PENLAC Drug Patent Profile

Which patents cover Penlac, and when can generic versions of Penlac launch?

Penlac is a drug marketed by Valeant Bermuda and is included in one NDA.

The generic ingredient in PENLAC 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 Penlac

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

Summary for PENLAC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	2
Patent Applications:	4,089
Drug Prices:	Drug price information for PENLAC
What excipients (inactive ingredients) are in PENLAC?	PENLAC excipients list
DailyMed Link:	PENLAC at DailyMed

See drug prices for PENLAC

Recent Clinical Trials for PENLAC

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

Sponsor	Phase
9305-9954 Quebec Inc	Phase 2
Rady Children's Hospital, San Diego	Phase 4

See all PENLAC clinical trials

US Patents and Regulatory Information for PENLAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Bermuda	PENLAC	ciclopirox	SOLUTION;TOPICAL	021022-001	Dec 17, 1999		DISCN	Yes	No

Expired US Patents for PENLAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Bermuda	PENLAC	ciclopirox	SOLUTION;TOPICAL	021022-001	Dec 17, 1999	4,957,730

International Patents for PENLAC

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0226984	ANTIMYCOTIC NAIL VARNISH
Germany	3544983
Hungary	200908	NAIL POLISH WITH ANTIMYOTIC EFFECT
Ireland	863312
Ireland	59318	Antimycotic nail varnish
Norway	173364
Portugal	83964	PROCESSO PARA A PREPARACAO DE VERNIZ PARA UNHAS COM ACTIVIDADE ANTIMICOTICA CONTENDO 1-HIDROXI-2-PIRIDONA

Market Dynamics and Financial Trajectory for PENLAC (Ciclopirox)

Introduction to PENLAC

PENLAC, also known as ciclopirox, is a synthetic antifungal agent used primarily for the treatment of mild to moderate onychomycosis of fingernails and toenails. It is available as a topical solution, specifically PENLAC NAIL LACQUER, 8%[2].

Market Size and Growth

The global onychomycosis treatment market, which includes PENLAC, is projected to grow significantly over the next few years. By 2024, this market is expected to reach USD 3.36 billion and is anticipated to grow at a CAGR of 4.46% to reach USD 4.18 billion by 2029[1].

Segment Contribution

PENLAC falls under the drugs segment of the onychomycosis treatment market, which holds a significant share due to the high effectiveness and easy availability of these products. The drugs segment is expected to continue its dominant trend over the forecast period[1].

Regional Market Performance

North America is the largest market for onychomycosis treatments, including PENLAC, driven by high drug costs, a rising geriatric population, and an increasing prevalence of onychomycosis and diabetic patients in this region. However, the Asia-Pacific region is expected to be the fastest-growing market over the forecast period[1].

Mechanism of Action and Efficacy

PENLAC (ciclopirox) acts by chelating polyvalent cations, which is believed to be part of its antifungal mechanism. Clinical studies have demonstrated its efficacy in treating onychomycosis, with statistical significance shown in endpoints such as "complete cure" and "almost clear" nail involvement[2].

Market Impact of COVID-19

The COVID-19 pandemic caused short-term disruptions in the onychomycosis treatment market, including supply chain issues and postponed non-urgent in-patient visits. However, the market is expected to recover and show positive growth over the forecast period. Telemedicine has also played a role in managing onychomycosis diagnosis and treatment during this time[1].

Competitive Landscape

PENLAC competes in a market with several major players, including Bausch Health Companies Inc (Valeant Pharmaceuticals Inc), Galderma S.A., Novartis AG, Pfizer, Inc, and Moberg Pharma AB. The competitive landscape is driven by the introduction of new treatments and the ongoing development of existing ones[1].

Financial Trajectory

Revenue Projections

The global ciclopirox market, which includes PENLAC, was valued at USD 11.8 million in 2023 and is projected to reach USD 19.5 million by 2033, growing at a CAGR. This growth is part of the broader onychomycosis treatment market expansion[5].

Cost and Pricing

The cost of developing and marketing antifungal treatments like PENLAC is significant. The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years. However, successful drugs can generate substantial revenue, making the investment worthwhile despite the risks[3].

Regulatory and Patent Landscape

PENLAC, as a branded drug, benefits from patent protection, which helps in maintaining market share and revenue. However, as patents expire, generic or biosimilar versions can enter the market, potentially reducing sales for the original brand-name drug. This highlights the importance of continuous innovation and strategic patent management[3].

Key Takeaways

• Market Growth: The onychomycosis treatment market, including PENLAC, is expected to grow at a CAGR of 4.46% from 2024 to 2029.
• Regional Dominance: North America holds the largest market share, while the Asia-Pacific region is the fastest-growing.
• Mechanism and Efficacy: PENLAC's antifungal mechanism and clinical efficacy make it a significant player in the market.
• COVID-19 Impact: The market experienced short-term disruptions but is expected to recover and grow positively.
• Competitive Landscape: PENLAC competes with other major pharmaceutical companies in the onychomycosis treatment market.
• Financial Projections: The global ciclopirox market is projected to grow from USD 11.8 million in 2023 to USD 19.5 million by 2033.

FAQs

What is the current market size of the global onychomycosis treatment market?

The global onychomycosis treatment market is expected to reach USD 3.36 billion in 2024[1].

Which region is the largest market for onychomycosis treatments?

North America is the largest market for onychomycosis treatments, including PENLAC[1].

How does PENLAC (ciclopirox) work?

PENLAC acts by chelating polyvalent cations, which is part of its antifungal mechanism[2].

What is the impact of COVID-19 on the onychomycosis treatment market?

The COVID-19 pandemic caused short-term disruptions, but the market is expected to recover and show positive growth over the forecast period[1].

Who are the major competitors in the onychomycosis treatment market?

Major competitors include Bausch Health Companies Inc, Galderma S.A., Novartis AG, Pfizer, Inc, and Moberg Pharma AB[1].

Sources

1. Mordor Intelligence: Onychomycosis Treatment Market Size & Share Analysis
2. Sanofi U.S.: PENLAC - (ciclopirox) Topical Solution, 8%
3. DrugBank Blog: Investment Trends in Pharmaceutical Research
4. Market Research Future: Ciclopirox Market Size, Growth, Trends, Report 2032
5. DrugPatentWatch: Generic CICLOPIROX INN entry, drug patent and freedom to operate