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Last Updated: December 22, 2024

NYSTATIN - Generic Drug Details


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What are the generic sources for nystatin and what is the scope of freedom to operate?

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, Leading, MLV, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Teva, Vistapharm, Wockhardt Bio Ag, 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. Forty-one suppliers are listed for this compound.

Drug Prices for NYSTATIN

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Drug Sales Revenue Trends for NYSTATIN

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Recent Clinical Trials for NYSTATIN

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

SponsorPhase
University of Santiago de CompostelaN/A
University of RochesterPhase 1
Deraya UniversityEarly Phase 1

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Pharmacology for NYSTATIN
Drug ClassPolyene Antifungal
Medical Subject Heading (MeSH) Categories for NYSTATIN

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
Bayer Pharms CANDEX nystatin LOTION;TOPICAL 050233-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva MYCO-TRIACET II nystatin; triamcinolone acetonide OINTMENT;TOPICAL 062045-002 Nov 26, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fougera Pharms Inc NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 062599-001 Oct 8, 1985 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Holland Rantos KOROSTATIN nystatin TABLET;VAGINAL 061718-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Heritage NYSTATIN nystatin TABLET;ORAL 062474-001 Dec 22, 1983 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Torrent NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 213142-001 Jul 14, 2020 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva NYSTATIN nystatin TABLET;ORAL 062506-001 Jan 16, 1984 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NYSTATIN Market Analysis and Financial Projection Experimental

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]

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