CICLOPIROX - Generic Drug Details

What are the generic 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. Sixteen 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:	16
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	13
Patent Applications:	6,749
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
Taro	CICLOPIROX	ciclopirox	SHAMPOO;TOPICAL	090269-001	Feb 23, 2011	AT	RX	No	No
Padagis Us	CICLOPIROX	ciclopirox	SHAMPOO;TOPICAL	078594-001	Feb 16, 2010	AT	RX	No	No
Padagis Israel	CICLOPIROX	ciclopirox	CREAM;TOPICAL	077364-001	Mar 3, 2006	AB	RX	No	No
Epic Pharma Llc	CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	078975-001	Feb 17, 2010		DISCN	No	No
Fougera Pharms	CICLOPIROX	ciclopirox	SHAMPOO;TOPICAL	090146-001	May 25, 2010	AT	RX	No	No
Taro Pharm Inds	CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	078144-001	Sep 18, 2007	AT	RX	No	No
Chartwell Rx	CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	078046-001	Sep 18, 2007	AT	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
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
Valeant Bermuda	PENLAC	ciclopirox	SOLUTION;TOPICAL	021022-001	Dec 17, 1999	4,957,730
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	7,981,909
Alvogen	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997	7,026,337
Alvogen	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997	7,018,656

CICLOPIROX Market Analysis and Financial Projection Experimental

Ciclopirox Market Dynamics and Financial Trajectory

Market Overview

The ciclopirox market is poised for significant growth, driven by several key factors. Here is a comprehensive look at the market dynamics and financial trajectory of this antifungal medication.

Market Size and Growth Projections

• The global ciclopirox market was valued at US$ 11.8 Million in 2023 and is projected to reach US$ 19.5 Million by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period[1].

Drivers of Market Growth

Increasing Awareness of Personal Hygiene

• The rising awareness among people about personal hygiene is a major driver of the ciclopirox market. As people become more conscious of their health and hygiene, the demand for antifungal treatments like ciclopirox increases[1].

Growing Population and Lifestyle Changes

• The global population is expected to reach 8.5 billion by 2030, leading to an increased demand for healthcare products, including antifungal medications. Lifestyle changes, such as increased exposure to fungal infections due to outdoor activities, also contribute to market growth[1].

Aging Population

• The aging population, particularly in countries like China, is another significant factor. Older individuals are more prone to fungal infections, which drives the demand for ciclopirox. In China, for instance, about 18% of the population was 60 years or older in 2020, and this percentage is expected to increase[1].

Rise in Disposable Income and E-commerce

• The growth in disposable income and the development of e-commerce platforms, especially in regions like China, make it easier for people to purchase ciclopirox online, further boosting market growth[1].

Regional Market Analysis

China

• China is one of the fastest-growing markets for ciclopirox, expected to grow at a CAGR of 5.8% and reach a valuation of US$ 3.6 Million by 2033. The increasing population, aging demographic, and rise in disposable income are key drivers in this region[1].

Other Regions

• Other regions, including North America, Europe, South America, Asia Pacific, and the Middle East and Africa, also show promising growth due to similar factors such as increasing awareness of personal hygiene and lifestyle changes[4].

Market Segmentation

By Application

• Ciclopirox is used to treat various fungal infections, including Tinea Cruris (jock itch), Tinea Pedis (athlete's foot), Tinea Unguium (onychomycosis), Tinea Corporis (ringworm), and Tinea Versicolor (pityriasis versicolor). Each application segment contributes to the overall market growth[4].

By Drug Type

• The market is segmented by drug type into cream, gel, nail polish, solution, and shampoo. These different forms cater to various patient needs and preferences, driving market expansion[4].

By Form and Route of Administration

• Ciclopirox is available in both topical and oral forms. The topical form, particularly the nail lacquer solution, has been highlighted as a cost-effective treatment for onychomycosis compared to oral antifungal therapies[3][4].

Cost-Effectiveness and Pharmacoeconomic Analysis

• A pharmacoeconomic analysis has shown that ciclopirox nail lacquer solution 8% is a cost-effective treatment for dermatophyte onychomycosis compared to oral antifungal agents like terbinafine, itraconazole, and fluconazole. The cost per mycologic cure rate and expected symptom-free days make ciclopirox a favorable option[3].

Research and Development

• In the long term, the market is expected to see increased investment in research and development. Dominant players will focus on finding unique solutions and innovations, which will further drive market growth and expand the use of ciclopirox[1].

Market Dynamics Outlook

Rapid Increase in Population

• The continuous increase in the global population will lead to an increased demand for healthcare products, including ciclopirox. This demographic shift is a significant driver of market growth[1].

Changing Lifestyle of People

• As people become more active and exposed to various environments, the risk of fungal infections increases. This change in lifestyle contributes to the rising demand for ciclopirox[1].

Financial Trajectory

Short-Term Projections (2023-2026)

• In the short term, the popularity of online sales is expected to drive steady growth for the ciclopirox market. People are increasingly inclined to purchase generic medications like ciclopirox directly from online platforms[1].

Medium-Term Projections (2026-2029)

• In the medium term, lifestyle changes, an aging population, and medical conditions like diabetes will contribute to the growth of the ciclopirox market. The use of antibiotics and other factors will also play a role in increasing market demand[1].

Long-Term Projections (2029-2033)

• In the long term, research and development will be a key focus. Companies will invest more in finding innovative solutions, which will drive market growth and expand the applications of ciclopirox[1].

Key Takeaways

• The ciclopirox market is expected to grow significantly due to increasing awareness of personal hygiene, a growing population, and lifestyle changes.
• The market is segmented by application, drug type, form, and route of administration, each contributing to its growth.
• Ciclopirox is a cost-effective treatment for fungal infections compared to other antifungal therapies.
• Research and development will play a crucial role in the long-term growth of the market.

FAQs

What is the current market size of the ciclopirox market?

The global ciclopirox market was valued at US$ 11.8 Million in 2023[1].

What is the projected growth rate of the ciclopirox market?

The market is projected to grow at a CAGR of 5.2% from 2023 to 2033[1].

Which region is expected to grow the fastest in the ciclopirox market?

China is expected to be one of the fastest-growing markets, with a CAGR of 5.8%[1].

What are the main drivers of the ciclopirox market?

The main drivers include increasing awareness of personal hygiene, a growing population, lifestyle changes, and an aging demographic[1].

Is ciclopirox a cost-effective treatment for fungal infections?

Yes, ciclopirox nail lacquer solution 8% is a cost-effective treatment for dermatophyte onychomycosis compared to oral antifungal therapies[3].

Sources

1. Fact.MR: Ciclopirox Market Size, Demand & Growth Report by 2033.
2. Synapse: CicloMed LLC - Drug pipelines, Patents, Clinical trials.
3. PubMed: Pharmacoeconomic analysis of ciclopirox nail lacquer solution 8%.
4. Market Research Future: Ciclopirox Market Size, Growth, Trends, Report 2032.