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. Fifteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Onexton

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:	3
Clinical Trials:	3
Patent Applications:	7
Drug Prices:	Drug price information 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

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

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
Poland	171127
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

Supplementary Protection Certificates for ONEXTON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID

Market Dynamics and Financial Trajectory for ONEXTON Gel

Introduction to ONEXTON Gel

ONEXTON Gel is a topical treatment combining clindamycin phosphate and benzoyl peroxide, indicated for the treatment of acne vulgaris in patients 12 years of age and older. Here, we will delve into the market dynamics and financial trajectory of this medication.

Market Overview of Acne Treatments

The U.S. acne market is projected to reach $4.49 billion by 2024, growing at a CAGR of 4.12% from 2019 to 2024. This growth is driven by an increasing youth population, rising purchasing power, and escalating healthcare expenditure[4].

Position of ONEXTON Gel in the Market

ONEXTON Gel is part of the topical drugs segment, which dominates the acne treatment market. In 2019, topical drugs held the largest share of the U.S. acne market. The product competes with other well-known brands such as Epiduo, Aczone, and Solodyne[4].

Market Forecast for ONEXTON Gel

The U.S. acne market forecast indicates a steady growth in demand for topical treatments. ONEXTON Gel, with its combination of clindamycin phosphate and benzoyl peroxide, is expected to maintain its market share due to its efficacy in treating acne vulgaris. The forecast suggests that the U.S. acne topical treatment population will continue to grow, benefiting products like ONEXTON Gel[4].

Revenue and Market Share

The revenue forecast for ONEXTON Gel is part of the broader U.S. acne market projections. While specific revenue figures for ONEXTON Gel are not provided in the available sources, the overall market trends suggest that topical treatments will continue to generate significant revenue. The dominant share of the market held by topical drugs, including ONEXTON Gel, indicates a stable financial trajectory for this product[4].

Growth Drivers

Several factors drive the growth of the acne treatment market, including:

Increasing Youth Population

The rising number of young individuals, who are more prone to acne, contributes to the increasing demand for acne treatments like ONEXTON Gel[4].

Rising Purchasing Power

As consumers' purchasing power increases, they are more likely to invest in skincare and acne treatments, boosting the market for products like ONEXTON Gel[4].

Escalating Healthcare Expenditure

Increased healthcare spending also fuels the growth of the acne treatment market, as more people seek and can afford medical treatments for acne[4].

Challenges and Limitations

Despite the positive market dynamics, there are challenges that ONEXTON Gel and similar products face:

Entry of Generic Drugs

The entry of generic drugs can pose a challenge to branded products like ONEXTON Gel, potentially affecting market share and revenue[4].

Side Effects and Safety Concerns

Local skin reactions such as erythema, scaling, itching, burning, and stinging are common side effects of ONEXTON Gel. While these reactions are generally mild and temporary, they can impact patient compliance and satisfaction[1].

Competitive Landscape

The acne treatment market is highly competitive, with several brands vying for market share. ONEXTON Gel competes with other topical treatments like Epiduo, Aczone, and Solodyne. The market is also segmented by drug type, with topical drugs being the dominant segment[4].

Financial Performance Indicators

While specific financial performance data for ONEXTON Gel is not available, the overall financial health of the companies involved in its production and distribution can provide insights. For instance, the pharmaceutical industry's financial performance is often influenced by factors such as revenue from new investments, operator restructurings, and the impact of generic drugs on branded products[2][5].

Key Takeaways

• Market Growth: The U.S. acne market is expected to grow, driven by an increasing youth population, rising purchasing power, and escalating healthcare expenditure.
• Market Position: ONEXTON Gel is part of the dominant topical drugs segment in the acne treatment market.
• Revenue Forecast: The product is expected to benefit from the overall growth in the topical treatment segment.
• Growth Drivers: Increasing youth population, rising purchasing power, and escalating healthcare expenditure drive market growth.
• Challenges: Entry of generic drugs and side effects are potential challenges.

FAQs

What is ONEXTON Gel used for?

ONEXTON Gel is used for the topical treatment of acne vulgaris in patients 12 years of age and older[1].

What are the active ingredients in ONEXTON Gel?

The active ingredients are clindamycin phosphate and benzoyl peroxide[1].

What are the common side effects of ONEXTON Gel?

Common side effects include erythema, scaling, itching, burning, and stinging[1].

How does ONEXTON Gel fit into the broader acne treatment market?

ONEXTON Gel is part of the topical drugs segment, which dominates the U.S. acne market[4].

What are the growth drivers for the acne treatment market?

The growth drivers include an increasing youth population, rising purchasing power, and escalating healthcare expenditure[4].

Sources

1. FDA NDA 50-819/S-12: ONEXTON Gel Prescribing Information.
2. Omega Healthcare: Second Quarter 2024 Results and Recent Developments.
3. a16z: Outclassed: The Battle for Therapeutic Market Share.
4. GlobeNewswire: U.S. Acne & Rosacea Market: Insights, Trends & Forecast (2020-2024).
5. Omega Healthcare: First Quarter 2024 Results and Recent Developments.

Last updated: 2024-12-17