Last updated: August 5, 2025
Introduction
The drug with National Drug Code (NDC): 00024-5851 pertains to Lysteda (Tranexamic Acid) Tablets, a prescription medication used to treat heavy menstrual bleeding (menorrhagia). As a marketed pharmaceutical product, understanding its market landscape, pricing, and future trajectory requires a comprehensive analysis of current supply, demand, competitive environment, regulatory landscape, and pricing trends.
This report provides an in-depth market analysis for Lysteda, including current pricing, sales volumes, competitive positioning, regulatory influences, and forward-looking price projections over the next phase.
Product Overview and Market Position
Lysteda (tranexamic acid) tablets, developed by Bayer Pharmaceuticals, gained FDA approval in 2009 for the indication of menorrhagia. Its unique positioning as an oral antifibrinolytic offers non-invasive management for heavy menstrual bleeding, making it a vital option for a specific patient demographic.
Market share: As the leading branded tranexamic acid formulation in the US, Lysteda holds significant market share among antifibrinolytics prescribed for gynecological conditions.
Innovations and formulations: The product’s formulation modernized the administration route, improving patient compliance compared to older intravenous formulations.
Current Market Dynamics
Demand Drivers
- Prevalence of Menorrhagia: An estimated 10-20% of women of reproductive age experience heavy menstrual bleeding, representing a sizable patient population [1].
- Treatment Guidelines: Clinical guidelines recommend tranexamic acid as first-line or adjunct therapy for menorrhagia, particularly for women who prefer medical management over surgical intervention [2].
- Patient Preference and Compliance: Oral administration enhances adherence, especially with ongoing treatment needs.
Competitive Landscape
- Generic Alternatives: While Lysteda maintains a branded presence, generic tranexamic acid products are increasingly available, exerting downward pressure on price points.
- Indirect Competition: Non-pharmacological options, such as intrauterine devices (IUDs) or surgical procedures, influence overall demand for pharmacotherapy.
Pricing Analysis
Current Price Points
As of Q1 2023, the average wholesale acquisition cost (WAC) for a 60-count bottle of Lysteda (650 mg tablets) hovers around $650–$700. Patient out-of-pocket costs vary based on insurance coverage but generally range from $40 to $100 with typical commercial insurance plans [3].
Insurance and Reimbursement
- Coverage Dynamics: Many commercial insurers and Medicare Part D plans cover Lysteda, but formulary restrictions and prior authorization requirements can influence access and pricing.
- Copay Assistance Programs: Bayer offers assistance programs that can reduce patient costs, affecting overall pricing dynamics in the market.
Regulatory and Market Influences
- Patent and Exclusivity: Lysteda benefits from primary formulation patent protection through the early 2010s; however, generic equivalents entered the market around 2018–2019, increasing price competition.
- Regulatory Trends: Ongoing emphasis on price transparency and formulary management could influence future drug pricing strategies.
Price Projection Analysis (2023–2028)
Factors influencing projections:
- Increasing adoption driven by updated clinical guidelines and rising prevalence.
- Entry of generics, likely to sustain downward pressure.
- Potential biosimilar or modified formulations entering the market.
- Market consolidation among payers leading to formulary shifts.
- Inflationary pressures and manufacturing costs.
Forecasted Price Trends:
| Year |
Expected Average Wholesale Price (AWP) per 60 tablets |
Key Drivers |
| 2023 |
$650–$700 |
Market stability, patent expiry impacts ongoing generic competition |
| 2024 |
$620–$680 |
Increased generic penetration, cost containment efforts |
| 2025 |
$600–$660 |
Further generic adoption, potential biosimilar development |
| 2026 |
$580–$640 |
Competitive pricing, new formulations unlikely yet |
| 2027 |
$560–$620 |
Market saturation, pressure from biosimilars and tech advances |
| 2028 |
$540–$600 |
Mature market, steady decline expected |
Summary: The overall trajectory indicates a gradual decline in average selling prices driven by increased generic competition, with potential stabilization as market saturation occurs.
Key Market Opportunities
- Expanding Indications: Exploration of tranexamic acid’s efficacy in other bleeding conditions could open new markets.
- Formulation Innovation: Developing sustained-release or combination therapies may bolster pricing power.
- Emerging Markets: Growth in emerging economies can offer new revenue streams at different price points, expanding the market footprint.
Risks and Challenges
- Patent Expiry and Generics: Market entry of generics decreases pricing power for the branded drug.
- Regulatory Changes: Price transparency laws and drug importation policies could influence pricing strategies.
- Market Penetration: Competition from alternative therapies and surgical interventions may limit growth.
Conclusion
The market for NDC 00024-5851 (Lysteda) is characterized by steady demand within a niche of women’s healthcare, albeit under pressure from generic entries and evolving treatment paradigms. Price projections suggest a gradual decline over the next five years, driven primarily by increasing generic competition and market maturation.
Long-term growth strategies should focus on expanding indications, innovating delivery mechanisms, and leveraging emerging markets to counteract downward pricing pressures.
Key Takeaways
- Current Price: Approximately $650–$700 wholesale per 60 tablets, with variability based on negotiations and insurance coverage.
- Market Dynamics: Strong demand driven by clinical guidelines, but challenged by patent expirations and generics.
- Price Trend: Anticipate a gradual decrease to ~$540–$600 by 2028, aligning with increased market competition.
- Strategic Opportunities: Diversify indications, invest in formulation innovation, and explore emerging markets to sustain revenue.
- Risks: Patent expirations, regulatory reforms, and competitive therapies remain significant factors to monitor.
FAQs
1. What factors influence the pricing of tranexamic acid (Lysteda)?
Pricing is influenced by patent protections, generic entry, insurance coverage, manufacturing costs, market competition, and regulatory policies.
2. How does generic competition impact Lysteda’s market share?
Generic availability typically reduces the market share and exerts downward pressure on prices, compelling Bayer to adapt strategies to sustain profitability.
3. Are there upcoming innovations that could alter the market landscape?
Potential developments include new formulations, combination therapies, or expanded indications, which could enhance product value and maintain market relevance.
4. How does insurance coverage affect patient access to Lysteda?
Insurance plans, especially with formulary restrictions, influence patient out-of-pocket costs and access, ultimately impacting demand and revenue.
5. What strategic moves should manufacturers consider in this market?
Investing in formulation improvements, diversifying indications, engaging in price negotiations, and expanding into emerging markets are key strategies to mitigate competitive pressures.
References
[1] National Institute of Child Health and Human Development. Menorrhagia Overview. 2022.
[2] American College of Obstetricians and Gynecologists. Management of Menorrhagia. 2021.
[3] SSR Health Data. Average Wholesale Prices. 2023.
