ONEXTON Drug Patent Profile

When do Onexton patents expire, and what generic alternatives are available?

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	8,288,434		Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	9,561,208		Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	9,504,704		Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	10,220,049		Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	10,137,142		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	5,733,886

International Patents for ONEXTON

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9300848	COMPOSICIONES DE CLINDAMICINA Y PEROXIDO DE BENZOILO PARA TRATAMIENTO DE ACNE.
South Africa	201008265	TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT
Denmark	0626844
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)
Russian Federation	2010146038	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ
Singapore	48195	Compositions of clyndamycin and benzoyl peroxide for acne treatment
Russian Federation	94040385

Supplementary Protection Certificates for ONEXTON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	C01458369/01	Switzerland		PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
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
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
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
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 (Sarecycline)

Last updated: December 29, 2025

Summary

ONEXTON (sarecycline) is an oral tetracycline-class antibiotic approved by the U.S. Food and Drug Administration (FDA) in 2018 for the treatment of acne vulgaris. Developing a comprehensive understanding of its market dynamics and financial trajectory is critical for stakeholders, including pharmaceutical companies, investors, and healthcare providers. This analysis examines the current market landscape, competitive positioning, growth drivers, challenges, and future financial prospects for ONEXTON.

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What Is ONEXTON (Sarecycline)?

Product Profile	Attribute	Details
Active Ingredient	Sarecycline (synthetic tetracycline antibiotic)
Indications	Acne vulgaris in patients aged 9 years and older
Approval Date	October 2018 (FDA)
Manufacturer	Almirall S.A. (licensed to Pfizer for U.S. commercialization)

Pharmacological Characteristics	Feature	Description
Spectrum	Narrow-spectrum activity targeting Gram-positive bacteria, reducing impact on gut microbiota
Dosing	Once daily oral capsule (60 mg for most patients)
Benefits	Reduced risk of antibiotic resistance, favorable safety profile in adolescents

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What Are the Key Market Dynamics Influencing ONEXTON?

1. Market Demand and Patient Population Growth

Projected growth in acne prevalence underpins ONEXTON's market potential:

Parameter	Data/Estimate
Global adolescent population	Approx. 1.2 billion (United Nations, 2021)
Acne prevalence in adolescents	85% (American Academy of Dermatology Association)
U.S. adolescent acne market	Estimated at over $350 million (2022), expected to grow annually

Implication: The growing adolescent demographic globally sustains a steady demand pipeline for acne treatments like ONEXTON.

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2. Competitive Landscape

Key Players	Products	Market Shares	Differentiators
AbbVie	Doxycycline, Minocycline	~30% (estimated)	Brand recognition, broad spectrum
Mayne Pharma	Oral antibiotics, topical agents	~20%	Portfolio diversity
Almirall (ONEXTON)	Sarecycline	Emerging	Narrow spectrum, DTC marketing, pediatric approval

Emerging Competitors

• Oral antibiotics (doxycycline, minocycline) dominate due to established efficacy and physician familiarity.
• Topical agents (clindamycin, benzoyl peroxide) remain frontline but face resistance issues.

Key Point: ONEXTON's narrow spectrum positions it uniquely, but its adoption hinges on physician perception and comparative efficacy.

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3. Regulatory and Policy Factors

• FDA Approvals: Besides acne, potential for expanded indications such as rosacea remains under consideration.
• Antimicrobial Stewardship: Policies aimed at reducing antibiotic resistance influence prescribing behaviors, favoring narrow-spectrum agents like sarecycline.
• Reimbursement & Pricing: Access depends on formularies; proposed price points have ranged from $750–$950 per cycle (30-day supply).

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4. Pricing Strategy and Reimbursement

Parameter	Data
Average Wholesale Price (AWP)	~$850 per 30-day cycle
Insurance Coverage	Favorable, with copay assistance programs
Patient Out-of-Pocket	Typically $20–$50 with insurance

Market Penetration Tactics

• Physician education emphasizing localized microbial impact
• Patient adherence programs
• Digital marketing targeting dermatologists and pediatricians

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5. Market Penetration and Sales Trajectory

Initial sales have been modest, reflecting early-stage market penetration:

Timeline	Revenue (Estimate)	Comments
2018	<$50M	Launch year, limited awareness
2020	~$150M	Increased physician familiarity
2022	~$250M	Growing prescriptions, expanded awareness

Projection:
Analysts forecast revenues to approach $400–$500 million by 2025 if market access expands and global sales increase.

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What Are Key Factors Driving ONEXTON’s Growth?

Drivers	Details
Pediatric and adolescent patient base	Growing awareness and approval for patients as young as 9
Narrow-spectrum profile	Aligns with antimicrobial stewardship, attracting prescribers concerned with resistance
Competitive differentiation	Unique positioning against broad-spectrum antibiotics
Digital marketing	Increased engagement with dermatologists via targeted campaigns

Note: The COVID-19 pandemic temporarily disrupted dermatology services, impacting early sales, but recovery is underway.

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What Challenges Could Impact ONEXTON’s Financial Trajectory?

Challenge	Impact
Competitive Dynamics	Dominance of doxycycline/minocycline may hinder adoption
Prescribing Trends	Shift towards non-antibiotic therapies (e.g., topical retinoids, light-based therapies)
Antimicrobial Resistance Policies	Could restrict antibiotic prescriptions further
Pricing & Reimbursement	Increasing price pressures and formulary restrictions

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How Does ONEXTON Compare to Competitors?

Aspect	ONEXTON (Sarecycline)	Doxycycline	Minocycline	Topical Options
Spectrum	Narrow	Broad	Broad	Localized
Resistance	Lower risk	Higher risk	Higher risk	N/A
Dosing	60 mg daily	50–100 mg daily	50–100 mg daily	Varies
FDA Approval	2018	Decades-old	Decades-old	Varies
Pediatric Use	Yes (≥9 years)	Yes	Yes	N/A

Summary:
ONEXTON’s unique narrow-spectrum approach and pediatric approval position it as a strategic alternative to traditional antibiotics.

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What Is the Long-Term Financial Outlook for ONEXTON?

Scenario	Revenue Estimate (USD)	Timeline	Assumptions
Conservative	~$300M by 2025	Slow uptake, competition intensifies	Limited market penetration, minimal international expansion
Moderate	~$500M by 2025	Steady growth, expanding indications	Increased prescriber acceptance, U.S. and select international markets
Optimistic	~$700M+ by 2025	Rapid adoption, expanded indications, global expansion	Successful global launches and positive clinical outcomes

Note: International markets, notably Europe and Asia, represent potential growth for ONEXTON, contingent upon regulatory approvals.

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Conclusion: What Are the Key Takeaways for Stakeholders?

• Growth Prospects: The adolescent acne market remains sizable and resilient, with a projected CAGR of approximately 7-9% through 2025. ONEXTON is positioned favorably due to its unique profile but faces stiff competition from traditional antibiotics and topical therapies.

• Market Challenges: Physician familiarity with existing antibiotics and cautious antimicrobial stewardship policies pose hurdles. Pricing pressures and formulary restrictions could temper growth.

• Strategic Opportunities: Expanding indications, leveraging digital marketing, emphasizing antimicrobial stewardship credentials, and pursuing international regulatory approvals can significantly enhance revenue trajectory.

• Investment Implications: Stakeholders should monitor prescription trends, clinical data on resistance patterns, and policy shifts that could either bolster or inhibit ONEXTON’s market penetration.

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FAQs

1. How does sarecycline differ from other tetracycline antibiotics in treating acne?

Sarecycline offers a narrow-spectrum activity targeting Gram-positive bacteria with minimal impact on gut microbiota, reducing the risk of resistance and gastrointestinal side effects common with doxycycline or minocycline. Its approval for pediatric use (≥9 years) also broadens treatment options.

2. What factors will influence ONEXTON's market penetration over the next five years?

Factors include prescriber acceptance, clinical trial outcomes validating its efficacy, physician awareness campaigns, formulary inclusion, competitive landscape shifts, and regulatory policies favoring narrow-spectrum antibiotics.

3. Is ONEXTON likely to expand into markets outside the U.S.?

Yes. Regulatory approval in Europe, Asia, and other regions is critical. Success depends on local market dynamics, regulatory pathways, and international partnerships.

4. Can ONEXTON address antibiotic resistance concerns prevalent with older tetracyclines?

Its narrow-spectrum design and targeted activity minimize off-target bacterial effects, aligning with antimicrobial stewardship goals, potentially making it a preferred option in resistant-prone environments.

5. What are the main barriers to ONEXTON's growth?

Key barriers include entrenched prescriber habits favoring established antibiotics, pricing pressures, formulary restrictions, and competition from topical treatments and emerging non-antibiotic therapies.

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References

1. [American Academy of Dermatology Association. Acne prevalence. 2021.]
2. [FDA Approval Announcement for ONEXTON. October 2018.]
3. [Almirall S.A. Corporate Reports, 2022.]
4. [Market Research Future. Acne Treatment Market Size, 2022.]
5. [United Nations. Demographic Data, 2021.]