NYSTATIN Drug Patent Profile

When do Nystatin patents expire, and when can generic versions of Nystatin launch?

Nystatin is a drug marketed by Actavis Mid Atlantic, Aurobindo Pharma, Chartwell Rx, Cosette, Crown Labs Inc, Fougera Pharms, Macleods Pharms Ltd, Padagis Us, Sun Pharma Canada, Torrent, Lyne, Zydus Lifesciences, Paddock Llc, Dr Reddys Labs Sa, Lupin, Nesher Pharms, Pharmobedient, Upsher Smith Labs, Zydus Pharms, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Genus, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Sciegen Pharms, Senores Pharms, Steranco Hlthcare, Taro, Teva, Vistapharm Llc, Heritage, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Fougera, Odyssey Pharms, Alembic, Amneal, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Perrigo New York, Dr Reddys, Epic Pharma Llc, Pai Holdings Pharm, Rising, and Strides Pharma. and is included in ninety-one NDAs.

The generic ingredient in NYSTATIN is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. 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

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

Summary for NYSTATIN

US Patents:	0
Applicants:	52
NDAs:	91
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	38
Patent Applications:	3,439
Drug Prices:	Drug price information 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
Deraya 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
Sun Pharma Canada	NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin; triamcinolone acetonide	CREAM;TOPICAL	062347-001	Mar 30, 1987		DISCN	No	No
Steranco Hlthcare	NYSTATIN	nystatin	SUSPENSION;ORAL	220367-001	Feb 5, 2026	AA	RX	No	No
Genus	NYSTATIN	nystatin	SUSPENSION;ORAL	065148-001	Jun 28, 2005	AA	RX	No	No

Market Dynamics and Financial Trajectory for Nystatin

Last updated: February 19, 2026

What is the Current Market Size and Growth Rate of Nystatin?

Nystatin is an antifungal agent predominantly used to treat fungal infections such as candidiasis. The global antifungal drugs market was valued at approximately $13.5 billion in 2022. Nystatin, as a niche antifungal, accounts for a small but stable segment within this market, estimated at around $100 million in 2022. The compound has maintained a steady growth rate of approximately 2-3% annually driven by its longstanding clinical utility and limited development of resistance.

What Are the Key Drivers and Barriers in the Nystatin Market?

Drivers:

• Clinical Utility: Nystatin's broad activity against Candida species and its safety profile in topical and oral formulations sustain its demand.
• Regulatory Approvals: No major regulatory shifts affecting its approval status; existing formulations have well-established safety profiles.
• Low Resistance Development: Unlike azoles, resistance to Nystatin remains relatively low, ensuring its continued relevance in specific indications.
• Limited Competition: Few alternatives offer equivalent safety in oral or topical forms, protecting its market niche.

Barriers:

• Availability of Alternatives: Azole antifungals like fluconazole and itraconazole often replace Nystatin due to systemic administration capabilities.
• Limited Patent Protection: Nystatin patents expired decades ago, leading to generic manufacturing and price erosion.
• Application Scope: Primarily limited to topical and oral preparations; lacks intravenous formulations, reducing potential market expansion.

How Do Regulatory and Patent Factors Impact Nystatin?

Nystatin was first approved in the 1960s. No recent patents limit its production, leading to widespread generic availability. Regulatory agencies, including the FDA and EMA, recognize established formulations, causing minimal barriers to entry for manufacturers. The lack of patent protections has restricted innovation but keeps manufacturing costs low and facilitates competition.

What Are the Revenue and Cost Trends for Nystatin?

Revenue is primarily determined by the volume of prescriptions for topical and oral formulations. Prices have declined consistently since patent expiry, with average unit costs in the U.S. hovering around $0.10 to $0.50 per tablet or tube. Manufacturing costs are low due to established production processes, with estimated per-unit costs below $0.05. Price erosion and competition have led to revenue declines in some regions, but steady demand in developing countries sustains overall volume.

What Is the Future Outlook for Nystatin?

Forecasts suggest modest growth due to its established role in antifungal therapy. Market expansion mainly hinges on increased approval for new formulations, such as pediatric or combination products, or expanded indications like oropharyngeal candidiasis and diaper dermatitis. The absence of significant patent protection means generic manufacturers will continue to drive competitive prices. The global antifungal market is expected to grow from $13.5 billion in 2022 to approximately $17 billion by 2027, but Nystatin's share will remain stable given its niche status.

Which Regional Markets Are Leading for Nystatin?

• United States: Mature but stable; low-cost generics dominate.
• Europe: Similar dynamics with high prescription volumes.
• Asia-Pacific: High growth potential due to increased healthcare access and infection prevalence; generics are heavily utilized.
• Latin America: Growing markets with expanding access to antifungal treatments.

How Do Competition and Innovation Affect Nystatin’s Trajectory?

Limited innovation restricts growth opportunities. The primary competitive pressure arises from alternative antifungals with systemic action and broader spectrum. However, Nystatin remains relevant where systemic antifungals are contraindicated or undesired, such as in pregnant women or infants.

What Are the Implications for Stakeholders?

Investors should note stabilized or declining revenues in mature markets. Manufacturers focusing on low-cost production and expanding into emerging markets may benefit from volume growth. R&D investments in new formulations or combination therapies are unlikely to significantly alter the financial outlook given patent expirations and market saturation.

Key Takeaways

• Nystatin’s market is stable, with annual growth of about 2-3% driven by its safety profile and niche applications.
• It sits within a larger antifungal market valued at $13.5 billion in 2022, representing a small, dedicated segment.
• Patent expiration has led to price erosion and generic competition, limiting profit margins.
• Future growth relies on expanding indications or formulations rather than new development.
• Regional growth varies, with Asia-Pacific offering the highest potential due to increasing healthcare access.

FAQs

1. Can Nystatin be used systemically?
No. Nystatin is limited to topical and oral formulations; it is not absorbed systemically when used orally.

2. Are there emerging competitors to Nystatin?
Systemic antifungals like fluconazole and echinocandins are competitors for systemic infections but do not replace topical or oral Nystatin for localized infections.

3. Is there ongoing research to develop new Nystatin formulations?
Research mostly focuses on novel formulations to improve delivery or reduce resistance, but no significant pipeline is aimed at patent protection or market expansion.

4. How does resistance impact Nystatin's market?
Resistance development remains low; it does not presently threaten Nystatin's clinical utility.

5. What regions present market entry opportunities for Nystatin?
Emerging markets in Asia-Pacific and Latin America offer opportunities due to increasing infection rates and healthcare infrastructure improvements.

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References

[1] MarketWatch. (2023). Global antifungal drugs market size. Retrieved from https://www.marketwatch.com
[2] IQVIA. (2022). Pharmaceuticals in antifungal segment.
[3] U.S. Food and Drug Administration. (2021). Nystatin approval and regulatory details.
[4] European Medicines Agency. (2022). Summary of medicinal product characteristics for Nystatin.
[5] Research and Markets. (2022). Antifungal drugs market forecast 2022-2027.