OXYTROL Drug Patent Profile

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

Oxytrol is a drug marketed by Allergan and Abbvie and is included in two NDAs.

The generic ingredient in OXYTROL 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

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	7
Patent Applications:	4,990
Drug Prices:	Drug price information for OXYTROL
What excipients (inactive ingredients) are in OXYTROL?	OXYTROL excipients list
DailyMed Link:	OXYTROL at DailyMed

See drug prices for OXYTROL

See drug sales revenues for OXYTROL

Recent Clinical Trials for OXYTROL

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 clinical trials

Pharmacology for OXYTROL

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Paragraph IV (Patent) Challenges for OXYTROL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXYTROL	Transdermal System Extended-release	oxybutynin	3.9 mg/24 hrs	021351	1	2008-08-19

US Patents and Regulatory Information for OXYTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003		RX	Yes	Yes
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013		OTC	Yes	Yes

Expired US Patents for OXYTROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	7,081,249
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	7,179,483
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	5,164,190
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	7,081,251
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003	7,081,250

EU/EMA Drug Approvals for OXYTROL

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

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

Country	Patent Number	Title	Estimated Expiration
Japan	2000153001	PERCUTANEOUS DELIVERY DEVICE FOR SUB-SATURATED DRUG FOR PROVIDING PROMOTED DRUG FLOW RATE
Japan	6209263
South Korea	20130026510	COMPOSITIONS AND METHODS FOR TRANSDERMAL OXYBUTININ THERAPY
Cyprus	1111498
Spain	2357699

Supplementary Protection Certificates for OXYTROL

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OXYTROL

Introduction

OXYTROL, an oxybutynin transdermal system, has been a significant player in the treatment of overactive bladder (OAB) symptoms, particularly among women. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key factors driving its growth and challenges.

Market Size and Growth

The oxybutynin transdermal system market, which includes OXYTROL, was valued at USD 7.48 billion in 2023 and is projected to reach USD 10.97 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.9% from 2024 to 2031[1].

Key Drivers of Growth

Several factors are driving the growth of the oxybutynin transdermal system market:

Increasing Prevalence of Overactive Bladder

The rising prevalence of OAB, especially among the elderly, is a significant driver. As the population ages, the demand for effective and non-invasive treatments like OXYTROL increases[1].

Technological Advancements

Advancements in transdermal patch design have improved the efficacy and comfort of these systems. Enhanced patch designs provide better adherence and controlled drug release, making them more appealing to patients[1].

Patient Preference for Non-Invasive Treatments

Patients are increasingly opting for non-invasive and comfortable treatment solutions. OXYTROL, being a transdermal patch, fits this preference perfectly, contributing to its market growth[1].

Regulatory Approvals and Healthcare Investments

Favorable regulatory approvals and increasing investments in healthcare infrastructure are also boosting the market. The FDA approval for OXYTROL as an over-the-counter (OTC) treatment has expanded its accessibility and contributed to its growth[4].

Market Segmentation

The oxybutynin transdermal system market is segmented based on type (patches, gels, films) and application (overactive bladder treatment), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1].

Competitive Landscape

The market for oxybutynin transdermal systems is competitive, with key players including Mylan N.V. (now Viatris Inc.), Allergan (AbbVie Inc.), Hisamitsu Pharmaceutical Co. Inc., Novartis AG, and Teva Pharmaceutical Industries Ltd. These companies are continually innovating and expanding their product offerings to capture market share[1].

Financial Performance

Revenue and Sales

OXYTROL, as part of the oxybutynin transdermal system market, has seen significant revenue growth. The market's projected growth to USD 10.97 billion by 2031 indicates a robust financial trajectory. The product's availability as an OTC treatment has further enhanced its sales, making it more accessible to a broader consumer base[1].

Cost and Pricing

The cost-effectiveness of OXYTROL compared to other treatments for OAB is another factor driving its financial performance. The transdermal system offers a convenient and cost-efficient solution, which is attractive to both patients and healthcare providers[4].

Regulatory and Approval Milestones

FDA Approval

OXYTROL for Women received FDA approval for OTC use in January 2013, marking a significant milestone. This approval was based on studies demonstrating that women could correctly recognize OAB symptoms and appropriately use the product[5].

Prescription-to-OTC Switch

The prescription-to-OTC switch for OXYTROL expanded its market reach, allowing more women to access the treatment without a prescription. This switch was a strategic move by Merck Consumer Care to leverage their experience in transitioning prescription drugs to OTC products[4].

Consumer Impact and Market Penetration

Consumer Awareness and Acceptance

The availability of OXYTROL as an OTC product has increased consumer awareness and acceptance. The product's discreet and easy-to-use design has made it a preferred choice for many women suffering from OAB symptoms[4].

Market Penetration

OXYTROL has penetrated the market significantly since its introduction. The product's nationwide availability in the U.S. and its marketing through leading retailers have contributed to its widespread adoption[4].

Challenges and Future Outlook

Competition from Other Treatments

The market for OAB treatments is competitive, with other products and therapies, such as sacral neuromodulation (SNM) systems, also vying for market share. Companies like Axonics Modulation Technologies are introducing innovative SNM systems that could pose competition to transdermal systems like OXYTROL[3].

Regulatory and Economic Factors

Economic instability and regulatory changes can impact the market. For instance, Brexit and other global economic shifts could affect the stability of financial markets and, by extension, the pharmaceutical industry[3].

Key Takeaways

• The oxybutynin transdermal system market, including OXYTROL, is expected to grow significantly, reaching USD 10.97 billion by 2031.
• Technological advancements, patient preference for non-invasive treatments, and favorable regulatory approvals are key drivers of growth.
• The market is segmented by type, application, and geography, with North America and Europe being significant regions.
• OXYTROL's availability as an OTC treatment has expanded its market reach and contributed to its financial performance.
• Despite challenges from other treatments and economic factors, OXYTROL remains a strong player in the OAB treatment market.

FAQs

What is the projected market size for oxybutynin transdermal systems by 2031?

The oxybutynin transdermal system market is expected to reach USD 10.97 billion by 2031[1].

What are the key drivers of growth for the oxybutynin transdermal system market?

Key drivers include the increasing prevalence of overactive bladder, technological advancements in patch design, patient preference for non-invasive treatments, and favorable regulatory approvals[1].

Who are the major players in the oxybutynin transdermal system market?

Major players include Mylan N.V. (now Viatris Inc.), Allergan (AbbVie Inc.), Hisamitsu Pharmaceutical Co. Inc., Novartis AG, and Teva Pharmaceutical Industries Ltd.[1].

When did OXYTROL for Women receive FDA approval for OTC use?

OXYTROL for Women received FDA approval for OTC use in January 2013[5].

How has the availability of OXYTROL as an OTC product impacted its market penetration?

The availability of OXYTROL as an OTC product has increased consumer awareness and acceptance, making it a preferred choice for many women suffering from OAB symptoms[4].

Sources

1. Market Research Intellect: Oxybutynin Transdermal System Market Size, Share and Trends.
2. Merck: Merck Announces Full-Year and Fourth-Quarter 2012 Financial Results.
3. Axonics Modulation Technologies, Inc.: Annual Reports.
4. Merck: OXYTROL FOR WOMEN, the First Over-the-Counter Treatment for Overactive Bladder in Women, Now Available Nationwide.
5. FDA: 202211s000 - accessdata.fda.gov.