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
Zydus Worldwide DMCC	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
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	9,233,117
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	10,206,939

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	8,080,530
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	8,815,816
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	8,415,311
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	8,093,219
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	7,550,440
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	6,133,310

International Patents for SOOLANTRA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004093886
Australia	2014287408	Treatment of inflammatory lesions of rosacea with ivermectin
South Korea	101863085
European Patent Office	3019174	TRAITEMENT DE LA ROSACÉE PAPULO-PUSTULEUSE À L'IVERMECTINE (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
Hong Kong	1223841	使用伊維菌素治療丘疹膿皰性紅斑痤瘡 (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
Russian Federation	2350333	ПРИМЕНЕНИЕ ИВЕРМЕКТИНА ДЛЯ ЛЕЧЕНИЯ ДЕРМАТОЛОГИЧЕСКИХ РАССТРОЙСТВ (IVERMECTINE APPLICATION FOR TREATMENT OF DERMATOLOGICAL DISORDERS)
Japan	2021059590

Supplementary Protection Certificates for SOOLANTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1620113	CR 2015 00045	Denmark		PRODUCT NAME: LVERMECTIN (22,23-DIHYDROAVERMECTIN B1 A + 22,23-DIHYDROAVERMECTIN B1 B); NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
1620113	C300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113	PA2015033,C1620113	Lithuania		PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113	C 2015 036	Romania		PRODUCT NAME: IVERMECTINA; NATIONAL AUTHORISATION NUMBER: RO7674/2015/01, RO7674/2015/02, RO7674/2015/03, RO7674/2015/04, RO7674/2015/05; DATE OF NATIONAL AUTHORISATION: 20150526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MALTA MA117/01101; DATE OF FIRST AUTHORISATION IN EEA: 20150402
1620113	C20150035 00175	Estonia		PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
1620113	300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MT MA117/01101 20150402

Market Dynamics and Financial Trajectory for SOOLANTRA (Ivermectin Cream)

Last updated: July 27, 2025

Introduction

SOOLANTRA, marketed as ivermectin cream, is a topical treatment for papulopustular rosacea, a chronic skin condition affecting millions worldwide. Since its approval, SOOLANTRA has positioned itself as a significant entrant in the dermatology segment, driven by increasing prevalence of rosacea, technological advancements, and evolving dermatological treatment protocols. This analysis explores the market dynamics influencing SOOLANTRA's trajectory and forecasts its financial performance amid competitive and regulatory landscapes.

Market Overview and Growth Drivers

Global Prevalence of Rosacea and Increased Demand

The global burden of rosacea is expanding, with prevalence estimates ranging from 1% to 10% of the adult population worldwide [1]. Factors such as heightened awareness, improved diagnostic criteria, and the rising elderly demographic contribute to increased diagnosis rates. As a result, demand for effective topical treatments like ivermectin cream is on the rise.

Efficacy and Favorable Profile of Ivermectin

The unique mechanism of ivermectin as an anti-inflammatory and antiparasitic agent positions SOOLANTRA favorably. Its efficacy in reducing papules, pustules, and erythema has been supported by multiple clinical trials, offering a therapeutic alternative to oral antibiotics, which carry systemic side effects [2]. These attributes underpin market acceptance and repurchase rates.

Evolving Dermatological Treatment Landscape

The shift toward targeted, minimally invasive, and topical therapies aligns with patient preferences. SOOLANTRA’s once-daily topical application and minimal adverse effects make it a preferred choice, fueling its growth.

Regulatory Approvals and Market Expansion

Initial approval by the U.S. Food and Drug Administration (FDA) in 2014, followed by approvals in Europe, Asia, and other regions, has facilitated global expansion. Regulatory bodies increasingly recognize ivermectin as a first-line treatment, further bolstering sales potential.

Market Challenges and Competitive Landscape

Competitive Treatments

SOOLANTRA faces competition from azelaic acid, metronidazole, and doxycycline, among others. While these have long been staples, recent evidence and patient tolerability issues favor ivermectin. Additionally, emerging biologics and laser therapies are gradually encroaching upon dermatological markets, though their high costs limit widespread adoption for rosacea.

Pricing and Reimbursement Policies

Pricing strategies significantly influence market penetration. Generics or biosimilars, if introduced, could pressure SOOLANTRA’s market share. Reimbursement policies differ regionally, affecting access and sales volumes.

Regulatory and Patent Dynamics

Patent expirations and potential generics could impact revenue streams. Nonetheless, patent protections and formulation exclusivities currently sustain SOOLANTRA’s premium positioning.

Supply Chain and Manufacturing

Reliable supply chains are crucial amid global disruptions such as geopolitical tensions and pandemics. Manufacturing scalability and quality assurance influence market reliability and financial stability.

Financial Trajectory Forecasts

Revenue Growth Projections

Based on market analyses and current sales data, SOOLANTRA's global revenue is expected to grow at a compound annual growth rate (CAGR) of approximately 10-12% over the next five years [3]. This growth is driven by:

• Expansion into emerging markets, where dermatology treatments are gaining acceptance.
• Increased diagnosis rates, fostering broader patient access.
• New formulations or combination therapies, enhancing efficacy and adherence.

Market Penetration and Pricing Trends

Premium pricing remains feasible due to the drug’s efficacy and safety profile. However, price erosion risks exist with increasing generics and biosimilar entries, potentially affecting profit margins.

Impact of Regulatory Developments and Patent Lifespan

Patent rights extending to 2030 provide a revenue runway, but upcoming patent expirations could necessitate strategic adjustments such as licensing or diversification. Regulatory approvals for new indications or formulations could unlock additional revenue streams.

Regional Revenue Analysis

North America currently accounts for approximately 50% of sales, driven by high awareness and reimbursement frameworks. Europe and Asia hold significant growth opportunities, with Asian markets projected to grow at a CAGR of 15%, as dermatological treatment access expands [4].

Market Dynamics: Opportunities and Risks

Opportunities

• Broadened Indication Portfolio: Potential approval for other inflammatory dermatoses.
• Combination Therapies: Synergistic formulations with other active ingredients.
• Digital Health Integration: Teledermatology and remote monitoring could increase access and adherence.

Risks

• Regulatory Delays or Restrictions: Stringent approval processes may hinder market expansion.
• Market Competition: Entry of biosimilars and newer therapies could compress margins.
• Reimbursement Limitations: Payer resistance could restrict access in certain markets.

Conclusion

SOOLANTRA’s future as a leading dermatological agent hinges on its ability to capitalize on rising rosacea prevalence, clinical efficacy, and favorable safety profile. While competitive pressures and patent landscapes pose risks, strategic expansion into emerging markets and pipeline innovations present opportunities for sustained financial growth. The drug’s journey exemplifies a niche product evolving within a dynamic healthcare ecosystem influenced by epidemiological trends, technological advances, and regulatory environments.

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Key Takeaways

• The global rosacea patient base is expanding, underpinning sustained demand for ivermectin cream.
• Clinical efficacy and patient preferences favor SOOLANTRA over traditional therapies, supporting its market penetration.
• Regional expansion and regulatory approvals are critical to the drug’s long-term revenue growth.
• Competitive pressures from generics, biologics, and evolving treatment paradigms necessitate ongoing innovation.
• Strategic responses to patent expirations, pricing pressures, and emerging market dynamics are essential to maintaining financial trajectory.

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FAQs

1. What distinguishes SOOLANTRA from other rosacea treatments?
SOOLANTRA’s active ingredient, ivermectin, offers anti-inflammatory and antiparasitic effects with a favorable safety profile, a once-daily topical application, and minimal side effects, making it preferable over some traditional therapies like topical metronidazole or oral antibiotics.

2. How does market competition impact SOOLANTRA’s sales?
The availability of alternative therapies, potential biosimilars, and emerging biologics threaten market share and pricing power. However, SOOLANTRA’s proven efficacy and regulatory exclusivity help sustain its position.

3. What is the outlook for SOOLANTRA in emerging markets?
Emerging markets represent significant growth opportunities due to increasing awareness, rising disposable incomes, and expanding dermatology infrastructures. Projected CAGR of approximately 15% indicates a robust future.

4. How do patent protections influence SOOLANTRA’s financial trajectory?
Patent protections extending to 2030 ensure market exclusivity, supporting stable revenues. Expiration could lead to generics, impacting profitability unless innovation or new indications are developed.

5. What strategic actions can manufacturers take to sustain growth?
Expanding indications, developing combination formulations, entering new regional markets, and leveraging digital health initiatives can bolster growth and offset competitive risks.

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References

[1] Bernstein, E. F., et al. (2014). "Rosacea: An overview of epidemiology, pathogenesis, and treatment." Journal of Clinical and Aesthetic Dermatology, 7(2), 31-38.

[2] Siliqua, C., et al. (2018). "Efficacy and safety of topical ivermectin for papulopustular rosacea." Dermatology Reports, 10(3), 7510.

[3] MarketWatch. (2022). "Global rosacea treatment market size, share, forecast to 2027." Available at: marketwatch.com

[4] Frost & Sullivan. (2022). "Emerging markets dermatology reports." Available at: frost.com