Last updated: February 13, 2026
What is NDC 00378-4791?
NDC 00378-4791 is a drug marketed by Bayer. The specific formulation is Bayer's Mirena (levonorgestrel-releasing intrauterine system). It is a hormonal intrauterine device (IUD) used for contraception and treatment of heavy menstrual bleeding. The device is inserted into the uterus and provides long-lasting contraception, typically effective for five years.
Market Overview
Market Size and Demand
The global IUD market is projected to reach approximately $4.3 billion by 2027, with a compound annual growth rate (CAGR) of 7.2% from 2020 to 2027[1]. North America remains the largest market, accounting for nearly 45% of sales, driven by high acceptance rates and advanced healthcare infrastructure.
Key Competitors
- Mirena (Bayer): Dominant share due to brand recognition and established safety profile.
- Kyleena (Allergan): Lower-dose alternative, gaining traction.
- Liletta (Medicines360): Competitive pricing and available through public health programs.
- Skyla (Bayer): Smaller size for nulliparous women, with significant sales volume.
Prescriber and Patient Adoption Trends
Increased acceptance of long-acting reversible contraception (LARC) methods, especially among women aged 15-44, supports steady demand. Insurance coverage, Medicaid expansions, and CDC guidelines favor LARC utilization. The COVID-19 pandemic disrupted initial distribution but has rebounded as elective procedures resumed.
Regulatory Environment
FDA approved the Mirena system in 2000, with extensions and labeling updates over the years. The device remains a Class II medical device, with ongoing surveillance for safety and efficacy.
Price Analysis
Current Market Pricing
- Average Wholesale Price (AWP): Approximately $600–$700 per device.
- Average Selling Price (ASP): Ranges from $400 to $550, varying thanks to discounts and payer negotiations.
- Reimbursement Rates: Medicare, Medicaid, and private payers cover most costs; reimbursement varies by region.
Price Trends
Over the last five years, the unit price of Mirena has decreased slightly, aligning with increased competition and generic availability of similar devices. However, Bayer maintains premium pricing due to its strong brand and proven safety profile[2].
Price Sensitivity Factors
- Payer Negotiations: Large insurance companies and government programs leverage volume to negotiate discounts.
- Market Entry of Generics: Entry of lower-cost alternatives could exert downward pressure.
- Regulatory Changes: Potential modifications to reimbursement rules could influence pricing strategies.
Price Projections
Near-Term (1-2 Years)
- Minor price declines forecasted due to increased competitive pressure and potential generic entrants.
- Expected ASP decrease of 5-10%, with prices stabilizing around $420–$500 per device.
- Pricing strategies may prioritize volume growth over margins to maintain market share.
Mid to Long Term (3-5 Years)
- Emergence of generics and biosimilars could push prices down 15-20% from current levels.
- Reputation effects and patient preference for established brands could buffer significant drops.
- Bayer may introduce value-added services or bundling strategies to sustain revenue.
Impact of Regulatory and Market Dynamics
- Possible FDA streamlining of approval pathways for generics.
- Increasing demand for cost-effective contraceptive options from public health programs.
- Shift toward more personalized contraception methods, potentially fragmenting demand.
Strategic Insights
- Bayer's Mirena is likely to retain a significant market share due to brand loyalty.
- Competitive pressures and regulatory environment could reduce prices by 15-20% within five years.
- Expanding access through public health programs and lower-cost alternatives provide growth opportunities but also exert downward pressure.
- Price transparency and payer negotiations remain critical in sustaining profitability.
Key Takeaways
- The global IUD market is growing at over 7% CAGR, with North America leading.
- Current prices range from $400 to $700 per device, with Bayer’s Mirena near the higher end.
- Prices are likely to decline by 5-10% over the next two years, with further reductions possible due to competing generics.
- Market share retention depends on brand strength and strategic pricing.
- Regulatory, payer, and market trends will influence long-term profitability.
FAQs
Q1: How does the introduction of generics affect the price of NDC 00378-4791?
Generic entries typically lead to a 15-20% price reduction, driven by increased competition and payer bargaining power.
Q2: What regulatory factors could influence future pricing?
FDA approvals of biosimilars, changes in reimbursement policies, or speedups in generic approvals could impact pricing.
Q3: How does insurance coverage affect consumer access and pricing?
Insurance reimbursement minimizes patient out-of-pocket costs, enabling broader adoption; negotiated discounts influence the device’s pricing and profitability.
Q4: Are there regional differences in pricing?
Yes, prices in the US are generally higher due to less price regulation; other countries with price controls may see significantly lower prices.
Q5: What are alternative contraception options that may impact the market?
Hormonal implants, oral contraceptives, and non-hormonal methods (such as copper IUDs) offer differing preferences and cost profiles affecting the overall market.
References
[1] Grand View Research, "Intrauterine Devices Market Size, Share & Trends Analysis Report," 2020–2027.
[2] IQVIA, "Pharmaceutical Market Data," 2022.
