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 twelve patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-seven patent family members in twenty-eight countries.

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Twenty-one 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:	77
US Patents:	12
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 twelve 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	8,470,788		Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	8,415,311		Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	8,815,816		Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	11,033,565		Y
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	9,233,118
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	7,550,440		Y

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
China	105828825	用伊维菌素治疗红斑痤疮的炎性病灶 (TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN)
South Africa	200507346	Topical formulation of ivermectin for the treatment of dermatological conditions
Hungary	S1500048
Denmark	1620113
France	2854074	UTILISATION DE L'IVERMECTINE POUR LE TRAITEMENT DE DESORDRES DERMATOLOGIQUES (Use of ivermectin for preparation of a composition for treating e.g. rosacea, common acne, seborrheic dermatitis, perioral dermatitis and acneform rashes)
China	105792829	使用伊维菌素治疗丘疹脓疱性红斑痤疮 (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
Hong Kong	1223842	用伊維菌素治療紅斑痤瘡的炎性病灶 (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	C01620113/01	Switzerland		PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
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	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	92915	Luxembourg		PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
1620113	C300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113	15C0069	France		PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 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

SOOLANTRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Soolantra

Introduction to Soolantra

Soolantra, a topical cream, is a key product in the therapeutic dermatology portfolio of Galderma, specifically designed to treat rosacea. It contains ivermectin as its active ingredient and is widely recognized for its efficacy in reducing the symptoms of rosacea, including inflammatory lesions and erythema.

Market Context

Rosacea Treatment Market

The global rosacea treatment market has been experiencing significant growth, driven by increasing consumer awareness, improving healthcare infrastructure, and the adoption of advanced technologies. The market was valued at USD 1.5 billion in 2017 and is anticipated to grow at a CAGR of 6.8% from 2019 to 2025[1].

Competitive Landscape

In this competitive landscape, Galderma, through its division Nestlé S.A., holds a dominant position. Soolantra, along with other products like Mirvaso, Oracea, and MetroGel, contributes substantially to Galderma's market share in the rosacea treatment segment[1].

Financial Performance of Galderma

Overall Net Sales

Galderma has been reporting robust financial performance across its product categories. For the first half of 2024, the company achieved record net sales of 2.2 billion USD, with a year-on-year growth of 10.8% on a constant currency basis. This growth is broad-based, with significant contributions from all product categories, including Therapeutic Dermatology[2].

Therapeutic Dermatology Segment

In the Therapeutic Dermatology segment, which includes Soolantra, Galderma has seen consistent growth. For the first nine months of 2023, this segment recorded high single-digit net sales growth year-on-year on a constant currency basis. Key brands such as Differin, Soolantra, and Aklief drove this growth, particularly through successful yield improvement measures in the U.S. and continued growth in international markets[4].

Full-Year 2023 Performance

For the full year 2023, Galderma reported net sales of 4.082 billion USD, with an 8.5% year-on-year growth on a constant currency basis. The Therapeutic Dermatology segment specifically saw an 8.7% year-on-year net sales growth, driven by the performance of key brands including Soolantra[5].

Geographical Performance

International Markets

Soolantra has shown strong performance in international markets. Galderma's international sales grew 12.3% year-on-year on a constant currency basis in 2023, with significant contributions from markets like China, India, Brazil, the UK, and Mexico. This growth underscores the global demand for effective rosacea treatments and Galderma's strategic expansion in these regions[5].

U.S. Market

In the U.S., despite a high comparative base in 2022, Galderma continued to gain market share in the Therapeutic Dermatology segment. The company's focus on yield improvement measures and brand strengthening has helped maintain a strong presence in the U.S. market for Soolantra and other therapeutic dermatology products[4].

Pipeline and Innovation

Continued Innovation

Galderma's success with Soolantra is part of its broader strategy of innovation and pipeline development. The company continues to invest in new technologies and products, such as nemolizumab and RelabotulinumtoxinA, which are expected to further bolster its market position in the future[2][4].

Financial Metrics and Profitability

Core EBITDA Margin

Galderma's financial health is also reflected in its Core EBITDA margin, which was 23.1% for 2023, representing a significant expansion of 281 basis points on a constant currency basis compared to the previous year. This margin expansion is driven by gains from premiumization, structural cost savings, and operating expenses leverage[5].

Future Guidance

For 2024, Galderma expects to maintain its Core EBITDA margin in line with 2023, despite increased investments in pipeline candidates like nemolizumab. This indicates a stable financial trajectory and a commitment to ongoing innovation and market expansion[5].

Key Takeaways

• Market Growth: The rosacea treatment market is growing, driven by increasing consumer awareness and improving healthcare infrastructure.
• Galderma's Dominance: Galderma, through its Nestlé S.A. division, leads the market with products like Soolantra.
• Financial Performance: Galderma has reported strong net sales growth across all product categories, including Therapeutic Dermatology.
• Geographical Expansion: Soolantra has seen significant growth in both international and U.S. markets.
• Innovation Pipeline: Continued investment in new technologies and products supports future growth.
• Financial Health: Galderma maintains a strong Core EBITDA margin and expects stable profitability in 2024.

FAQs

Q: What is the current market size of the rosacea treatment market? A: The global rosacea treatment market was valued at USD 1.5 billion in 2017 and is expected to grow at a CAGR of 6.8% from 2019 to 2025[1].

Q: Which company leads the rosacea treatment market? A: Galderma, through its division Nestlé S.A., holds a dominant position in the rosacea treatment market with products like Soolantra[1].

Q: What was Galderma's net sales growth for the first half of 2024? A: Galderma achieved a net sales growth of 10.8% year-on-year on a constant currency basis for the first half of 2024[2].

Q: How has Soolantra performed in international markets? A: Soolantra has shown strong performance in international markets, contributing to Galderma's 12.3% year-on-year growth in these regions[5].

Q: What are Galderma's expectations for 2024? A: Galderma expects to deliver 7-10% net sales growth on a constant currency basis and maintain its Core EBITDA margin in line with 2023[5].

Sources

1. Grand View Research: Rosacea Treatment Market Size & Share | Industry Report, 2019-2025
2. Galderma Investors: Galderma Delivers Record Net Sales of 2.2 Billion USD and 10.8% Year-on-Year Growth at Constant Currency for the First Half of 2024
3. Galderma News: Galderma delivers a strong start to the year with record net sales of over 1 billion USD for the first quarter and 12.4% year-on-year growth
4. Business Wire: Galderma Reports Record Net Sales of Over 3 B USD for the First Nine Months of 2023 With Strong Growth Momentum Across All Product Categories
5. Galderma News: Galderma announces record 2023 net sales of over 4 B USD and significant core EBITDA margin expansion