Nystatin - Generic Drug Details

What are the generic sources for nystatin and what is the scope of patent protection?

Nystatin is the generic ingredient in seventeen branded drugs marketed by Bayer Pharms, Delcor Asset Corp, Alpharma Us Pharms, Lederle, Actavis Mid Atlantic, Cosette, Crown Labs Inc, Fougera Pharms, Macleods Pharms Ltd, Padagis Us, Strides Pharma, Taro, Torrent, Lyne, Zydus Lifesciences, Barlan, Paddock Llc, Adrastea Pharma, Dr Reddys Labs Sa, Epic Pharma Llc, Lupin, Nesher Pharms, Upsher Smith Labs, Zydus Pharms, Warner Chilcott, Chartwell Molecules, Fougera Pharms Inc, G And W Labs Inc, Genus, Medley Pharms, MLV, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Teva, Vistapharm Llc, Xttrium Labs Inc, Savage Labs, Chartwell Rx, Heritage, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Holland Rantos, Fougera, Odyssey Pharms, Mylan, Alembic, Amneal, Dr Reddys, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Perrigo New York, Pai Holdings Pharm, and Rising, and is included in one hundred and twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for nystatin. Thirty-eight suppliers are listed for this compound.

Summary for nystatin

US Patents:	0
Tradenames:	17
Applicants:	59
NDAs:	121
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	38
Patent Applications:	7,250
Drug Prices:	Drug price trends for nystatin
Drug Sales Revenues:	Drug sales revenues for nystatin
What excipients (inactive ingredients) are in nystatin?	nystatin excipients list
DailyMed Link:	nystatin at DailyMed

See drug prices for nystatin

See drug sales revenues for nystatin

Recent Clinical Trials for nystatin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Santiago de Compostela	N/A
University of Rochester	Phase 1
Minia University	Early Phase 1

See all nystatin clinical trials

Pharmacology for nystatin

Drug Class

Polyene Antifungal

Medical Subject Heading (MeSH) Categories for nystatin

Anti-Bacterial Agents

Antifungal Agents

Ionophores

Anatomical Therapeutic Chemical (ATC) Classes for nystatin

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D01AA	Antibiotics
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for nystatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Warner Chilcott	NYSERT	nystatin	SUPPOSITORY;VAGINAL	050478-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fougera Pharms	NYSTATIN	nystatin	CREAM;TOPICAL	062129-001	Approved Prior to Jan 1, 1982	AT	RX	No	No
Taro	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin; triamcinolone acetonide	CREAM;TOPICAL	062347-001	Mar 30, 1987		DISCN	No	No
G And W Labs Inc	NYSTATIN	nystatin	SUSPENSION;ORAL	062349-001	Jul 14, 1982		DISCN	No	No
Quantum Pharmics	NYSTATIN	nystatin	TABLET;ORAL	062525-001	Oct 29, 1984		DISCN	No	No
Zydus Pharms	NYSTATIN	nystatin	POWDER;TOPICAL	208581-001	Jun 8, 2017	AT	RX	No	No
Torrent	NYSTATIN	nystatin	OINTMENT;TOPICAL	211838-001	Jan 28, 2019	AT	RX	No	No

Nystatin Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Nystatin

Market Overview

Nystatin, an antifungal antibiotic, is a crucial component in the treatment of various fungal infections. Here’s a detailed look at the market dynamics and financial trajectory of nystatin.

Global Market Size and Growth

The global nystatin market has been experiencing steady growth. As of 2023, the global nystatin market size was valued at a significant figure, although the exact amount is not specified in the available sources. The market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2031, indicating a positive outlook for the industry[1].

Segmentation and Application

The nystatin market is segmented based on type, application, and end-use. The types include USP Grade, Research Grade, and other categories. Applications are primarily in the skin and oral cavity, with other uses also being significant. The end-use segments are divided into adult and children[1].

Regional Analysis

The market is geographically segmented into North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region has its own growth trajectory and market share. For instance, North America is a dominant region due to its well-established healthcare system and high awareness of fungal infections. The Asia-Pacific region, however, is expected to grow at the fastest rate due to improving healthcare access and a higher prevalence of diabetes, which increases the risk of fungal diseases[1][4].

Drivers and Opportunities

Several factors drive the growth of the nystatin market:

• Increasing Fungal Infections: The rise in chronic conditions such as diabetes, cancer, and HIV/AIDS, which weaken the immune system, has led to an increase in fungal infections. This escalation in infections drives the demand for antifungal treatments like nystatin[4].
• Advancements in Diagnostics and Healthcare Infrastructure: Improved diagnostics and healthcare infrastructure support early detection and treatment of fungal infections, further boosting the market[4].
• Antibiotic Resistance: The growing issue of antibiotic resistance has shifted focus towards antifungal treatments, contributing to the market's growth[4].

Restraints and Challenges

Despite the positive growth trajectory, there are several challenges:

• Competition from Other Antifungal Drugs: The market for antifungal drugs is competitive, with other classes like Azoles, Polyenes, and Echinocandins also vying for market share. The Azoles segment, for example, is expected to reach $10.7 billion by 2030, growing at a CAGR of 4.5%[2].
• Regulatory Hurdles: Strict regulatory requirements and the need for continuous innovation can pose challenges for manufacturers[2].

Financial Performance and Projections

The financial performance of the nystatin market is closely tied to the broader antifungal drugs market. Here are some key financial projections:

• Global Antifungal Drugs Market: The global antifungal drugs market was estimated at $16.5 billion in 2023 and is projected to reach $22 billion by 2030, growing at a CAGR of 4.2% from 2023 to 2030[2].
• Nystatin Market CAGR: While the exact CAGR for nystatin is not specified, it is part of the larger antifungal market that is experiencing significant growth. The nystatin market is expected to grow at a notable CAGR from 2024 to 2031[1].

Competitive Landscape

The competitive landscape of the nystatin market includes several key players:

• Pure Chemistry Scientific, LGM Pharma, BOC Sciences, Toronto Research Chemicals, J & K SCIENTIFIC, and others are prominent in the market. These companies are involved in various strategies such as new product launches, expansions, mergers & acquisitions, and partnerships to maintain their market position[1].

Technological and Production Aspects

Nystatin is produced through the cultivation of the organism Streptomyces noursei in a sterile liquid nutrient medium. The antibiotic is recovered from the mycelium and is known for its stability and effectiveness against a wide variety of fungi[5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the nystatin market. While there were initial disruptions in supply chains and manufacturing, the increased focus on healthcare and the rise in fungal infections among immunocompromised patients have ultimately driven demand for antifungal treatments[1].

Key Takeaways

• Growing Demand: The nystatin market is driven by increasing fungal infections and advancements in healthcare.
• Regional Growth: North America leads the market, but the Asia-Pacific region is expected to grow the fastest.
• Competitive Market: The market is competitive with several key players and other antifungal drug classes.
• Financial Projections: The broader antifungal market is projected to grow significantly, indicating a positive financial trajectory for nystatin.

FAQs

1. What is the current market size of the global nystatin market?

The exact current market size of the global nystatin market is not specified in the available sources, but it is part of a larger antifungal market valued at $16.5 billion in 2023[2].

2. What is the projected growth rate of the nystatin market?

The nystatin market is expected to grow at a notable CAGR from 2024 to 2031, though the exact rate is not provided[1].

3. Which regions are leading the nystatin market?

North America currently leads the market, but the Asia-Pacific region is expected to grow at the fastest rate due to improving healthcare access and a higher prevalence of diabetes[1][4].

4. What are the main drivers of the nystatin market?

The main drivers include increasing fungal infections, advancements in diagnostics and healthcare infrastructure, and the growing issue of antibiotic resistance[4].

5. Who are the key players in the nystatin market?

Key players include Pure Chemistry Scientific, LGM Pharma, BOC Sciences, Toronto Research Chemicals, J & K SCIENTIFIC, and others[1].

Cited Sources:

1. Cognitive Market Research - Global Nystatin Market Report 2024 Edition[1]
2. GlobeNewswire - Antifungal Drugs Strategic Business Report 2024-2030[2]
3. Market Research Intellect - Compound Nystatin Market[3]
4. GlobeNewswire - Anti-Fungal Treatment Market Sees Steady Growth Driven by Rising Infections and Advancements in Therapies[4]
5. Google Patents - Nystatin and method of producing it[5]