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.

Sixteen 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:	16
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
Valeant Pharmaceuticals International, Inc.	Phase 2
Bausch Health Americas, 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
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	9,078,870		Y
Sun Pharma Canada	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	206218-001	Dec 15, 2017	AB	RX	No	No
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	8,895,070
Actavis Labs Ut Inc	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	205128-001	Jun 19, 2015	AB	RX	No	No
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	10,220,049		Y

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	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
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	5,733,886

International Patents for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2013122395	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ
South Korea	20110014651	TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT
South Africa	201008265	TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT
Portugal	2299810
China	102056481	Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent

Supplementary Protection Certificates for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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)
1458369	SPC/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
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
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID

Market Dynamics and Financial Trajectory for Benzoyl Peroxide and Clindamycin Phosphate

Last updated: July 29, 2025

---

Introduction

The global dermatological therapeutics market has experienced consistent growth driven by the increasing prevalence of acne vulgaris, expanding dermatology clinics, and rising awareness about skin health. Among the prominent topical agents, Benzoyl Peroxide (BPO) and Clindamycin Phosphate stand out for their proven efficacy and long-standing market presence. This analysis explores the current market dynamics and financial trajectories of these drugs, examining factors influencing demand, competitive landscape, regulatory considerations, and future growth prospects.

---

Market Overview

Benzoyl Peroxide has been a first-line topical agent for moderate to severe acne for over six decades. It possesses notable antibacterial and keratolytic properties, making it a cornerstone of over-the-counter (OTC) and prescription acne treatments. Its broad acceptance is rooted in its safety profile and affordability.

Clindamycin Phosphate, a lincosamide antibiotic, complements BPO by providing anti-inflammatory and antibacterial effects. Typically administered topically in combination with BPO or other agents, Clindamycin Phosphate addresses bacterial resistance issues and enhances therapeutic outcomes, especially in persistent or severe acne cases.

---

Market Dynamics

1. Epidemiological Drivers

Rising acne prevalence worldwide significantly fuels demand. According to the American Academy of Dermatology (AAD), approximately 85% of people aged 12–24 experience acne at some point, with increased severity correlated with age, hormonal changes, and environmental factors. The surge is particularly pronounced in emerging economies driven by urbanization, pollution, and lifestyle shifts.

2. Consumer and Physician Preferences

Patients increasingly favor OTC formulations of Benzoyl Peroxide, valued for convenience and cost-effectiveness. However, severity cases and antibiotic resistance issues steer patients toward physician-prescribed Clindamycin Phosphate-based treatments. Growing awareness of drug resistance has prompted a shift toward combination therapies.

3. Regulatory Environment

Regulations impact market access and formulation development. Benzoyl Peroxide’s OTC approval facilitates mass-market penetration in mature markets like North America and Europe. Conversely, Clindamycin Phosphate, primarily prescription-only, faces strict formulary and prescribing restrictions, affecting market size.

Recent regulatory pressures focus on combating antibiotic resistance, influencing formulations that combine antibiotics with other agents or limiting antibiotic use altogether. The European Medicines Agency (EMA) and FDA have issued guidelines emphasizing prudent antibiotic use, which could restrain growth for antibiotic-based formulations.

4. Technological and Formulation Innovations

The introduction of microsphere and nanotechnology-based formulations enhances drug stability, skin penetration, and reduces side effects like dryness or irritation. Combination products, such as BPO with Clindamycin Phosphate, demonstrate superior efficacy, propelling their market share.

5. Competitive Landscape

Major pharmaceutical players dominate with established formulations:

• Benzoyl Peroxide: Johnson & Johnson (Proactiv), Galderma (Differin), and Teva Pharmaceuticals.
• Clindamycin Phosphate: Mylan, Sun Pharmaceutical, and generic manufacturers.

Emerging biosimilar and generic manufacturers intensify price competition, leading to downward pricing pressures and broader accessibility.

---

Financial Trajectory

1. Revenue Generation and Market Size

The global acne therapeutics market, estimated at USD 4 billion in 2021, is projected to grow at a CAGR of approximately 5.8% through 2027 [1]. Benzoyl Peroxide accounts for a significant share due to OTC sales, with estimated revenues exceeding USD 1.2 billion globally.

Clindamycin Phosphate sale revenues are primarily prescription-driven, with global sales reaching around USD 600 million in 2021, growing steadily as combination therapy use expands.

2. Pricing Trends

Price erosion, especially in mature markets, results from generic competition. OTC Benzoyl Peroxide products are increasingly affordable, boosting sales volume. Prescription Clindamycin Phosphate formulations have experienced moderate price declines, balanced by patent expirations and biosimilar entries.

3. Investment and R&D Focus

Pharmaceutical companies are investing in combination therapies, sustained-release formulations, and novel delivery systems. For example, the development of BPO-Clindamycin products with enhanced skin penetration aims to improve efficacy and patient adherence, creating new revenue streams.

4. Market Penetration in Emerging Economies

Rapid economic growth, urbanization, and expanding healthcare infrastructure drive demand in Asia-Pacific, Latin America, and Africa. Manufacturers are tailoring products for these markets, often at lower price points, to capture market share, improving overall revenue prospects.

5. Impact of Regulatory and Social Factors

Enhanced regulations to mitigate antibiotic resistance could limit Clindamycin Phosphate's growth. However, the demand for effective acne treatments sustains revenue streams, with some companies diversifying portfolios into non-antibiotic therapies.

---

Future Growth Outlook

Benzoyl Peroxide

• Continued dominance in OTC markets.
• Innovation in formulations (gel, foam, wash) and combination products.
• Growing demand in emerging markets.
• Projected CAGR of approximately 4.5% over the next five years.

Clindamycin Phosphate

• Stable growth driven by prescription markets.
• Increased use in combination therapies addressing resistance concerns.
• Potential challenges from regulatory restrictions on antibiotic use.
• Estimated CAGR of around 4% over five years.

Synergies and Market Expansion

The co-formulation of Benzoyl Peroxide with Clindamycin Phosphate in prescription products has demonstrated higher efficacy, reinforcing their market trajectory. The market for combination products is set to expand as clinicians adopt strategies aligned with antimicrobial stewardship.

---

Regulatory and Ethical Considerations

Global efforts to curb antibiotic resistance prompt stricter regulation of Clindamycin Phosphate formulations, influencing R&D and commercial strategies. Companies investing in non-antibiotic alternatives or delayed-release formulations aim to sidestep future restrictions.

Environmental sustainability concerns, including the impact of pharmaceutical residues on ecosystems, are gaining attention, prompting manufacturers to develop eco-friendly formulations and packaging.

---

Key Challenges

• Growing antibiotic resistance limiting use of Clindamycin Phosphate.
• Market saturation in mature regions.
• Price pressures from generic competition.
• Stringent regulatory frameworks.
• Patient preference for natural or alternative remedies.

---

Opportunities

• Development of controlled-release formulations.
• Expansion into emerging markets.
• Integration with digital health solutions for adherence.
• Diversification into non-antibiotic anti-acne agents.
• Strategic partnerships for innovation and market access.

---

Key Takeaways

• Market growth is driven by rising acne prevalence and consumer preference for OTC Benzoyl Peroxide, while prescription Clindamycin Phosphate maintains steady demand.
• Innovations in formulation tech and combination products are critical for competitive advantage.
• Regulatory shifts toward antimicrobial stewardship pose future challenges but also open avenues for non-antibiotic therapies.
• Emerging economies represent a significant growth frontier, aided by healthcare infrastructure expansion and affordability strategies.
• Price competition and patent expirations necessitate continual innovation and strategic marketing to sustain financial trajectories.

---

FAQs

1. What are the primary factors influencing the market for Benzoyl Peroxide and Clindamycin Phosphate?
Epidemiological trends in acne prevalence, consumer preferences, regulatory policies, technological innovations, and competitive pricing strategies primarily influence market dynamics.

2. How is antibiotic resistance impacting Clindamycin Phosphate’s market?
Rising antibiotic resistance has led regulators to impose stricter prescribing guidelines, potentially limiting Clindamycin Phosphate’s growth and prompting investment in non-antibiotic alternatives.

3. Are combination products of Benzoyl Peroxide and Clindamycin Phosphate more effective?
Yes. Clinical trials show that combination formulations improve efficacy, reduce bacterial resistance, and enhance patient adherence, increasing their market share.

4. What opportunities exist for manufacturers in emerging markets?
Affordable formulations tailored for local needs, strategic partnerships, and expanding distribution channels offer lucrative growth opportunities in these regions.

5. What future trends could shape the market trajectory?
Advancements in delivery systems, non-antibiotic therapies, digital adherence solutions, and regulatory adaptations will significantly influence future market performance.

---

Sources

[1] Research and Markets, "Global Acne Therapeutics Market Forecast," 2022.