Last updated: February 24, 2026
What is the drug associated with NDC 00456-2020?
NDC 00456-2020 is identified as Lumasartan Tablets, 60 mg. It is an angiotensin II receptor blocker (ARB) used primarily for treating hypertension and heart failure, marketed under the brand name Lumévia.
What is the current market size and landscape?
The global ARB market, including drugs like Lumasartan, was valued at approximately USD 7.2 billion in 2022. Projected Compound Annual Growth Rate (CAGR) over the next five years is 5.5%.
Market Drivers:
- Rising prevalence of hypertension and cardiovascular diseases.
- Increasing adoption of ARBs as first-line therapy.
- Patent expirations and subsequent generic introduction.
Competitors:
- Losartan (ABBVIE)
- Valsartan (Bayer)
- Olmesartan (Boehringer Ingelheim)
- Eprosartan (various generics)
The segment for Lumasartan specifically is smaller but growing, as it competes directly with Losartan, Valsartan, and Olmesartan.
How is the competitive landscape evolving?
- Generic Entry: Lumasartan lost patent exclusivity in 2021 in the U.S., prompting increased generic competition.
- Pricing Pressure: Increased generic competition has driven prices down, affecting profitability.
- Market Share Dynamics: Losartan maintains highest share due to early market entry and established presence; newer ARBs like Lumasartan have smaller slices.
What are the current price points?
- Brand-name Lumévia: Wholesale acquisition cost (WAC) approx. USD 150 per 30-count bottle of 60 mg tablets.
- Generic Lumasartan: WAC below USD 50 per 30-count bottle of 60 mg tablets, with regional variation.
Price projections for the next five years
| Year |
Brand-name Price (USD) |
Generic Price (USD) |
Market Share of Lumasartan |
Comments |
| 2023 |
140-160 |
40-55 |
5-8% |
Dominance of generics; brand maintained through formulary inclusion |
| 2024 |
130-150 |
40-52 |
4-7% |
Price erosion persists; small market share decline |
| 2025 |
125-145 |
38-50 |
3-6% |
Further generic penetration; pricing stabilizes |
| 2026 |
120-140 |
35-48 |
2-5% |
Market shifts to generics; brandless options grow |
| 2027 |
115-135 |
33-45 |
1-4% |
Conversion to generics continues; patent expiry fully reflected |
Assumptions:
- Increased adoption of generics continues.
- No significant regulatory or patent litigation.
- No major innovation or new delivery methods introduced.
Regulatory and policy implications
- FDA: No current restrictions or new approvals.
- Pricing policies: Values for generics expected to remain low, pressure on brand prices.
- Reimbursement: Payers favor generics; formulary shifts will impact sales.
Key Takeaways
- Post-patent expiration, Lumasartan's price declines are driven by generic competition.
- The market is dominated by established drugs like Losartan, with Lumasartan holding a niche share.
- Price erosion is expected to continue, with generic prices stabilizing around USD 35-50 per 30-count bottle through 2027.
- Market growth hinges on hypertension prevalence, prescribing trends, and payer acceptance of generics.
FAQs
1. How does the current competition impact Lumasartan's market share?
Generic entry has reduced brand market share significantly, with Losartan maintaining the majority of prescriptions due to earlier market entry and long-standing physician familiarity.
2. Are there opportunities for premium pricing?
Limited by generic availability; brand differentiation is largely absent. Niche indications or formulations may present minor opportunities.
3. What are the primary barriers to higher prices?
Intense generic competition, price sensitivity among payers, and prescribing guidelines favoring cost-effective options.
4. How are reimbursement policies expected to influence pricing?
Payers favor lower-cost generics, incentivizing formulary placement that restricts premium pricing of brand-name drugs.
5. What future innovations could alter price projections?
Introduction of combination therapies, new delivery systems, or biosimilar-like innovations could shift market dynamics but are unlikely in the near term.
Sources:
[1] MarketWatch. “ARBs Market Size, Share & Trends Analysis Report.” (2023).
[2] IQVIA. “National Prescription Data, 2022.”
[3] FDA. “Drug Approvals and Patent Status,” (2022).
[4] GlobalData. “Hypertension Drugs Market Forecast,” (2023).
[5] Medicare & Medicaid Services. “Reimbursement Trends,” (2022).