Adapalene; benzoyl peroxide - Generic Drug Details

What are the generic sources for adapalene; benzoyl peroxide and what is the scope of patent protection?

Adapalene; benzoyl peroxide is the generic ingredient in four branded drugs marketed by Actavis Labs Ut Inc, Actavis Mid Atlantic, Alembic, Encube, Glenmark Pharms Ltd, Padagis Israel, Taro, Zydus Pharms, Galderma Labs Lp, Galderma Labs, and Bausch, and is included in thirteen NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide has sixty-eight patent family members in twenty-five countries.

Thirteen suppliers are listed for this compound.

Summary for adapalene; benzoyl peroxide

International Patents:	68
US Patents:	10
Tradenames:	4
Applicants:	11
NDAs:	13
Finished Product Suppliers / Packagers:	13
Clinical Trials:	42
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adapalene; benzoyl peroxide
DailyMed Link:	adapalene; benzoyl peroxide at DailyMed

Recent Clinical Trials for adapalene; benzoyl peroxide

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

Sponsor	Phase
University of Oklahoma	Phase 3
delta medical promotions ag	N/A
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"	N/A

See all adapalene; benzoyl peroxide clinical trials

Pharmacology for adapalene; benzoyl peroxide

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for adapalene; benzoyl peroxide

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D10AE	Peroxides
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for ADAPALENE; BENZOYL PEROXIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPIDUO FORTE	Gel	adapalene; benzoyl peroxide	0.3%/2.5%	207917	1	2016-05-04
EPIDUO	Gel	adapalene; benzoyl peroxide	0.1%/2.5%	022320	1	2011-12-30

US Patents and Regulatory Information for adapalene; benzoyl peroxide

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			Y
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes			Y
Encube	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	206164-001	May 23, 2018	AB	RX	No	No
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes			Y
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes
Glenmark Pharms Ltd	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	208108-001	Nov 8, 2019	AB	RX	No	No

Expired US Patents for adapalene; benzoyl peroxide

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
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008

International Patents for adapalene; benzoyl peroxide

Country	Patent Number	Title	Estimated Expiration
Germany	122008000041
France	2903603	COMBINAISON D'ADAPALENE ET DE PEROXYDE DE BENZOLE DANS LE TRAITEMENT DE L'ACNE (Use of adapalene for the preparation of composition to be administered in combination/in association with benzoyl peroxide for reducing the number of acne injuries such as inflammatory and/or non-inflammatory type)
Colombia	6150136	COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAR LESIONES DE ACNE
Spain	2423951
Lithuania	2450035
Cyprus	1107583
Spain	2275948

Supplementary Protection Certificates for adapalene; benzoyl peroxide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	C01458369/01	Switzerland		PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369	380	Finland
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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	SZ 31/2008	Austria		PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
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

Adapalene; benzoyl peroxide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Adapalene Benzoyl Peroxide Gel

Introduction

Adapalene benzoyl peroxide gel, a topical fixed-dose combination treatment for severe acne vulgaris, has been gaining significant traction in the pharmaceutical market. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this product.

Market Growth and Projections

The adapalene benzoyl peroxide gel market has witnessed substantial growth in recent years and is expected to continue this upward trend. According to market research reports, the market is projected to experience significant expansion from 2023 to 2031, driven by increasing demand for effective acne treatments[1][3].

Market Size and Revenue

The global adapalene benzoyl peroxide gel market is anticipated to grow substantially, with market size projections indicating a sustained and significant expansion. The market size is measured in USD million, and the forecast period from 2024 to 2031 shows promising growth rates[1][3].

Key Drivers of Market Growth

Several factors are driving the growth of the adapalene benzoyl peroxide gel market:

Increasing Prevalence of Acne

The rising prevalence of acne, particularly among teenagers and young adults, is a major driver. According to the National Center for Biotechnology Information, about 15 to 30 teenagers suffer from moderate to severe acne, which is more common in females than males[4].

Regulatory Approvals

Regulatory approvals, such as the FDA approval of Differin gel 0.1% for over-the-counter (OTC) treatment of acne, have boosted the market. Additionally, the launch of generic versions of Epiduo gel by companies like Teva Pharmaceutical Industries Ltd. has expanded market access[4].

Combination Therapy

The effectiveness of adapalene benzoyl peroxide gel as a combination therapy, particularly when used with oral antibiotics like doxycycline, has been a significant factor. Clinical trials have shown that this combination significantly improves treatment success rates and reduces acne severity[2].

Market Segmentation

The market is segmented based on several criteria:

By Type

The market is categorized into different types (Type I, Type II, Type III, Type IV), each with its own market dynamics and growth prospects[1].

By Application

The application segments include online sales and offline sales, with each channel contributing to the overall market growth[1].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America is expected to hold the highest market share, while Europe is anticipated to exhibit the highest CAGR[1][4].

Key Players and Market Share

Several key players dominate the adapalene benzoyl peroxide gel market:

Galderma

Galderma, known for its product Differin, is a major player in the market[4].

Teva

Teva Pharmaceutical Industries Ltd. has also made significant contributions with the launch of generic Epiduo gel[4].

Other Key Players

Other notable companies include Padagis, Mayne Pharma, Sincreus Florida, Fuhe Group, and Jinyao Pharmaceutical[1][3].

Market Dynamics: Drivers, Restraints, Opportunities, and Challenges

Drivers

• Increasing Demand for Acne Treatments: The growing prevalence of acne and the need for effective treatments drive the market.
• Regulatory Approvals: FDA approvals and the launch of generic products have expanded market access.
• Combination Therapy: The efficacy of adapalene benzoyl peroxide gel in combination with oral antibiotics is a significant driver[2].

Restraints

• Adverse Effects: Common adverse effects such as dry skin, burning sensation, and contact dermatitis can limit market growth[2].
• Pregnancy and Contraception Concerns: The product should be avoided in pregnant women, women planning a pregnancy, and those using inadequate contraception, which can restrict its use[2].

Opportunities

• Emerging Markets: Growing healthcare expenditure and increasing disposable income in emerging economies present opportunities for market expansion.
• Technological Advancements: The use of AI-based skin apps, such as My Skin Track PoreScan by La Roche-Posay, can drive demand for adapalene products[4].

Challenges

• Recurrence of Acne: Uncertainty about whether acne will recur after stopping adapalene benzoyl peroxide gel treatment is a challenge that needs to be addressed through further clinical trials[2].

Financial Trajectory

Revenue Growth

The market is expected to grow from $5.84 billion in 2023 to $6.11 billion in 2024, with a CAGR of 4.6%. By 2028, the market is projected to reach $7.3 billion, driven by factors such as faster economic growth, increased healthcare expenditure, and a rising teenage population[5].

Investment and Expenditure

Increased disposable income and healthcare expenditure are key financial drivers. For instance, the rise in disposable personal income by $7.3 billion in July 2023, as reported by the Bureau of Economic Analysis, indicates a positive financial trajectory for the market[5].

Clinical Efficacy and Benefits

Acute Treatment Success

Clinical trials have shown that adapalene benzoyl peroxide gel, when used in combination with oral doxycycline, significantly improves treatment success rates. For example, a study found that the treatment success rate at 12 weeks was higher with adapalene benzoyl peroxide gel and doxycycline compared to doxycycline alone (31.5% vs 8.4%, respectively)[2].

Maintenance Therapy

The benefits of adapalene benzoyl peroxide gel are maintained for 6 months with continued therapy. A maintenance phase study showed that 79% of patients treated with adapalene benzoyl peroxide gel maintained their improved total lesion count compared to 46% who received a placebo[2].

Consumer Behavior and Preferences

Increasing Awareness

Consumer awareness about the effectiveness of adapalene benzoyl peroxide gel is increasing, driven by marketing efforts and positive clinical outcomes. Social media campaigns and AI-based skin apps are also contributing to this awareness[4].

Preference for Combination Therapies

Consumers are increasingly preferring combination therapies that offer comprehensive treatment solutions. The combination of adapalene and benzoyl peroxide addresses multiple aspects of acne treatment, making it a preferred choice[2].

Regional Market Analysis

North America

North America is expected to hold the highest market share due to the high prevalence of acne and the launch of various adapalene products in the region[4].

Europe

Europe is anticipated to exhibit the highest CAGR, driven by the increasing launches of adapalene products and growing healthcare expenditure[4].

Asia-Pacific

The Asia-Pacific region is also seeing significant growth due to increasing healthcare expenditure and a rising population with acne-related issues[1].

Key Takeaways

• The adapalene benzoyl peroxide gel market is expected to experience significant growth from 2023 to 2031.
• Key drivers include increasing acne prevalence, regulatory approvals, and the effectiveness of combination therapy.
• The market is segmented by type, application, and geography, with North America holding the highest market share.
• Major players include Galderma, Teva, and other pharmaceutical companies.
• Financial growth is driven by increased healthcare expenditure and disposable income.

FAQs

What are the key ingredients in adapalene benzoyl peroxide gel?

Adapalene benzoyl peroxide gel contains adapalene 0.1% (a retinoid) and benzoyl peroxide 2.5% (an antimicrobial)[2].

Who should avoid using adapalene benzoyl peroxide gel?

Pregnant women, women planning a pregnancy, and women using inadequate contraception should avoid using adapalene benzoyl peroxide gel due to potential risks to the fetus[2].

What are the common adverse effects of adapalene benzoyl peroxide gel?

Common adverse effects include dry skin, burning sensation, and contact dermatitis[2].

Can adapalene benzoyl peroxide gel be used as a maintenance therapy?

Yes, adapalene benzoyl peroxide gel can be continued as maintenance therapy without an oral antibiotic, maintaining the benefits for up to 6 months[2].

Which regions are expected to see the highest growth in the adapalene benzoyl peroxide gel market?

North America is expected to hold the highest market share, while Europe is anticipated to exhibit the highest CAGR[1][4].

Sources

1. Market Research Intellect, "Global Adapalene Benzoyl Peroxide Gel Market Size, Trends and Forecasts 2023-2031".
2. NPS MedicineWise, "Adapalene with benzoyl peroxide (Epiduo) for severe acne vulgaris".
3. Market Research Pulse, "Adapalene Benzoyl Peroxide Gel Market Trends, Scope And Outlook".
4. Coherent Market Insights, "Adapalene Products Market - Share, Size and Industry Analysis".
5. The Business Research Company, "Global Acne Drugs Market Report 2024".