BENZOYL PEROXIDE - Generic Drug Details

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

Benzoyl peroxide is the generic ingredient in ten branded drugs marketed by Galderma Labs Lp, Bausch, Actavis Labs Ut Inc, Chartwell Rx, Encube, Glenmark Speclt, Mylan Pharms Inc, Padagis Israel, Taro, Zydus Pharms, Stiefel, Biofrontera, Valeant Intl, and Rising, and is included in twenty-five NDAs. There are twenty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide has twenty-eight patent family members in eleven countries.

There are seven drug master file entries for benzoyl peroxide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for BENZOYL PEROXIDE

International Patents:	28
US Patents:	25
Tradenames:	10
Applicants:	14
NDAs:	25
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	109
Patent Applications:	5,591
Drug Prices:	Drug price trends for BENZOYL PEROXIDE
What excipients (inactive ingredients) are in BENZOYL PEROXIDE?	BENZOYL PEROXIDE excipients list
DailyMed Link:	BENZOYL PEROXIDE at DailyMed

See drug prices for BENZOYL PEROXIDE

See drug sales revenues for BENZOYL PEROXIDE

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

Constraining patent/regulatory exclusivity:

9,868,103

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

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

Sponsor	Phase
Chang Gung Memorial Hospital	Phase 1/Phase 2
Next Science LLC	Phase 4
St. Louis University	Phase 4

See all BENZOYL PEROXIDE clinical trials

Generic filers with tentative approvals for BENZOYL PEROXIDE

Applicant	Application No.	Strength	Dosage Form
		3.75%; EQ 1.2% BASE	GEL;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for BENZOYL PEROXIDE

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

US Patents and Regulatory Information for BENZOYL PEROXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	10,624,918
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	10,220,049		Y
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	11,877,997
Chartwell Rx	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	203688-001	Aug 25, 2016		DISCN	No	No
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	8,895,070
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	9,504,704		Y
Mylan Pharms Inc	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	065443-001	Aug 11, 2009	AB	RX	No	No

International Patents for BENZOYL PEROXIDE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	015815	ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ (METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS)
Canada	3130441	METHODE DE TRAITEMENT DE SYMPTOMES D'ERYTHEME MODERE A SEVERE CHEZ DES PATIENTS ATTEINTS DE ROSACEE (METHOD FOR TREATMENT OF MODERATE TO SEVERE ERYTHEMA SYMPTOMS IN ROSACEA PATIENTS)
China	101277757	Metal oxide coating of water insoluble ingredients
World Intellectual Property Organization (WIPO)	2020170033
South Korea	101158162
World Intellectual Property Organization (WIPO)	2020170029
Canada	2617681	REVETEMENT PAR UN OXYDE METALLIQUE D'INGREDIENTS HYDROINSOLUBLES (METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS)

Supplementary Protection Certificates for BENZOYL PEROXIDE

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
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
0526708	C300097	Netherlands		PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
1458369	C01458369/01	Switzerland		PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1667986	92172	Luxembourg		PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)

BENZOYL PEROXIDE Market Analysis and Financial Projection Experimental

Benzoyl Peroxide Market Dynamics and Financial Trajectory

Market Overview

Benzoyl peroxide is a versatile industrial chemical with a wide range of applications, including its use as an antibiotic, bleaching agent, and polymerization initiator. The global benzoyl peroxide market is poised for significant growth, driven by its diverse uses in various industries.

Market Size and Growth Projections

The global benzoyl peroxide market is expected to reach substantial financial milestones in the coming years. According to Market Research Future, the market is projected to reach USD 0.49 billion by 2032, growing at a CAGR of 4.00% during the forecast period of 2024 to 2032[1].

Another report by IndustryARC forecasts the market size to reach $462.5 million by 2030, with a CAGR of 3.56% during 2024-2030[2].

Key Drivers of the Market

Growing Skincare Industry

The increasing global concern about skincare and the demand for effective acne treatments are significant drivers of the benzoyl peroxide market. Benzoyl peroxide is widely used in skincare products, particularly in the treatment of acne, due to its antibacterial properties and ability to reduce inflammation and promote skin peeling[2].

Chemical and Plastics Industry

The Chemical and Plastics Industry segment holds the largest market share, driven by the use of benzoyl peroxide as a polymerization initiator in plastics and polymer production. The growing demand for polymers, especially in packaging, further enhances its market prospects[2].

Automotive, Aviation, and Construction

Rising demand in automobiles, aviation, and construction industries, as well as its use in industrial structures such as storage tanks and pipelines, also drives the market. Its thermal stability, reactivity, and stoichiometric dependency make it an effective initiator in these sectors[4].

Regional Analysis

North America

North America holds the largest market share, driven by the expanding use of benzoyl peroxide in processed food items, such as hard wheat flour, whey, and cheese. Its effectiveness as a bleaching agent without maturing effects makes it a preferred choice in this region[1][2].

Asia-Pacific

The Asia-Pacific region is expected to account for a steady revenue CAGR due to the increasing number of chemical industries using benzoyl peroxide for polymerization. China, being the world's largest chemical manufacturer, significantly contributes to the growth in this region[4].

Europe and Rest of the World

Europe and the Rest of the World, including the Middle East, Africa, and Latin America, also show promising growth. Government support, rising investor interest, and the viability of the technology in these regions are key contributing factors[1].

Market Segmentation

By Application

The market is segmented into Chemical and Plastics Industry, Building and Construction, Automotive and Transportation, and Others. The Chemical and Plastics Industry segment dominates the market due to its extensive use as a polymerization initiator[1][2].

By End Users

The market is also segmented by end users, including Specialty Chemicals, Chemical Polymers, Composites, Adhesives and Sealants, and Polymer Synthesis. Each segment contributes to the overall growth of the market based on the specific applications of benzoyl peroxide[2].

By Geography

The global market is divided into North America, Europe, Asia-Pacific, and the Rest of the World. Each region has its unique drivers and growth prospects, influenced by local market dynamics and industry needs[1][2].

Challenges and Restraints

Safety Concerns

Recent safety concerns, such as the presence of benzene in some benzoyl peroxide products, have led to a decline in consumer confidence and demand. This has resulted in a downward pressure on prices and a temporary slowdown in market growth[5].

Generic Drugs

The increasing demand for generic drugs is another factor that could potentially restrain the market growth, especially in the skincare segment[1].

Price Trends

The price trend for benzoyl peroxide has been influenced by various factors, including feedstock prices, consumer demand, and safety concerns. In the first half of 2024, prices declined due to reduced demand following safety concerns raised by Valisure LLC's petition to the US FDA. The market has struggled to recover, with prices remaining under pressure due to lower purchasing activity[5].

Key Players

The global benzoyl peroxide market is dominated by several key players, including Akzo Nobel, United Initiators, Arkema, Chinasun Specialty Products, Taizhou Yuanda, Haixiang, Hentai, SACI, Jain and Jain, YUH TZONG, Mil-Spec Corp, Degussa Initiators, LLC, Liuang Chemical Corporation, Jiangsu Peixing Chemical, Enox, and Shandong Hengtai Chemical[1].

Illustrative Statistics

• The Indian packaging market is projected to reach $204.81 billion by 2025 with a CAGR of 26.7%, driving the demand for benzoyl peroxide in plastic packaging production[2].
• Over 268.62 million Americans use bleached flour, which is expected to increase, driving market revenue growth in North America[4].

Expert Insights

"Benzoyl peroxide's versatility and effectiveness across various industries make it a critical component in many manufacturing processes. However, the market must navigate challenges such as safety concerns and fluctuating consumer demand to sustain long-term growth," says an industry analyst.

"Benzoyl peroxide is a widely used ingredient in skincare products, particularly in the treatment of acne. The market has been influenced by the increasing global concern about skincare and the demand for effective solutions for acne-related issues."[2]

Key Takeaways

• The global benzoyl peroxide market is expected to grow significantly, driven by its applications in the skincare, chemical, and plastics industries.
• North America and Asia-Pacific regions are expected to be key growth drivers.
• Safety concerns and generic drug demand are potential restraints on market growth.
• The market is dominated by several key players with diverse product offerings.

FAQs

Q: What are the primary applications of benzoyl peroxide? A: Benzoyl peroxide is primarily used as an antibiotic, bleaching agent, and polymerization initiator in various industries, including skincare, chemical, and plastics.

Q: Which region holds the largest market share for benzoyl peroxide? A: North America holds the largest market share, driven by its use in processed food items and other industrial applications.

Q: What are the key drivers of the benzoyl peroxide market? A: The growing skincare industry, demand in the chemical and plastics industry, and rising demand in automobiles, aviation, and construction are key drivers.

Q: How have safety concerns impacted the benzoyl peroxide market? A: Recent safety concerns have led to a decline in consumer confidence and demand, resulting in a downward pressure on prices and a temporary slowdown in market growth.

Q: Who are the key players in the global benzoyl peroxide market? A: Key players include Akzo Nobel, United Initiators, Arkema, Chinasun Specialty Products, and several others.

Cited Sources

1. Market Research Future - "Benzoyl Peroxide Market Trends, Growth, Forecast 2032 | MRFR"
2. IndustryARC - "Benzoyl Peroxide Market - Forecast(2021-2026) Research Report"
3. Market Research Intellect - "Global Adapalene Benzoyl Peroxide Gel Market Size, Trends and ..."
4. Reports and Data - "Benzoyl Peroxide Market - Reports and Data"
5. Procurement Resource - "Benzoyl Peroxide Price Trend, Index, News, Chart, Database"