Benzoyl peroxide; clindamycin phosphate - Generic Drug Details

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

Benzoyl peroxide; clindamycin phosphate is the generic ingredient in five branded drugs marketed by Bausch, Actavis Labs Ut Inc, Chartwell Rx, Encube, Glenmark Speclt, Mylan Pharms Inc, Padagis Israel, Taro, Zydus Pharms, and Stiefel, and is included in nineteen NDAs. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide; clindamycin phosphate has twenty patent family members in fourteen countries.

Fifteen suppliers are listed for this compound.

Summary for benzoyl peroxide; clindamycin phosphate

International Patents:	20
US Patents:	9
Tradenames:	5
Applicants:	10
NDAs:	19
Finished Product Suppliers / Packagers:	15
Clinical Trials:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for benzoyl peroxide; clindamycin phosphate
DailyMed Link:	benzoyl peroxide; clindamycin phosphate at DailyMed

Recent Clinical Trials for benzoyl peroxide; clindamycin phosphate

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

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 2
Icahn School of Medicine at Mount Sinai	Phase 2
Valeant Pharmaceuticals International, Inc.	Phase 2

See all benzoyl peroxide; clindamycin phosphate clinical trials

Pharmacology for benzoyl peroxide; clindamycin phosphate

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

Anatomical Therapeutic Chemical (ATC) Classes for benzoyl peroxide; clindamycin phosphate

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

Paragraph IV (Patent) Challenges for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ONEXTON	Gel	benzoyl peroxide; clindamycin phosphate	1.2%/3.75%	050819	1	2015-09-30
ONEXTON	Gel	benzoyl peroxide; clindamycin phosphate	1.2%/2.5%	050819	1	2012-12-20
DUAC	Gel	benzoyl peroxide; clindamycin phosphate	1% / 5%	050741	1	2008-12-11

US Patents and Regulatory Information for 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
Mylan Pharms Inc	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	065443-001	Aug 11, 2009	AB	RX	No	No
Glenmark Speclt	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	209252-001	Mar 14, 2019	AB	RX	No	Yes
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	10,624,918
Taro	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	208683-001	Jun 5, 2018	AB	RX	No	No
Encube	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	212433-001	Apr 28, 2021	AB	RX	No	No
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	8,288,434		Y

Expired US Patents for benzoyl peroxide; clindamycin phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	5,733,886
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	5,733,886
Stiefel	DUAC	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050741-001	Aug 26, 2002	5,466,446
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	6,117,843

International Patents for benzoyl peroxide; clindamycin phosphate

Country	Patent Number	Title	Estimated Expiration
Japan	2011522820
Croatia	P20200450
Portugal	2299810
Spain	2773931
World Intellectual Property Organization (WIPO)	2009148584
Japan	6006272

Supplementary Protection Certificates for benzoyl peroxide; clindamycin phosphate

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

Benzoyl peroxide; clindamycin phosphate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Benzoyl Peroxide; Clindamycin Phosphate

Market Size and Forecast

The global market for Clindamycin Phosphate and Benzoyl Peroxide has been experiencing significant growth, driven by increasing demand for effective acne treatments. As of 2023, the market was valued at approximately USD 214 million[1][2][4].

By 2030, the market is forecasted to reach USD 322.8 million, with a compound annual growth rate (CAGR) of 6.2% during the period from 2024 to 2030[1][4]. Another forecast extends this growth to 2032, predicting the market to reach around USD 366.68 million, reflecting a CAGR of 6.4% from 2024 to 2032[2].

Key Drivers of Growth

Several factors are driving the growth of the Clindamycin Phosphate and Benzoyl Peroxide market:

Rising Incidence of Acne

The increasing prevalence of acne vulgaris, particularly among adolescents and young adults, is a significant driver. This demographic is more likely to seek effective treatments, boosting demand for Clindamycin Phosphate and Benzoyl Peroxide[2][3].

Growing Awareness of Skin Conditions

Increased awareness and education regarding skin conditions and their treatment options lead to higher rates of diagnosis and treatment, further driving demand[3].

Preference for Topical Treatments

There is a growing preference for topical medications over systemic treatments due to their localized action and typically fewer systemic side effects. This trend favors the use of Clindamycin Phosphate and Benzoyl Peroxide[3].

R&D and Innovation

Ongoing research and development in dermatology, including the formulation of more effective and patient-friendly topical treatments, stimulate growth in the market[3].

Market Expansion in Developing Regions

Increasing access to healthcare and rising disposable incomes in developing regions, such as the Asia-Pacific, expand the market as more individuals seek treatment for acne and other skin issues[2][3].

Market Segmentation

The Clindamycin Phosphate and Benzoyl Peroxide market is segmented in several ways:

By Type

The market is classified into different concentrations such as 1.2%/2.5%, 1.2%/3.75%, 1%/5%, and 1%/3%[1][4].

By Application

The primary applications are in hospitals and drug stores[1][4].

By Geography

North America, particularly the U.S., holds a substantial share due to high awareness levels and the presence of key market players. The Asia-Pacific region is emerging as a promising market, driven by rapid urbanization, increasing disposable incomes, and a growing middle-class population. Europe also exhibits a strong demand, while the Middle East and Africa present unique challenges and opportunities[2][3].

Key Players

The market is dominated by several major players, including:

• Bausch Health
• Perrigo
• Mylan
• Tolmar
• TARO
• GSK
• Pfizer Inc.
• Teva Pharmaceutical Industries Ltd.
• Glenmark Pharmaceuticals Ltd.
• Aurobindo Pharma Limited
• Sun Pharmaceutical Industries Ltd.
• AbbVie Inc.
• Fidia Farmaceutici S.p.A.
• Galderma S.A.[1][3].

Market Opportunities

Personalized Skincare Solutions

The rising demand for personalized skincare solutions offers a lucrative avenue for manufacturers to innovate and differentiate their products[2].

Online Retail Channels

The expansion of online retail channels allows for broader market reach and consumer engagement, making it easier for consumers to access these products[2].

Preventative Skincare

The growing emphasis on preventative skincare solutions is another significant opportunity, as consumers seek products that prevent future breakouts in addition to treating existing conditions[2].

Market Challenges

Adverse Side Effects

The potential for adverse side effects associated with Clindamycin Phosphate and Benzoyl Peroxide, such as severe colitis and application site reactions, may deter consumers from using these products[2][5].

Alternative Treatments

The presence of alternative treatments and therapies could limit market share. Regulatory challenges and stringent approval processes for new formulations can also hinder market entry for innovative products[2].

Competition and Pricing

Intensifying competition among various brands and products leads to price wars that may affect profitability. Educating consumers about the correct use of these products is crucial, as improper use can lead to resistance and reduced efficacy[2].

Regulatory Environment

The fluctuating regulatory environment poses challenges for manufacturers in terms of compliance and product development[2].

Investment Analysis and Opportunities

The Clindamycin Phosphate and Benzoyl Peroxide market presents numerous investment opportunities, particularly in areas such as:

Innovative Formulations

Investing in the development of more effective and patient-friendly topical treatments can drive growth. New product launches and regulatory approvals for various formulations can increase market availability and options for consumers[3].

Expanding Distribution Channels

The rise of e-commerce platforms and telemedicine has made it easier for consumers to access prescription medications, enhancing market growth. Healthcare providers integrating telemedicine into their practices improve access to care and treatment adherence[2][3].

Emerging Markets

Countries like India and China in the Asia-Pacific region offer significant growth potential due to rapid urbanization, increasing disposable incomes, and a growing youth population[2][3].

Geographic Dynamics

North America

North America, particularly the U.S., is a lucrative market due to the high prevalence of skin disorders and the growing trend of aesthetic treatments among adolescents and young adults[2].

Europe

Europe exhibits a similar trend, with countries like Germany and the UK leading the charge, driven by increased awareness of skin health and dermatologic innovations[3].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth, fueled by rising rates of acne, a burgeoning youth population, and improving healthcare access in countries like India and China[2][3].

Middle East & Africa

This region presents unique challenges, including varying levels of healthcare access and consumer awareness. However, there is a growing recognition of the importance of skincare, particularly in urban areas[2].

Key Takeaways

• The Clindamycin Phosphate and Benzoyl Peroxide market is expected to grow significantly, reaching USD 322.8 million by 2030.
• Key drivers include the rising incidence of acne, growing awareness of skin conditions, and a preference for topical treatments.
• The market is segmented by type, application, and geography, with North America and the Asia-Pacific region being key markets.
• Major players include Bausch Health, Perrigo, Mylan, and others.
• Opportunities exist in personalized skincare solutions, online retail channels, and emerging markets.
• Challenges include adverse side effects, alternative treatments, and regulatory hurdles.

FAQs

Q: What is the forecasted market size for Clindamycin Phosphate and Benzoyl Peroxide by 2030?

A: The market is expected to reach USD 322.8 million by 2030[1][4].

Q: What is the CAGR for the Clindamycin Phosphate and Benzoyl Peroxide market from 2024 to 2030?

A: The market is expected to exhibit a CAGR of 6.2% during this period[1][4].

Q: Which regions are expected to drive the growth of the Clindamycin Phosphate and Benzoyl Peroxide market?

A: North America and the Asia-Pacific region are expected to be key drivers of market growth[2][3].

Q: What are the main types of Clindamycin Phosphate and Benzoyl Peroxide products available in the market?

A: The market is classified into different concentrations such as 1.2%/2.5%, 1.2%/3.75%, 1%/5%, and 1%/3%[1][4].

Q: What are some of the challenges facing the Clindamycin Phosphate and Benzoyl Peroxide market?

A: Challenges include adverse side effects, alternative treatments, regulatory hurdles, and intensifying competition among brands[2].

Sources

1. Valuates Reports: Clindamycin Phosphate and Benzoyl Peroxide - Market Size[1].
2. Global Growth Insights: Clindamycin Phosphate and Benzoyl Peroxide Market[2].
3. Verified Market Research: Clindamycin Phosphate Topical Market Size, Share And Forecast[3].
4. Business Research Insights: Clindamycin Phosphate and Benzoyl Peroxide Market Size [2032][4].
5. FDA Draft Guidance: Benzoyl Peroxide; Clindamycin Phosphate[5].