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EPIDUO FORTE Drug Patent Profile

Which patents cover Epiduo Forte, and what generic alternatives are available?

Epiduo Forte is a drug marketed by Galderma Labs and is included in one NDA.

The generic ingredient in EPIDUO FORTE 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 Forte

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

Summary for EPIDUO FORTE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	31
Patent Applications:	22
Drug Prices:	Drug price information for EPIDUO FORTE
Drug Sales Revenues:	Drug sales revenues for EPIDUO FORTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIDUO FORTE
What excipients (inactive ingredients) are in EPIDUO FORTE?	EPIDUO FORTE excipients list
DailyMed Link:	EPIDUO FORTE at DailyMed

See drug prices for EPIDUO FORTE

See drug sales revenues for EPIDUO FORTE

Recent Clinical Trials for EPIDUO FORTE

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 FORTE clinical trials

Pharmacology for EPIDUO FORTE

Drug Class

Retinoid

Paragraph IV (Patent) Challenges for EPIDUO FORTE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPIDUO FORTE	Gel	adapalene; benzoyl peroxide	0.3%/2.5%	207917	1	2016-05-04

US Patents and Regulatory Information for EPIDUO FORTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes

Expired US Patents for EPIDUO FORTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015

International Patents for EPIDUO FORTE

When does loss-of-exclusivity occur for EPIDUO FORTE?

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 FORTE around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2450035
Australia	2002364437
Australia	2008246274
Argentina	038924	UTILIZACION DEL ACIDO 6-[3-(1-ADAMANTIL)-4-METOXIFENIL)-2-NAFTOICO PARA EL TRATAMIENTO DE DESORDENES DERMATOLOGICOS

Supplementary Protection Certificates for EPIDUO FORTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	380	Finland
1458369	122008000041	Germany		PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369	SPC/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369	132008901685368	Italy		PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618

EPIDUO FORTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epiduo Forte

Introduction

Epiduo Forte, a topical gel formulation of adapalene and benzoyl peroxide, is a widely used treatment for acne vulgaris. Developed by Galderma Laboratories, L.P., this drug has been a significant player in the dermatological skincare market. Here, we delve into the market dynamics and financial trajectory of Epiduo Forte.

Market Sales and Revenue

As of September 2021, Epiduo Forte generated annual sales of $253 million in the U.S., according to IQVIA data[2][5].

• This figure highlights the drug's strong market presence and demand, particularly in the U.S. market.

Historical Sales Trends

Historical data shows that Epiduo Forte has maintained a stable and growing sales trend.

• In the 12 months preceding January 2018, market sales of the generic version of Epiduo Gel (0.1%/2.5%) were approximately $164 million[4].
• The transition to Epiduo Forte (0.3%/2.5%) saw an increase in sales, reflecting the product's effectiveness and market acceptance.

Impact of Generic Versions

The introduction of generic versions has had a mixed impact on Epiduo Forte's sales.

• In 2021, Teva announced the launch of an authorized generic of Epiduo Forte Gel, which could potentially affect Galderma's market share[5].
• However, Galderma's strong brand loyalty and the drug's efficacy have helped maintain its market position despite generic competition.

Parent Company Performance

Galderma, the parent company of Epiduo Forte, has shown robust financial performance.

• In FY 2022, Galderma delivered a 13.9% year-on-year net sales growth on a constant currency basis, reaching $3.76 billion in net sales. The company also achieved a 14.5% year-on-year Core EBITDA growth on a constant currency basis[3].

Segment Performance

Epiduo Forte falls under Galderma's Dermatological Skincare segment, which has been a high-growth area.

• This segment saw a 30.7% year-on-year net sales growth on a constant currency basis in FY 2022, driven by increased consumer demand, new launches, channel expansion, and robust e-commerce performance[3].

Challenges and Competition

Despite strong growth, the Therapeutic Dermatology segment, which includes Epiduo Forte, faced some challenges.

• The segment experienced a year-on-year net sales decline due to the loss of exclusivity for Epiduo Forte and Soolantra in the U.S., increased patient access rebates, and greater competition. However, the segment continued to grow in Asia and Latin America[3].

Geographic Performance

Epiduo Forte's performance varies geographically.

• While it faces challenges in the U.S. due to generic competition and loss of exclusivity, it continues to grow in other regions such as Asia and Latin America[3].

Future Outlook

Galderma expects to continue its growth trajectory.

• For 2023, the company projects 6-9% net sales growth on a constant currency basis and a 200-300 basis points Core EBITDA margin expansion compared to 2022. This growth is expected to be driven by innovation, commercial execution, and geographic expansion[3].

Consumer Demand and Market Trends

Consumer demand for dermatological skincare products remains strong.

• The market is driven by increasing awareness of skincare, new product launches, and the expansion of distribution channels, including e-commerce. These factors contribute to the sustained growth of products like Epiduo Forte[3].

Regulatory Environment

The pharmaceutical industry, including Galderma, operates in a complex regulatory environment.

• Factors such as healthcare reforms, pricing regulations, and the impact of the COVID-19 pandemic can affect sales and profitability. However, Galderma has navigated these challenges effectively, as evidenced by its strong financial performance[3][5].

Innovation and Pipeline

Galderma's innovation pipeline is a key driver of its growth.

• The company is developing new products, such as RelabotulinumtoxinA and nemolizumab, which are expected to contribute to future growth. These innovations help Galderma maintain its market leadership in dermatology[3].

"Galderma delivered at the top end of its 2022 revenue guidance with 13.9% net sales year-on-year growth on a constant currency basis and exceeded its 2022 profitability guidance, delivering 14.5% Core EBITDA year-on-year growth on a constant currency basis." - Flemming Ørnskov, M.D., MPH, Chief Executive Officer, Galderma[3]

Key Takeaways

• Strong Sales Performance: Epiduo Forte generated $253 million in annual sales in the U.S. as of September 2021.
• Parent Company Growth: Galderma achieved 13.9% year-on-year net sales growth and 14.5% year-on-year Core EBITDA growth in FY 2022.
• Segment Growth: The Dermatological Skincare segment, which includes Epiduo Forte, saw a 30.7% year-on-year net sales growth.
• Geographic Variance: While facing challenges in the U.S., Epiduo Forte continues to grow in other regions.
• Future Outlook: Galderma expects 6-9% net sales growth and a 200-300 basis points Core EBITDA margin expansion in 2023.

FAQs

Q: What are the annual sales of Epiduo Forte in the U.S.? A: As of September 2021, Epiduo Forte had annual sales of $253 million in the U.S.[2][5].

Q: How has the introduction of generic versions affected Epiduo Forte's sales? A: The introduction of generic versions has had a mixed impact, but Galderma's strong brand loyalty and the drug's efficacy have helped maintain its market position[5].

Q: What is the growth trend for Galderma's Dermatological Skincare segment? A: The segment saw a 30.7% year-on-year net sales growth on a constant currency basis in FY 2022, driven by increased consumer demand and new launches[3].

Q: What challenges has the Therapeutic Dermatology segment faced? A: The segment experienced a year-on-year net sales decline due to loss of exclusivity, increased patient access rebates, and greater competition in the U.S.[3].

Q: What is Galderma's outlook for 2023? A: Galderma expects 6-9% net sales growth and a 200-300 basis points Core EBITDA margin expansion in 2023, driven by innovation and commercial execution[3].

Sources

1. Drug Sales Trends for Epiduo Forte - DrugPatentWatch
2. Epiduo® Forte (adapalene/benzoyl peroxide) - OptumRx
3. Galderma delivers strong FY 2022 growth driven by innovation and commercial performance - Galderma
4. FDA Grants Final Approval For Epiduo Gel And Estrace Cream Generics - Drug Discovery Trends
5. Teva Announces Launch of an Authorized Generic of Epiduo® Forte Gel - BioSpace