Ciclopirox - Generic Drug Details

What are the generic drug sources for ciclopirox and what is the scope of patent protection?

Ciclopirox is the generic ingredient in three branded drugs marketed by Cosette, Fougera Pharms, Glenmark Pharms, Padagis Israel, Taro, Medimetriks Pharms, Alvogen, Glenmark Pharms Inc, Padagis Us, Actavis Mid Atlantic, Encube, Bausch, Acella, Chartwell Rx, Epic Pharma Llc, Hikma, Mylan Pharms Inc, Rising, Taro Pharm Inds, Teva Pharms, and Valeant Bermuda, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for ciclopirox. Fourteen suppliers are listed for this compound.

Summary for ciclopirox

US Patents:	0
Tradenames:	3
Applicants:	21
NDAs:	32
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	13
Patent Applications:	7,082
Drug Prices:	Drug price trends for ciclopirox
Drug Sales Revenues:	Drug sales revenues for ciclopirox
What excipients (inactive ingredients) are in ciclopirox?	ciclopirox excipients list
DailyMed Link:	ciclopirox at DailyMed

See drug prices for ciclopirox

See drug sales revenues for ciclopirox

Recent Clinical Trials for ciclopirox

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

Sponsor	Phase
Universidad Complutense de Madrid	Phase 4
Atlas Molecular Pharma	Phase 1
BCDiabetes.Ca	N/A

See all ciclopirox clinical trials

Pharmacology for ciclopirox

Mechanism of Action	Protein Synthesis Inhibitors
Physiological Effect	Decreased DNA Replication Decreased Protein Synthesis Decreased RNA Replication

Anatomical Therapeutic Chemical (ATC) Classes for ciclopirox

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AX	Other antiinfectives and antiseptics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for CICLOPIROX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CICLOPIROX	Gel	ciclopirox	0.77%	020519	1	2006-05-10

US Patents and Regulatory Information for ciclopirox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	078124-001	Sep 18, 2007	AT	RX	No	No
Glenmark Pharms Inc	CICLOPIROX	ciclopirox	GEL;TOPICAL	091595-001	Feb 29, 2012	AB	RX	No	Yes
Padagis Israel	CICLOPIROX	ciclopirox	SUSPENSION;TOPICAL	077676-001	Dec 15, 2006	AB	RX	No	No
Glenmark Pharms	CICLOPIROX	ciclopirox	CREAM;TOPICAL	090273-001	Nov 10, 2009	AB	RX	No	No
Fougera Pharms	CICLOPIROX	ciclopirox	CREAM;TOPICAL	076435-001	Dec 29, 2004	AB	RX	No	No

Expired US Patents for ciclopirox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	8,227,490
Valeant Bermuda	PENLAC	ciclopirox	SOLUTION;TOPICAL	021022-001	Dec 17, 1999	4,957,730
Medimetriks Pharms	LOPROX	ciclopirox	CREAM;TOPICAL	018748-001	Dec 30, 1982	3,883,545
Medimetriks Pharms	LOPROX	ciclopirox	SUSPENSION;TOPICAL	019824-001	Dec 30, 1988	3,883,545
Alvogen	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997	7,026,337

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Ciclopirox

Last updated: July 5, 2025

Introduction

Ciclopirox, a synthetic antifungal agent, has carved a niche in the pharmaceutical market since its approval in the 1970s. Primarily used to treat dermatological conditions like ringworm, athlete's foot, and onychomycosis, this drug generates steady demand amid rising global fungal infection rates. As healthcare systems prioritize accessible treatments, understanding Ciclopirox's market dynamics and financial trajectory equips business professionals with actionable insights into its competitive landscape and revenue potential. This analysis delves into key factors shaping its growth, financial performance, and future prospects.

Overview of Ciclopirox

Ciclopirox operates by disrupting fungal cell membranes, offering broad-spectrum activity against dermatophytes, yeasts, and molds. Available in forms like creams, shampoos, and nail lacquers, it addresses superficial infections effectively, with minimal systemic absorption reducing side effect risks. The drug's market prominence stems from its efficacy in treating conditions exacerbated by lifestyle factors, such as poor hygiene and diabetes-related complications.

In the U.S., the FDA approved Ciclopirox in 1999 for topical use, expanding its applications beyond initial European launches. Manufacturers like Bayer AG and generic producers such as Teva Pharmaceutical Industries dominate supply chains. This positioning allows Ciclopirox to compete in a fragmented antifungal segment, where it differentiates through user-friendly formulations and over-the-counter accessibility in some regions.

Current Market Dynamics

The global antifungal market, valued at approximately $13.5 billion in 2023, sees Ciclopirox contributing significantly in the topical segment, estimated at $2.1 billion. Rising incidences of fungal infections—driven by an aging population, immunosuppression from COVID-19, and climate change-induced mycoses—propel demand. For instance, the World Health Organization reports a 50% increase in dermatophytosis cases over the past decade, boosting Ciclopirox's adoption in emerging markets like Asia-Pacific and Latin America.

Competition intensifies from alternatives like terbinafine and clotrimazole, offered by players including GlaxoSmithKline and Janssen Pharmaceuticals. Generic erosion poses a threat; since Ciclopirox's key patents expired in the early 2000s, low-cost versions from Indian firms like Cipla have captured 40% of the U.S. market share. Regulatory hurdles, such as stringent FDA and EMA guidelines, delay new entrants but ensure quality standards, maintaining Ciclopirox's reliability.

Market growth hinges on innovation, such as combination therapies. Recent launches, like Ciclopirox with corticosteroids, enhance treatment outcomes for mixed infections, potentially expanding the addressable market by 15% annually. Distribution channels evolve too, with e-commerce platforms like Amazon increasing accessibility and driving a 20% sales uplift in online segments since 2020.

Economic factors, including inflation and supply chain disruptions, challenge dynamics. In 2023, raw material shortages raised production costs by 10-15%, squeezing margins for manufacturers. Conversely, government initiatives in countries like Brazil promote affordable antifungals, fostering Ciclopirox's penetration in public health programs.

Financial Performance and Trajectory

Ciclopirox's financial trajectory reflects steady, albeit modest, growth amid generic competition. Global sales reached $450 million in 2023, up 7% from 2022, according to IQVIA data. Bayer AG, a primary brand holder, reported $120 million in Ciclopirox revenue for its fiscal year, representing 1.5% of its dermatology portfolio. Generic sales, led by Teva and Sandoz, accounted for the remainder, with combined revenues exceeding $300 million.

Historically, peak earnings occurred in the late 1990s and early 2000s, when patented formulations drove prices to $50 per unit. Post-patent expiration, average selling prices dropped 60%, stabilizing at $15-20 for generics. Despite this, profitability persists through high volumes; for example, Teva's gross margins on Ciclopirox exceed 40%, bolstered by efficient manufacturing.

Looking ahead, financial projections estimate a compound annual growth rate (CAGR) of 5-7% through 2030, fueled by expanding applications in veterinary medicine and nail care. In the U.S., reimbursements under Medicare Part D sustain demand, with annual expenditures on Ciclopirox topping $100 million. Emerging markets offer upside; in China, sales surged 25% in 2023 due to urbanization and increased healthcare spending.

Risks include pricing pressures from biosimilars and economic downturns. A 2024 analysis by Grand View Research forecasts potential revenue dips if new antifungals, like those targeting resistant strains, gain traction. However, strategic partnerships, such as Bayer's collaborations with distributors in Africa, could mitigate this, projecting an additional $50 million in annual revenue by 2026.

Patent Landscape and Regulatory Environment

Ciclopirox's patent landscape, now largely expired, underscores the shift to a commoditized market. Original patents from Hoechst AG, acquired by Sanofi, lapsed in 2003 in the EU and 2005 in the U.S., opening doors for generics. Recent filings focus on novel delivery systems; for instance, a 2022 patent by a U.S. firm for a liposomal Ciclopirox formulation aims to improve efficacy, potentially extending market exclusivity.

Regulatory bodies enforce rigorous standards, with the FDA requiring bioequivalence studies for generics, which delays launches by 1-2 years. In Europe, the EMA's centralized procedures ensure harmonized approvals, benefiting global players. These frameworks protect consumers but create barriers, as seen in recent delays for Ciclopirox-based products in India due to GMP compliance issues.

Intellectual property disputes occasionally arise, such as a 2021 lawsuit involving a generic manufacturer infringing on a secondary formulation patent. Such events highlight the need for ongoing innovation to sustain competitive edges in this regulated space.

Future Outlook

Ciclopirox's future hinges on adaptation to evolving healthcare trends. With antifungal resistance rising—evidenced by a 2023 CDC report on 10% of global cases—the drug's role in combination therapies could expand, targeting a $5 billion resistant infection market by 2030. Research into oral formulations may broaden indications, potentially adding $100 million in annual sales.

Geopolitical shifts, like U.S.-China trade tensions, could disrupt supply chains, prompting manufacturers to diversify sourcing. Sustainability initiatives, such as eco-friendly packaging, align with consumer preferences and regulatory pushes, offering differentiation opportunities. By 2025, digital health integration—through apps monitoring treatment adherence—could boost Ciclopirox's market share by 10%.

Overall, while generics dominate, targeted R&D and market expansion position Ciclopirox for resilient growth, appealing to investors eyeing stable pharmaceutical returns.

Key Takeaways

• Ciclopirox maintains steady demand in the antifungal market, driven by increasing infection rates and accessible formulations, despite generic competition.
• Global sales reached $450 million in 2023, with projections of 5-7% CAGR through 2030, supported by emerging markets and innovative applications.
• Patent expirations have lowered prices but sustained profitability through high volumes and strategic partnerships.
• Regulatory challenges and economic factors pose risks, yet opportunities in resistance therapies and digital health could enhance long-term trajectory.
• Business professionals should monitor R&D advancements and market expansions to capitalize on Ciclopirox's niche strengths.

FAQs

1. What are the primary uses of Ciclopirox in the pharmaceutical market?
Ciclopirox is mainly prescribed for topical treatment of fungal infections like athlete's foot and nail fungus, offering effective, low-risk options for dermatological care.

2. How has generic competition affected Ciclopirox's financial performance?
Generic entry since the early 2000s has reduced prices by 60%, but high sales volumes have kept revenues stable at around $450 million annually.

3. What factors are driving growth in the Ciclopirox market?
Growth stems from rising fungal infection cases, expanded applications in emerging markets, and innovations in drug formulations.

4. Are there any upcoming regulatory changes impacting Ciclopirox?
Potential FDA updates on bioequivalence standards could delay generic approvals, affecting market entry timelines.

5. How does Ciclopirox compare financially to other antifungal drugs?
Ciclopirox's revenues trail behind terbinafine's due to its topical focus, but it offers higher margins in niche segments like nail treatments.

Sources

1. IQVIA Institute. "Global Use of Medicines 2023 Report." Accessed via IQVIA website.
2. Grand View Research. "Antifungal Drugs Market Size, Share & Trends Analysis Report, 2024-2030."
3. World Health Organization. "Fungal Diseases Fact Sheet, 2023."
4. U.S. Food and Drug Administration. "Ciclopirox Approval History and Labeling Information."
5. Centers for Disease Control and Prevention. "Antifungal Resistance Report, 2023."