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Last Updated: December 12, 2025

NYSTATIN; TRIAMCINOLONE ACETONIDE - Generic Drug Details


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

Nystatin; triamcinolone acetonide is the generic ingredient in seven branded drugs marketed by Teva, Delcor Asset Corp, Mylan, Cosette, Savage Labs, Alembic, Alpharma Us Pharms, Amneal, Chartwell Rx, Crown Labs Inc, Fougera Pharms Inc, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Padagis Israel, Perrigo New York, Pharmafair, Sun Pharma Canada, Torrent, Pharmaderm, Dr Reddys, Epic Pharma Llc, Pai Holdings Pharm, Rising, Strides Pharma, and Zydus Lifesciences, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

Eighteen suppliers are listed for this compound.

Summary for NYSTATIN; TRIAMCINOLONE ACETONIDE
US Patents:0
Tradenames:7
Applicants:26
NDAs:42
Finished Product Suppliers / Packagers: 18
DailyMed Link:NYSTATIN; TRIAMCINOLONE ACETONIDE at DailyMed
Pharmacology for NYSTATIN; TRIAMCINOLONE ACETONIDE
Anatomical Therapeutic Chemical (ATC) Classes for NYSTATIN; TRIAMCINOLONE ACETONIDE
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D01AA Antibiotics
D01A ANTIFUNGALS FOR TOPICAL USE
D01 ANTIFUNGALS FOR DERMATOLOGICAL USE
D Dermatologicals
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XB Corticosteroids, moderately potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
G01AA Antibiotics
G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01 GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G Genito-urinary system and sex hormones
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R03BA Glucocorticoids
R03B OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs

US Patents and Regulatory Information for NYSTATIN; TRIAMCINOLONE ACETONIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 214090-001 Mar 31, 2021 AT RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mylan MYCOLOG-II nystatin; triamcinolone acetonide OINTMENT;TOPICAL 060572-001 Jun 28, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Padagis Israel NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide OINTMENT;TOPICAL 207380-001 Dec 20, 2016 AT RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Delcor Asset Corp MYCOLOG-II nystatin; triamcinolone acetonide CREAM;TOPICAL 060576-002 May 1, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Crown Labs Inc NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide OINTMENT;TOPICAL 207731-001 Dec 26, 2017 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chartwell Rx NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 208326-001 Oct 26, 2016 AT RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chartwell Rx NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide OINTMENT;TOPICAL 207316-001 Nov 18, 2019 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Nystatin and Triamcinolone Acetonide

Last updated: July 31, 2025

Introduction

The pharmaceutical landscape consistently evolves driven by innovation, regulatory changes, and market demand. Among diverse therapeutic agents, Nystatin and Triamcinolone Acetonide represent distinct yet vital segments—antifungal agents and corticosteroids, respectively. Analyzing their market dynamics and financial trajectories provides insights into investment potential, commercialization strategies, and future growth prospects in the pharmaceutical industry.


Nystatin: Market Dynamics and Financial Trajectory

Overview

Nystatin, an antifungal agent discovered in 1950, primarily targets Candida infections. Its topical and oral formulations have longstanding clinical utility, especially in managing mucocutaneous candidiasis. Despite being an aged molecule, Nystatin retains relevance in niche markets and specific regional markets where newer antifungal agents are inaccessible or cost-prohibitive.

Market Size and Key Drivers

The global antifungal agents market was valued at approximately USD 13.9 billion in 2021 and is projected to grow at a CAGR of around 4.4% until 2028 [1]. Nystatin's market share within this segment remains modest due to competition from newer systemic antifungals like fluconazole and voriconazole. However, in developing regions, Nystatin’s affordability and safety profile sustain its local market, particularly in pediatric and outpatient settings.

Key drivers influencing Nystatin's market include:

  • Rising Incidence of Fungal Infections: Increasing prevalence of candidiasis, particularly in immunocompromised patients, sustains demand.
  • Cost-effectiveness: Nystatin remains cost-effective compared to newer agents, appealing in low-income regions.
  • Regulatory Approvals: In some markets, Nystatin remains off-patent or available as a generic, encouraging widespread use and accessibility.

Challenges and Market Constraints

  • Limited Spectrum: Nystatin's efficacy is confined mainly to Candida species, restricting broader antifungal coverage.
  • Market Competition: The advent of newer antifungal agents with better pharmacokinetics and broader spectra has limited Nystatin’s dominance.
  • Formulation Limitations: Poor oral absorption restricts systemic application, limiting market opportunities to topical and localized applications.

Financial Trajectory

Given that Nystatin largely functions as a generic drug, its revenue streams are modest and steady rather than high-growth. Generic manufacturers, primarily sourcing via off-patent status, enjoy stable margins but limited upside. The global demand remains stable, with regional variations driven by healthcare infrastructure and affordability metrics.

Investment Outlook

The financial prospects for Nystatin are characterized by incremental growth primarily in emerging markets. High-margin innovation or formulation improvements are unlikely, given the drug's age and market saturation. Strategic investments may focus on formulations for specialized use or combination therapies where Nystatin complements other antifungals.


Triamcinolone Acetonide: Market Dynamics and Financial Trajectory

Overview

Triamcinolone Acetonide, a synthetic corticosteroid, plays a pivotal role in managing inflammatory and allergic conditions. Since its approval in the 1950s, it has been incorporated across diverse formulations—topical, injectable, and intra-articular—expanding its reach within specialty therapeutic areas.

Market Size and Key Drivers

The corticosteroids market was valued at approximately USD 7.3 billion in 2020 and is forecast to reach over USD 9.8 billion by 2028, registering a CAGR of approximately 4.2% [2]. Triamcinolone Acetonide is a dominant player within corticosteroids, particularly noted for intra-articular injections used in osteoarthritis, tendinitis, and other musculoskeletal disorders.

The primary factors fueling growth include:

  • Rising Prevalence of Chronic Inflammatory Conditions: Ageing populations and increased obesity rates augment osteoarthritis and asthma cases.
  • Expanding Therapeutic Indications: Use in dermatology, rheumatology, and ENT inadvertently boosts demand.
  • Advances in Delivery Systems: Innovations such as sustained-release formulations increase patient compliance and expand market opportunities.

Market Challenges and Constraints

  • Regulatory and Safety Concerns: Potential adverse effects, including adrenal suppression and osteoporosis, necessitate cautious prescribing, affecting market dynamics.
  • Generic Competition: Multiple approved generics lead to price competition, pressure margins.
  • Market Saturation: Established formulations have limited disruptive innovation potential, constraining rapid growth.

Financial Trajectory

Triamcinolone Acetonide's patent expiry and widespread availability as a generic drug generate a mature but stable revenue stream. The drug exhibits robust demand in both developed and emerging markets, with significant growth potential in biosimilar formulations and novel delivery systems.

In specific sectors such as intra-articular injections, rising adoption driven by aging demographics and obesity trends motivate steady market expansion. Additionally, new formulations, such as long-acting injectables, can enhance market penetration and generate premium pricing.

Emerging Market Potentials

The expansion into developing regions presents new revenue streams, driven by increasing healthcare access and rising chronic disease prevalence. Furthermore, strategic focus on biosimilars and patent cliffs in developed markets can fortify financial trajectories, especially as brand-name corticosteroids face biosimilar competition.


Comparative Analysis and Strategic Implications

While Nystatin's market remains niche and regional, Triamcinolone Acetonide demonstrates broader applications with steady growth prospects. Investments and R&D efforts thus favor agents like Triamcinolone Acetonide, where innovation, new formulations, and expanding indications can unlock substantial revenue potential.

For Nystatin, focusing on niche marketing, formulations, or combination therapies could provide incremental value, but significant growth is improbable without innovation or regulatory shifts. Conversely, Triamcinolone Acetonide's diversified portfolio and ongoing clinical developments offer more dynamic financial trajectories.


Regulatory Landscape and Market Access

Regulatory agencies like the FDA and EMA continuously reevaluate safety profiles for corticosteroids, influencing market access and prescribing practices. Generic proliferation for both drugs fosters price competition but also stabilizes supply and affordability in essential healthcare sectors.

Accelerated approval pathways for biosimilars, especially in corticosteroid form, are set to reshape the competitive environment, promising increased accessibility and potential price drops.


Conclusion and Future Outlook

Nystatin

  • Remains relevant primarily in niche markets with stable but limited financial growth.
  • Future viability hinges on formulation innovations, regional market expansion, or combination therapies.
  • Price competition and generics restrict upside potential but ensure steady revenues in strategic markets.

Triamcinolone Acetonide

  • Exhibits consistent growth driven by expanded indications and delivery innovations.
  • Opportunities exist in biosimilar development, long-acting formulations, and emerging markets.
  • Patent expirations and biosimilar entries will intensify price competition but can catalyze volume growth.

Overall Market Outlook

Both drugs' trajectories reflect broader industry trends: generics dominate with stable revenue streams, while innovation in formulations, delivery systems, and indications constitutes the primary growth drivers. Strategic focus on emerging markets, biosimilars, and combination therapies will be decisive in optimizing financial performance.


Key Takeaways

  • Nystatin offers limited growth prospects confined to niche and regional markets; innovation and strategic marketing are essential to sustain relevance.
  • Triamcinolone Acetonide remains a cornerstone corticosteroid with robust growth fueled by new formulations and expanding therapeutic indications.
  • The increasing prevalence of chronic and infectious diseases sustains demand for both agents, but competitiveness and regulatory considerations influence pricing and market share.
  • Biosimilar and formulation innovations are critical pathways for future revenue expansion, particularly for Triamcinolone Acetonide.
  • Market access in emerging economies remains a critical opportunity; price sensitivity and healthcare infrastructure development will shape future growth.

FAQs

1. What factors influence the demand for Nystatin in global markets?
Demand is primarily driven by regional incidence of candidiasis, healthcare infrastructure, affordability, and competition from newer antifungal agents. Its continued use in low-income regions sustains demand despite limited innovation.

2. How is the patent landscape impacting Triamcinolone Acetonide's market?
Patent expirations and the introduction of biosimilars intensify price competition but also expand access and volume sales, especially in cost-sensitive markets. Innovation in delivery systems further opens new market segments.

3. Are there recent innovations in formulations for Nystatin?
Research focuses on novel delivery methods like liposomal formulations and combination therapies; however, commercial adoption remains limited, and the core formulations remain unchanged.

4. What regulatory challenges could impact the future growth of Triamcinolone Acetonide?
Regulatory agencies prioritize safety monitoring, especially regarding long-term corticosteroid use. Approval of biosimilars further complicates market dynamics, requiring rigorous comparative studies.

5. Which markets offer the highest growth potential for these drugs?
Emerging economies with growing healthcare infrastructure and higher disease prevalence present the most promising opportunities. Investment in local manufacturing and distribution can optimize market entry.


Sources

  1. MarketsandMarkets. Antifungal Drugs Market Size & Share Analysis. 2022.
  2. Grand View Research. Corticosteroids Market Size & Trends. 2021.

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