EPIDUO Drug Patent Profile

Which patents cover Epiduo, and when can generic versions of Epiduo launch?

Epiduo is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in two NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-eight patent family members in twenty-five countries.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epiduo

A generic version of EPIDUO was approved as adapalene; benzoyl peroxide by PADAGIS ISRAEL on January 23^rd, 2018.

Summary for EPIDUO

International Patents:	68
US Patents:	4
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	31
Patent Applications:	22
Drug Prices:	Drug price information for EPIDUO
Drug Sales Revenues:	Drug sales revenues for EPIDUO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIDUO
What excipients (inactive ingredients) are in EPIDUO?	EPIDUO excipients list
DailyMed Link:	EPIDUO at DailyMed

See drug prices for EPIDUO

See drug sales revenues for EPIDUO

Recent Clinical Trials for EPIDUO

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

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 2
Beiersdorf	Phase 2
Mahidol University	Phase 2

See all EPIDUO clinical trials

Pharmacology for EPIDUO

Drug Class

Retinoid

Paragraph IV (Patent) Challenges for EPIDUO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPIDUO	Gel	adapalene; benzoyl peroxide	0.1%/2.5%	022320	1	2011-12-30

US Patents and Regulatory Information for EPIDUO

EPIDUO is protected by four 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	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes	8,080,537
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes	7,820,186		Y
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes	8,129,362
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes	8,071,644		Y

Expired US Patents for EPIDUO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	RE34440
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	8,105,618
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	4,717,720
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	8,936,800

International Patents for EPIDUO

When does loss-of-exclusivity occur for EPIDUO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Colombia

Cyprus

Denmark

European Patent Office

France

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EPIDUO around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	200403759	GEL COMPRISING AT LEAST A RETINOID AND BENZOYL PEROXIDE
Luxembourg	85849
Poland	2114392
Cyprus	1107583

Supplementary Protection Certificates for EPIDUO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	08C0024	France		PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
0199636	300209	Netherlands		300209, 20060411, EXPIRES: 20070702
1458369	SPC/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369	SZ 31/2008	Austria		PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID

Market Dynamics and Financial Trajectory for the Drug: EPIDUO

Introduction to EPIDUO

EPIDUO, a topical gel formulation developed by Galderma, is a combination therapy that targets acne vulgaris. It contains adapalene and benzoyl peroxide, two active ingredients that work synergistically to reduce acne lesions and prevent new ones from forming.

Market Growth and Drivers

The global acne vulgaris market, in which EPIDUO is a key player, is experiencing significant growth. The market is projected to grow at a rate of 3.80% over the forecast period, driven by increasing awareness and concerns about the harmful effects of acne vulgaris among the global population[1].

Product Performance and Innovations

Galderma's EPIDUO has been a strong contributor to the company's growth. The drug has efficiently targeted acne vulgaris, boosting the market's progress. However, the market also faces challenges such as the loss of exclusivity for certain formulations like EPIDUO Forte and increased competition, which have impacted sales in some regions[2].

Financial Performance of Galderma

Galderma, the manufacturer of EPIDUO, has delivered strong financial performance in recent years. In 2022, the company achieved 13.9% year-on-year net sales growth on a constant currency basis, reaching $3.76 billion USD. This growth was driven by strong performance in Injectable Aesthetics and Dermatological Skincare, with the latter category seeing a 30.7% year-on-year growth[2].

Segment-Specific Performance

Dermatological Skincare

In the Dermatological Skincare segment, EPIDUO plays a crucial role. Despite the anticipated annualization of EPIDUO Forte and Soolantra's loss of exclusivity in the U.S., Galderma's Dermatological Skincare category continued to outperform the market. The segment saw robust growth, particularly fueled by increased consumer demand, new product launches, channel expansion, and strong e-commerce performance[2].

Therapeutic Dermatology

The Therapeutic Dermatology segment, which includes EPIDUO, experienced a year-on-year net sales decline in some regions due to the loss of exclusivity and increased competition. However, the segment continued to grow in Asia and Latin America, indicating potential for future expansion[2].

Pricing and Cost Considerations

EPIDUO is generally more expensive than purchasing its individual components over-the-counter. A month's supply of EPIDUO can cost around $438, whereas the individual ingredients (adapalene and benzoyl peroxide) can be obtained for significantly less, around $12 and $10 respectively[5].

Clinical Trials and Pipeline Progress

Galderma's ongoing research and development activities are crucial for the long-term growth of products like EPIDUO. The company has made significant progress in its pipeline, including the completion of phase III clinical trials for nemolizumab, a monoclonal antibody targeting prurigo nodularis and atopic dermatitis. These advancements are expected to fuel sustainable growth in the future[2].

Market Expansion and Geographic Performance

Galderma's products, including EPIDUO, have shown strong growth in fast-growing markets such as China, India, and Mexico. In the U.S., despite a high comparative base in 2022, Galderma continued to gain market share in Injectable Aesthetics and maintained a strong performance in Dermatological Skincare[3].

Challenges and Restraints

The acne vulgaris market, and by extension the sales of EPIDUO, face challenges such as poor return on investment for pharmaceutical companies, which can deter investment in research and development. Additionally, the loss of exclusivity for certain formulations and increased competition can impact sales negatively[1].

Future Outlook

Galderma is on track to deliver 6-9% net sales growth on a constant currency basis in 2023, with a Core EBITDA margin expansion of 200-300 basis points. The company's consistent performance and progress in deleveraging its business have led to upgrades in its credit rating by major rating agencies[3].

Key Takeaways

• Market Growth: The global acne vulgaris market is growing at a rate of 3.80%, driven by increasing awareness and concerns.
• Product Performance: EPIDUO has been a strong contributor to Galderma's growth, despite challenges like loss of exclusivity and competition.
• Financial Performance: Galderma achieved significant net sales and Core EBITDA growth in 2022, driven by strong performance in Dermatological Skincare and Injectable Aesthetics.
• Pricing: EPIDUO is more expensive than its individual components, but its convenience and efficacy justify the cost for many users.
• Clinical Trials: Galderma's ongoing R&D activities, including phase III trials for new treatments, are crucial for future growth.
• Geographic Performance: Strong growth in Asian and Latin American markets, along with market share gains in the U.S.

FAQs

Q: What are the key ingredients in EPIDUO? A: EPIDUO contains adapalene and benzoyl peroxide, which work together to treat acne vulgaris.

Q: How has Galderma's financial performance been in recent years? A: Galderma has delivered strong financial performance, with 13.9% year-on-year net sales growth and 14.5% Core EBITDA growth in 2022.

Q: What challenges does the acne vulgaris market face? A: The market faces challenges such as poor return on investment for pharmaceutical companies and increased competition.

Q: How is EPIDUO priced compared to its individual components? A: EPIDUO is significantly more expensive than purchasing its individual ingredients over-the-counter.

Q: What are Galderma's growth expectations for 2023? A: Galderma expects to deliver 6-9% net sales growth and a Core EBITDA margin expansion of 200-300 basis points in 2023.

Sources

1. BioSpace: Global Acne Vulgaris Market Growth Rate of 3.80 % over the Forecast Period 2019-2027.
2. Galderma Press Release: Galderma Delivers Strong FY 2022 Growth Driven by Innovation and Commercial Performance.
3. Business Wire China: Galderma Reports Record Net Sales of Over 3 B USD for the First Nine Months of 2023.
4. DrugPatentWatch: Drug Sales Trends for Epiduo Forte.
5. North River Pediatrics: Understanding the Cost of Medications.

Last updated: 2024-12-17