Introduction
The pharmaceutical market is a complex and dynamic sector, influenced by various factors including regulatory changes, market demand, and competitive pressures. This analysis focuses on the market and price projections for the Good Neighbor Pharmacy Nicotine Lozenges, identified by the National Drug Code (NDC) 46122-176.
Product Overview
Generic Name and Active Ingredient
The Good Neighbor Pharmacy Nicotine Lozenges are labeled under the generic name Nicotine Polacrilex, with an active ingredient strength of 2 mg per lozenge[1].
Dosage Form and Route of Administration
These lozenges are administered orally, designed to help individuals quit smoking by managing nicotine cravings.
Marketing and Distribution
The product is marketed and distributed by Amerisource Bergen, and it has been available on the market since August 2, 2013[1].
Market Trends in the Pharmaceutical Industry
Overall Market Growth
The U.S. pharmaceutical market is projected to grow significantly, from $846.72 billion in 2022 to $1.28 trillion by 2025. This growth is driven by increasing demand for healthcare services and innovative treatments[4].
Pricing and Access Issues
Pricing and access to drugs remain significant concerns for the life sciences industry. Nearly half of C-suite executives surveyed expect pricing and access issues to significantly impact their strategies in 2025[3].
Pricing Mechanisms
Average Manufacturer Price (AMP) and Unit Rebate Amount (URA)
For drugs participating in the Medicaid Drug Rebate Program, the ceiling price is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) for the smallest unit of measure. This price is then adjusted based on the package size and case pack size[2].
Ceiling Price Calculation
The 340B ceiling price, relevant for covered entities, is calculated using the formula: (AMP – URA) x PS x CSP, where PS is the package size and CSP is the case pack size. This ensures that the final price is operational in the marketplace[2].
Price Projections for NDC 46122-176
Current Pricing
As of the latest available data, specific price projections for NDC 46122-176 are not provided. However, prices for nicotine replacement therapy products tend to be relatively stable due to their established market presence.
Competitive Landscape
The market for nicotine replacement therapy (NRT) products is competitive, with various brands and generic options available. This competition can influence pricing, as manufacturers may adjust prices to remain competitive[1].
Regulatory Impact
Regulatory changes, such as those related to the Medicaid Drug Rebate Program, can impact pricing. Manufacturers must adhere to statutory pricing formulas, which can affect the final price of the product to covered entities[2].
Market Demand and Growth
Smoking Cessation Market
The demand for smoking cessation products, including nicotine lozenges, remains steady due to ongoing public health campaigns and individual efforts to quit smoking. This consistent demand can support stable pricing for these products.
Health and Wellness Trends
Increasing awareness of health and wellness trends can drive demand for NRT products. As more people seek to quit smoking, the market for nicotine lozenges is likely to remain robust.
Challenges and Opportunities
Generic and Biosimilar Competition
The life sciences industry faces significant competition from generic drugs and biosimilars. However, for NRT products like nicotine lozenges, the impact of generics is already factored into the market, as many of these products are already generic[3].
Patent Expirations
While patent expirations are a concern for many high-revenue pharmaceutical products, nicotine lozenges are not typically affected by this issue since they are already generic or over-the-counter products[3].
Key Takeaways
- Stable Market Presence: Nicotine lozenges, including those with NDC 46122-176, have a stable market presence due to consistent demand for smoking cessation products.
- Regulatory Pricing: Prices are influenced by regulatory mechanisms such as the Medicaid Drug Rebate Program.
- Competitive Landscape: The market is competitive, but prices tend to be stable due to the established nature of NRT products.
- Health Trends: Increasing health awareness supports ongoing demand for these products.
FAQs
What is the active ingredient in Good Neighbor Pharmacy Nicotine Lozenges?
The active ingredient is Nicotine Polacrilex, with a strength of 2 mg per lozenge[1].
How are the prices for NDC 46122-176 calculated?
Prices are calculated based on the Average Manufacturer Price (AMP) minus the Unit Rebate Amount (URA), adjusted for package size and case pack size[2].
What regulatory programs affect the pricing of NDC 46122-176?
The Medicaid Drug Rebate Program significantly affects the pricing for covered entities[2].
How does competition from generic drugs impact NDC 46122-176?
Since NDC 46122-176 is already a generic product, the impact of generic competition is minimal[1].
What are the key trends influencing the market for nicotine lozenges?
Key trends include stable demand for smoking cessation products, regulatory pricing mechanisms, and overall health and wellness trends[3][4].
Sources
- FDA Report: NDC 46122-176 Oral Lozenge Good Neighbor Pharmacy Nicotine.
- HRSA: NDC Product Details - Log into 340B OPAIS.
- Deloitte Insights: 2025 life sciences outlook.
- DrugPatentWatch: Latest drug prices and trends for NDC 50419-0392.
Last updated: 2025-01-05
