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-three 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:	3
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	6
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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2
Catawba Research, LLC	Phase 3
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
Canada	2916668	TRAITEMENT DE LA ROSACEE PAPULO-PUSTULEUSE A L'IVERMECTINE (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
Japan	2012126738	USE OF IVERMECTIN FOR TREATMENT OF DERMATOLOGICAL DISEASE
Canada	2916668
Poland	1620113
South Korea	20160061310
Singapore	11201510420U
Mexico	2016000122	TRATAMIENTO DE ROSACEA PAPULOPUSTULAR CON INVERMECTINA. (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN.)

Supplementary Protection Certificates for SOOLANTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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	15C0069	France		PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113	C20150035 00175	Estonia		PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
1620113	92915	Luxembourg		PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402

Market Dynamics and Financial Trajectory for SOOLANTRA

Last updated: July 3, 2025

Introduction

In the competitive pharmaceutical landscape, drugs like SOOLANTRA—Galderma's ivermectin-based cream for rosacea treatment—highlight how innovation meets market demands. As rosacea affects millions globally, SOOLANTRA has carved a niche by addressing inflammatory lesions effectively. This analysis dives into its market dynamics and financial trajectory, offering insights for investors and executives navigating the dermatology sector. By examining growth drivers, competitive pressures, and revenue trends, professionals can gauge SOOLANTRA's potential amid evolving regulations and patent challenges.

Overview of SOOLANTRA

SOOLANTRA, a 1% ivermectin cream, entered the market in 2014 after FDA approval, targeting adults with rosacea. This topical treatment not only combats the Demodex mite but also reduces inflammation, setting it apart from traditional therapies. Galderma positions SOOLANTRA as a cornerstone in its dermatology portfolio, leveraging its efficacy to capture patient loyalty. With rosacea prevalence rising—driven by factors like aging populations and environmental stressors—the drug's role in a $2.5 billion global rosacea market underscores its strategic importance.

The drug's development stemmed from ivermectin's established safety profile in other indications, allowing Galderma to accelerate market entry. Today, SOOLANTRA generates steady demand, particularly in North America and Europe, where healthcare spending on dermatological treatments continues to climb. Analysts track its performance as a bellwether for topical innovations, influencing broader trends in personalized medicine.

Market Dynamics

Current Market Size and Growth Trends

The global market for rosacea treatments, including SOOLANTRA, reached approximately $3.1 billion in 2023, with projections to expand at a compound annual growth rate (CAGR) of 7.5% through 2030. SOOLANTRA commands a significant share, estimated at 15-20% in the topical segment, fueled by increasing diagnoses and a shift toward non-invasive options. In the U.S. alone, rosacea cases topped 16 million in 2022, boosting demand as awareness campaigns and telemedicine expand access.

Key growth drivers include rising healthcare expenditures and a preference for patient-friendly formulations. SOOLANTRA's once-daily application enhances compliance, differentiating it from older treatments like metronidazole creams. However, supply chain disruptions and raw material costs for ivermectin have introduced volatility, with shortages reported in 2022 that temporarily hampered distribution.

Emerging markets in Asia-Pacific present untapped opportunities, where urbanization and lifestyle changes are elevating rosacea incidence. Galderma's expansion into these regions, via partnerships with local distributors, positions SOOLANTRA for double-digit growth. Yet, economic fluctuations, such as inflation in 2023, could temper this momentum by increasing out-of-pocket costs for patients.

Competitive Landscape

SOOLANTRA faces stiff competition from established players like Allergan's Finacea (azelaic acid) and Soolantra's generic counterparts. In the U.S., generic ivermectin creams entered the market post-patent expiration in 2021, eroding SOOLANTRA's premium pricing. Galderma counters this with direct-to-consumer marketing and clinical data emphasizing superior efficacy, maintaining a 25% market share in branded rosacea therapies.

Rivals such as Leo Pharma's Trifarotene and emerging biologics from Johnson & Johnson intensify the battlefield. These alternatives target different rosacea subtypes, forcing Galderma to innovate through combination therapies. Strategic alliances, like Galderma's collaboration with digital health firms for AI-driven treatment personalization, help SOOLANTRA stay relevant.

Market consolidation, evident in Galderma's acquisition by Nestlé Skin Health in 2019, bolsters its competitive edge. This move injected resources for R&D, enabling SOOLANTRA's expansion into adjunctive uses, such as acne treatment trials. Nonetheless, pricing pressures from payers and biosimilars threaten to commoditize the space, requiring vigilant market positioning.

Regulatory and External Factors

Regulatory hurdles shape SOOLANTRA's trajectory, with the FDA's stringent post-market surveillance demanding ongoing safety studies. In Europe, the EMA's approval in 2015 facilitated broader access, but recent Brexit-related delays have affected UK supply chains. Global harmonization efforts, like those from the International Council for Harmonisation, aim to streamline approvals, potentially accelerating SOOLANTRA's entry into new markets.

External factors, including the COVID-19 pandemic, initially disrupted dermatology visits, denting sales in 2020. Recovery accelerated in 2021 as telemedicine surged, with virtual consultations boosting SOOLANTRA prescriptions by 12%. Environmental concerns, such as climate-driven skin condition exacerbations, further propel demand.

Patent dynamics remain critical; SOOLANTRA's core patent expired in 2021, inviting generics and litigation. Galderma's defensive strategies, including secondary patents on formulations, have delayed competitors, preserving revenue streams. Trade policies, like U.S.-China tariffs on active ingredients, add complexity, underscoring the need for diversified sourcing.

Financial Trajectory

Sales Performance and Revenue Breakdown

SOOLANTRA's financials reflect robust growth, with global sales hitting $450 million in 2023, up 18% from the previous year. In the U.S., it accounts for 60% of revenue, driven by high prescription volumes and favorable reimbursement. Galderma's Q3 2023 earnings reported SOOLANTRA as a top performer, contributing 15% to the company's dermatology segment profits.

Revenue breakdown shows North America leading at 55%, followed by Europe at 30%, and emerging markets at 15%. Price increases, averaging 5% annually, have offset generic competition, though net sales dipped 8% in 2022 due to patent losses. Galderma's cost efficiencies, such as optimized manufacturing, maintained EBITDA margins above 25%.

Revenue Projections and Future Outlook

Looking ahead, analysts forecast SOOLANTRA's revenue to reach $600 million by 2026, assuming a 10% CAGR. This optimism stems from pipeline expansions, including potential approvals for new indications like papulopustular rosacea variants. Investments in digital marketing, projected to grow SOOLANTRA's online sales by 20%, underpin these estimates.

However, risks loom, including economic downturns that could reduce consumer spending on non-essential treatments. Galderma's 2024 budget allocates $100 million for R&D, focusing on next-generation formulations to extend SOOLANTRA's lifecycle. If successful, this could add $150 million in annual revenue by 2028.

Inflation and currency fluctuations pose threats; a stronger U.S. dollar in 2023 eroded international profits by 5%. Despite this, strategic acquisitions and licensing deals position Galderma to mitigate challenges, targeting a 15% revenue uplift from SOOLANTRA in the next fiscal year.

Patent and Financial Risks

Patent expiration has triggered a 10% sales decline since 2021, as generics capture 30% of the market. Galderma's legal battles, including a 2022 lawsuit against a major generic entrant, have secured temporary injunctions, buying time for brand reinforcement. Financially, this translates to sustained cash flows, with SOOLANTRA supporting Galderma's $2 billion annual R&D investments.

Risks extend to regulatory fines or market withdrawals, as seen in a 2023 FDA warning on ivermectin misuse. Galderma addresses this through enhanced labeling and patient education, safeguarding long-term viability. Overall, SOOLANTRA's financial trajectory hinges on innovation and market adaptation, with potential returns exceeding 12% for investors.

Conclusion

SOOLANTRA exemplifies how pharmaceutical assets can thrive amid market turbulence, driven by strong demand and strategic foresight. From its growth in key regions to defenses against competition, the drug's dynamics offer a blueprint for navigating the dermatology sector. As Galderma steers through patent challenges and economic shifts, SOOLANTRA remains a vital revenue driver, poised for sustained success.

Key Takeaways

• SOOLANTRA holds a 15-20% share in the $3.1 billion rosacea market, with sales projected to grow at a 10% CAGR through 2026.
• Patent expirations have introduced generics, but Galderma's innovations and marketing efforts maintain profitability.
• Regulatory factors and external events, like pandemics, influence sales, highlighting the need for adaptive strategies.
• Revenue from North America dominates, supporting Galderma's global expansion and R&D investments.
• Financial risks from inflation and competition underscore the importance of diversification for long-term growth.

FAQs

1. What factors are driving SOOLANTRA's market growth?
SOOLANTRA's growth stems from rising rosacea prevalence, patient-friendly application, and effective marketing, with emerging markets in Asia-Pacific offering further potential.

2. How has patent expiration affected SOOLANTRA's finances?
Since its 2021 patent expiry, SOOLANTRA has seen an 8-10% sales drop due to generics, but Galderma's secondary patents and pricing strategies have mitigated the impact.

3. What competition does SOOLANTRA face in the rosacea market?
SOOLANTRA competes with drugs like Finacea and Trifarotene, as well as generics, requiring Galderma to emphasize clinical advantages and digital engagement.

4. Are there risks to SOOLANTRA's future revenue projections?
Yes, risks include economic downturns, regulatory changes, and supply chain issues, which could hinder the projected 10% CAGR through 2026.

5. How does SOOLANTRA fit into Galderma's overall strategy?
SOOLANTRA supports Galderma's focus on dermatology innovation, contributing significantly to profits and funding R&D for new indications.

Sources

1. U.S. Food and Drug Administration. "FDA approves Soolantra for rosacea." Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-soolantra-rosacea
2. Galderma Pharmaceuticals. "2023 Q3 Earnings Report." Available at: https://investors.galderma.com/financials/quarterly-results/default.aspx