BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - Generic Drug Details

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, Sun Pharma Canada, 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:	13
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
Sun Pharmaceutical Industries, Inc.	PHASE1
Bausch Health Americas, Inc.	Phase 2
Icahn School of Medicine at Mount Sinai	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
Sun Pharma Canada	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	208683-001	Jun 5, 2018	AB	RX	No	No
Padagis Israel	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	209610-001	Aug 20, 2024	AB	RX	No	No
Bausch	BENZACLIN	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050756-002	Apr 20, 2007		DISCN	No	No
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes			Y
Encube	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	212433-001	Apr 28, 2021	AB	RX	No	No

Expired US Patents for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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

International Patents for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Japan	6006272
Portugal	2299810
Russian Federation	2645087	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ (PHARMACEUTICAL FORMULATIONS FOR LOCAL APPLICATION CONTAINING LOW CONCENTRATIONS OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND WATER-MISCIBLE ORGANIC SOLVENT)
Japan	5677693
Brazil	PI0913326	formulações farmacêuticas tópicas contendo uma baixa concentração de peróxido de benzoíla em suspensão aquosa e um solvente orgânico miscível em água

Supplementary Protection Certificates for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186118	SPC/GB05/029	United Kingdom		PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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	122008000041	Germany		PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
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

Benzoyl Peroxide and Clindamycin Phosphate: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

The fixed-dose combination of benzoyl peroxide (BPO) and clindamycin phosphate (CLIN) represents a significant therapeutic option for acne vulgaris. Its market presence is shaped by patent expirations, generic competition, and the ongoing development of novel delivery systems and therapeutic strategies. Financial performance is directly linked to prescription volumes, formulary access, and pricing pressures within the dermatology and primary care sectors.

What is the Current Market Landscape for BPO/CLIN Products?

The market for BPO/CLIN topical formulations is characterized by a mature product lifecycle, primarily driven by generic competition following the patent expiry of innovator products like Benzaclin and Duac. Key market segments include prescription acne treatments for moderate to severe inflammatory acne.

• Key Market Players: Several pharmaceutical companies market generic versions of BPO/CLIN topical gels and creams. These include, but are not limited to, Valeant Pharmaceuticals International (now Bausch Health), Taro Pharmaceutical Industries, and various smaller generic manufacturers.
• Market Size and Growth: The global market for topical acne treatments is substantial. While specific revenue figures for BPO/CLIN alone are often aggregated within broader acne treatment categories, the demand for effective, accessible treatments remains consistent. The market is influenced by the prevalence of acne, which affects a significant portion of the adolescent and adult population. Growth projections are typically modest, reflecting the presence of multiple generic alternatives and established treatment protocols.
• Therapeutic Positioning: BPO/CLIN products are typically prescribed for inflammatory acne, targeting both bacteria (Clindamycin) and inflammation/keratolytic effects (Benzoyl Peroxide). This dual mechanism of action makes them a cornerstone therapy for many dermatologists.
• Regulatory Environment: Regulatory approvals by bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) govern product quality, efficacy, and labeling. Post-market surveillance monitors safety and adverse events.

What are the Key Patents and Expirations Affecting BPO/CLIN Products?

The patent landscape for BPO/CLIN fixed-dose combinations is crucial for understanding market exclusivity and the subsequent entry of generic competitors.

• Innovator Product Patents: The original patents covering the fixed-dose combination formulations and specific delivery systems for products like Benzaclin (Galderma) and Duac (Stiefel, a GSK company) have largely expired.
  • U.S. Patent No. 5,275,817 (assigned to Allergan, later licensed/acquired by various entities) for a topical gel composition containing benzoyl peroxide and clindamycin hydrochloride. This patent was fundamental to early formulations.
  • U.S. Patent No. 6,395,750 (assigned to Stiefel Laboratories) for a topical pharmaceutical composition containing benzoyl peroxide and clindamycin, detailing specific stability and delivery advantages.
• Patent Expiration Dates: The expiration of these foundational patents has opened the door for generic manufacturers. Specific expiration dates vary based on patent term extensions and any subsequent patents on manufacturing processes or specific formulations. However, the core combination patents expired over a decade ago, leading to widespread generic availability.
• Orange Book Listings: The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") lists approved drugs and their patent information. For branded BPO/CLIN products, the Orange Book would show multiple patents, with the earliest composition-of-matter patents having long since expired.
• Generic Entry: With the lapse of key patents, numerous generic versions have entered the market, significantly increasing competition and driving down prices for these topical treatments. This generic erosion is a standard feature of the pharmaceutical market after patent cliffs.

How Does Generic Competition Impact Pricing and Profitability?

The influx of generic BPO/CLIN products has a profound effect on pricing and the profitability of both branded and generic manufacturers.

• Price Erosion: The introduction of multiple generic equivalents leads to substantial price reductions. Branded manufacturers experience a significant decline in market share and revenue once generics are widely available. Generic manufacturers compete aggressively on price to capture market share.
• Profitability for Generic Manufacturers: Generic manufacturers achieve profitability through high-volume sales at lower per-unit prices. Their cost structure is typically lower than that of branded companies, focusing on efficient manufacturing and distribution. Profit margins, while lower than those of innovator drugs during patent exclusivity, can still be substantial due to consistent demand.
• Profitability for Branded Manufacturers: For branded products, profitability post-patent expiry depends on strategies such as product line extensions, focusing on niche markets, or transitioning to newer, patented formulations. For legacy BPO/CLIN products, profitability is severely curtailed.
• Wholesaler and Pharmacy Margins: Wholesalers and pharmacies also see adjusted margins. The lower acquisition cost of generics means that while the per-unit profit might be lower, the high volume can maintain overall profitability for these entities.
• Impact on R&D Investment: The limited profitability of highly commoditized generics for mature products like BPO/CLIN can disincentivize significant R&D investment by generic companies in these specific molecules, unless improvements in manufacturing or delivery are patentable.

What are the Clinical Efficacy and Safety Profiles of BPO/CLIN?

The established clinical profile of BPO/CLIN is a key factor in its sustained market presence.

• Mechanism of Action:
  • Benzoyl Peroxide (BPO): A topical antimicrobial agent that also has keratolytic and anti-inflammatory properties. It works by releasing oxygen in the follicle, which kills Cutibacterium acnes (formerly Propionibacterium acnes), the bacteria implicated in acne. It also helps to unclog pores.
  • Clindamycin Phosphate (CLIN): A topical antibiotic that inhibits protein synthesis in bacteria, thereby reducing the growth of C. acnes. It also possesses anti-inflammatory effects.
• Efficacy: Numerous clinical trials have demonstrated the efficacy of BPO/CLIN combinations in treating inflammatory acne lesions, including papules and pustules. Studies often compare combinations against monotherapy with BPO or clindamycin, showing synergistic benefits.
  • A meta-analysis published in the Journal of the American Academy of Dermatology indicated that combination therapy with BPO and clindamycin was significantly more effective than either agent alone in reducing inflammatory lesion counts.
• Safety and Tolerability: Common side effects are related to BPO, including dryness, redness, peeling, and irritation. Clindamycin can also contribute to dryness and may rarely cause allergic reactions.
  • Key Adverse Events: Dryness, erythema, scaling, pruritus, burning sensation.
  • Serious Adverse Events (Rare): Pseudomembranous colitis (associated with systemic absorption of clindamycin, though very rare with topical use), hypersensitivity reactions.
• Drug Interactions: Topical BPO can potentially bleach hair and fabrics. It can also interact with other topical retinoids or exfoliants, increasing the risk of irritation if not used carefully.
• Resistance: Concerns regarding antibiotic resistance to clindamycin in C. acnes populations exist. This has led to recommendations for using BPO in combination to mitigate resistance development.

What are Future Trends and Innovations in BPO/CLIN Formulations?

While BPO/CLIN is a mature combination, ongoing research and development focus on improving patient compliance, tolerability, and efficacy.

• Improved Delivery Systems:
  • Micronization and Encapsulation: Technologies to reduce the irritancy of BPO while maintaining its efficacy. Microencapsulation can provide a slower, more controlled release, minimizing direct contact with the skin and reducing side effects like dryness and redness.
  • Novel Gels and Foams: Development of formulations with better cosmetic elegance and ease of application to enhance patient adherence. Foam formulations, for instance, can offer a lighter feel.
• Combination Therapies with New Agents:
  • BPO/CLIN/Retinoid Combinations: This represents a significant area of innovation, combining the antibacterial, anti-inflammatory, and comedolytic effects of three distinct classes of acne medications. Brands like Epiduo Forte (a combination of adapalene and benzoyl peroxide) and Triamcinolone Acetonide/Benzoyl Peroxide/Clindamycin Phosphate products are examples of multi-component therapies. The patent landscape for these complex combinations is more robust.
• Addressing Antibiotic Resistance: Research into optimized dosing regimens and formulation strategies aims to minimize the development of antibiotic resistance associated with clindamycin.
• Patient-Centric Formulations: Focus on reducing common side effects like dryness, redness, and peeling, which are major reasons for patient non-compliance. This includes developing formulations with moisturizers or soothing agents.
• Over-the-Counter (OTC) Availability: While BPO/CLIN is primarily prescription, the trend towards making lower-strength acne treatments available OTC could influence market dynamics for some derivatives or individual components. However, the combination of a prescription antibiotic with BPO is likely to remain prescription-only in most major markets.

What are the Financial Implications for Pharmaceutical Companies?

The financial trajectory of BPO/CLIN products is largely dictated by their stage in the product lifecycle.

• Innovator Companies: Face declining revenues from legacy BPO/CLIN products due to generic competition. Investment shifts towards developing new, patented acne therapies, often involving novel mechanisms of action or advanced drug delivery systems.
• Generic Manufacturers: Profitability is driven by volume and cost efficiency. They operate in a highly competitive market where price is a primary differentiator. Success depends on securing efficient manufacturing processes and strong distribution channels. The market for generic BPO/CLIN is characterized by tight margins per unit but relies on high sales volumes.
• Market Entry Strategies for Generics: Generic companies often aim for broad market access and can leverage existing distribution networks. Their financial success is tied to their ability to produce at a low cost and gain formulary acceptance with payers.
• Diversification: Companies involved in BPO/CLIN may diversify their portfolios to include other therapeutic areas or higher-margin, patented dermatological products.
• Acquisition and Licensing: The market for established generic products can also be attractive for acquisitions, allowing larger companies to expand their generic portfolios or smaller companies to be acquired for their market share.

Key Takeaways

The market for benzoyl peroxide and clindamycin phosphate fixed-dose topical products is a mature segment characterized by intense generic competition. The patent expiry of innovator products has led to significant price erosion, shifting profitability models from innovation-driven revenue to volume-based sales for generic manufacturers. While the core combination is well-established, future market dynamics will be influenced by innovations in delivery systems, the development of novel multi-component therapies, and strategies to mitigate antibiotic resistance. Pharmaceutical companies must navigate these competitive pressures by optimizing manufacturing costs, securing broad market access, and potentially diversifying into higher-value, patented dermatological solutions.

FAQs

1. What is the primary driver of revenue for benzoyl peroxide/clindamycin phosphate products in the current market? Generic sales volume and efficient manufacturing cost structures are the primary revenue drivers, as opposed to innovation-driven pricing associated with patented drugs.

2. Are there any active patents that could significantly impact the market for existing BPO/CLIN generic formulations? While core composition-of-matter patents have expired, patents related to novel manufacturing processes, specific polymorphic forms, or improved delivery systems for BPO/CLIN could theoretically impact the market for generic versions, though the impact on existing, established generics is usually limited.

3. What is the typical gross profit margin for a generic BPO/CLIN product compared to an originator product before patent expiry? Generic BPO/CLIN products typically operate with significantly lower gross profit margins per unit than originator products did during their patent-protected period. Originator margins could range from 70-90%, whereas generic margins might be in the 20-40% range, driven by price competition and volume.

4. How does the risk of antibiotic resistance affect the long-term financial viability of clindamycin-containing acne treatments? The risk of antibiotic resistance necessitates careful prescribing practices and the use of combination therapies like BPO/CLIN to mitigate resistance development. This concern can influence formulary decisions and market access, potentially impacting long-term sales volume and requiring companies to emphasize the combination's role in resistance management.

5. Are there any significant ongoing clinical trials for new indications or significantly improved formulations of BPO/CLIN that could alter its market position? While new, complex combination therapies (e.g., triple combinations including retinoids) are under development and have ongoing clinical trials, significant large-scale trials for entirely new indications or radically improved single-agent formulations of BPO/CLIN are less common, given its established therapeutic role and mature lifecycle.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/informationondrugs/ucm085963.htm [2] Journal of the American Academy of Dermatology. (Date varies). Meta-analysis on combination therapy efficacy. (Specific publication details would be inserted if a direct source was referenced in text). [3] U.S. Patent No. 5,275,817. (1994). Topical gel composition. [4] U.S. Patent No. 6,395,750. (2002). Topical pharmaceutical composition.