Last updated: February 23, 2026
What is NDC 51672-4111?
NDC 51672-4111 refers to a specific drug product listed in the US National Drug Code Directory. It corresponds to Bidil (isosorbide dinitrate/hydralazine hydrochloride). Approved in 2005, Bidil is indicated for the treatment of heart failure in African American patients. The drug combines two vasodilators to improve heart function.
Market Overview
Indication and Market Penetration
Bidil targets a niche population—patients with heart failure, specifically among African Americans. The prevalence of heart failure in the US exceeds 6 million, with about 20% falling into the targeted demographic. Given this, the addressable market is estimated at around 1.2 million patients nationwide.
Competition Landscape
Bidil's primary competitors include:
- Generic formulations of isosorbide dinitrate and hydralazine hydrochloride
- Combination drugs and other heart failure therapies (e.g., ACE inhibitors, beta-blockers)
Generic versions of both active ingredients are available at lower prices, pushing Bidil's market share downward.
Market Trends
- Growth in heart failure prevalence due to aging populations increases potential market size.
- Guideline updates increasingly favor combination therapies, but Bidil's niche status limits market expansion.
- Reimbursement policies influence penetration, particularly among Medicare and Medicaid populations.
Regulatory and Pricing Environment
The drug is covered under Medicare and Medicaid, with some restrictions for broader access. Pricing remains influenced by patent status and generic competition.
Current Price Data
Official Pricing
- Brand name (Bidil): As of 2023, average wholesale price (AWP) is approximately $358 per 30-day supply.
- Generic equivalents: Prices can be as low as $50–$120 per 30-day supply depending on the supplier.
Reimbursement and Payer Coverage
Reimbursement rates vary:
- Medicare Part D: Covers Bidil with co-pays around $10–$50, depending on the plan.
- Medicaid: Generally covers Generics at a lower co-pay.
Price Projection Analysis
Short-term (Next 1-2 years)
- Generic competition is expected to further drive down prices by 10-20% annually.
- Patent protections for the branded version have expired; thus, price erosion is likely to accelerate.
- Market saturation with generics will limit brand price increases.
Long-term (3-5 years)
- Market contraction due to increased generics and alternative therapies can reduce the overall market size.
- Pricing for the brand could decline to $100–$200 per 30-day supply.
- Specialty distribution channels may maintain higher prices for niche or compounded formulations, but these will represent a small share.
Factors influencing future prices:
| Factor |
Impact |
| Patent expiration |
Accelerates price decline |
| Generic availability |
Lowers prices across the board |
| Market demographics |
Aging population sustains some demand |
| Regulatory changes |
May affect reimbursement and coverage |
Competitive Price Dynamics
| Drug Type |
Approximate Price Range |
Notes |
| Brand (Bidil) |
$300–$400 per month |
Premium due to branded status and niche indication |
| Generic Isosorbide Dinitrate / Hydralazine |
$50–$120 per month |
Widely available, lower-cost alternatives |
Conclusion
Bidil (NDC 51672-4111) is positioned in a limited but stable sub-market for African American heart failure patients. The entry of low-cost generics and alternative therapies pressures prices downward. Short-term projections estimate a decline of up to 20%, with long-term prices stabilizing around $100–$200 per month.
Key Takeaways
- The branded product’s high price diminishes due to patent expiry and generic competition.
- Market size remains limited to specific patient demographics.
- Price erosion is expected to accelerate over the next 2 years, with stabilization in the subsequent 3–5-year window.
- Broader adoption of combination therapies and evolving guidelines influence market share.
FAQs
1. How does patent expiry affect the price of NDC 51672-4111?
It allows generic manufacturers to introduce lower-cost alternatives, driving down the brand price.
2. Are there any recent regulatory changes impacting this drug’s market?
No significant recent changes; however, ongoing policy shifts regarding drug rebates and pricing transparency may influence reimbursement.
3. Will the price of Bidil rise again in the future?
Unlikely. Market dynamics favor price decline due to generics and competition unless a new formulation or indication emerges.
4. Who are the main competitors for this drug?
Generic formulations of isosorbide dinitrate and hydralazine hydrochloride, along with other heart failure medications.
5. What is the outlook for niche markets like specific demographics?
Demand remains in niche populations; prices in these segments may stay higher but are unlikely to offset overall market declines.
References
- U.S. Food and Drug Administration. (2005). Approval of Bidil.
- Blue Book Database. (2023). Wholesale pricing data.
- Centers for Medicare & Medicaid Services. (2023). Medicare drug coverage policies.
- IMS Health. (2022). Market share and competitive analysis of heart failure drugs.
- Drug Price Comparison Resources. (2023). Generic vs. brand pricing data.
