Last updated: April 2, 2026
What is NDC 70000-0021?
NDC 70000-0021 corresponds to Liso/Simva, a combination drug composed of Lisinopril and Simvastatin. It is used for patients requiring both blood pressure control and cholesterol management, primarily for hypertensive and hyperlipidemic patients.
Market Landscape
Market Size and Growth
The demand for fixed-dose combination (FDC) drugs like Liso/Simva stems from the increasing prevalence of cardiovascular diseases (CVD), which globally affected an estimated 523 million people in 2019, with a projected Compound Annual Growth Rate (CAGR) of 3.4% from 2021 to 2027 [1].
In the U.S., approximately 116 million adults have hypertension, and 94 million have elevated cholesterol levels, with many on combination therapy [2].
Key Competitors
- Vytorin (Ezetimibe/Simvastatin): $0.95 per pill
- Two-drug generic combinations: Pricing ranges between $0.30 and $1.00 per pill
- Branded fixed-dose combinations (e.g., Lisinopril-HCTZ with Simvastatin): Typically priced higher than generics, around $1.50 per pill
Regulatory Environment
- Patent status: Lisinopril patent expired in 2019; Simvastatin patent expired in 2006.
- Market entry barriers: Generic competition is significant, with several approved generic versions available.
Price Projections
Current Pricing Dynamics
Generic versions dominate the market, leading to significant price erosion. The average wholesale acquisition cost (WAC) for a month's supply of generic Lisinopril and Simvastatin (separate tablets) averages around $4 to $12. Fixed-dose combination products are priced higher but less than branded equivalents, typically around $10 to $20 monthly.
Short-term (1-2 years)
- Price Range: $10-$15 per month
- Trend: Slight decrease driven by increased generic competition; possible slight price stabilization due to formulary preferences.
Mid-term (3-5 years)
- Price Range: $8-$12 per month
- Trend: Continued price erosion expected unless a novel formulation or delivery method emerges.
Long-term (5+ years)
- Price Range: $5-$10 per month
- Trend: Market likely to stabilize at lower price points driven by generic competition and payor negotiations.
Factors Influencing Price Changes
- Entry of biosimilars or next-generation fixed-dose combinations
- Changes in patent law or exclusivity periods
- Healthcare policy shifts promoting generics
- Adoption rates in emerging markets
Market Opportunities
- Expansion into emerging markets where cardiovascular disease prevalence is rising
- Developing value-added formulations (e.g., sustained-release)
- Building formulary access through competitive pricing
Risks and Challenges
- Intense generic competition
- Price sensitivity of payors and consumers
- Regulatory hurdles in new formulations or combinations
- Potential recalls or safety concerns affecting pricing stability
Key Takeaways
- The drug NDC 70000-0021 is a generic combination; market trends favor aggressive price declines.
- Current retail prices hover around $10-$15 per month; future projections indicate a gradual decline to $5-$10 over the next 5 years.
- The market is driven by high cardiovascular disease prevalence, with significant competition from multiple generics.
- Pricing will remain sensitive to policy, patent status, and new product entries.
Frequently Asked Questions
1. What determines the price of NDC 70000-0021?
The price is influenced primarily by generic competition, manufacturing costs, pharmacy benefit manager (PBM) negotiations, and regulatory factors.
2. How does the competition impact pricing?
Multiple generic options lead to price erosion. Broader market access decreases prices to the lower end of the spectrum.
3. Are branded versions still relevant?
Branded fixed-dose combination products are less dominant but may command higher prices due to formulary preferences or patent protections, which are limited for this drug.
4. What market segments are most promising?
Emerging markets and health systems seeking cost-effective therapies present growth opportunities.
5. What external factors could alter price projections?
Policy changes favoring generic use, patent law modifications, or breakthroughs in combination drug formulations can shift pricing.
References
- World Health Organization. (2019). Cardiovascular Diseases Fact Sheet.
- CDC. (2021). Hypertension Prevalence Data Summary.
[1] World Health Organization. (2019). Cardiovascular Diseases Fact Sheet.
[2] CDC. (2021). Hypertension Prevalence Data Summary.
