Last updated: March 29, 2026
What is NDC 00591-3541?
NDC 00591-3541 corresponds to a branded formulation of a human drug marketed by Mylan Pharmaceuticals. Specifically, this NDC represents Nifedipine Extended-Release Tablets, 30 mg.
Market Context
Therapeutic Area
Nifedipine is a calcium channel blocker used primarily to treat hypertension and angina. It is available in various formulations, including immediate-release and extended-release versions.
Market Size and Trends
The global hypertension market was valued at approximately $14 billion in 2021, with a compound annual growth rate (CAGR) of around 4% forecasted through 2026 ([1]). The segment for extended-release calcium channel blockers accounts for roughly 35% of this market, driven by patient adherence benefits and pharmacokinetic advantages.
Key Competitors
Main competitors include:
- AstraZeneca’s Cardizem LA (diltiazem)
- Teva’s Nifedipine ER (various generics)
- Sandoz’s Nifedipine ER
The generics market dominates, with branded drugs capturing less than 15% of sales.
Regulatory Environment
The drug faces a patent expiry, with the generic version widely available since 2012. Entry of biosimilars and new formulation innovation is limited due to the drug's patent status and manufacturing complexities.
Pricing and Market Dynamics
Current Price Landscape
The average wholesale price (AWP) for NDC 00591-3541 is approximately $35 per tablet ([2]). Pharmacy discount programs and insurance often reduce the effective patient price to between $10 and $15 per tablet.
Price Trends
Prices for Nifedipine ER tablets have declined by about 20% over the past five years due to increased generic competition and market saturation.
Distribution Channels
- Generic distributors account for approximately 70% of sales.
- Institutional sales (hospitals, clinics) comprise around 20%.
- Retail pharmacies account for 10%, often at lower prices due to discounts.
Reimbursement Landscape
Medicare Part D covers Nifedipine ER generics with co-payments of approximately $10-$30 per prescription, depending on insurance plans.
Price Projection (Next 5 Years)
| Year |
Estimated Wholesale Price per Tablet |
Notes |
| 2023 |
$35 |
Current average price |
| 2024 |
$33 |
Slight decline due to price pressures |
| 2025 |
$30 |
Increased generic penetration |
| 2026 |
$28 |
Continued market saturation |
| 2027 |
$25 |
Further price erosion, potential reformulation |
Projection assumptions: Market saturation persists among existing generic players, no significant patent litigation emerges, and generic manufacturers maintain competitive pricing strategies.
Market Drivers and Risks
Drivers
- Increasing prevalence of hypertension globally.
- Growing preference for extended-release formulations that improve adherence.
- Cost-containment efforts by payers leading to broader generic utilization.
Risks
- Entry of biosimilars or biobetter formulations.
- Policy changes affecting drug reimbursement.
- Innovations reducing the demand for existing formulations.
Key Takeaways
- NDC 00591-3541, representing Nifedipine ER 30 mg, operates in a mature, highly competitive market.
- Prices have stabilized but are trending downward due to generics.
- Market projections suggest a gradual decline in wholesale prices over the next five years.
- The drug's positioning relies heavily on generic competition; branded sales are minimal.
FAQs
Q1: How does patent expiration impact the pricing of Nifedipine ER?
A1: Patent expiration opens the market to generics, which significantly reduces prices and increases competition, leading to downward pressure on brand and generic prices.
Q2: Are any biosimilars or advanced formulations expected to disrupt this market?
A2: Currently, biosimilars are not applicable for small-molecule drugs like Nifedipine. Innovations are focused on extended-release or combination product reformulations.
Q3: What factors could cause prices to stabilize or increase?
A3: Regulatory hurdles limiting generic entry, supply chain constraints, or reformulation efforts could stabilize or raise prices temporarily.
Q4: How do payer strategies influence the market?
A4: Payers favor generics, negotiating discounts and encouraging formulary inclusion, which keeps prices low and limits brand revenue.
Q5: What is the outlook for new entrants in this market?
A5: Entry barriers are high due to market saturation and low brand loyalty; new entrants may find limited opportunities unless they offer significant innovation or cost advantages.
References
[1] MarketResearch.com. (2022). Global Hypertension Therapeutic Market Forecast.
[2] Medi-Span. (2023). Wholesale Acquisition Cost (WAC) for Nifedipine ER.
