OXYTROL FOR WOMEN Drug Patent Profile

When do Oxytrol For Women patents expire, and what generic alternatives are available?

Oxytrol For Women is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in OXYTROL FOR WOMEN is oxybutynin. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxybutynin profile page.

Summary for OXYTROL FOR WOMEN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	7
Drug Prices:	Drug price information for OXYTROL FOR WOMEN
What excipients (inactive ingredients) are in OXYTROL FOR WOMEN?	OXYTROL FOR WOMEN excipients list
DailyMed Link:	OXYTROL FOR WOMEN at DailyMed

See drug prices for OXYTROL FOR WOMEN

Recent Clinical Trials for OXYTROL FOR WOMEN

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

Sponsor	Phase
Astellas Scientific & Medical Affairs, Inc.
Christopher Patrick Smith	Phase 3
Bayer	Phase 3

See all OXYTROL FOR WOMEN clinical trials

Pharmacology for OXYTROL FOR WOMEN

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

US Patents and Regulatory Information for OXYTROL FOR WOMEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013		OTC	Yes	Yes

Expired US Patents for OXYTROL FOR WOMEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	7,081,250
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	5,601,839
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	7,081,252
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	7,081,251
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	7,081,249
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	6,743,441
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013	5,834,010

EU/EMA Drug Approvals for OXYTROL FOR WOMEN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Kentera (previously Oxybutynin Nicobrand)	oxybutynin	EMEA/H/C/000532 Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.	Authorised	no	no	no	2004-06-15

International Patents for OXYTROL FOR WOMEN

See the table below for patents covering OXYTROL FOR WOMEN around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	20052625
Denmark	0871420
South Africa	200503316	Compositions and methods for transdermal oxybutynin therapy
Denmark	1565136
Australia	2012216593	Compositions and methods for transdermal oxybutynin therapy
Australia	2003287377	COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTYNIN THERAPY
European Patent Office	2606865	Compositions destinées à la thérapie par oxybutynine transdermique (Compositions for transdermal oxybutynin therapy)

Supplementary Protection Certificates for OXYTROL FOR WOMEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0871420	CA 2005 00010	Denmark
0871420	05C0008	France		PRODUCT NAME: OXYBUTININ; REGISTRATION NO/DATE: EU/1/03/270/001 20040615

OXYTROL FOR WOMEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OXYTROL FOR WOMEN

Introduction

OXYTROL FOR WOMEN, a groundbreaking over-the-counter (OTC) treatment for overactive bladder (OAB) in women, has significantly impacted the market since its introduction. Here, we delve into the market dynamics and financial trajectory of this innovative product.

Market Need and Demand

Overactive bladder affects more than 20 million women in the United States, causing symptoms such as urinary incontinence, urgency, and frequency. These symptoms can have a profound physical and emotional impact on sufferers. The demand for effective and convenient treatments is high, and OXYTROL FOR WOMEN has filled this gap by providing the first OTC option specifically designed for women[1][4].

Product Overview

OXYTROL FOR WOMEN is a thin, flexible patch that delivers 3.9 mg of oxybutynin per day for continuous four-day use. It is applied to the abdomen, hip, or buttock and works by relaxing the bladder muscle to reduce symptoms of OAB. This transdermal system allows for non-invasive, comfortable treatment that can be worn during everyday activities, including showering and exercising[1][4].

Regulatory Approval

The FDA approved the prescription-to-OTC switch for OXYTROL FOR WOMEN on January 25, 2013. This approval was based on well-designed studies that demonstrated women's ability to correctly recognize OAB symptoms, understand safety messages, and appropriately use the product in an unsupervised setting[1][2][4].

Market Expansion and Growth

The market for oxybutynin transdermal systems, including OXYTROL FOR WOMEN, is expanding significantly. Key drivers include:

• Growing Awareness and Prevalence: Increasing awareness of advanced treatment options and the rising prevalence of OAB, particularly among the elderly, are driving market growth[3].
• Technological Advancements: Improvements in patch design, providing greater adherence and controlled drug release, are enhancing the efficacy and appeal of transdermal systems[3].
• Patient Preference: Patients are increasingly opting for non-invasive, comfortable treatment solutions, further boosting the market[3].

Financial Trajectory

The oxybutynin transdermal system market, which includes OXYTROL FOR WOMEN, has a robust financial outlook:

• Market Size: The global oxybutynin transdermal system market was valued at USD 7.48 billion in 2023 and is expected to reach USD 10.97 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.9%[3].
• Revenue Impact: The availability of OXYTROL FOR WOMEN as an OTC product has increased accessibility and convenience, contributing to higher sales and revenue. Merck Consumer Care's strategic move to leverage their prescription-to-OTC switch experience has enhanced their market presence and financial performance[1][4].

Competitive Landscape

OXYTROL FOR WOMEN holds a unique position as the first and only OTC treatment for OAB in women. This exclusivity, combined with its prescription-strength efficacy, gives it a competitive edge in the market. The product's convenience, cost-effectiveness, and the backing of a reputable pharmaceutical company like Merck further solidify its market position[1][4].

Safety and Efficacy

The safety and efficacy of OXYTROL FOR WOMEN have been extensively evaluated. Clinical trials and post-marketing data have shown that the product maintains a favorable benefit/risk ratio when used in an OTC setting. The most common adverse effect reported is dry mouth, but overall, the product has been deemed safe and effective for self-management of OAB symptoms by women[2][5].

Consumer Impact

For women suffering from OAB, OXYTROL FOR WOMEN offers a newfound sense of control over their condition. By providing a convenient and cost-effective treatment option, it addresses the significant delay (often over three years) many women experience before seeking care. This product empowers women to manage their symptoms effectively, improving their quality of life[1][4].

Future Outlook

The future outlook for OXYTROL FOR WOMEN is promising, driven by:

• Aging Population: The increasing prevalence of OAB among the elderly will continue to drive demand for effective treatments.
• Technological Innovations: Ongoing advancements in transdermal patch technology will likely enhance the product's efficacy and user experience.
• Regulatory Support: Favorable regulatory approvals and continued support from healthcare infrastructure investments will aid market growth[3].

Key Takeaways

• OXYTROL FOR WOMEN is the first OTC treatment for overactive bladder in women, offering a prescription-strength solution.
• The product has a significant market impact due to its convenience, efficacy, and cost-effectiveness.
• The market for oxybutynin transdermal systems is growing, driven by technological advancements and increasing awareness.
• The financial trajectory is positive, with the market expected to reach USD 10.97 billion by 2031.
• The product's safety and efficacy have been well-documented, making it a reliable choice for women managing OAB.

FAQs

What is OXYTROL FOR WOMEN?

OXYTROL FOR WOMEN is a thin, flexible patch that delivers 3.9 mg of oxybutynin per day to treat overactive bladder symptoms in women.

How is OXYTROL FOR WOMEN applied?

The patch is applied to the abdomen, hip, or buttock once every four days.

What are the key benefits of OXYTROL FOR WOMEN?

It offers a convenient, cost-effective, and prescription-strength OTC option for managing OAB symptoms, including urinary incontinence, urgency, and frequency.

Why was OXYTROL FOR WOMEN approved only for women?

The FDA approved it only for women due to concerns about potential prostate-related complications in men.

What is the expected market growth for oxybutynin transdermal systems?

The market is expected to grow at a CAGR of 4.9%, reaching USD 10.97 billion by 2031.

Sources

1. UroToday: "OXYTROL FOR WOMEN, the first over-the-counter treatment for overactive bladder in women, now available nationwide."
2. FDA: "202211s000 - accessdata.fda.gov"
3. Market Research Intellect: "Oxybutynin Transdermal System Market Size, Share and Trends"
4. Merck: "OXYTROL FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women, Now Available Nationwide"
5. Citeline: "Oxytrol for Women Oxybutynin transdermal system, 3.9 mg/day"