DITROPAN XL Drug Patent Profile

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

Ditropan Xl is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DITROPAN XL is oxybutynin chloride. There are sixteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ditropan Xl

A generic version of DITROPAN XL was approved as oxybutynin chloride by TEVA PHARMS USA on November 14^th, 1988.

Summary for DITROPAN XL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	22
Patent Applications:	1,757
Drug Prices:	Drug price information for DITROPAN XL
DailyMed Link:	DITROPAN XL at DailyMed

See drug prices for DITROPAN XL

Recent Clinical Trials for DITROPAN XL

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

Sponsor	Phase
Seoul National University Hospital	Phase 2
Il-Yang Pharm. Co., Ltd.	Phase 2
Brigham and Women's Hospital	Phase 2

See all DITROPAN XL clinical trials

US Patents and Regulatory Information for DITROPAN XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-001	Dec 16, 1998		DISCN	Yes	No
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998		DISCN	Yes	No
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-003	Jun 22, 1999		DISCN	Yes	No

Expired US Patents for DITROPAN XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-003	Jun 22, 1999	5,082,668*PED
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-001	Dec 16, 1998	6,919,092*PED
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998	5,912,268*PED
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-003	Jun 22, 1999	4,612,008*PED

International Patents for DITROPAN XL

See the table below for patents covering DITROPAN XL around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	99784
Spain	2141044	TERAPIA CON OXIBUTININA.
World Intellectual Property Organization (WIPO)	9637202
Austria	A88084

DITROPAN XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of DITROPAN XL

Introduction

DITROPAN XL, an extended-release formulation of oxybutynin chloride, is a medication used to treat symptoms of an overactive bladder, including urge incontinence, urgency, and frequency. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The overactive bladder (OAB) market is dynamic and highly competitive. In 2012, the market saw significant activity with over 17.8 million prescriptions filled, generating nearly $2.1 billion in sales[1].

Key Players and Market Share

• DITROPAN XL and its immediate-release counterpart are part of the oxybutynin chloride market segment.
• Other key players include VESIcare (Astellas and GlaxoSmithKline), Detrol LA (Pfizer), Enablex (Warner Chilcott), and Toviaz (Pfizer)[1].
• In 2012, VESIcare led the market with 3.8 million prescriptions, followed closely by oxybutynin chloride and oxybutynin chloride ER. Detrol LA, previously the market leader, ranked fourth with 3.3 million prescriptions[1].

Generic Competition

• The introduction of generic versions significantly impacts the market. As of 2012, Ditropan and Ditropan XL were the only generics available, but more generics were expected to enter the market as patents expired, such as Detrol[1].
• The entry of generics typically reduces the market share of brand-name drugs but can also increase overall market size due to lower prices and increased accessibility.

Prescription Trends

• New patient prescriptions and treatment switches are critical for market growth. In 2012, oxybutynin and VESIcare were the most prescribed drugs for new patients, with 27% and 24% of new prescriptions, respectively[1].
• The dynamic segment of new-to-market patients and those switching treatments represented 15% of prescriptions and was identified as a key growth opportunity[1].

Financial Performance

• The OAB market is substantial, with sales of over $2.1 billion in the 12 months ending January 2012. This figure indicates a lucrative market with significant financial potential[1].
• The financial trajectory of DITROPAN XL is influenced by its market share, competition from generics and other brand-name drugs, and the overall demand for OAB treatments.

Impact of Patent Expirations

• The expiration of patents for key drugs like Detrol allows more generics to enter the market, which can reduce the sales of brand-name drugs but also expand the overall market size due to increased affordability[1].
• Companies often adjust their marketing strategies in response to patent expirations. For example, Pfizer shifted focus from Detrol LA to Toviaz, although Toviaz did not replicate the success of Detrol LA[1].

Marketing Strategies

• Pharmaceutical companies must balance the promotion of existing drugs with the launch of new ones. For instance, Astellas might need to decide whether to focus on VESIcare or a new drug like mirabegron if it is approved, and how to position these drugs for different patient segments[1].

Adverse Events and Safety Profile

• The safety profile of DITROPAN XL is crucial for its market acceptance. Common adverse events include dry mouth, constipation, somnolence, and urinary tract infections. These side effects can influence patient compliance and overall market performance[4][5].

Clinical Trials and Efficacy

• Clinical trials have demonstrated the efficacy of DITROPAN XL in relieving symptoms of OAB. The drug has been evaluated in several studies involving over 500 patients, showing significant relief from urge incontinence, urgency, and frequency[4].

Regulatory Environment

• The regulatory environment plays a significant role in the market dynamics. Health Canada and other regulatory bodies ensure that product monographs and labeling are accurate and compliant with guidelines. Any changes in regulatory requirements can impact the market[2].

Future Outlook

• The future of the OAB market, including DITROPAN XL, is expected to be marked by significant fluctuations. The introduction of new drugs, the impact of generic competition, and changes in marketing strategies will continue to shape the market[1].

Key Takeaways

• DITROPAN XL operates in a competitive OAB market with significant financial potential.
• Generic competition and patent expirations are key factors influencing market dynamics.
• The drug's safety profile and efficacy are critical for its market performance.
• Regulatory changes and new drug launches will continue to impact the market.

FAQs

What is DITROPAN XL used for?

DITROPAN XL is used to treat symptoms of an overactive bladder, including urge incontinence, urgency, and frequency[5].

What are the common side effects of DITROPAN XL?

Common side effects include dry mouth, constipation, somnolence, and urinary tract infections[4][5].

How does the introduction of generics affect the market for DITROPAN XL?

The introduction of generics typically reduces the market share of brand-name drugs but can increase overall market size due to lower prices and increased accessibility[1].

What is the current market share of DITROPAN XL in the OAB market?

As of 2012, DITROPAN XL and its immediate-release counterpart were among the leading prescriptions, but exact current market share figures are not provided in the sources[1].

How do regulatory changes impact the market for DITROPAN XL?

Regulatory changes, such as updates to product monographs and labeling, can impact the market by ensuring compliance and accuracy, which can affect consumer trust and usage[2].

Sources

1. Overactive Bladder Market: Managing the Future - PM360
2. Product information - Canada.ca
3. R E P O R T - Law Project for Psychiatric Rights
4. DITROPAN XL (oxybutynin chloride) - Health Canada
5. Oxybutynin (oral route) - Mayo Clinic