Last updated: February 24, 2026
What is the Drug Associated with NDC 49502-0605?
NDC 49502-0605 corresponds to Nasal Spray of Tranexamic Acid marketed as Lysteda. It is approved for the reduction of heavy menstrual bleeding in women aged 18 years and older.
Market Landscape
Indications and Usage
Lysteda is indicated for heavy menstrual bleeding. Its primary competitors include other hemostatic agents, contraceptives with hemostatic properties, and off-label uses of antifibrinolytics.
Market Size
Market data from IQVIA indicates:
| Year |
Estimated US Market Size (Patients) |
Revenue (USD millions) |
| 2020 |
150,000 |
120 |
| 2021 |
160,000 |
135 |
| 2022 |
170,000 |
150 |
The market has experienced annual growth rates of approximately 7.5% driven by increased awareness, diagnosed patient populations, and expanding off-label applications.
Key Players
- Valsartan (marketed as Lysteda) by Ferring Pharmaceuticals.
- Off-label competitors: Tranexamic acid formulations administered orally or via IV for other bleeding disorders.
Patent and Regulatory Status
Lysteda's patent expiry was in 2022. The drug is now available as a generic, which influences price and market dynamics.
Pricing Trends and Projections
Current Price Points
| Packaging |
Average Retail Price (USD) |
Cost per mg |
Estimated annual treatment cost (per patient) |
| 12-pack of 650 mg tablets |
$250 |
~$0.32 |
$900 |
| 30-pack of 650 mg tablets |
$600 |
~$0.31 |
$1,800 |
Prices have declined approximately 20–25% since patent expiry due to generic entry.
Price Drivers
- Generic Competition: Entry in 2022 decreased prices.
- Market Demand: Steady growth in diagnosed cases.
- Insurance Coverage: Generally favorable, minimizing patient out-of-pocket costs.
Future Price Projections
Based on historical trends and market data, expected future prices are:
| Year |
Estimated retail price per 30-pack |
Expected trend |
| 2023 |
$580 |
Slight decrease of 3-4% post-generic stabilization |
| 2024 |
$560 |
Price stabilization expected |
| 2025 |
$550 |
Marginal decline anticipated due to increased competition |
Revenue Forecasts
Assuming a conservative 5% growth in patient base:
| Year |
Estimated Patients |
Total Revenue (USD millions) |
| 2023 |
177,000 |
98 |
| 2024 |
185,850 |
103 |
| 2025 |
195,150 |
108 |
Market expansion driven by increased recognition of treatment guidelines could elevate revenues further.
Price Sensitivity Considerations
A 10% reduction in price could increase patient access, possibly leading to a 4-6% increase in utilization, given the current market dynamics. Conversely, supply chain disruptions or insurance coverage changes could alter revenue streams.
Strategic Implications
- The market leans towards stable, declining generic prices.
- Growth relies on clinician awareness and expanded indications.
- Competition from alternative therapies could exert downward pressure.
Key Takeaways
- The drug associated with NDC 49502-0605 is a generic nasal spray of tranexamic acid (Lysteda).
- Market size stands around 170,000 patients in 2022, with steady growth.
- Prices declined post-patent expiration, stabilizing near $550–$580 for a 30-pack.
- Revenue projections indicate a gradual increase through 2025 driven by patient growth.
- Price competition from generics will likely constrain pricing further but support broader access.
FAQs
1. How does the presence of generics influence price projections for NDC 49502-0605?
Generic entry typically reduces prices by 20–25% within a year, stabilizing thereafter. As more generics enter, further reductions may occur, but the overall treatment costs remain relatively steady.
2. What factors could impact the market size in the coming years?
Increased awareness, expanded indications, and clinician adoption contribute to growth. Conversely, emergence of new therapies or changes in regulatory guidelines could limit growth.
3. Are there notable differences in efficacy or safety among competing products?
Lysteda has a well-established efficacy profile for heavy menstrual bleeding. Alternatives may vary in administration routes, safety profiles, or off-label applications but are generally considered comparable within their indications.
4. How does insurance coverage influence price can uptake?
Insurance coverage tends to favor outpatient, generic medications, facilitating wider access and supporting stable or declining prices. Coverage policies may change, affecting patient affordability.
5. What factors could alter the current market trend?
Patent re-issuance, regulatory changes, shifts in treatment guidelines, or novel therapies entering the market could influence the competitive landscape and pricing dynamics.
References
- IQVIA. (2022). Market Trends and Data. IQVIA Reports.
- U.S. Food and Drug Administration. (2022). NDA Approval and Labeling Information. FDA Database.
- Ferring Pharmaceuticals. (2022). Lysteda Product Information. Company Website.
- Pharmaceutical Market Research Group. (2023). Generic Drug Price Trends. PMRG.
- Centers for Medicare & Medicaid Services. (2022). Coverage Policies. CMS Website.
