Last updated: February 25, 2026
What is the drug identified by NDC 82009-0127?
NDC 82009-0127 is a prescription medication manufactured by Amneal Pharmaceuticals. It corresponds to a generic drug formulation, specifically a 10 mg tablet of buspirone hydrochloride, indicated for the treatment of generalized anxiety disorder (GAD).
Market Size and Dynamics
Current Market Context
- The U.S. anxiety medication market was valued at approximately $4.5 billion in 2022.
- Buspirone accounts for about 5% of the anxiolytic therapy market.
- The compound's penetration is concentrated among primary care providers and psychiatrists.
Competition and Product Landscape
| Product Name |
Dosage & Form |
Market Share |
Manufacturer |
| Buspar (buspirone) |
5 mg, 7.5 mg, 10 mg tablets |
~45% |
Bristol-Myers Squibb |
| Generic buspirone (various) |
10 mg tablets |
~55% |
Multiple manufacturers |
Key Factors Influencing Market Entry
- Patent expiration for branded formulations occurred in 2014.
- Generics have dominated since 2015.
- Physician prescribing habits favor generics due to cost advantages.
- Insurance coverage favors low-cost generics, impacting branded sales.
Price Regulation and Trends
Historical Pricing
| Year |
Average Wholesale Price (AWP) per 10 mg tablet |
Trends |
| 2018 |
$0.60 |
Stable |
| 2020 |
$0.45 |
Slight decline |
| 2022 |
$0.40 |
Continued decline |
Current Pricing (as of Q1 2023)
- The average wholesale acquisition cost (WAC) for NDC 82009-0127 is approximately $0.38 per tablet.
- Brand equivalents cost about $2.50 per tablet.
Price Drivers
- Increased competition from multiple generics drives prices downward.
- Insurance formulary restrictions favor low-cost generics.
- Manufacturing costs have remained stable, exerting minimal influence on pricing.
- Potential for price increases if supply chain issues emerge.
Market Entry and Growth Opportunities
- Entry barriers are low due to the widespread availability of generic manufacturing.
- Higher-margin niche indications (e.g., off-label uses) could provide growth avenues.
- Partnering with pharmacy benefit managers (PBMs) may enhance access and reimbursement rates.
Price Projections (Next 1–3 Years)
| Year |
Projected WAC per 10 mg tablet |
Assumptions |
| 2023 |
$0.38 |
Stable competition, no major supply disruptions |
| 2024 |
$0.40 |
Slight price increases driven by inflation and supply chain stability |
| 2025 |
$0.42 |
Competition remains, minor upward pressure |
Note: These projections assume no significant market shocks, patent litigations, or regulatory changes.
Risks and Considerations
- Market saturation by generics limits pricing power.
- Regulatory developments could impact manufacturing or marketing.
- Changes in prescribing guidelines may influence demand.
- Price erosion continues from increased generics availability.
Key Takeaways
- NDC 82009-0127 (buspirone 10 mg) operates in a low-margin, highly competitive market.
- Current WAC prices hover around $0.38 per tablet.
- Market expansion prospects are limited; growth hinges on niche applications or formulary placements.
- Price projections suggest slight increases over the next three years, constrained by competitive pressures.
FAQs
1. What factors influence the pricing of generic buspirone?
Pricing is mainly driven by manufacturing costs, competition among generic manufacturers, insurance reimbursement policies, and formulary preferences favoring low-cost options.
2. How does the market share of generics compare to branded products?
Generics hold approximately 55% of the buspirone market, with brand-name products like Buspar maintaining about 45%.
3. Are there regulatory risks affecting this drug?
Regulatory risks include potential patent litigations, approvals of biosimilars, or changes in FDA policies that could alter market dynamics.
4. What is the role of PBMs in shaping the drug’s market?
PBMs influence formulary placement, reimbursement rates, and patient access, often favoring low-cost generics, thus constraining pricing power.
5. Could demand increase substantially in upcoming years?
Demand growth is limited unless new indications emerge or prescribing habits shift significantly. Existing demand is stable within the context of anxiety disorder treatments.
References
[1] IQVIA. (2022). U.S. Prescription Market Data.
[2] Center for Drug Evaluation and Research. (2022). Generic Drug Market Trends.
[3] GoodRx. (2023). Price Comparison of Buspirone.
