BENZOYL PEROXIDE; TRETINOIN - Generic Drug Details

What are the generic drug sources for benzoyl peroxide; tretinoin and what is the scope of freedom to operate?

Benzoyl peroxide; tretinoin is the generic ingredient in one branded drug marketed by Galderma Labs Lp and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide; tretinoin has sixty-three patent family members in thirteen countries.

One supplier is listed for this compound.

Summary for BENZOYL PEROXIDE; TRETINOIN

International Patents:	63
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
DailyMed Link:	BENZOYL PEROXIDE; TRETINOIN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BENZOYL PEROXIDE; TRETINOIN

Constraining patent/regulatory exclusivity:

11,071,878

Dosage:

CREAM;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 BENZOYL PEROXIDE; TRETINOIN

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

Sponsor	Phase
GWT-TUD GmbH	Phase 4
Galderma Laboratories, L.P.	Phase 4
Zeichner, Joshua, M.D.	Phase 4

See all BENZOYL PEROXIDE; TRETINOIN clinical trials

Pharmacology for BENZOYL PEROXIDE; TRETINOIN

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for BENZOYL PEROXIDE; TRETINOIN

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

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for BENZOYL PEROXIDE; TRETINOIN

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	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,070,629		Y
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,053,546		Y
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	9,868,103		Y

International Patents for BENZOYL PEROXIDE; TRETINOIN

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201200347
Australia	2006274541	Metal oxide coating of water insoluble ingredients
Eurasian Patent Organization	200970724	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ ПЕРОКСИД И РЕТИНОИД

Supplementary Protection Certificates for BENZOYL PEROXIDE; TRETINOIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	SPC/GB11/054	United Kingdom		PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID

BENZOYL PEROXIDE; TRETINOIN Market Analysis and Financial Projection Experimental

Benzoyl Peroxide and Tretinoin: Market Dynamics and Financial Trajectory

Introduction

Benzoyl peroxide and tretinoin are two widely used dermatological treatments, particularly for acne and other skin conditions. Understanding their market dynamics and financial trajectories is crucial for stakeholders in the pharmaceutical and skincare industries.

Benzoyl Peroxide Market Overview

Market Size and Growth

The benzoyl peroxide market is projected to reach $462.5 million by 2030, growing at a CAGR of 3.56% during the 2024-2030 period. This growth is driven by its versatile applications, including its use in the pharmaceutical sector, particularly for treating acne[1].

Key Applications

• Pharmaceutical Sector: Benzoyl peroxide is primarily used in the treatment of acne due to its efficacy in reducing acne-causing bacteria.
• Industrial Applications: It is widely used in the chemical and plastics industry as a polymerization initiator, bleaching agent, and cross-linking agent. The industrial grade segment holds the largest market share, driven by its use in paints, coatings, and adhesives[1].

Geographic Distribution

• North America: This region witnessed the highest growth in the benzoyl peroxide market, with a market share of 32% in 2023. The demand is driven by its use in processed food items and skincare products[1].

Tretinoin Market Overview

Market Size and Growth

The tretinoin market was valued at $2.5 billion in 2024 and is projected to reach $7.5 billion by 2031, growing at a CAGR of 10.1% during the forecast period. This significant growth is attributed to the expanding beauty and cosmetics sector, particularly in skincare products[3].

Key Applications

• Skincare Products: Tretinoin is known for its skin-renewing and anti-aging properties, making it a frequent ingredient in skincare formulations.
• Dermatological Treatments: It is prescribed for various dermatological conditions, including acne and other skin issues. The demand is driven by the preference for topical treatments and recommendations from dermatologists[3].

Geographic Distribution

• North America: This region is a significant market for tretinoin, along with Europe and the Asia-Pacific, where the skincare market is growing rapidly[3].

Market Drivers

Growing Skincare Industry

Both benzoyl peroxide and tretinoin benefit from the growing skincare industry. The increasing global concern about skincare and the demand for effective solutions for acne and other skin issues drive the market forward[1][3].

Demographic Factors

• Acne Prevalence: The escalating number of acne cases, influenced by genetics, sensitive skin, stressful lifestyles, and increasing obesity rates, particularly in North America, contributes to the growing demand for these treatments[1].
• Aging Population: The anti-aging properties of tretinoin make it popular among an aging population seeking skincare solutions[3].

Technological Advancements

• Proprietary Technologies: Innovations such as Sol-Gel Technologies' proprietary technology to encapsulate benzoyl peroxide within silica-based microcapsules enhance the efficacy and safety profile of these treatments. This technology is used in products like EPSOLAY, which treats inflammatory lesions of rosacea[2][5].

Financial Trajectory

Revenue and Growth

• Benzoyl Peroxide: The market is expected to grow steadily, driven by its industrial and pharmaceutical applications. The industrial grade segment's dominance and the growing demand in the North American region are key financial drivers[1].
• Tretinoin: The market is experiencing robust growth, with a CAGR of 10.1% from 2024 to 2031. This growth is fueled by the increasing demand for skincare products and the expanding beauty and cosmetics sector[3].

Company Performance

• Sol-Gel Technologies: This company has seen significant growth in its dermatology products, including EPSOLAY and TWYNEO, which contain benzoyl peroxide and other active ingredients. The company's revenue from these products, received from its commercial partner Galderma, indicates a strong financial trajectory. As of 2022, Sol-Gel had a cash balance of $35.3 million, which is expected to fund operational and capital expenditures through the first quarter of 2024[2][5].

Competitive Landscape

Market Share Analysis

• Benzoyl Peroxide: The industrial grade segment dominates the market, with a significant share driven by its versatile applications in the chemical and plastics industry[1].
• Tretinoin: The market is competitive, with various players offering tretinoin-based products. Dermatologists' recommendations and patient preference for topical treatments are key factors influencing market share[3].

Distribution Channels

Benzoyl Peroxide

• Pharmaceuticals: Available in skincare products and pharmaceutical formulations.
• Industrial: Supplied to various industries such as paints, coatings, and adhesives[1].

Tretinoin

• Pharmacies and Drugstores: Over-the-counter and prescription-based products.
• Online Retail: Available through e-commerce platforms, contributing to its growing market presence[3].

Key Takeaways

• Growing Demand: Both benzoyl peroxide and tretinoin are experiencing growing demand driven by the skincare industry and demographic factors.
• Technological Innovations: Proprietary technologies are enhancing the efficacy and safety of these treatments.
• Financial Growth: The markets for both compounds are projected to grow significantly, with benzoyl peroxide reaching $462.5 million by 2030 and tretinoin reaching $7.5 billion by 2031.
• Geographic Distribution: North America is a key market for both compounds, with significant growth also expected in other regions.

FAQs

What are the primary applications of benzoyl peroxide?

Benzoyl peroxide is primarily used in the pharmaceutical sector for treating acne and in the chemical and plastics industry as a polymerization initiator, bleaching agent, and cross-linking agent[1].

How is the tretinoin market expected to grow?

The tretinoin market is projected to grow at a CAGR of 10.1% from 2024 to 2031, reaching $7.5 billion by 2031, driven by the expanding beauty and cosmetics sector[3].

What technological advancements are enhancing the efficacy of benzoyl peroxide treatments?

Sol-Gel Technologies' proprietary technology to encapsulate benzoyl peroxide within silica-based microcapsules is a significant advancement, enhancing the efficacy and safety profile of treatments like EPSOLAY[2][5].

Which regions are driving the growth of the benzoyl peroxide market?

North America is witnessing the highest growth in the benzoyl peroxide market, driven by its use in processed food items and skincare products[1].

How does the competitive landscape look for tretinoin-based products?

The market is competitive, with various players offering tretinoin-based products. Dermatologists' recommendations and patient preference for topical treatments are key factors influencing market share[3].

Sources

1. IndustryARC, "Benzoyl Peroxide Market - Forecast(2021-2026) Research Report"
2. GlobeNewswire, "Sol-Gel Technologies Reports Third Quarter 2022 Financial Results and Provides Corporate Update"
3. Verified Market Research, "Tretinoin Market Size, Share, Scope, Trends And Forecast"
4. Fortune Business Insights, "U.S. Acne Treatment Market Size, Share | Growth Report [2030]"
5. Sol-Gel Technologies, "Sol-Gel Technologies Reports Second Quarter 2022 Financial Results and Provides Corporate Update"