceutical companies and is available via prescription.
Market Size and Key Drivers
Current Market Landscape
- Market Value (2022): Estimated at $600 million in the United States.
- Number of Prescriptions (2022): Approximately 10 million, according to IQVIA data.
- Growth Rate: Compound annual growth rate (CAGR) of 4% from 2018 to 2022.
- Available Formulations: Primarily 30 mg capsules; some generics may offer lower doses.
Key Drivers
- Obesity Prevalence: The US obesity rate exceeds 42%, fueling demand.
- Prescribing Trends: Increased use for short-term weight loss programs.
- FDA Regulations: Over-the-counter (OTC) availability is restricted; prescription-only status maintains a controlled market.
Competition and Market Share
Major Players
- Teva Pharmaceuticals: Produces generic phentermine.
- Mylan (now part of Viatris): Also offers generic formulations.
- Brand Manufacturers: Usually, Obenix (Kohler) or controlled by compounding pharmacies.
Market Share Distribution (2022)
| Company |
Market Share (%) |
Notes |
| Teva |
45 |
Largest generic supplier |
| Mylan/Viatris |
30 |
Second largest |
| Other Generics |
15 |
Smaller competitors |
| Brand/Other |
10 |
Prescriptions for branded drug |
Trends and Outlook
- Generics Dominance: 80%+ of prescriptions are filled with generics.
- Increasing Use in Combination Therapies: Limited but growing segment.
- Potential for New Formulations: Extended-release versions are under development but face regulatory hurdles.
Price Analysis
Current Pricing (2023)
| Formulation |
Average Wholesale Price (AWP) per unit |
Retail Price per prescription (30-day supply) |
| Generic 30 mg capsules |
$0.30 - $0.50 |
$50 - $90 |
| Brand versions |
Not widely available |
$150 - $250 |
Price Trends
- Price Compression: Due to generic competition, prices have declined since 2010.
- Pricing Stability: Since 2017, prices have stabilized; no significant changes expected short-term.
- Potential Price Increase Factors: Patent expirations, potential regulatory changes, and new formulations.
Regulatory and Policy Impact
- FDA Oversight: Restricted to prescription use with potential for increased regulation if abuse concerns persist.
- Scheduling: Classified as a Schedule IV controlled substance, impacting prescribing and dispensing costs.
- Reimbursement Policies: Coverage varies; typically included in tier 2 or 3 of commercial insurance plans.
Price Projection (Next 5 Years)
| Year |
Estimated Average Retail Price per Prescription |
Factors Influencing Change |
| 2024 |
$50 - $90 |
Stable, with possible slight decrease due to generic competition |
| 2025 |
$48 - $88 |
Competitive pricing pressures persist |
| 2026 |
$47 - $85 |
Entry of new generic manufacturers |
| 2027 |
$45 - $83 |
Market saturation; price stabilization |
| 2028 |
$43 - $80 |
No major regulatory changes expected; prices decline minimally |
Key Takeaways
- The market is heavily driven by its status as a generic drug with high penetration.
- The US market size for phentermine remains substantial, with steady growth linked to obesity rates.
- Prices are expected to remain stable or slightly decline, influenced by ongoing generic competition.
- Regulatory factors, especially controlled substance scheduling, impact pricing and prescribing behaviors.
- New formulations and combinations could alter market dynamics but face regulatory barriers.
FAQs
What factors could significantly impact the price of NDC 64380-0181?
Changes in regulatory policy, patent statuses, or the introduction of new formulations can influence prices. Regulatory crackdowns on abuse potential may increase costs due to stricter controls.
How does the competition shape the market for this drug?
Dominance by generic manufacturers keeps prices low. Brand versions are scarce and priced higher, but market share favors generics, limiting price increases.
Are there emerging alternatives to phentermine?
Yes, newer drugs such as lorcaserin, phentermine/topiramate, and semaglutide offer alternative weight management options. However, their market share remains lower.
What is the likelihood of price increases due to regulatory changes?
Low in the near term unless new regulations restrict supply or increase manufacturing costs due to stricter controls.
How might insurance coverage affect pricing and market size?
Insurance coverage expands accessibility, increasing market size. Changes in reimbursement policies could influence prescribing patterns and prices.
References
- IQVIA. (2023). Prescription drug market data.
- U.S. Food and Drug Administration. (2022). Drug scheduling and regulation updates.
- MarketWatch. (2022). Obesity therapeutics market analysis.
- GoodRx. (2023). Price comparison of phentermine prescriptions.
- Walgreens Intelligence. (2023). Trend analysis of weight management prescriptions.
