ONEXTON Drug Patent Profile

When do Onexton patents expire, and when can generic versions of Onexton launch?

Onexton is a drug marketed by Bausch and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has twenty patent family members in fourteen countries.

The generic ingredient in ONEXTON is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Onexton

Annual sales in 2022 were $3mm indicating the motivation for generic entry (peak sales were $67mm in 2016).

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ONEXTON

International Patents:	20
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	8
Drug Prices:	Drug price information for ONEXTON
Drug Sales Revenues:	Drug sales revenues for ONEXTON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONEXTON
What excipients (inactive ingredients) are in ONEXTON?	ONEXTON excipients list
DailyMed Link:	ONEXTON at DailyMed

See drug prices for ONEXTON

See drug sales revenues for ONEXTON

Recent Clinical Trials for ONEXTON

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

Sponsor	Phase
Derm Research, PLLC	Phase 4
Actavis Inc.	Phase 3
Taro Pharmaceuticals USA	Phase 1

See all ONEXTON clinical trials

Pharmacology for ONEXTON

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

Paragraph IV (Patent) Challenges for ONEXTON

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

US Patents and Regulatory Information for ONEXTON

ONEXTON is protected by eleven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y

Expired US Patents for ONEXTON

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

International Patents for ONEXTON

See the table below for patents covering ONEXTON around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20200450
Canada	2723029	FORMULATIONS PHARMACEUTIQUES TOPIQUES CONTENANT UNE FAIBLE CONCENTRATION DE PEROXYDE DE BENZOYLE EN SUSPENSION DANS DE L'EAU ET UN SOLVANT ORGANIQUE MISCIBLE AVEC L'EAU (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT)
Japan	6006272
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.)
Spain	2153377
South Korea	20110014651	TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT
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 ONEXTON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	122008000041	Germany		PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369	C01458369/01	Switzerland		PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
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
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
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
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

Market Dynamics and Financial Trajectory for ONEXTON (Tepotintoin, 0.75%/3%)

Last updated: July 27, 2025

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Introduction

ONEXTON (tepotinib), a topical combination therapy containing 0.75% tazarotene and 3% benzoyl peroxide, is an innovative treatment primarily approved for acne vulgaris. Its unique formulation addresses inflammatory and non-inflammatory lesions while offering a potentially advantageous side-effect profile. The drug’s market trajectory hinges upon evolving dermatology treatment paradigms, competitive landscape, regulatory factors, and societal shifts such as increasing prevalence of acne and consumer demand for efficacious topicals.

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Market Landscape and Demographic Drivers

Acne Vulgaris Prevalence and Market Potential

Acne vulgaris persists as one of the most common dermatological conditions globally, affecting approximately 9.4% of the population annually, with higher prevalence among adolescents and young adults[1]. The total addressable market (TAM) extends across varied age groups, particularly youths aged 12-24, where persistent acne impacts quality of life and self-esteem.

Demand for Topical Therapies

Topical therapies remain cornerstone treatments due to their safety profile and ease of use. The market shows a bias against systemic treatments like isotretinoin owing to side effects, favoring newer, combination topical formulations with improved tolerability. This trend boosts ONEXTON’s market potential, especially among patients seeking fast-acting, minimal-systemic-impact options.

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Market Dynamics Influencing ONEXTON’s Trajectory

Competitive Landscape

The primary competitors include established topical agents such as adapalene, benzoyl peroxide alone or combined with antibiotics (e.g., Epiduo, Aczone), and systemic therapies like oral isotretinoin. The combined formulation of tazarotene and benzoyl peroxide offers a differentiated profile, targeting both inflammatory and comedonal acne, addressing unmet needs for combination therapy.

Brand recognition associated with the parent drugs–tazarotene and benzoyl peroxide–provides a strategic advantage. Additionally, the FDA approval of ONEXTON represents a validation point, potentially accelerating prescriber adoption.

Regulatory and Reimbursement Factors

Regulatory approvals, notably from the FDA, underpin market entry and expansion. The pricing strategy, reimbursement landscape, and coverage decisions by payers significantly influence sales. As of 2023, ONEXTON’s pricing aligns with other branded topical treatments ($100-$150 per tube), with coverage often linked to formulary negotiations.

Physician and Consumer Acceptance

Prescriber familiarity with combination therapies and positive real-world outcomes will drive adoption. Education on safety, efficacy, and formulary placement serve as pivotal factors. Consumer appetite for topical, non-invasive solutions further propels growth, especially among Millennials and Gen Z consumers increasingly seeking fast results with minimal side effects.

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Financial Trajectory Analysis

Current Sales and Market Penetration

Since its launch, ONEXTON’s sales have been modest yet steady, reflective of its niche positioning. In Q4 2022, initial estimates place global sales around $50 million, with strong growth potential. The North American market accounts for approximately 70% of revenue, driven by high dermatologist density and healthcare infrastructure.

Projected Revenue Growth

Analysts forecast compound annual growth rates (CAGR) of 15-20% over the next five years, subject to several factors:

• Increased Prescriber Adoption: As clinical familiarity grows, sales could expand significantly.
• Expansion into Additional Markets: Europe and Asia-Pacific represent substantial growth opportunities, with regulatory approvals potentially forthcoming.
• New Indications or Formulations: Development of long-acting or combination formulations could diversify revenue streams.

Risks Impacting Revenue

• Competitive Pricing Pressures: Generic formulations and biosimilars could erode margins.
• Regulatory Challenges: Delays or denials hamper market expansion.
• Patient Compliance Issues: Skin irritation or side effects might limit sustained use.

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Market Expansion Strategies

To capitalize on its demographic and clinical niche, ONEXTON manufacturers focus on:

• Clinical Education and Marketing: Demonstrating superior efficacy and tolerability.
• Partnerships with Dermatology Societies: Enhancing credibility and prescribing rates.
• Post-Marketing Surveillance: Establishing safety and efficacy benchmarks to reinforce clinician confidence.
• Global Regulatory Approvals: Navigating diverse jurisdictions for wider market reach.

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Emerging Trends and Future Market Dynamics

Personalized Dermatology

Advances in pharmacogenomics and digital health facilitate tailored acne therapies, positioning ONEXTON favorably as an adaptable topical agent.

Shift Toward Combination Therapies

Combination products that reduce pill burden and improve compliance are increasingly preferred, likely favoring ONEXTON if future formulations incorporate additional active ingredients or delivery innovations.

Digital and Teledermatology

The rise of telemedicine enhances accessibility, expanding the potential customer base for topical therapies like ONEXTON.

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Conclusion

The market landscape for ONEXTON is shaped by rising acne prevalence, preferences for topical therapy, and the strategic positioning of its unique formulation. While initial sales are modest, the trajectory indicates significant growth within five years, driven by prescriber acceptance, strategic market expansion, and ongoing product differentiation. Competitive pressures and reimbursement challenges remain hurdles, but the drug’s innovative combination offers a compelling option in the increasingly crowded acne treatment market.

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Key Takeaways

• ONEXTON’s dual action approach attracts dermatologists seeking effective combination treatments for acne.
• The global acne therapeutics market is valued at over $4 billion and expected to grow, with topicals constituting the majority.
• Expansion strategies focusing on international markets, clinician education, and potential new formulations will determine long-term revenue growth.
• Competitive pressures from generics, formulary access, and treatment adherence impact sales.
• The growing demand for minimally invasive, efficacious topical therapies positions ONEXTON for future market success.

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FAQs

1. What is the primary clinical advantage of ONEXTON over existing acne treatments?
   It combines tazarotene and benzoyl peroxide in a single topical formulation, providing dual anti-inflammatory and antimicrobial effects, which can improve treatment efficacy and patient adherence.

2. How does ONEXTON’s market share compare to other acne therapies?
   As a relatively new entrant, ONEXTON’s market share remains limited but is expected to expand as prescriber familiarity increases and new markets open.

3. What are the main barriers to ONEXTON’s wider adoption?
   Key barriers include pricing and reimbursement constraints, competition from generics, potential skin irritation side effects, and limited awareness among non-specialist physicians.

4. Are there upcoming regulatory approvals that could impact ONEXTON’s market trajectory?
   Pending approvals in Europe and Asia could significantly expand its geographic footprint, contingent upon local regulatory pathways.

5. How might emerging digital health tools influence ONEXTON’s sales?
   Teledermatology and digital marketing can enhance awareness, facilitate patient education, and streamline prescribing, thereby accelerating sales growth.

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Sources:

[1] Doshi, A., et al. (2019). "Global Epidemiology of Acne." Journal of the American Academy of Dermatology.