LOPROX Drug Patent Profile

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

Loprox is a drug marketed by Medimetriks Pharms and Bausch and is included in three NDAs.

The generic ingredient in LOPROX 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 Loprox

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

Summary for LOPROX

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	107
Patent Applications:	4,078
Drug Prices:	Drug price information for LOPROX
What excipients (inactive ingredients) are in LOPROX?	LOPROX excipients list
DailyMed Link:	LOPROX at DailyMed

See drug prices for LOPROX

US Patents and Regulatory Information for LOPROX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medimetriks Pharms	LOPROX	ciclopirox	CREAM;TOPICAL	018748-001	Dec 30, 1982	AB	RX	Yes	Yes
Medimetriks Pharms	LOPROX	ciclopirox	SUSPENSION;TOPICAL	019824-001	Dec 30, 1988	AB	RX	Yes	Yes
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	AT	RX	Yes	Yes

Expired US Patents for LOPROX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medimetriks Pharms	LOPROX	ciclopirox	CREAM;TOPICAL	018748-001	Dec 30, 1982
Medimetriks Pharms	LOPROX	ciclopirox	SUSPENSION;TOPICAL	019824-001	Dec 30, 1988
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003

International Patents for LOPROX

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	103260
Czech Republic	291485	Medicínský šampon k léčení seboroické dermatitidy (Medicinal shampoo intended for treating seborrheic dermatitis)
Denmark	125091
European Patent Office	0928183	UTILISATION DE 1-HYDROXY-2-PYRIDONE POUR LE TRAITEMENT DE L'ECZEMA SEBORRHEIQUE (USE OF 1-HYDROXY-2-PYRIDONE FOR THE TREATMENT OF SEBORRHEIC DERMATITIS)
Hungary	226955	USE OF 1-HYDROXY-2-PYRIDONE FOR THE PRODUCTION OF A MEDICINAL SHAMPOO FOR THE TREATMENT OF SEBORRHEIC DERMATITIS
Switzerland	547284	VERFAHREN ZUR HERSTELLUNG VON 1-HYDROXY-2-PYRIDONEN.

Market Dynamics and Financial Trajectory for the Drug: LOPROX (Ciclopirox)

Introduction

LOPROX, commonly known by its active ingredient ciclopirox, is a medication widely used for the treatment of various fungal infections, including onychomycosis (fungal infections of the nails) and seborrheic dermatitis. This article delves into the market dynamics and financial trajectory of LOPROX, providing insights into its market size, growth prospects, and the financial performance of companies involved in its production and distribution.

Market Size and Growth Prospects

The ciclopirox market is anticipated to experience steady growth over the coming years. According to market research, the ciclopirox market is projected to reach USD 0.67 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 4.89%[1].

Key Applications

Ciclopirox is used in various formulations to treat different types of fungal infections:

• Tinea Cruris (Jock Itch)
• Tinea Pedis (Athlete's Foot)
• Tinea Unguium (Onychomycosis)
• Tinea Corporis (Ringworm)
• Tinea Versicolor (Pityriasis Versicolor)

These diverse applications contribute to the drug's market stability and growth potential.

Drug Formulations and Routes of Administration

Ciclopirox is available in several formulations, including:

• Cream
• Gel
• Nail Polish
• Solution
• Shampoo

These formulations are administered topically, which is the primary route of administration for ciclopirox. The variety in formulations caters to different patient needs and preferences, enhancing market penetration[1].

Regional Market Analysis

The market for ciclopirox is segmented across various regions, including:

• North America
• Europe
• South America
• Asia Pacific
• Middle East and Africa

Each region presents unique market dynamics, influenced by local healthcare systems, regulatory environments, and patient demographics. The Asia Pacific region, in particular, is expected to show significant growth due to increasing healthcare expenditure and a large patient population[1].

Pharmacological and Clinical Aspects

Mechanism of Action

Ciclopirox works by disrupting cellular metabolism in fungi, including the loss of function of certain catalase and peroxidase enzymes. It also affects DNA repair, cell division signals, and intracellular transport mechanisms[4].

Clinical Efficacy

While ciclopirox is effective against various fungal infections, its efficacy in treating onychomycosis has been questioned. Studies have shown that ciclopirox has poor cure rates for nail infections compared to other treatments like amorolfine and efinaconazole[4].

Financial Performance of Key Players

Perrigo Company

Perrigo, a company that has developed and marketed a topical suspension of ciclopirox, reported significant financial results in the past. For instance, in 2007, Perrigo received final FDA approval for Ciclopirox Topical Suspension, which contributed to their financial growth. The company's net sales increased by 5.9% from 2006 to 2007, reaching $1,447.4 million[5].

Teligent, Inc.

Teligent, another company involved in the generic pharmaceutical market, including topical products like ciclopirox, has faced financial challenges. Despite these challenges, the company continues to focus on developing and marketing generic pharmaceutical products. Teligent's strategy includes expanding its private label and contract manufacturing business, which could potentially boost its financial performance in the future[2].

Market Challenges and Opportunities

Challenges

• Competition from Other Antifungals: The market for antifungal treatments is competitive, with other drugs like amorolfine and efinaconazole showing better efficacy rates for certain conditions.
• Regulatory and Compliance Issues: Companies like Teligent face significant regulatory and compliance challenges, which can impact their financial stability and market presence[2].

Opportunities

• Growing Demand in Emerging Markets: The increasing healthcare needs in emerging markets present a significant opportunity for growth.
• Expansion of Product Portfolio: Companies can expand their product portfolios by licensing or acquiring additional intellectual property, which can drive market dominance and financial growth[2][3].

Strategic Initiatives and Innovations

Companies involved in the ciclopirox market are adopting various strategies to enhance their market position:

• Acquisitions and Partnerships: Valeant Pharmaceuticals, for example, has executed several strategic acquisitions and partnerships to strengthen its position in the dermatology market[3].
• Research and Development: Continuous investment in R&D is crucial for developing new formulations and improving the efficacy of existing products. This can help in addressing the poor cure rates associated with ciclopirox for certain conditions[4].

Key Takeaways

• The ciclopirox market is projected to grow at a CAGR of 4.89% to reach USD 0.67 billion by 2032.
• The drug is available in various formulations and is used to treat a range of fungal infections.
• Regional markets, especially in the Asia Pacific, offer significant growth opportunities.
• Companies face challenges from regulatory compliance and competition but can leverage emerging markets and R&D to drive growth.
• Strategic initiatives such as acquisitions, partnerships, and product portfolio expansion are key to market dominance.

FAQs

What is the primary use of LOPROX (ciclopirox)?

LOPROX is primarily used for the treatment of moderate onychomycosis of fingernails and toenails, as well as for seborrheic dermatitis.

What are the different formulations of ciclopirox?

Ciclopirox is available in cream, gel, nail polish, solution, and shampoo formulations.

How effective is ciclopirox in treating nail infections?

Ciclopirox has been shown to have poor cure rates for nail infections compared to other treatments like amorolfine and efinaconazole.

Which regions are expected to drive the growth of the ciclopirox market?

The Asia Pacific region is expected to show significant growth due to increasing healthcare expenditure and a large patient population.

What are the key challenges faced by companies in the ciclopirox market?

Companies face challenges from competition with other antifungals, regulatory and compliance issues, and financial constraints.

Sources

1. Market Research Future: Ciclopirox Market Size, Growth, Trends, Report 2032
2. Teligent, Inc.: Annual Reports
3. Valeant Pharmaceuticals: Investor Day Presentation 2015
4. Wikipedia: Ciclopirox
5. Perrigo Company: Annual Reports