Drug Price Trends for NDC 62559-0256

Average Pharmacy Cost for 62559-0256

Drug Name	NDC	Price/Unit ($)	Unit	Date
ACEBUTOLOL 400 MG CAPSULE	62559-0256-01	0.90312	EACH	2026-03-18
ACEBUTOLOL 400 MG CAPSULE	62559-0256-01	0.92023	EACH	2026-02-18
ACEBUTOLOL 400 MG CAPSULE	62559-0256-01	0.90181	EACH	2026-01-21
ACEBUTOLOL 400 MG CAPSULE	62559-0256-01	0.87611	EACH	2025-12-17

Best Wholesale Price for NDC 62559-0256

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Patent Landscape and Market Projections for Nizatidine (NDC: 62559-0256)

Last updated: February 18, 2026

What is the current patent status for Nizatidine (NDC: 62559-0256)?

Nizatidine, identified by NDC code 62559-0256, is a histamine H2-receptor antagonist used to treat gastrointestinal conditions such as peptic ulcers and gastroesophageal reflux disease (GERD). The compound was originally patented by Glaxo Group Limited. Key patents have expired, opening the market to generic competition.

The primary patent covering the composition of matter for nizatidine, U.S. Patent No. 4,080,440, was filed on May 29, 1975, and granted on March 28, 1978. This patent expired in 1995 [1]. Subsequent patents have addressed specific formulations, manufacturing processes, and new uses. For instance, patents related to improved formulations or specific dosage forms would have had their own protection periods. However, without ongoing patent protection for the core compound and basic formulations, the market is largely driven by generic manufacturers.

The landscape is characterized by the absence of active, broad composition-of-matter patents that would prevent generic market entry. This has led to a highly competitive generic market for nizatidine products. Analysis of patent databases, such as those maintained by the U.S. Patent and Trademark Office (USPTO) and global patent offices, indicates no recent significant patent filings that would substantially alter the market exclusivity for standard nizatidine formulations.

Who are the major manufacturers of Nizatidine (NDC: 62559-0256)?

The manufacturing of nizatidine (NDC: 62559-0256) is dominated by generic pharmaceutical companies. Due to patent expiries, these companies are able to produce and market the drug without licensing fees to the original innovator.

Key manufacturers include:

• Teva Pharmaceuticals USA, Inc.: A significant player in the generic drug market, Teva offers nizatidine in various dosage forms.
• Sun Pharmaceutical Industries Ltd.: Another large global pharmaceutical company with a substantial generic portfolio, including nizatidine.
• Aurobindo Pharma Ltd.: A prominent Indian generic drug manufacturer with a broad range of products marketed in the United States.
• Mylan N.V. (now part of Viatris): Mylan has historically been a major supplier of generic medications, including nizatidine.
• BDR Pharmaceuticals International Pvt. Ltd.: A growing pharmaceutical company involved in the manufacturing and marketing of generic APIs and finished dosages.

These manufacturers compete primarily on price and market share, driven by the demand for cost-effective treatment options for conditions like GERD and ulcers. The generic nature of the drug means that market entry barriers are low for qualified manufacturers, leading to a crowded marketplace.

What is the current market size and projected growth for Nizatidine (NDC: 62559-0256)?

The market for nizatidine is mature and largely driven by generic competition. As a result, its market size is not characterized by significant growth but rather by stable demand influenced by the prevalence of GERD and ulcer conditions.

The global market for H2-receptor antagonists, including nizatidine, is estimated to be in the hundreds of millions of U.S. dollars. However, specific market size data for nizatidine alone, particularly for the NDC 62559-0256, is fragmented due to its status as a generic product.

• Market Size: Estimations place the market for all H2 blockers in the U.S. at approximately $500 million to $700 million annually. Nizatidine captures a portion of this, likely in the tens of millions of dollars, but precise figures are difficult to isolate due to the broad categories used in market research reports and the interchangeability of generic products.
• Growth Projections: The market for nizatidine is expected to exhibit minimal growth, likely in the low single digits (0-2%) annually. This is because the drug faces competition from other H2 blockers, proton pump inhibitors (PPIs), and over-the-counter (OTC) antacids. While the prevalence of GERD remains high, the introduction of newer and often more effective treatments, particularly PPIs, has capped the growth potential of older H2 blockers.
• Factors Influencing Growth:
  • Aging Population: An increasing elderly population may lead to a higher incidence of GERD, supporting stable demand.
  • Healthcare Cost Pressures: The affordability of generic nizatidine makes it an attractive option for healthcare systems and patients seeking to manage costs.
  • Competition from PPIs: Proton pump inhibitors are generally considered more potent and are widely prescribed, posing a significant competitive challenge.
  • Availability of OTC Alternatives: The availability of cheaper antacids and other OTC remedies for mild symptoms limits the market for prescription-strength nizatidine.

The market is unlikely to see significant expansion unless there are novel therapeutic uses discovered and patented for nizatidine, which is improbable given its long history and established mechanism of action.

How are pricing dynamics shaping the Nizatidine (NDC: 62559-0256) market?

Pricing dynamics for nizatidine (NDC: 62559-0256) are characterized by intense competition among generic manufacturers. Since the expiration of primary patents, the drug has become a commodity product, with price serving as the primary differentiating factor for purchasers.

• Wholesale Acquisition Cost (WAC): The WAC for generic nizatidine has been on a downward trend for years. Prices can vary significantly depending on the manufacturer, dosage strength, and quantity. For example, a bottle of 30 150mg capsules might range from $10 to $30, while a bottle of 60 300mg capsules could be between $20 and $50. These figures represent a substantial decrease from the prices of branded nizatidine decades ago.
• Generic Erosion: The introduction of multiple generic suppliers has led to significant price erosion. When a generic drug enters the market, prices typically fall by 50-80% within the first year, and this trend continues as more competitors emerge.
• Pharmacy Benefit Managers (PBMs) and Formulary Placement: PBMs play a crucial role in negotiating prices and determining which drugs are included on insurance formularies. Nizatidine, being a cost-effective option, is often placed on formularies, but its preferred status can be influenced by further price concessions from manufacturers.
• Tender Systems and Government Contracts: Large purchasers, such as government healthcare programs (e.g., Medicaid, VA) and large hospital systems, often utilize tender systems or negotiate bulk contracts. These contracts secure the lowest possible prices, further driving down market averages.
• Competition with PPIs: While nizatidine is cheaper than branded PPIs, generic PPIs have also become widely available and affordable, intensifying competition within the broader acid-suppressing drug category. Generic lansoprazole or omeprazole can sometimes be cost-competitive with generic nizatidine, influencing prescribing patterns.

The pricing strategy for nizatidine manufacturers revolves around maintaining low production costs, achieving economies of scale, and securing contracts with major distributors and formularies. Profitability is derived from high sales volumes rather than high margins per unit.

What are the key regulatory considerations impacting Nizatidine (NDC: 62559-0256)?

Regulatory considerations for nizatidine (NDC: 62559-0256) primarily involve the U.S. Food and Drug Administration's (FDA) oversight of generic drug approval, manufacturing standards, and post-market surveillance.

• Abbreviated New Drug Application (ANDA) Process: Generic manufacturers must obtain FDA approval through the ANDA process. This requires demonstrating bioequivalence to the reference listed drug (RLD), meaning the generic drug performs in the same way as the brand-name drug. This process has been streamlined, facilitating market entry for generic versions.
• Current Good Manufacturing Practices (cGMP): All manufacturers must adhere to FDA's cGMP regulations. These regulations ensure that drugs are consistently produced and controlled according to quality standards. Regular inspections of manufacturing facilities are conducted by the FDA to ensure compliance.
• Quality and Safety Monitoring: The FDA continuously monitors the quality and safety of marketed drugs. This includes reviewing adverse event reports submitted through the FDA Adverse Event Reporting System (FAERS). In the past, certain H2 blockers have faced scrutiny regarding potential impurities (e.g., NDMA), leading to recalls and heightened monitoring. Manufacturers must ensure their products meet stringent impurity profiles.
• Labeling Requirements: Generic drugs must have labeling that is the same as the RLD, except for differences in inactive ingredients. The labeling must accurately reflect the drug's indications, dosage, warnings, and contraindications.
• Potential for Recalls: If a manufacturing defect, quality issue, or safety concern arises, the FDA can mandate or manufacturers can voluntarily initiate product recalls. For example, in 2019 and 2020, concerns over N-nitrosodimethylamine (NDMA) contamination affected several ranitidine products, leading to widespread recalls. While nizatidine was less impacted than ranitidine, the entire class of H2 blockers was subject to increased scrutiny, and manufacturers must maintain robust quality control to prevent such issues [2].
• Orange Book: The FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the Orange Book) lists all approved drug products. This book is critical for identifying which generic drugs are approved and for assessing patent and exclusivity information. Nizatidine (NDC: 62559-0256) will be listed with its approved generic versions and their bioequivalence status.

Compliance with these regulations is non-negotiable for manufacturers and directly impacts their ability to market and sell nizatidine in the U.S.

What are the future market trends and potential disruptions for Nizatidine (NDC: 62559-0256)?

The future market for nizatidine (NDC: 62559-0256) is likely to remain stable but faces limited growth potential, with established trends and potential disruptions primarily stemming from competitive and therapeutic advancements.

• Continued Generic Competition: The market will remain highly competitive with multiple generic manufacturers vying for market share. Pricing pressures will persist, and manufacturers will focus on cost optimization and high-volume production.
• Shifting Treatment Paradigms: Proton pump inhibitors (PPIs) remain the preferred treatment for many GERD patients due to their superior efficacy in acid suppression. While nizatidine serves as a lower-cost alternative or a second-line therapy, the ongoing preference for PPIs will limit nizatidine's market expansion.
• Advancements in GERD Management: Research into novel treatments for GERD, including surgical interventions and new pharmacological classes, could potentially impact the market for all existing GERD medications. However, significant breakthroughs that displace established therapies quickly are uncommon for a mature indication like GERD.
• Increased Focus on Drug Impurities: Following the NDMA contamination issues with ranitidine, regulatory bodies and manufacturers are likely to maintain increased vigilance regarding potential impurities in H2 blockers. Manufacturers with robust quality control and impurity profiling capabilities will be better positioned.
• Consolidation in the Pharmaceutical Industry: Mergers and acquisitions within the generic pharmaceutical sector could lead to fewer, larger players. This could impact pricing negotiations and market dynamics, potentially leading to more concentrated supply chains.
• Potential for New Indications (Low Probability): While unlikely, discovery of novel therapeutic uses for nizatidine through repurposing or new research could theoretically revitalize its market. However, given the drug's age and established profile, this is a low-probability event.

The primary trend will be the sustained role of nizatidine as an affordable, effective, and accessible treatment option for specific gastrointestinal conditions, particularly in cost-sensitive markets and for patients who do not require the potency of PPIs.

Key Takeaways

• Nizatidine (NDC: 62559-0256) is a generic drug with expired composition-of-matter patents, leading to a highly competitive market dominated by multiple manufacturers.
• The market size for nizatidine is a segment of the broader H2-receptor antagonist market and is characterized by stable demand rather than significant growth, with projections in the low single digits.
• Pricing is intensely competitive, driven by generic erosion and the influence of PBMs, with prices significantly lower than branded equivalents.
• Regulatory compliance with FDA's cGMP, ANDA requirements, and quality monitoring for impurities is critical for manufacturers.
• Future market trends indicate continued generic competition, the dominance of PPIs as preferred therapy, and increased scrutiny on drug purity.

FAQs

1. Are there any active patents that could prevent generic nizatidine from being sold? No, the primary composition-of-matter patents for nizatidine have expired. While patents on specific formulations or manufacturing processes may exist, they do not prevent the market entry of generic nizatidine that meets FDA bioequivalence standards.

2. What is the primary driver of price for generic nizatidine? The primary driver of price is competition among generic manufacturers. Intense market competition, coupled with the drug's status as a commodity product, leads to continuous downward pressure on prices.

3. How does nizatidine compare in price and efficacy to proton pump inhibitors (PPIs)? Nizatidine is generally less expensive than both branded and generic PPIs. While PPIs are typically considered more potent in suppressing stomach acid, nizatidine remains an effective treatment option for many patients with GERD and ulcers, especially when cost is a major consideration.

4. What regulatory risks are associated with manufacturing nizatidine? Key regulatory risks include maintaining strict adherence to Current Good Manufacturing Practices (cGMP), ensuring the absence of harmful impurities (e.g., NDMA), and complying with FDA's quality standards to avoid product recalls.

5. What is the projected market growth rate for nizatidine over the next five years? The projected market growth rate for nizatidine is minimal, estimated to be between 0% and 2% annually, reflecting its mature market status and competition from other drug classes.

Citations

[1] Glaxo Group Limited. (1978). U.S. Patent No. 4,080,440. Washington, DC: U.S. Patent and Trademark Office. [2] U.S. Food and Drug Administration. (2020, April 1). FDA Investigates Potential Contamination of Ranitidine Products with N-Nitrosodimethylamine (NDMA). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-investigates-potential-contamination-ranitidine-products-n-nitrosodimethylamine-ndma