You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 14, 2025

SOOLANTRA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 24th, 2014.

  Try for Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for SOOLANTRA?
  • What are the global sales for SOOLANTRA?
  • What is Average Wholesale Price for SOOLANTRA?
Drug patent expirations by year for SOOLANTRA
Drug Prices for SOOLANTRA

See drug prices for SOOLANTRA

Drug Sales Revenue Trends for SOOLANTRA

See drug sales revenues for SOOLANTRA

Recent Clinical Trials for SOOLANTRA

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

SponsorPhase
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2
Catawba Research, LLCPhase 3
Zydus Worldwide DMCCPhase 3

See all SOOLANTRA clinical trials

Pharmacology 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 ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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) ⤷  Try for Free
Japan 2012126738 USE OF IVERMECTIN FOR TREATMENT OF DERMATOLOGICAL DISEASE ⤷  Try for Free
Canada 2916668 ⤷  Try for Free
Poland 1620113 ⤷  Try for Free
South Korea 20160061310 ⤷  Try for Free
Singapore 11201510420U ⤷  Try for Free
Mexico 2016000122 TRATAMIENTO DE ROSACEA PAPULOPUSTULAR CON INVERMECTINA. (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN.) ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SOOLANTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 300756 Netherlands ⤷  Try for Free 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 ⤷  Try for Free 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 ⤷  Try for Free 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 ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113 C20150035 00175 Estonia ⤷  Try for Free PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
1620113 92915 Luxembourg ⤷  Try for Free PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.