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Last Updated: April 28, 2025

MYCOSTATIN Drug Patent Profile


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When do Mycostatin patents expire, and what generic alternatives are available?

Mycostatin is a drug marketed by Delcor Asset Corp and is included in seven NDAs.

The generic ingredient in MYCOSTATIN is nystatin. There are eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the nystatin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mycostatin

A generic version of MYCOSTATIN was approved as nystatin by FOUGERA PHARMS on September 23rd, 1982.

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Summary for MYCOSTATIN
Drug patent expirations by year for MYCOSTATIN
Recent Clinical Trials for MYCOSTATIN

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SponsorPhase
University of RochesterPhase 1
M.D. Anderson Cancer CenterPhase 2
National Cancer Institute (NCI)Phase 2

See all MYCOSTATIN clinical trials

US Patents and Regulatory Information for MYCOSTATIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Delcor Asset Corp MYCOSTATIN nystatin PASTILLE;ORAL 050619-001 Apr 9, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Delcor Asset Corp MYCOSTATIN nystatin OINTMENT;TOPICAL 060571-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Delcor Asset Corp MYCOSTATIN nystatin TABLET;ORAL 060574-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Delcor Asset Corp MYCOSTATIN nystatin CREAM;TOPICAL 060575-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Delcor Asset Corp MYCOSTATIN nystatin TABLET;VAGINAL 060577-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Delcor Asset Corp MYCOSTATIN nystatin POWDER;TOPICAL 060578-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Market Dynamics and Financial Trajectory for Mycostatin (Nystatin)

Introduction to Mycostatin (Nystatin)

Mycostatin, commonly known by its active ingredient nystatin, is an antifungal drug developed by Rachel Brown and Elizabeth Hazen in 1950. It is used to treat various fungal infections, particularly those affecting the skin and oral cavity. Here, we delve into the market dynamics and financial trajectory of nystatin.

Global Antifungal Drugs Market Context

The global antifungal drugs market, within which nystatin operates, was estimated at USD 15.8 billion in 2023 and is projected to grow at a CAGR of 3.8% from 2024 to 2030[1].

Market Size and Growth Rate

While the exact current market size of the global nystatin market is not specified, it is part of the larger antifungal market valued at $16.5 billion in 2023. The nystatin market is expected to grow at a notable CAGR from 2024 to 2031, although the exact rate is not provided[3][4].

Segmentation and Application

The nystatin market is segmented based on type (USP Grade, Research Grade, and other categories), application (primarily skin and oral cavity), and end-use (adult and children). This segmentation helps in understanding the diverse needs and opportunities within the market[3][4].

Regional Analysis

North America currently dominates the nystatin market due to its well-established healthcare system and high awareness of fungal infections. However, the Asia-Pacific region is expected to grow at the fastest rate, driven by improving healthcare access and a higher prevalence of diabetes, which increases the risk of fungal diseases[3][4].

Drivers and Opportunities

Several factors drive the growth of the nystatin market:

  • Increasing Fungal Infections: The rise in fungal infections, particularly among immunocompromised patients, is a significant driver.
  • Advancements in Diagnostics and Healthcare Infrastructure: Improvements in diagnostic techniques and healthcare infrastructure enhance the detection and treatment of fungal infections.
  • Growing Issue of Antibiotic Resistance: The increasing resistance to antibiotics has shifted focus towards antifungal treatments, boosting demand for nystatin[3][4].

Competitive Landscape

The nystatin market is competitive, with several key players such as Pure Chemistry Scientific, LGM Pharma, BOC Sciences, Toronto Research Chemicals, and J & K SCIENTIFIC. These companies engage in strategies like new product launches, expansions, mergers & acquisitions, and partnerships to maintain their market position[3][4].

Regulatory Hurdles

The antifungal drugs market, including nystatin, is subject to stringent regulatory requirements. For instance, FDA approvals and compliance standards are crucial for ensuring product safety and efficacy. This regulatory scrutiny can pose challenges for manufacturers but also fosters consumer trust[1].

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: Projected to reach $22 billion by 2030, growing at a CAGR of 4.2% from 2023 to 2030[3].
  • Nystatin Market: Expected to grow at a notable CAGR from 2024 to 2031, though the exact rate is not specified. The market's growth is influenced by the overall antifungal market trends[3][4].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the nystatin market. Initial disruptions in supply chains and manufacturing were offset by the increased focus on healthcare and the rise in fungal infections among immunocompromised patients, ultimately driving demand for antifungal treatments[3].

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[3].

Historical Significance and Funding

The discovery of nystatin by Rachel Brown and Elizabeth Hazen was supported by the Research Corporation for Science Advancement (RCSA), which helped them patent and license their discovery as Mycostatin. The profits from this drug were used to create the Brown-Hazen Research Fund, supporting independent research projects in mycology from 1956 to 1978[2].

Key Takeaways

  • Growing Demand: Driven by increasing fungal infections and advancements in healthcare.
  • Regional Growth: North America leads, but the Asia-Pacific region is expected to grow the fastest.
  • Competitive Market: Several key players and other antifungal drug classes compete for market share.
  • 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, but it is part of a larger antifungal market valued at $16.5 billion in 2023[3].

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[3].

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[3][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[3][4].

5. Who are the key players in the nystatin market? Key players include Pure Chemistry Scientific, LGM Pharma, BOC Sciences, Toronto Research Chemicals, and J & K SCIENTIFIC[3][4].

Sources:

  1. Grand View Research: Antifungal Drugs Market Size, Share & Growth Report, 2030
  2. Research Corporation for Science Advancement: 100 Years Funding Research and Supporting Early Career Scientists
  3. Drug Patent Watch: Generic NYSTATIN INN equivalents, pharmaceutical patent ...
  4. Cognitive Market Research: Global Nystatin Market Report 2024 Edition, Market Size, Share ...

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