Last Updated: September 28, 2026

NYSTATIN TRIAMCINOLONE ACETONIDE Drug Patent Profile


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When do Nystatin Triamcinolone Acetonide patents expire, and what generic alternatives are available?

Nystatin Triamcinolone Acetonide is a drug marketed by Pharmaderm and is included in one NDA.

The generic ingredient in NYSTATIN TRIAMCINOLONE ACETONIDE is nystatin; triamcinolone acetonide. Eighteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nystatin Triamcinolone Acetonide

A generic version of NYSTATIN TRIAMCINOLONE ACETONIDE was approved as nystatin; triamcinolone acetonide by FOUGERA PHARMS INC on October 8th, 1985.

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Summary for NYSTATIN TRIAMCINOLONE ACETONIDE
US Patents:0
Applicants:1
NDAs:1

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
Pharmaderm NYSTATIN TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 062596-001 Oct 8, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: February 15, 2026

What Is the Investment Potential for NYSTATIN TRIAMCINOLONE ACETONIDE?

Nystatin Triamcinolone Acetonide combines an antifungal agent (nystatin) with a corticosteroid (triamcinolone acetonide). Its market prospects hinge on its indications, patent status, competitive landscape, and regulatory environment.

What Are the Key Market Indications and Therapeutic Uses?

The drug is primarily indicated for fungal skin infections involving inflammation. These include:

  • Candidiasis of the skin
  • Dermatitis exhibiting fungal etiology
  • Other superficial mycoses combined with inflammatory skin conditions

The combination's efficacy in reducing inflammation while managing fungal infections offers a niche for dermatology-focused prescriptions.

How Do the Product's Fundamentals Stand?

Patent and Regulatory Status

  • Patent: Likely expired or close to expiration; combination topical formulations often are off-patent, reducing exclusivity incentives.
  • Regulatory Approval: Approved in multiple markets, including the US and EU, with clear labeling for dermatologic indications.

Manufacturing and Supply Chain

  • Manufactured by several generic pharmaceutical companies.
  • Raw material sourcing is stable, but formulation complexity necessitates strict quality control.

Pricing and Market Penetration

  • Price points tend to be moderate relative to branded alternatives.
  • Existing competition from generic formulations limits premium pricing potential.

Clinical Evidence and Efficacy

  • Clinical trials demonstrate efficacy in treating fungal dermatitis with anti-inflammatory effects.
  • Lower recurrence rates compared to monotherapy with either agent alone.

Competitive Landscape

  • Competes with other topical antifungal and corticosteroid combinations.
  • Despite being a niche product, generic competition dominates, constraining revenue growth.

What Are the Risks?

Patent Expiration and Generic Competition

  • With patent expiration, pricing pressures intensify.
  • Margins decline as generics capture large market shares.

Safety and Side Effects

  • Corticosteroid side effects (skin thinning, hypothalamic-pituitary-adrenal axis suppression) restrict long-term use.
  • Prescribing practices limit market expansion.

Regulatory Changes

  • Potential restrictions on corticosteroid use in topical formulations.
  • Emerging regulations for combination drugs in dermatology.

What Are the Opportunities for Investment?

  • Developing enhanced formulations with improved bioavailability or reduced side effects could capture higher-margin segments.
  • Expanding indications to deeper skin infections or other fungal conditions may broaden market reach.
  • Focus on emerging markets where dermatology disease burden is rising.

What Are the Key Competitive Advantages?

  • Established efficacy in specific dermatologic indications.
  • Multi-therapeutic approach combines antifungal and anti-inflammatory effects.
  • Wide approval and market presence lend credibility.

How Do Financials Compare to Similar Products?

Feature NYSTATIN TRIAMCINOLONE ACETONIDE Typical Generic Steroid-Combos Market Share (est.)
Revenue (annual) $10-20 million (est.) <$10 million Low for this niche
Price point Moderate Low Competitive, constrained margins
Patent status Expired or close to expiration Off-patent High generic competition

What Is the Outlook?

Market growth is limited by patent expiry, generic competition, and safety concerns. Opportunities exist in formulation innovation and geographic expansion, particularly in emerging markets.

Key Takeaways

  • The drug has a defined niche in dermatology but faces pressure from generic competition.
  • Patent expiration diminishes exclusivity, challenging revenue growth.
  • Market expansion relies on reformulation, new indications, and geographic growth strategies.
  • Safety profile limits long-term or broad use, constraining market potential.
  • Competitive advantage hinges on established efficacy, with differentiation difficult against generics.

FAQs

Q1: What is the primary driver for growth in this drug?
Market expansion through formulation improvements and entering emerging markets.

Q2: How does patent expiration affect revenue?
It leads to generic competition, reducing prices and margins.

Q3: Are safety concerns a significant barrier?
Yes. Long-term corticosteroid side effects restrict broader indications.

Q4: What regulatory factors influence the market?
Potential restrictions on corticosteroid use in topical formulations; approvals vary across regions.

Q5: What are alternative therapies replacing this drug?
Other topical antifungal and corticosteroid combinations, or single agents with improved safety profiles.


References
[1] Market data and drug status as per FDA and EMA approvals.
[2] Industry analysis reports on dermatology pharmaceuticals.

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