CICLOPIROX Drug Patent Profile

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

Ciclopirox is a drug marketed by Cosette Pharms Nc, Fougera Pharms, Glenmark Pharms, Padagis Israel, Sun Pharma Canada, Alvogen, Padagis Us, Actavis Mid Atlantic, Encube, Acella, Chartwell Rx, Epic Pharma Llc, Hikma, Mylan Pharms Inc, Rising, Taro Pharm Inds, and Teva Pharms. and is included in twenty-eight NDAs.

The generic ingredient in CICLOPIROX is ciclopirox. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ciclopirox

A generic version of CICLOPIROX was approved as ciclopirox by FOUGERA PHARMS on August 6^th, 2004.

Summary for CICLOPIROX

US Patents:	0
Applicants:	17
NDAs:	28
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	14
Patent Applications:	4,690
Drug Prices:	Drug price information 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
Atlas Molecular Pharma	PHASE1
Universidad Complutense de Madrid	Phase 4
Atlas Molecular Pharma	Phase 1

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
Sun Pharma Canada	CICLOPIROX	ciclopirox	SUSPENSION;TOPICAL	077092-001	Aug 10, 2005		DISCN	No	No
Cosette Pharms Nc	CICLOPIROX	ciclopirox	CREAM;TOPICAL	078463-001	Dec 20, 2010	AB	RX	No	No
Encube	CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	077687-001	Sep 18, 2007	AT	RX	No	No
Taro Pharm Inds	CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	078144-001	Sep 18, 2007		DISCN	No	No
Fougera Pharms	CICLOPIROX	ciclopirox	GEL;TOPICAL	077896-001	Jun 10, 2008	AB	RX	No	No
Padagis Israel	CICLOPIROX	ciclopirox	CREAM;TOPICAL	077364-001	Mar 3, 2006	AB	RX	No	No

Expired US Patents for CICLOPIROX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997
Alvogen	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997

International Patents for CICLOPIROX

See the table below for patents covering CICLOPIROX around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	008858	PREPARADOS FARMACEUTICOS QUE CONTIENEN DERIVADOS 1-HIDROXI-2-(1H) PIRIDONA, PROCEDIMIENTO PARA SU OBTENCION Y EMPLEO DE LOS MISMOS PARA LA PREPARACION DEUN MEDICAMENTO PARA EL TRATAMIENTO Y PROFILAXIS DE MICOSIS CUTANEAS.
Austria	216882
Australia	4703797
Australia	718837
Bulgaria	103262
Bulgaria	63864

Ciclopirox Market Dynamics and Financial Trajectory (Revenue, Pricing, Exclusivity, and Competitive Pressure)

Last updated: July 30, 2026

Ciclopirox (topical antifungal; widely used in dermatology) is a mature, multi-source product with limited scope for branded exclusivity-driven revenue. Market dynamics are shaped by (1) generic and low-cost competition, (2) channel mix between prescription and over-the-counter (where applicable by jurisdiction), (3) formulary placement by managed care, and (4) local regulatory and reimbursement rules for antifungal topicals. Financial trajectory is typically characterized by flat-to-declining branded revenue, with incremental gains driven by new dosage forms, line extensions, and tenders rather than monopoly pricing.

What drives ciclopirox market dynamics in dermatology and antifungal care?

Ciclopirox is positioned as a topical antifungal used for superficial mycoses, especially dermatophyte and Malassezia-related conditions. Demand is influenced by incidence and prescribing behavior for common fungal indications, plus the substitution pattern among topical antifungals.

Key demand factors

• Indication breadth within dermatology: patients seeking treatment for tinea and seborrheic dermatitis-like presentations increases the addressable user base for antifungal creams/shampoos/solutions depending on jurisdiction.
• Seasonality and chronicity: seborrheic dermatitis and related conditions can be recurrent, supporting intermittent repeat use.
• Prescriber switching: dermatology prescribing tends to remain active but substitution between topical antifungals is frequent when clinical endpoints are comparable.

Key supply and competitive factors

• Low differentiation vs. other topical antifungals: terbinafine, azoles (clotrimazole, ketoconazole), and ciclopirox formulations compete at the same therapeutic tier.
• Generic availability: ciclopirox products commonly face multiple generic entrants, limiting branded pricing power.
• Local tender dynamics: in some markets, government or hospital tender pricing determines volume more than brand promotion.

How has ciclopirox pricing evolved as generics entered?

Ciclopirox pricing typically compresses after generic introductions because the drug is small-molecule, topical, and widely manufacturable. Branded products, where they exist, usually lose share and pricing leverage once equivalent generics gain formulary acceptance.

Typical financial impact pattern

• Brand erosion: decline in branded share after generic launches.
• Revenue mix shift: shift to lower ASP products and smaller pack sizes in some channels.
• Promotion reduction: marketing spend often falls post-loss of exclusivity.

What is the competitive landscape for ciclopirox products vs ketoconazole and terbinafine?

In topical antifungal use, ciclopirox competes in the same therapeutic space as azoles and allylamines. The competitive set includes:

• Azoles: ketoconazole, clotrimazole, miconazole.
• Allylamine: terbinafine.
• Other topical antifungals: depending on country formularies, ciclopirox may be compared to ciclopirox olamine alternatives or combination products.

How ciclopirox differentiates in practice

• Formulation-dependent positioning: shampoos, solutions, and creams may be preferred based on lesion location (scalp vs body) and vehicle tolerability.
• Adherence and application fit: product texture and dosing frequency matter; vehicles can influence real-world use and switch propensity.

When does ciclopirox lose exclusivity and what does that imply for revenue?

Ciclopirox itself is not expected to have a single unified exclusivity end-date globally; instead, exclusivity and patent coverage depend on:

• Specific dosage forms (e.g., shampoo vs cream vs solution),
• Concentration and salt/solvate forms (notably ciclopirox olamine in many marketed products),
• Manufacturing methods and formulation IP,
• Country-specific patent filings and term adjustments.

Because ciclopirox is broadly used, revenue outcomes generally align with multi-source competition rather than long exclusivity windows.

How many patents protect ciclopirox and how strong is the patent estate?

The practical market reality for ciclopirox is that patent coverage, where it remains, is usually segmented by:

• formulation vehicle improvements,
• specific concentration ranges,
• use patents for defined indications (less commonly),
• manufacturing process or stability claims.

For mature actives, the number of active, enforceable patents tends to be smaller and less central to commercialization than generic equivalence.

What patents protect ciclopirox formulations and method-of-use claims?

Patent protection, when present, typically covers:

• Topical formulation compositions: vehicle, excipient system, stability, and delivery characteristics.
• Manufacturing processes: mixing, milling, filtration, sterilization where relevant, and shelf-life.
• Use regimes: treatment of fungal infections in specific body sites or patient populations.

What patent litigation affects ciclopirox generic entry risk?

Ciclopirox generic entry risk is usually determined more by regulatory equivalence and patent screening outcomes than by active litigation at scale. For a mature topical, the barrier to entry is often:

• Orange Book-style listing status (US) for relevant branded product codes and patents,
• Local patent landscape (EU, UK, JP) for formulation/vehicle products,
• Market authorization transfer constraints (bioequivalence does not typically apply for topical small molecules in the same way as injectables).

What is the Orange Book status of ciclopirox in the US?

Ciclopirox market structure in the US generally reflects mature generic availability. Orange Book status would be product- and applicant-specific; for most actives at this maturity, branded listings are either expired or do not block generic approvals beyond any remaining formulation patents for specific strengths and dosage forms.

What generic entry risks exist for ciclopirox in key jurisdictions?

Generic entry risk depends on which specific ciclopirox product (dosage form and strength) is being evaluated:

• US: risk is driven by whether any listed patents remain enforceable against specific branded NDCs.
• EU/UK: risk is driven by national patent validity/enforceability for formulation claims and any granted supplementary protection certificates tied to specific products.
• Japan: risk is shaped by local patent enforcement and marketing authorization references.

How does ciclopirox compare with competing topical antifungals financially?

For most topical antifungals, the financial comparison is driven by:

• Generic penetration (often high across the class),
• Reimbursement and formulary inclusion (country dependent),
• Product differentiation based on vehicle and scalp vs body indications.

Ciclopirox typically does not maintain class-leading pricing unless a differentiated formulation is protected and has favorable formulary placement.

What regulatory milestones matter for ciclopirox market growth?

Topical antifungal growth is less about breakthrough regulatory events and more about:

• new marketing authorizations for reformulations (new vehicles or strengths),
• updated labeling for indications,
• substitution and tender cycles.

How does the financial trajectory differ between ciclopirox brands and generic suppliers?

• Branded suppliers: tend to show declining revenue as generic penetration rises, unless a specific formulation or combination is protected.
• Generic suppliers: tend to grow volume when they secure supply chain advantages and win tender/formulary placement, but margin remains constrained by pricing pressure.

What delivery systems and formulations drive incremental sales for ciclopirox?

Ciclopirox incremental volume often comes from dosage form shifts:

• Scalp-targeted forms (solutions or shampoos) can capture recurrent dandruff-like presentations.
• Body-targeted creams/ointments support tinea and localized superficial fungal treatment where vehicle choice improves tolerability.

What formulation IP typically supports line extensions?

• improved stability and skin feel,
• reduced irritation through excipient change,
• vehicle optimization for penetration and adherence.

Commercial outlook: where can ciclopirox still expand revenue?

Given maturity and multi-source availability, expansion is most realistic through:

• geographic tender wins where pricing and supply reliability dominate,
• premium vehicle variants where differentiation persists (temporarily via formulation patents or market positioning),
• channel expansion in pharmacies and healthcare systems that adopt standardized antifungal formularies.

Key takeaways on ciclopirox financial trajectory

• Ciclopirox operates as a mature topical antifungal with generic-driven pricing pressure.
• Revenue trajectory is usually flat-to-declining for branded products and volume-driven with thin margins for generics.
• The most meaningful upside comes from formulation-specific line extensions and local reimbursement/tender dynamics, not from sustained monopoly pricing.
• Exclusivity and patent strength are product- and formulation-specific, so financial impact hinges on the exact NDC/dosage form and the remaining patent and regulatory listing status.

FAQs

1. How do generic tenders affect ciclopirox revenue in EU markets?
2. Which ciclopirox dosage forms (cream vs solution vs shampoo) typically hold the strongest pricing power?
3. What role do formulary restrictions play in switching between ciclopirox and azole antifungals?
4. Does ciclopirox face different substitution rules for scalp vs body fungal indications?
5. How do patent listings for specific ciclopirox NDCs influence Paragraph IV strategy for generics?

References

DrugChatter Q&A for CICLOPIROX

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