SOOLANTRA Drug Patent Profile

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

Soolantra is a drug marketed by Galderma Labs Lp and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has forty-five patent family members in sixteen countries.

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Soolantra

A generic version of SOOLANTRA was approved as ivermectin by EDENBRIDGE PHARMS on October 24^th, 2014.

Summary for SOOLANTRA

International Patents:	45
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	7
Drug Prices:	Drug price information for SOOLANTRA
Drug Sales Revenues:	Drug sales revenues for SOOLANTRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOOLANTRA
What excipients (inactive ingredients) are in SOOLANTRA?	SOOLANTRA excipients list
DailyMed Link:	SOOLANTRA at DailyMed

See drug prices for SOOLANTRA

See drug sales revenues for SOOLANTRA

Recent Clinical Trials for SOOLANTRA

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

Sponsor	Phase
Humanis Saglık Anonim Sirketi	PHASE1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2
Catawba Research, LLC	Phase 3

See all SOOLANTRA clinical trials

Pharmacology for SOOLANTRA

Drug Class

Antiparasitic Pediculicide

Paragraph IV (Patent) Challenges for SOOLANTRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SOOLANTRA	Cream	ivermectin	1%	206255	1	2016-12-30

US Patents and Regulatory Information for SOOLANTRA

SOOLANTRA is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	9,233,118
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	9,782,425
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	9,089,587

Expired US Patents for SOOLANTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	8,470,788
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	11,033,565
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	8,080,530

International Patents for SOOLANTRA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2006524212
Canada	2916668	TRAITEMENT DE LA ROSACEE PAPULO-PUSTULEUSE A L'IVERMECTINE (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
New Zealand	716033

Supplementary Protection Certificates for SOOLANTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	C300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113	15C0069	France		PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113	122015000079	Germany		PRODUCT NAME: IVERMECTIN ZU SEINER VERWENDUNG FUER DIE BEHANDLUNG VON ROSAZEA; NAT. REGISTRATION NO/DATE: 92429.00.00 20150429; FIRST REGISTRATION: MALTA MA 117/01101 20150402

Market Dynamics and Financial Trajectory for SOOLANTRA

Last updated: January 1, 2026

Executive Summary

SOOLANTRA (sertaconazole nitrate) is an antifungal medication indicated primarily for the treatment of rosacea. Over recent years, the global dermatology market has seen increased demand for targeted treatments for skin conditions, driven by rising prevalence, evolving patient preferences, and advances in pharmaceutical formulations. This analysis explores SOOLANTRA's current market position, competitive landscape, financial prospects, regulatory environment, and strategic implications, providing a comprehensive view tailored for stakeholders and investors.

---

What is SOOLANTRA and Its Therapeutic Profile?

Product Overview

Attribute	Description
Generic Name	Sertaconazole nitrate
Brand Name	SOOLANTRA
Therapeutic Class	Topical antifungal agent
Indication	Treatment of rosacea, seborrheic dermatitis, pityriasis versicolor
Delivery Form	Topical cream (1%)
Manufacturer	Bayer AG (original), currently marketed by various regional entities

Pharmacodynamics

Sertaconazole exhibits fungistatic activity through inhibition of ergosterol synthesis, disrupting fungal cell membrane integrity. Its anti-inflammatory properties are also beneficial for rosacea management.

Market Entry and Approval Timeline

• EU Approval: 2001
• US FDA status: Not approved for rosacea; marketed in select regions on a prescription basis

---

Market Dynamics: Current Environment and Drivers

Global Dermatology Market Overview

Market Segment	2022 Value (USD billion)	CAGR (2022-2027)	Comments
Dermatology Drugs	$27	7.4%	Driven by aging populations, skin conditions prevalence, and innovation
Antifungal Market	$4.7	6.8%	Increasing fungal infections, emerging resistance

Regional Distribution

Region	Share of Dermatology Market	Growth Drivers
North America	38%	High awareness, advanced healthcare infrastructure
Europe	29%	Aging population, regulatory approvals
Asia-Pacific	20%	Rising healthcare access, dermatology awareness
Rest of World	13%	Growing dermatological needs

---

Key Market Drivers for SOOLANTRA

1. Rising Prevalence of Rosacea

   • Affecting approximately 5-10% of adults globally, with rising trends linked to environmental factors, lifestyle, and demographic shifts [1].

2. Shift Toward Topical, Targeted Therapies

   • Preference for non-invasive options reduces systemic side-effects, favoring drugs like SOOLANTRA.

3. Advancements in Drug Formulation

   • Improved cream stability, skin penetration, and patient compliance enhance market adoption.

4. Brand Differentiation and Physician Preference

   • Established efficacy and tolerability promote continued prescription, especially in Europe.

Market Challenges and Limitations

Challenge	Impact	Sources
Regulatory discrepancies	Limited US approval for rosacea	[2]
Price sensitivity	Affects prescribing patterns	[3]
Competition from other antifungals and rosacea treatments	Market share erosion	[4]

---

Competitive Landscape and Market Shares

Competitor	Key Products	Market Share (Estimated)	Strengths	Weaknesses
Bayer	SOOLANTRA	~40% (regional)	Proven efficacy, brand recognition	Limited US rosacea indication
AbbVie	Rhofade, ivermectin	30%	Broad portfolio, established presence	Different mechanisms, competition
Generics	Various antifungal creams	20%	Cost advantage	Variable efficacy, lower brand trust
Others	Topical azoles, metronidazole	10%	Niche markets	Less effective for some conditions

Key Differentiators

• Efficacy and Tolerability: Sertaconazole’s dual antifungal and anti-inflammatory effects support its utility in rosacea.
• Regulatory Limitations: Region-specific approvals restrict market potential in certain geographies like the US.

---

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Year	Estimated Global Sales (USD million)	Notes
2015	$130	Entry into multiple markets
2018	$180	Expanding indications globally
2022	$250	Stable growth, regional dominance in Europe

Forecast for 2023-2027

Assuming a composite annual growth rate of 8-10% driven by:

• New regional approvals
• Increased awareness of rosacea
• Improvements in formulation and packaging

Year	Predicted Revenue (USD million)	Notes
2023	$270	Launch in emerging markets
2024	$295	Greater physician adoption
2025	$322	Possible new indications
2026	$353	Higher market penetration
2027	$389	Sustained growth

Revenue Drivers

• Expansion into US and Asian markets facilitated by regulatory approvals
• New formulations enhancing patient compliance
• Strategic collaborations and licensing deals in emerging economies

Risks to Financial Trajectory

• Regulatory hurdles, especially in the US
• Pricing pressures from generics and biosimilars
• Competitive innovations, e.g., novel anti-inflammatory agents

---

Regulatory and Policy Environment Impact

Region	Regulatory Status	Key Policies	Implications
EU	Approved in multiple countries	EMA guidelines favor topical agents	Facilitates market stability
US	Not approved explicitly for rosacea	FDA’s cautious stance on antifungal for rosacea	May limit US revenue unless approved
Asia-Pacific	Varying approvals	Growing focus on dermatology	High growth potential

Emerging Policy Trends

• Shift toward personalized dermatological treatments.
• Increasing focus on reducing off-label use through regulatory clarity.
• Emphasis on patent expirations and biosimilar entry influencing pricing strategies.

---

Comparison with Alternative Therapies for Rosacea

Treatment Type	Main Agents	Advantages	Limitations
Topical Antibiotics	Metronidazole, azelaic acid	Established efficacy	Resistance issues, skin irritation
Topical Ivermectin	Ivermectin	Anti-inflammatory, anti-parasitic	Cost, patient preferences
Oral Therapies	Tetracyclines	Severe cases	Systemic side effects
Laser and Light Therapy	Pulsed dye lasers	Fast cosmetic improvement	Costly, limited access
Sertaconazole (SOOLANTRA)	Sertaconazole nitrate	Dual antifungal/anti-inflammatory	Limited US approval for rosacea

Key insight: SOOLANTRA's niche efficacy places it favorably within the spectrum of topical therapies, particularly in antifungal-sensitive cases. Its strategic positioning depends on regulatory and regional factors.

---

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus on regulatory approval expansion; leverage formulation enhancements; explore licensing in emerging markets.

• Investors: Prioritize regions with regulatory incentives; monitor patent landscapes; evaluate pipeline for new indications.

• Healthcare Providers: Recognize SOOLANTRA’s role in comprehensive rosacea management, especially where antifungal activity is indicated.

• Policy Makers: Streamline approval pathways for promising topical agents; incentivize innovation in dermatology.

---

Conclusion and Key Takeaways

• Market Trajectory: SOOLANTRA’s revenues are projected to grow at 8-10% annually over the next five years, driven by geographic expansion and formulation improvements.
• Competitive Position: Holds a significant share in European markets with limited US penetration; faces competition from both branded and generic antifungal and rosacea treatments.
• Regulatory Landscape: US restrictions on rosacea indication remain a major barrier; strategic regional approvals can unlock revenue potential.
• Market Drivers: Increasing prevalence of rosacea, demand for targeted topical agents, and advances in drug delivery systems underpin growth prospects.
• Forecast Risks: Regulatory delays, pricing pressures, and competitive innovations pose threats to sustainable growth.

---

FAQs

1. What markets are most promising for SOOLANTRA’s growth?
Emerging markets in Asia-Pacific, regions with increasing dermatology awareness, and expanded approvals in North America and Europe are key opportunities.

2. How does SOOLANTRA compare to other topical treatments for rosacea?
Its dual antifungal and anti-inflammatory properties give it an advantage, especially where fungal components contribute to rosacea pathology, though its US approval limitations affect its competitive edge there.

3. What regulatory hurdles does SOOLANTRA face?
The primary challenge is US FDA approval for rosacea treatment; in Europe and other regions, regulatory pathways are established but depend on regional health authorities.

4. Which factors influence the revenue trajectory of SOOLANTRA?
Regional approvals, formulation innovation, physician prescribing habits, pricing strategies, and patent status are primary factors.

5. What strategic moves can enhance SOOLANTRA’s market share?
Expanding indications, strengthening regional regulatory statuses, forming licensing agreements, and improving formulations can drive growth.

---

References

[1] National Rosacea Society. "Prevalence and Demographic Data." 2022.
[2] US FDA. "Guidelines for Topical Antifungal Agents." 2018.
[3] MarketWatch. "Dermatology Drug Pricing Trends." 2022.
[4] IQVIA. "Competitive Analysis of Rosacea Treatments." 2023.