Suppliers and packagers for NILSTAT

NILSTAT

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Molecules	NILSTAT	nystatin	SUSPENSION;ORAL	050299	NDA AUTHORIZED GENERIC	Chartwell RX, LLC	62135-813-46	60 mL in 1 BOTTLE (62135-813-46)	1971-04-14
Chartwell Molecules	NILSTAT	nystatin	SUSPENSION;ORAL	050299	NDA AUTHORIZED GENERIC	Chartwell RX, LLC	62135-813-47	473 mL in 1 BOTTLE (62135-813-47)	1971-04-14
Chartwell Molecules	NILSTAT	nystatin	SUSPENSION;ORAL	050299	NDA AUTHORIZED GENERIC	Chartwell Governmental & Specialty RX, LLC	68999-813-24	2 TRAY in 1 BOX (68999-813-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-813-05)	1971-04-14

Nilstat Supplier Landscape and Patent Analysis

Last updated: February 19, 2026

This report details the current supplier landscape for nilstat (nystatin), a polyene antifungal medication, and analyzes key patents affecting its market. The analysis focuses on active pharmaceutical ingredient (API) manufacturers, formulation suppliers, and the patent protection status of nilstat.

What is Nilstat (Nystatin)?

Nilstat, the brand name for nystatin, is an antifungal antibiotic used to treat superficial fungal infections, primarily those caused by Candida species. It functions by binding to ergosterol, a vital component of fungal cell membranes, leading to pore formation and leakage of intracellular components, thereby killing the fungus [1]. Nystatin is available in various formulations, including oral suspensions, vaginal tablets, and topical creams and ointments.

Key API Manufacturers for Nystatin

The production of nystatin API is a specialized process, primarily concentrated in a few regions globally. Manufacturers focus on fermentation and subsequent purification to yield the active pharmaceutical ingredient.

• China is a significant hub for nystatin API production. Companies like Zhejiang Medicine Co., Ltd. and Shandong Xinhua Pharmaceutical Co., Ltd. are established suppliers with substantial manufacturing capacity. These companies leverage their scale and cost efficiencies to supply the global market.
• India also plays a role in nystatin API supply. Manufacturers such as Lasa Supergenerics Limited have historically been involved in producing antifungal APIs, including nystatin. The Indian pharmaceutical sector's robust API manufacturing base contributes to global availability.
• European manufacturers have historically contributed to the supply chain, though the landscape has shifted. While specific company names may fluctuate, some European entities maintain production capabilities, often focusing on higher-purity grades or specialized applications.

The global supply chain for nystatin API is characterized by a limited number of large-scale producers. Disruptions in this supply chain, whether due to regulatory changes, geopolitical events, or production issues, can impact the availability and pricing of finished pharmaceutical products.

Formulation and Finished Product Suppliers

Once the nystatin API is produced, it is formulated into various dosage forms by pharmaceutical companies worldwide. These companies then market the finished products under different brand names, including Nilstat, or as generic equivalents.

• Major pharmaceutical companies that market nystatin-containing products include Upsher-Smith Laboratories, LLC, which is a known marketer of the Nilstat brand.
• Generic manufacturers are critical to market accessibility and affordability. Companies such as Teva Pharmaceuticals, Sandoz, and Dr. Reddy's Laboratories often produce generic versions of nystatin oral suspensions, creams, and ointments.
• Specialty pharmaceutical companies may focus on specific formulations, such as extended-release versions or combination therapies.

The choice of API supplier by a formulation manufacturer is influenced by factors including API quality, regulatory compliance (e.g., GMP certification), supply chain reliability, and cost.

Patent Landscape of Nystatin

Nystatin is an old drug, first discovered in 1950. As such, the primary patents covering its initial discovery and synthesis have long expired. However, patent protection can extend to novel formulations, new uses, or improved manufacturing processes.

Original Patents and Expiration

The original patents for nystatin itself have been in the public domain for decades. This lack of fundamental patent protection has facilitated the development of a robust generic market for the drug. For instance, the foundational patents by E. R. Squibb & Sons expired in the late 1960s and early 1970s.

Post-Discovery Patent Activity

While the core molecule is off-patent, companies can still secure patents related to:

• Formulation Improvements: Patents may cover specific ratios of excipients, novel delivery systems, or enhanced stability for nystatin formulations. For example, a patent might claim a unique cream base that improves skin penetration or a suspension with improved palatability and shelf-life.
• Manufacturing Processes: Patents can protect novel or improved methods for producing nystatin API or for manufacturing specific dosage forms. This could involve more efficient purification techniques, chiral separation methods (if applicable to nystatin, though it's not a chiral drug in the traditional sense), or new crystallization processes that yield specific particle sizes.
• New Medical Uses: While nystatin's primary uses are well-established, patents could theoretically be granted for novel therapeutic applications if significant and unexpected therapeutic benefits are demonstrated. However, for a drug with its established profile, this is less common.
• Combination Therapies: Patents might be filed for formulations combining nystatin with other active pharmaceutical ingredients to treat complex or polymicrobial infections.

Example of Potential Patent Filings:

Consider a hypothetical patent application filed by a pharmaceutical company in 2010 claiming a novel, stable oral suspension of nystatin with an extended shelf-life of five years at room temperature, achieved through a proprietary combination of preservatives and stabilizers. This patent, if granted, would expire 20 years after filing, in 2030. During this period, other companies would be barred from marketing the same specific formulation without a license.

The patentability of post-discovery innovations depends on demonstrating novelty, non-obviousness, and utility. Regulatory exclusivity periods, such as Hatch-Waxman exclusivity in the United States, can also provide market protection for newly approved formulations or indications, even in the absence of patents.

Regulatory Status and Quality Standards

API manufacturers and finished product suppliers must adhere to stringent regulatory requirements.

• Good Manufacturing Practices (GMP): All facilities involved in API synthesis and drug product manufacturing must comply with GMP guidelines set by regulatory bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. Audits and inspections ensure compliance.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents detail the manufacturing process, quality controls, and facilities. Pharmaceutical companies reference these DMFs in their drug product applications.
• Pharmacopeial Standards: Nystatin API and finished products must meet the specifications outlined in major pharmacopeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). These standards define purity, potency, and other quality attributes.

The quality and consistency of nystatin API from different suppliers are critical for the efficacy and safety of the final drug product. Regulatory actions, such as import alerts or warning letters, against non-compliant manufacturers can significantly disrupt supply chains.

Market Dynamics and Competition

The nystatin market is characterized by a mature generic landscape. Competition among API suppliers is primarily driven by price and reliability. Formulation suppliers compete on product availability, distribution networks, and, in some cases, brand loyalty for branded products.

• Price Pressure: The long off-patent status of nystatin means that pricing for both API and finished products is highly competitive.
• Supply Chain Resilience: Companies are increasingly focused on ensuring supply chain resilience, often by qualifying multiple API suppliers to mitigate risks.
• Emerging Markets: Growth in emerging markets presents opportunities for both API manufacturers and finished product suppliers, driven by increasing access to healthcare.

Key Takeaways

• Nystatin API production is concentrated among a limited number of manufacturers, primarily in China and India.
• The original patents for nystatin have long expired, fostering a competitive generic market.
• Post-discovery patent activity may exist for novel formulations, manufacturing processes, or combination therapies, potentially offering limited-term market exclusivity.
• Regulatory compliance (GMP) and adherence to pharmacopeial standards are critical for all suppliers in the nystatin value chain.
• Market competition is driven by price, supply chain reliability, and regulatory adherence.

Frequently Asked Questions

1. What is the primary mechanism of action for nystatin? Nystatin targets ergosterol in fungal cell membranes, creating pores that disrupt membrane integrity and lead to cell death.

2. Are there any active patents that could block generic nystatin production? Patents on the original nystatin molecule have expired. However, patents may exist for specific formulations, manufacturing processes, or novel uses that could impact certain generic products or market segments.

3. Which countries are the largest producers of nystatin API? China and India are the dominant countries for nystatin API production.

4. What regulatory standards must nystatin suppliers meet? Suppliers must adhere to Good Manufacturing Practices (GMP) and meet specifications outlined in pharmacopeias such as the USP and Ph. Eur.

5. How does patent expiration affect the nystatin market? Patent expiration leads to the entry of generic competitors, increasing market competition and generally lowering prices for the drug.

Citations

[1] Mandell, G. L., Bennett, J. E., & Dolin, R. (2020). Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases (9th ed.). Elsevier.