Last updated: February 24, 2026
What is the drug associated with NDC 42794-0012?
The drug identified by NDC 42794-0012 is Phentermine Hydrochloride 37.5 mg. It is classified as an anorectic agent used primarily for short-term weight management in adults with obesity or overweight with comorbidities.
Market Overview
Current Market Dynamics
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Market Size: The global obesity drug market was valued at approximately USD 4.8 billion in 2022. The appetite suppressant segment, which includes phentermine, accounts for about 25% of this market.
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Competitors: The market contains generic formulations and brand-name products such as Adipex-P (Phentermine), Lomaira, and alternative combinations like phentermine-topiramate (Qsymia).
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Regulatory Status: Phentermine is a Schedule IV controlled substance in the U.S., which influences prescribing patterns due to abuse potential.
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Demand Drivers: Rising obesity rates, increasing awareness about weight management, and a shift toward pharmacological treatment augment market growth.
Regulatory and Supply Considerations
- The drug's patent rights have expired, increasing generic competition.
- Several manufacturers produce phentermine generics, leading to price erosion.
- Supply has remained stable, although adulteration concerns have led to increased scrutiny in distribution channels.
Price Projection Analysis
Current Pricing Landscape
| Manufacturer Type |
Price Per Unit (USD) |
Packaging |
Notes |
| Brand Name (Adipex-P) |
$2.50 - $4.00 |
30 capsules (37.5 mg) |
Premium pricing, limited by controlled substance regulations |
| Generic (Phentermine) |
$0.15 - $0.50 |
30 capsules (37.5 mg) |
Significantly lower, dominant market share |
| Repackaged/Compounded |
$0.10 - $0.25 |
Varies |
Often used in clinics or compounding pharmacies |
Price Projection:
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Short-term (Next 1 Year): Prices are expected to decline marginally by 5%-10%, driven by increased generic entries and heightened competition. The average market price for a 30-capsule pack will stabilize around $0.20 - $0.30.
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Medium-term (1-3 Years): Prices could stabilize further or decline slightly by an additional 2%-5%, assuming consistent competition and no regulatory changes affecting manufacturing or prescribing. The average cost per capsule is projected to remain below $0.50.
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Long-term (3-5 Years): Prices may plateau with minimal fluctuations unless a reformulation or new formulations emerge. Market consolidation or new indications could accelerate price stabilization.
Factors Influencing Price Trends
- Regulatory Restrictions: Changes to Schedule classification could alter manufacturing costs and dispensing restrictions.
- Market Entry of New Formulations: Innovations such as extended-release versions or combination therapies could shift pricing strategies.
- Healthcare Policy Changes: Medicaid and insurance formularies influencing coverage could either compress or expand margins.
- Global Supply Chain Dynamics: Raw material costs, import/export tariffs, and manufacturing efficiencies affect manufacturing costs and thereby prices.
Market Outlook
The entrenched position of generic phentermine, combined with its low production costs and high demand, supports a stable to slightly declining price environment. Innovation or regulatory shifts remain the primary unknowns that could impact prices significantly.
Conclusion
The drug associated with NDC 42794-0012, Phentermine Hydrochloride 37.5 mg, faces a highly competitive market with low-cost generics dominating sales. Prices are projected to decline gradually over the next five years, stabilizing near current generic levels unless new regulatory or formulary actions intervene.
Key Takeaways
- Phentermine 37.5 mg's market is saturated with generics, limiting price increases.
- Current pricing for generics is approximately $0.15 to $0.50 per capsule.
- Prices are expected to decline modestly over the next 1-3 years due to competition.
- Regulatory and formulary shifts could influence future pricing trajectories.
- The market's growth is driven by obesity prevalence and increasing demand for weight management drugs.
FAQs
1. How does regulatory classification impact phentermine pricing?
Schedule IV classification restricts prescribing and dispensing, potentially limiting supply chains. Changes to this schedule could alter manufacturing costs and access, influencing prices.
2. What factors could cause a significant price increase for phentermine?
Introduction of new formulations, demand surges due to regulatory changes, or shortages in raw materials could push prices up temporarily.
3. Are there emerging competitors in the phentermine market?
While no novel competitors currently threaten the core generic market, combination therapies and extended-release formulations are under development, which could reshape market dynamics.
4. How does insurance coverage affect the market?
Insurance and pharmacy benefit managers favor low-cost generics, which suppress retail prices but expand access. Changes in coverage policies can influence demand and pricing.
5. What is the outlook for brand-name phentermine products?
Brand-name products like Adipex-P will likely maintain a premium price margin but face increasing pressure from generics, especially if regulatory changes impact prescribing restrictions.
References
[1] Market Research Future. (2022). "Obesity Drugs Market Analysis."
[2] IQVIA. (2022). "Pharmaceutical Price Trends."
[3] FDA. (2021). "Schedule IV Controlled Substances."
[4] Statista. (2023). "Global Obesity Drug Market Size."
[5] MedSources. (2022). "Cost Analysis of Phentermine Products."
