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Last Updated: March 29, 2025

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - Generic Drug Details


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

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
Recent Clinical Trials for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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

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

See all BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE clinical trials

Pharmacology for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes 10,220,049 ⤷  Try for Free Y ⤷  Try for Free
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes 8,288,434 ⤷  Try for Free Y ⤷  Try for Free
Taro CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 206218-001 Dec 15, 2017 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Taro CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 206575-001 Aug 19, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Expired US Patents for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 5,733,886 ⤷  Try for Free
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 6,117,843 ⤷  Try for Free
Stiefel DUAC benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050741-001 Aug 26, 2002 5,466,446 ⤷  Try for Free
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 5,733,886 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

International Patents for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

CountryPatent NumberTitleEstimated Expiration
Australia 2009255679 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent ⤷  Try for Free
Mexico 2010013152 FORMULACIONES FARMACEUTICAS TOPICAS QUE CONTIENEN UNA BAJA CONCENTRACION DE PEROXIDO DE BENZOILO EN SUSPENSION EN AGUA Y UN SOLVENTE ORGANICO MISCIBE EN AGUA. (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT.) ⤷  Try for Free
Russian Federation 2013122395 ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2009148584 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Supplementary Protection Certificates for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1667986 92172 Luxembourg ⤷  Try for Free 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)
1458369 C01458369/01 Switzerland ⤷  Try for Free PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
0591275 SPC/GB05/030 United Kingdom ⤷  Try for Free 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 SPC/GB10/005 United Kingdom ⤷  Try for Free PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 4 of 4 entries

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].

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.