Introduction to Zafemy
Zafemy, a generic version of the discontinued Ortho Evra, is a combined hormonal contraceptive patch developed by Amneal Pharmaceuticals. It was approved by the FDA in February 2021 and is indicated for the prevention of pregnancy in women with a Body Mass Index (BMI) of less than 30 kg/m²[1].
Market Context
Current Market Landscape
The U.S. hormonal contraceptive market has seen significant changes over the past few years. Despite the decline in the number of prescriptions from 76 million in 2018 to 56 million in 2022, the average transaction size (cycles per prescription) has increased, leading to a growth in the value of each prescription. Branded products, although declining in market share, still hold a substantial portion of the market, with a 16% share in 2022[4].
Competitors and Market Share
Zafemy competes directly with Xulane, another generic version of Ortho Evra, which is manufactured by Mylan. As of December 2022, Xulane held a 2.8% share of the combined hormonal contraceptive (CHC) market, while Zafemy had a market share of 0.8%[4].
Pricing and Cost Analysis
Current Pricing
The cost of Zafemy varies depending on the pharmacy and any discounts or coupons used. For cash-paying customers, a supply of 3 films can cost around $49.35, which translates to approximately $16.45 per unit[2].
Wholesale Acquisition Cost (WAC)
The WAC for Zafemy and Xulane is currently priced at $122.15 per cycle, which is comparable to other non-oral forms of CHC like the vaginal ring[4].
Price Projections and Trends
Generic Drug Impact
The introduction of generic drugs typically leads to a significant reduction in prices. For drugs with generic options, the average wholesale price (AWP) per claim can decrease by 6% to 17% annually after the generic launch. Additionally, the generic drug ratio (GDR) often exceeds 90% for drugs with available generic alternatives, indicating a high adoption rate of generics over brand-name drugs[3].
Market Projections
Given the trend of increasing generic adoption, it is likely that Zafemy will see increased market share and potentially lower prices as more patients transition from brand-name products to generics. The 2024 Commercial Drug Trends report suggests that commercial drug prices may increase by 13% to 17% annually from 2023 to 2025, but this increase is expected to be mitigated by the growing use of generics and biosimilars[3].
Regulatory and Legislative Impact
Changes in regulatory environments, such as the removal of the Average Manufacturer Price cap (AMP Cap) under the American Rescue Plan Act, can have downstream effects on commercial drug pricing. However, these changes are more directly related to Medicaid pricing and may have indirect effects on the commercial market[3].
Sales Performance and Revenue
Initial Sales and Growth
Since its approval in 2021, Zafemy has generated significant revenue. In 2022, Zafemy generated estimated gross sales of $88.8 million, indicating a strong market acceptance despite being a relatively new entrant in the market[4].
Market Potential
The market research suggests that there is a strong demand for multiple choices in transdermal contraceptive patches. The rapid uptake and continued sales of Xulane and the initial success of Zafemy indicate a favorable market environment for these products. As more healthcare providers and patients become aware of Zafemy, it is expected to capture a larger share of the CHC market[4].
Challenges and Risks
Effectiveness and BMI Considerations
Zafemy may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more, which could impact its adoption rate among heavier women[1].
Regulatory and Competitive Risks
The pharmaceutical industry is highly competitive, and Zafemy faces risks from both brand and generic competitors. Changes in regulatory environments, such as shifts in FDA approval requirements or healthcare reform, can also impact the product's market position[1].
Key Takeaways
- Market Share: Zafemy has a growing market share, currently at 0.8% as of December 2022, with potential for further growth.
- Pricing: The current cost of Zafemy is around $49.35 for a supply of 3 films, with potential for price reductions as generic adoption increases.
- Regulatory Impact: Changes in regulatory environments, such as the removal of the AMP Cap, may have indirect effects on commercial pricing.
- Sales Performance: Zafemy has generated significant revenue since its launch, with estimated gross sales of $88.8 million in 2022.
- Market Potential: Strong demand for transdermal contraceptive patches suggests a favorable market environment for Zafemy.
FAQs
1. What is Zafemy, and how is it used?
Zafemy is a generic version of the combined hormonal contraceptive patch Ortho Evra. It is used to prevent pregnancy in women with a BMI of less than 30 kg/m².
2. How much does Zafemy cost?
The cost of Zafemy can vary, but for cash-paying customers, a supply of 3 films typically costs around $49.35.
3. Is Zafemy effective for all women?
Zafemy may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more.
4. What are the main competitors of Zafemy in the market?
Zafemy competes directly with Xulane, another generic version of Ortho Evra.
5. How has Zafemy performed in terms of sales since its launch?
Since its approval in 2021, Zafemy has generated estimated gross sales of $88.8 million in 2022, indicating strong market acceptance.
Sources
- Amneal Receives Approval for Generic Version of Ortho Evra - Amneal Pharmaceuticals.
- Zafemy Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com.
- Commercial drug trends: 2024 release - Milliman.
- Form 10-K for Agile Therapeutics INC filed 03/23/2023 - AnnualReports.co.uk.
- Zafemy Prices - U.S. & International - PharmacyChecker.com.
