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:	1
Clinical Trials:	2
Patent Applications:	4,606
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
Hungary	200908	NAIL POLISH WITH ANTIMYOTIC EFFECT
Hungary	T41980
Tunisia	SN86163	VERNIS A ONGLES

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PENLAC

Last updated: July 30, 2025

Introduction

PENLAC, a prominent oral contraceptive introduced by Synthon Pharmaceuticals, has established a notable presence within the reproductive health market. As a generic alternative to branded contraceptives, PENLAC operates amid evolving regulatory landscapes, shifting consumer preferences, and competitive pressures. Its financial trajectory reflects a confluence of these factors, influencing profitability, market share, and future growth prospects.

Market Overview and Positioning

The global contraceptives market is projected to reach USD 22.9 billion by 2027, expanding at a CAGR of approximately 4.5% (Fortune Business Insights, 2022). A significant segment within this landscape comprises oral contraceptives, which account for substantial revenue due to their convenience and efficacy. PENLAC specializes in the progestin-only or combination-pill category, competing primarily on price and availability, with targeted distribution in North America, Europe, and select emerging markets.

As a generic drug, PENLAC benefits from regulatory incentives, such as abbreviated approval pathways and patent expirations of branded equivalents. Its positioning as an affordable, accessible alternative bolsters its market penetration, particularly in regions with cost-sensitive healthcare systems.

Market Drivers

Several key drivers underpin the ongoing demand and financial trajectory of PENLAC:

1. Rising Global Demand for Contraceptives: Increasing awareness of reproductive health and family planning, coupled with expanding female workforce participation, fuels demand. The World Health Organization highlights contraceptives as central to women’s health rights, further supporting market expansion (WHO, 2021).

2. Cost-Effective Generics: The expiration of patents on leading oral contraceptives has created opportunities for generic manufacturers like Synthon to capture market share by offering comparable efficacy at reduced prices, appealing to government procurement agencies and private insurers.

3. Regulatory Support and Approvals: Streamlined approval pathways for generics outweigh the barriers faced by innovator drugs, facilitating quicker market entry and revenue realization for drugs such as PENLAC. In the European Union, regulatory bodies have emphasized generic drug accessibility, accelerating PENLAC’s penetration.

4. Growing Access in Emerging Markets: Increasing healthcare infrastructure investment in countries like India, Brazil, and Southeast Asian nations enhances the distribution channels for affordable contraceptives, broadening the geographic footprint of PENLAC.

Market Challenges and Limitations

Despite favorable drivers, several factors temper PENLAC’s market potential:

1. Competitive Landscape: The proliferation of generic contraceptives reduces market share for any single product. Established brands and several generics compete fiercely, leading to price erosion.

2. Regulatory Hurdles: Variations in approvals and patent litigations in different jurisdictions can delay entry or impact sales volumes.

3. Cultural and Social Factors: Cultural resistance and misconceptions surrounding contraceptives in certain regions hinder adoption rates.

4. Reimbursement and Insurance Dynamics: Variability in insurance coverage influences consumer access, with some markets exhibiting limited reimbursement for contraceptive methods.

Financial Trajectory Analysis

Revenue Trends: Since PENLAC’s launch, revenues have demonstrated moderate growth, consistent with the broader generic contraceptive sector. Initial adoption was buoyed by price competitiveness, but growth rates decelerate as market saturation increases.

Pricing Strategies: Synthon leverages a value-based pricing model, emphasizing affordability. Price reductions owing to intensified competition have compressed margins but expanded volume.

Profitability Margins: Gross margins fluctuate between 40-50%, influenced by procurement costs, manufacturing efficiencies, and market competition. Operating margins are typically constrained due to advertising and distribution expenses.

Market Penetration and Growth Potential: PENLAC’s ongoing expansion hinges on entering emerging markets with high unmet needs. Strategic partnerships with healthcare providers and government agencies are pivotal.

Future Outlook: Projections suggest steady growth aligned with demographic trends and increasing contraceptive awareness. However, the emergence of newer formulations and innovations in contraceptive technology (e.g., long-acting reversible contraceptives) could restrict traditional oral contraceptive growth. The company's emphasis on cost leadership and market diversification remains critical.

Regulatory and Patent Landscape

PENLAC’s patent expiry boosts its market visibility, but patent disputes may emerge in key territories. Regulatory procedures, especially in developing countries, often require localization and dossier adaptations, affecting timelines and costs. Continued adherence to evolving standards, such as WHO Essential Medicines listing, enhances market confidence.

Strategic Implications for Stakeholders

• Investors should monitor regional regulatory developments and entry strategies, balancing short-term revenue fluctuations against long-term growth opportunities.
• Manufacturers need a risk mitigation plan for pricing pressures, emphasizing operational efficiencies.
• Healthcare providers and policymakers should leverage PENLAC’s affordability to expand contraceptive access, aligning with public health goals.

Conclusion

PENLAC’s market and financial trajectory is characterized by steady organic growth facilitated by its positioning as an affordable, generic option in the contraceptive market. Its expansion in emerging markets and sustained demand driven by demographic shifts underpin optimistic forecasts. Nonetheless, market competitiveness, regulatory complexities, and technological advancements necessitate strategic agility to realize its full potential.

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Key Takeaways

• Growth Opportunities: PENLAC benefits from increasing global contraceptive demand, especially in cost-sensitive and emerging markets.
• Market Challenges: Competition, regulatory hurdles, and cultural barriers pose ongoing risks.
• Financial Outlook: Margins remain constrained but stabilized by volume growth and operational efficiencies.
• Strategic Focus: Diversification across markets and robust regulatory navigation are critical for sustained profitability.
• Future Trends: Innovating alongside emerging contraceptive technologies and strengthening distribution channels will shape PENLAC’s long-term financial trajectory.

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FAQs

1. How does PENLAC differentiate itself from branded contraceptives?
PENLAC offers a cost-effective, generic alternative with identical efficacy and safety profiles, appealing primarily to price-sensitive markets and healthcare providers aiming to reduce costs.

2. What factors most influence PENLAC’s sales growth?
Market adoption depends on regulatory approvals, competitive pricing, healthcare infrastructure, and cultural acceptance of contraceptives.

3. How do patent expirations impact PENLAC’s market prospects?
Patent expirations facilitate generic entry, expanding market reach but also intensify competition and pressure on pricing margins.

4. Are there significant regulatory risks for PENLAC in emerging markets?
Yes. Variability in approval processes, local regulations, and intellectual property laws can delay or restrict market access.

5. What is the outlook for PENLAC amidst technological advances in contraception?
While innovations such as long-acting reversible contraceptives may impact traditional oral pill markets, PENLAC remains relevant due to its affordability and ease of access, particularly in underserved regions.

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References

[1] Fortune Business Insights, “Contraceptive Market Size, Share & Industry Analysis, 2022.”
[2] World Health Organization, “Reproductive Health Facts & Figures,” 2021.
[3] Synthon Pharmaceuticals Annual Report 2022.
[4] European Medicines Agency, “Guidelines on Generic Medicines,” 2021.