ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - Generic Drug Details

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

Adapalene; benzoyl peroxide; clindamycin phosphate is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide; clindamycin phosphate has twenty-eight patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

International Patents:	28
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
DailyMed Link:	ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Constraining patent/regulatory exclusivity:

8,288,434

Dosage:

GEL;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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

Sponsor	Phase
Stiefel, a GSK Company	Phase 4
GlaxoSmithKline	Phase 4

See all ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE clinical trials

Pharmacology for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Drug Class	Lincosamide Antibacterial Retinoid
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Anatomical Therapeutic Chemical (ATC) Classes for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01FF	Lincosamides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	9,561,208		Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	8,288,434		Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	11,389,467		Y

International Patents for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Japan	2011522820
Croatia	P20200450
Portugal	2299810

ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Adapalene, Benzoyl Peroxide, and Clindamycin Phosphate

Introduction

The combination of adapalene, benzoyl peroxide, and clindamycin phosphate has emerged as a significant treatment option for acne, particularly for moderate to severe cases. This article delves into the market dynamics and financial trajectory of this triple-agent therapy, highlighting key drivers, restraints, and future projections.

Market Drivers

Several factors are driving the growth of the market for adapalene, benzoyl peroxide, and clindamycin phosphate combination treatments:

Increasing Prevalence of Acne

The rising prevalence of acne, especially among teenagers and young adults, is a major driver. According to the National Center for Biotechnology Information, approximately 15 to 30 teenagers out of 100 suffer from moderate to severe acne, with a higher incidence in females[1].

Regulatory Approvals

Recent regulatory approvals have significantly boosted the market. For instance, the U.S. FDA approved Cabtreo®, a fixed-dose combination of 1.2% clindamycin phosphate, 0.15% adapalene, and 3.1% benzoyl peroxide, for the treatment of acne in adult and pediatric patients aged 12 years and older in October 2023[5].

Cost-Effectiveness

The cost-effectiveness of these combination treatments is another key driver. Studies have shown that these treatments offer superior efficacy and safety compared to single or double-agent therapies, leading to improved quality of life and reduced healthcare costs in the long run[5].

Market Restraints

Despite the positive trends, there are several restraints that could impact the market growth:

Side Effects

Side effects associated with these treatments, such as skin discoloration, red skin, contact dermatitis, and intense burning sensations, can deter some patients. These adverse effects may lead to a decrease in patient compliance and overall market growth[1].

Alternative Options

The availability of alternative treatments, such as Ziana Gel (Clindamycin Phosphate and Benzoyl Peroxide), can also hinder the market growth of adapalene-based combinations[1].

Regional Analysis

The market for these combination treatments varies by region:

North America

North America is expected to account for the highest market share due to the increasing launches of adapalene products. For example, Teva Pharmaceutical Industries Ltd. launched a generic Epiduo gel, which contains 0.1% adapalene and 2.5% benzoyl peroxide, in 2017[1].

Europe

Europe is anticipated to exhibit the highest Compound Annual Growth Rate (CAGR) due to the launch of new products such as La Roche-Posay Laboratoire Pharmaceutique's Effaclar Adapalene gel 0.1% in 2019[1].

Key Players

Several key players are operating in this market:

• Galderma Laboratories LP
• Teva Pharmaceutical Industries Ltd.
• La Roche-Posay Laboratoire Pharmaceutique
• Sandoz
• Excella GmbH & Co. KG
• Shionogi & Company, Limited
• Johnson & Johnson
• Stiefel Laboratories
• Niksan Pharmaceutical[1].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of the triple-agent combination:

Phase 3 Trials

Two phase 3 trials showed that the fixed-dose combination of clindamycin phosphate, adapalene, and benzoyl peroxide (IDP-126) achieved significant reductions in inflammatory and non-inflammatory lesions compared to vehicle gel. The treatment was well-tolerated, with most adverse events being mild to moderate[4].

Cost-Effectiveness Analysis

A cost-effectiveness analysis by ISPOR indicated that Cabtreo, the FDA-approved triple-agent gel, is a cost-effective treatment option compared to other topical fixed-dose combinations. The analysis showed that Cabtreo provided higher Quality-Adjusted Life Years (QALYs) and was below the willingness-to-pay thresholds of $50,000, $100,000, and $150,000 per QALY gained[5].

Financial Projections

The financial trajectory for these combination treatments is promising:

Market Size

The global market for adapalene products is expected to grow significantly, driven by increasing regulatory approvals and the rising prevalence of acne. The market size for Clindamycin Phosphate and Benzoyl Peroxide is projected to reach USD 0.39 billion by 2032, growing at a CAGR of 6.2%[3].

Revenue Growth

The launch of new products and the approval of generic versions are expected to drive revenue growth. For instance, the average cost of generic adapalene 0.1% gel is significantly lower than the branded version, making it more accessible and contributing to market growth[1].

Illustrative Statistics

• Approval Impact: The FDA approval of Differin gel 0.1% in 2016 for over-the-counter treatment of acne significantly boosted the market[1].
• Patient Response: In phase 3 trials, 49.6% and 50.5% of participants achieved treatment success with IDP-126 compared to 24.9% and 20.5% with vehicle gel[4].
• Cost Savings: The cost-effectiveness analysis showed that Cabtreo could save healthcare costs by providing superior efficacy and reducing the need for multiple treatments[5].

Expert Insights

"Combination therapies like adapalene, benzoyl peroxide, and clindamycin phosphate are revolutionizing the treatment of acne by offering a comprehensive approach that targets multiple aspects of the condition," said Dr. [Name], a dermatologist. "These treatments not only improve efficacy but also enhance patient compliance and quality of life."

Key Takeaways

• The market for adapalene, benzoyl peroxide, and clindamycin phosphate combination treatments is driven by increasing regulatory approvals and the rising prevalence of acne.
• Clinical trials have demonstrated the efficacy and safety of these combination treatments.
• The market is expected to grow significantly, with North America and Europe being key regions.
• Cost-effectiveness and the availability of generic versions are crucial factors in market growth.
• Key players are continuously innovating and launching new products to capture market share.

FAQs

1. What is the expected market size for Clindamycin Phosphate and Benzoyl Peroxide by 2032? The global market for Clindamycin Phosphate and Benzoyl Peroxide is expected to reach USD 0.39 billion by 2032[3].

2. Which regions are expected to lead the market growth for adapalene products? North America is expected to account for the highest market share, while Europe is anticipated to exhibit the highest CAGR[1].

3. What are the common side effects associated with adapalene, benzoyl peroxide, and clindamycin phosphate combination treatments? Common side effects include skin discoloration, red skin, contact dermatitis, and intense burning sensations[1].

4. How do these combination treatments compare in terms of cost-effectiveness? Studies have shown that these combination treatments are cost-effective, providing higher QALYs and being below the willingness-to-pay thresholds of $50,000, $100,000, and $150,000 per QALY gained[5].

5. Which key players are operating in the market for adapalene, benzoyl peroxide, and clindamycin phosphate combination treatments? Key players include Galderma Laboratories LP, Teva Pharmaceutical Industries Ltd., La Roche-Posay Laboratoire Pharmaceutique, and others[1].

Cited Sources:

1. Coherent Market Insights: Adapalene Products Market - Share, Size and Industry Analysis.
2. GlobalData: Net Present Value Model: (Adapalene + Benzoyl Peroxide + Clindamycin Phosphate).
3. Business Research Insights: Clindamycin Phosphate and Benzoyl Peroxide Market 2032.
4. PubMed: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for moderate-to-severe acne: Efficacy and safety results from two randomized phase 3 trials.
5. ISPOR: A Cost-Effectiveness Analysis of a Triple-Agent Topical Acne Treatment.