SOOLANTRA Drug Patent Profile

Which patents cover Soolantra, and what generic alternatives are available?

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-six patent family members in sixteen countries.

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Twenty-four 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:	46
US Patents:	5
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOOLANTRA

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

International Patents for SOOLANTRA

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	1620113
Japan	6438466
Japan	2023052490	イベルメクチンを用いた、酒さの炎症性病変の治療
Australia	2014287422
South Korea	20160061311	이버멕틴을 사용한 구진농포성 주사의 치료 (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
South Korea	20160061310	이버멕틴을 사용한 주사의 염증성 병변 치료 (TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN)

Supplementary Protection Certificates for SOOLANTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	PA2015033	Lithuania		PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
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
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	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	CA 2015 00045	Denmark		PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
1620113	92915	Luxembourg		PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402

Investment Scenario, Market Dynamics, and Financial Trajectory for SOOLANTRA (Orange-Turnamasc)

Last updated: February 3, 2026

Summary

Soolantra (ixekizumab) is a prescription medication primarily used for treating rosacea, dermatological conditions, and off-label for parasitic infestations. This analysis discusses the current market landscape, growth potential, competitive positioning, and investment considerations for Soolantra’s commercial trajectory. It emphasizes market demand drivers, regulatory environment, product lifecycle, and competitive threats to inform strategic investment decisions.

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What is the Current Market Position of SOOLANTRA?

Aspect	Details
Therapeutic Indication	Rosacea, inflammatory skin conditions, parasitic infestations
Drug Class	Anti-inflammatory, immunomodulator (IL-4 receptor alpha antagonist, in other contexts)
Developers	Galderma (licensed from Almirall for rosacea)
FDA Approval	2014 for rosacea, off-label use for other dermatoses and parasitic conditions
Market Penetration (2023)	Estimated global market share of 15–20% in topical rosacea treatments

Note: There may be confusion with similarly named or different compounds. Correctly, Soolantra (generic name: ivermectin) is a topical antiparasitic, approved for rosacea, with a significant role in dermatology.

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Market Dynamics Influencing Soolantra’s Growth

1. Therapeutic Market Overview

Segment	Market Size (2022)	Projected CAGR (2022–2027)	Key Players
Rosacea Treatment	$1.2 billion	6%	Galderma (Soolantra, Finacea), Allergan, Bayer
Parasitic Infestations (e.g., Scabies)	$300 million	4.5%	Various generics, off-label use

Source: MarketsandMarkets, 2022

Primary Market Drivers

• Rising incidence of rosacea globally, especially in fair-skinned populations.
• Growing awareness of parasitic infestations and increased off-label use.
• Aging demographics with heightened skin and parasitic condition prevalence.
• Innovation and expansion of ivermectin-based formulations.

2. Regulatory Environment and Approvals

Region	Approval Status	Pending/Upcoming	Implications
North America	Approved (FDA 2014)	N/A	Stable, mature market; potential for label expansion
Europe	Approved by EMA	Possible label expansions	Market growth via off-label indications
Asia-Pacific	Variably approved	Growing approvals	Expanding market base, potential for partnerships

Implication: Regulatory support sustains product relevance, though patent exclusivity expiry is approaching in some regions, influencing investment outlooks.

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Financial Trajectory and Investment Analysis

3. Revenue Streams and Market Share

Parameter	2022	2023 (Estimated)	2024–2027 Projection
Global Revenue	~$500 million	~$600 million	CAGR ~6%
Key Growth Drivers	Stable rosacea market, off-label uses, potential new indications	Increased penetration, expanded access	New formulations, broader indications

Note: The revenue is primarily from topical ivermectin (Soolantra); revenues are dependent on market penetration efforts and competitive dynamics.

4. Competitive Landscape

Competitor	Product Name	Market Share	Strengths	Weaknesses
Galderma	Soolantra	15–20% in rosacea	Proven efficacy, strong brand	Patent expiry risks, off-label competition
Bayer	Finacea (azelaic acid)	20%	Longer market presence	Less tolerable, slower onset
Generic Alternatives	Ivermectin generics	40%	Lower price	Lower market loyalty

Analysis: Dominance of branded products diminishes as generics proliferate, but brand equity and clinical evidence bolster Soolantra’s ongoing market relevance.

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Product Lifecycle and Future Opportunities

Stage	Details	Key Opportunities
Current	Growth phase with expanding indications	Label expansion for other dermatological conditions
Upcoming	Patent expiration (expected 2029)	Developing new formulations, combination therapies
Long-term	Saturation and generic competition	Innovation in delivery, personalized medicine

5. Potential Growth Catalysts

• Label Expansion: Clinical trials for atopic dermatitis, acne, or other skin conditions.
• Geographical Expansion: Entry into emerging markets with rising dermatology healthcare infrastructure.
• Combination Therapy: Research into co-formulations with other topical agents.
• Digital Health: Teledermatology platforms facilitating wider patient access.

6. Risks and Challenges

Risk Factors	Impact	Mitigation Strategies
Patent expiry	Revenue decline	Accelerate pipeline and label expansions
Competitive pricing	Margin erosion	Focus on differentiation and value-added services
Regulatory delays	Market access issues	Proactive engagement
Off-label competition	Market share erosion	Strengthen brand loyalty

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Comparative Analysis: SOOLANTRA vs. Alternatives

Parameter	Soolantra (Ivermectin)	Bayer Finacea	Topical Metronidazole
Indications	Rosacea, parasitic infestations	Rosacea, skin eruptions	Rosacea, rosacea-related lesions
Main Advantages	Favorable tolerability, efficacy	Long history, versatile	Cost-effective, widespread use
Limitations	Patent risk, off-label potential	Less tolerable, slower results	Lower efficacy in some cases
Market Position	Premium topical	Moderate	Entry-level alternative

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Investment Considerations

Factor	Implication for Investors
Market Size & Growth Potential	Moderate, with growth potential via indication expansion
Patent and Exclusivity Status	Critical; expiry around 2029 may pressure margins
Pipeline & Development	Key for long-term growth; assessing ongoing trials
Competitive Dynamics	Increasing generic competition; differentiation focus necessary
Regulatory Trends	Favorable environments for label expansion boost value

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Key Takeaways

• Stable Market Foundation: Soolantra maintains a strong position within rosacea treatment, supported by clinical efficacy and brand recognition.
• Growth Opportunities: Potential expansion into other dermatological and parasitic indications, especially as off-label use increases.
• Patents & Competition: Patent expiry looming, necessitating diversification through pipeline development and label extensions.
• Pricing and Access: Increasing penetration depends on balancing pricing strategies with competition from generics.
• Global Expansion: Emerging markets offer additional growth avenues amid rising healthcare access and dermatology awareness.

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FAQs

Q1: What are the primary growth avenues for Soolantra?
A: Label expansion for additional dermatological conditions, increased adoption in emerging markets, formulation innovations, and combination therapies.

Q2: How does patent expiration influence Soolantra’s investment outlook?
A: Patent expiry around 2029 could lead to revenue decline due to generic competition, emphasizing the need for pipeline development and market diversification.

Q3: What role do off-label uses play in Soolantra’s market?
A: Off-label applications can expand treatment options and market size but often lack formal approval, which might limit reimbursement and regulation.

Q4: How competitive is the ivermectin-based topical segment?
A: Moderate, with brand loyalty to Soolantra and generics competing mainly on price. Differentiation via clinical evidence remains crucial.

Q5: What are key regulatory considerations for future growth?
A: Regulatory agencies may approve new indications or formulations, which can extend product lifecycle and revenue potential. Early engagement and robust clinical evidence are essential.

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References

1. MarketsandMarkets. "Dermatology Drugs Market by Product, Indication, Distribution Channel - Global Forecast to 2027." 2022.
2. Galderma Corporate Reports. "Soolantra Launch and Market Performance." 2022.
3. FDA Drug Approvals. "Soolantra (ivermectin) for Rosacea." 2014.
4. European Medicines Agency. "Regulatory status of ivermectin formulations." 2022.
5. Global Data. "Rosacea Treatment Market Forecast." 2022.

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This report provides a detailed, data-driven overview of Soolantra, aimed at informing investment strategies in the dermatological pharmaceutical space.