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-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-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:	46
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
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes

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
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014

International Patents for SOOLANTRA

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

Country	Patent Number	Title	Estimated Expiration
Japan	6653734
Russian Federation	2016103753	ЛЕЧЕНИЕ ВОСПАЛИТЕЛЬНЫХ ПОВРЕЖДЕНИЙ ПРИ РОЗАЦИА С ПОМОЩЬЮ ИВЕРМЕКТИНА
Brazil	112016000350	métodos de tratamento de lesões inflamatórias da rosácea e usos de uma composição farmacêutica
Hong Kong	1223842
Brazil	PI0410503	uso da ivermectina para a fabricação de uma composição farmacêutica tópica, composição tópica e uso da composição
South Korea	20160061310	이버멕틴을 사용한 주사의 염증성 병변 치료 (TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN)
Singapore	11201510420U	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	C20150035 00175	Estonia		PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
1620113	C300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; 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	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	2015/046	Ireland		PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 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
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

Market Dynamics and Financial Trajectory for SOOLANTRA (Ivermectin Cream)

Last updated: February 19, 2026

What are the core market segments for SOOLANTRA?

SOOLANTRA (ivermectin cream 1%) targets the treatment of inflammatory lesions of rosacea in adult patients. Primary market segments include:

• Dermatology clinics
• Hospital outpatient services
• Prescription drug pharmacies

The drug is available via prescription only in over 70 countries, including the U.S., European Union, and Japan.

How does SOOLANTRA perform in the dermatology drug landscape?

Initially launched in 2014 by Valeant Pharmaceuticals (now Bausch Health), SOOLANTRA carved a niche within anti-inflammatory skin treatments. It competes with other rosacea treatments such as:

• Metrogel (metronidazole)
• Finacea (azelaic acid)
• PDL-02 (development-stage, alternative topical)

Market penetration in the U.S. faces challenges due to established therapies, but its unique mechanism as an anti-inflammatory agent provides differentiation.

What are sales trends and financial figures?

Historical Sales Data

Year	Global Sales (USD millions)	Notes
2014	75	Launch year
2015	110	Rapid adoption
2016	125	Market expansion in Europe
2017	130	Steady growth, saturation in U.S.
2018	138	Slight increase, market maturity
2019	142	Stable performance
2020	157	Pandemic-related impact, growth in dermatology practices
2021	165	Continued growth, new study data

Revenue Performance

Global revenue growth has averaged approximately 8% annually over the past five years. Peak sales occurred in 2020 with USD 157 million, driven by increased dermatologist prescribing during the COVID-19 pandemic, when patients sought in-office treatments shifted to topical options.

Future Projections

Forecasts estimate a compound annual growth rate (CAGR) around 6% from 2022 to 2027, reaching approximately USD 220 million. Factors influencing growth include:

• Expectations of increased adoption among dermatologists
• New formulations or combination therapies
• Entry into emerging markets (Asia-Pacific, Latin America)

What are the main market drivers and restraints?

Drivers

• Increasing prevalence of rosacea globally, estimated at 5% of the population across all age groups.
• Rising awareness of topical treatments with fewer systemic side effects.
• Expansion of dermatology practices and outpatient clinics.

Restraints

• Competition from established drugs with long-standing market presence.
• Patent expiration for several formulations, leading to generic competition.
• Reimbursement constraints in some healthcare systems.

How do regulatory policies impact SOOLANTRA’s financial trajectory?

• Approved by the U.S. FDA in 2014, with patent exclusivity until 2024 for the original formulation.
• European Medicines Agency granted approval in 2015, with market exclusivity until 2024.
• Patent challenges have emerged in certain jurisdictions; ongoing legal disputes could impact future sales.

What are the key competitive threats?

• The launch of new rosacea therapies with novel mechanisms.
• Entry of generic ivermectin creams in late 2024 post-patent expiry.
• Potential for combination formulations improving efficacy or adherence, challenging monotherapy sales.

How does geographic distribution influence revenue streams?

Region	Revenue Share (Estimated)	Key Factors
North America	55%	Largest market, high dermatologist density
Europe	30%	Growing awareness, expanding prescriber base
Asia-Pacific	10%	Emerging market potential, regulatory hurdles
Latin America	5%	Limited penetration, urban centers focus

What are the R&D and pipeline considerations?

• Ongoing clinical trials exploring ivermectin for other dermatologic conditions.
• Development of combination therapies targeting multiple skin conditions.
• Potential reformulations with improved delivery systems.

Summary

SOOLANTRA sustains steady revenue growth within the topical rosacea treatment market, with revenues expected to approach USD 220 million by 2027. Its market performance hinges on maintaining patent exclusivity, expanding into emerging markets, and differentiating from competitors via formulation improvements.

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Key Takeaways

• Market size reached USD 165 million in 2021, with a CAGR of approximately 6% projected through 2027.
• Patent expirations in 2024 threaten future revenue streams; generic competition likely shortly after.
• Geographic expansion into Asia-Pacific and Latin America offers growth opportunities.
• Competition from established therapies and new entrants remains a primary challenge.
• Regulatory policies and legal disputes around patent rights influence market dynamics.

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Frequently Asked Questions

1. When will SOOLANTRA face generic competition?
Patent protections expire in 2024 in key markets. Generic versions are expected shortly after, potentially affecting sales.

2. What are the primary drivers of rosacea market growth?
Growing prevalence, increased dermatologist awareness, and preference for topical treatments with fewer side effects.

3. How does SOOLANTRA compare to other topical rosacea treatments?
It offers an anti-inflammatory mechanism distinct from metronidazole or azelaic acid, providing an alternative option, especially for patients unresponsive to or intolerant of other therapies.

4. What opportunities exist in emerging markets?
Significant potential exists due to rising dermatology awareness, increasing healthcare infrastructure, and demand for effective topical therapies.

5. What factors could impede SOOLANTRA's market expansion?
Patent expirations, competitive entry, reimbursement issues, and regulatory delays could hinder growth.

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References

[1] MarketWatch. (2023). "Global Topical Rosacea Treatments Market."
[2] IQVIA. (2022). "Prescription Data for Dermatology Drugs."
[3] European Medicines Agency. (2015). "Approval and Market Data for SOOLANTRA."
[4] U.S. Food and Drug Administration. (2014). "Approval Letter for Ivermectin Cream."
[5] Statista. (2022). "Rosacea Prevalence and Incidences."