Oxybutynin chloride - Generic Drug Details

What are the generic sources for oxybutynin chloride and what is the scope of patent protection?

Oxybutynin chloride is the generic ingredient in four branded drugs marketed by Abbvie, Chartwell Rx, Ortho Mcneil Janssen, Lannett Co Inc, Pharm Assoc, Pharmobedient Cnsltg, Janssen Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Impax Pharms, Norvium Bioscience, Osmotica Pharm Us, Rubicon, Unique, Zydus Pharms, Abhai Llc, Avet Lifesciences, Beximco Pharms Usa, Hibrow Hlthcare, Leading, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Strides Pharma, Teva Pharms Usa, Trupharma, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in thirty-eight NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin chloride has twenty-two patent family members in thirteen countries.

There are nine drug master file entries for oxybutynin chloride. Forty suppliers are listed for this compound.

Summary for oxybutynin chloride

International Patents:	22
US Patents:	3
Tradenames:	4
Applicants:	32
NDAs:	38
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	23
Patent Applications:	2,577
Drug Prices:	Drug price trends for oxybutynin chloride
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxybutynin chloride
What excipients (inactive ingredients) are in oxybutynin chloride?	oxybutynin chloride excipients list
DailyMed Link:	oxybutynin chloride at DailyMed

See drug prices for oxybutynin chloride

See drug sales revenues for oxybutynin chloride

Recent Clinical Trials for oxybutynin chloride

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

Sponsor	Phase
Il-Yang Pharm. Co., Ltd.	Phase 2
Seoul National University Hospital	Phase 2
Alliance for Clinical Trials in Oncology	Phase 2

See all oxybutynin chloride clinical trials

Pharmacology for oxybutynin chloride

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for oxybutynin chloride

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for OXYBUTYNIN CHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GELNIQUE	Gel	oxybutynin chloride	10%	022204	1	2014-06-19

US Patents and Regulatory Information for oxybutynin chloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	207138-001	Feb 29, 2016	AB	RX	No	No
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-003	Jun 22, 1999		DISCN	Yes	No
Chartwell Rx	OXYBUTYNIN CHLORIDE	oxybutynin chloride	GEL;TRANSDERMAL	207329-001	May 31, 2018		DISCN	No	No
Amneal Pharms	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	204010-001	Nov 23, 2015	AB	RX	No	No

Expired US Patents for oxybutynin chloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-001	Dec 16, 1998
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-003	Jun 22, 1999
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-003	Jun 22, 1999

International Patents for oxybutynin chloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3287122	DISPOSITIF DE STOCKAGE ET D'ADMINISTRATION DE COMPOSITIONS TOPIQUES D'OXYBUTYNINE DANS LE CADRE DU TRAITEMENT DE VESSIES HYPERACTIVES (DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS FOR TREATING OVERACTIVE BLADDERS.)
Japan	5485377
Mexico	338166	UN PROCEDIMIENTO PARA TRATAR VEJIGAS HIPERACTIVAS Y UN DISPOSITIVO PARA ALMACENAMIENTO Y ADMINISTRACION DE COMPOSICIONES TOPICAS DE OXIBUTININA. (A METHOD FOR TREATING OVERACTIVE BLADDERS AND A DEVICE FOR STORAGE AND ADMINISTRATION OF TOPICAL OXYBUTYNIN COMPOSITIONS.)
Spain	2721513

Oxybutynin chloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxybutynin Chloride

Introduction

Oxybutynin chloride is a widely used medication for the symptomatic treatment of overactive bladder (OAB), characterized by symptoms such as urge urinary incontinence, frequency, and urgency. This article delves into the market dynamics and financial trajectory of oxybutynin chloride, exploring its current market position, future projections, and the factors influencing its growth.

Market Size and Growth Projections

The oxybutynin transdermal system market, which includes oxybutynin chloride, is expected to experience significant growth. The market is projected to increase at a CAGR of 3 to 5 percent from 2023 to 2031, indicating a robust expansion during the forecast period[1].

Segmentation and Geographic Distribution

The market for oxybutynin chloride is segmented based on application (hospital, drug store), product form (gel, patch), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market dynamics and opportunities across different regions and sectors[1].

Product Forms and Pricing

Oxybutynin chloride is available in various formulations, including tablets, syrup, extended-release tablets, transdermal patches, and transdermal gel. The pricing varies significantly depending on the formulation and dosage. For example, Oxytrol 3.9 mg/24hr patches are priced around $20.87 per patch, while Gelnique 10% gel sachets cost approximately $5.17 per gram[2].

Clinical Efficacy and Patient Impact

Oxybutynin chloride has been proven effective in treating OAB symptoms, including urge urinary incontinence, frequency, and urgency. It possesses anticholinergic and spasmolytic properties, which improve both subjective and objective measures of bladder function. However, it can cause adverse effects such as dry mouth, constipation, and blurred vision, leading to treatment discontinuation in some patients[3].

Market Competition

The OAB market is highly competitive, with several key players including Allergan and Recordati S.p.A. Oxybutynin chloride competes with other anticholinergic drugs like tolterodine (Detrol), solifenacin (Vesicare), and darifenacin (Enablex). The market share of oxybutynin chloride is significant, especially among new-to-market patients and those switching treatments[4].

Prescription Trends and Sales

Historically, oxybutynin chloride and its extended-release form have had substantial prescription numbers. In the 12 months ending January 2012, oxybutynin chloride and oxybutynin chloride ER had 3.7 million and 3.6 million prescriptions, respectively. This contributed to a significant portion of the $2.1 billion in sales for OAB drugs during that period[4].

Regulatory Approvals and Clinical Trials

Oxybutynin chloride has a long history of regulatory approvals. The tablets were approved in 1975, the syrup in 1979, and the extended-release tablets in 1998. The transdermal patch (Oxytrol TDS) was approved in 2003, and the transdermal gel (Gelnique) was approved based on a large phase 3 trial demonstrating its efficacy and safety[5].

Financial Investments and Promotional Strategies

Pharmaceutical companies invest heavily in promoting their OAB drugs. For instance, Pfizer spent over $252 million promoting Toviaz in the 12 months ending November 2011, which accounted for 38% of the promotional spending in the OAB market. Similarly, Astellas invested significantly in promoting Vesicare, which led the market with 3.8 million prescriptions during the same period[4].

Future Outlook and Challenges

The future of the OAB market, including oxybutynin chloride, is expected to be dynamic. The potential launch of new drugs like mirabegron and the introduction of generics will influence market dynamics. Companies must balance their promotional strategies to maintain market share. For example, Astellas may need to decide whether to focus on Vesicare or the new drug mirabegron, or to market both effectively without cannibalizing each other’s market share[4].

Competitive Landscape

The competitive landscape is characterized by the presence of established and emerging players. Key companies like Allergan and Recordati S.p.A. are profiled in market reports, highlighting their market entry year, product offerings, and regional presence. This competitive analysis helps in understanding the market positioning and strategies of these companies[1].

Market Opportunities and Challenges

The market for oxybutynin chloride presents several opportunities, including the growing prevalence of OAB and the need for effective treatments. However, challenges such as patent expirations, the introduction of generics, and the launch of new drugs with different modes of action must be navigated. Companies need to adapt their strategies to capitalize on opportunities while mitigating these challenges[1][4].

Economic, Political, and Social Factors

The market is influenced by economic, political, and social factors. Economic factors include the cost of treatment and reimbursement policies, while political factors involve regulatory approvals and patent protections. Social factors, such as patient awareness and preference, also play a crucial role in shaping the market[1].

Porter's 5 Forces Analysis

A Porter's 5 Forces analysis reveals the competitive forces at play. The threat of new entrants is moderate due to regulatory barriers, while the threat of substitutes is high with the presence of other anticholinergic drugs. The bargaining power of buyers is significant due to the availability of generics, and the bargaining power of suppliers is moderate. The intensity of rivalry among existing competitors is high, driven by promotional spending and product differentiation[1].

Value Chain Analysis

The value chain analysis highlights the various stages from product development to distribution. Companies like Watson Laboratories, which sponsored the approval of oxybutynin transdermal gel, play a crucial role in this chain. The analysis also includes the role of pharmacies and hospitals in the distribution and application of the drug[5].

Pricing Analysis

Pricing is a critical factor in the market dynamics of oxybutynin chloride. The prices of different formulations vary widely, and companies must balance pricing strategies to ensure profitability while remaining competitive. The cost of treatment and the availability of generics influence pricing decisions[2].

Key Takeaways

• The oxybutynin transdermal system market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
• The market is segmented by application, product form, and geographical regions.
• Oxybutynin chloride is available in various formulations with varying prices.
• The drug is effective in treating OAB symptoms but can cause adverse effects.
• The market is highly competitive with significant promotional spending.
• Future outlook includes the launch of new drugs and the introduction of generics.
• Economic, political, and social factors influence market dynamics.

FAQs

What is oxybutynin chloride used for?

Oxybutynin chloride is used for the symptomatic treatment of overactive bladder, which causes symptoms such as urge urinary incontinence, frequency, and urgency[2][3].

What are the different formulations of oxybutynin chloride?

Oxybutynin chloride is available in various formulations including tablets, syrup, extended-release tablets, transdermal patches, and transdermal gel[2][5].

How does oxybutynin chloride compare to other OAB treatments?

Oxybutynin chloride is as effective as other anticholinergic drugs like propantheline and propiverine but may have different side effect profiles. It is the only drug available in a transdermal formulation for OAB treatment[3][5].

What are the potential side effects of oxybutynin chloride?

Common side effects include dry mouth, constipation, and blurred vision. These can be troublesome enough to necessitate treatment discontinuation in up to 25% of patients[3].

How is the market for oxybutynin chloride expected to evolve in the future?

The market is expected to grow with a CAGR of 3 to 5 percent from 2023 to 2031. The introduction of new drugs and generics will influence market dynamics, and companies will need to adapt their strategies to maintain market share[1][4].

Sources

1. Market Research Intellect - Global Oxybutynin Transdermal System Market Size And Forecast 2
2. DrugBank - Oxybutynin: Uses, Interactions, Mechanism of Action
3. PubMed - Oxybutynin. A review of its pharmacodynamic and pharmacokinetic properties
4. PM360 - Overactive Bladder Market: Managing the Future
5. FDA - SUMMARY REVIEW for Regulatory Action - Gelnique/Oxybutynin chloride