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Last Updated: December 22, 2024

OXYBUTYNIN CHLORIDE Drug Patent Profile


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Which patents cover Oxybutynin Chloride, and when can generic versions of Oxybutynin Chloride launch?

Oxybutynin Chloride is a drug marketed by Chartwell Rx, Lannett Co Inc, Pharm Assoc, Pharmobedient Cnsltg, 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-four NDAs.

The generic ingredient in OXYBUTYNIN CHLORIDE 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 Oxybutynin Chloride

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

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Drug patent expirations by year for OXYBUTYNIN CHLORIDE
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Drug Sales Revenue Trends for OXYBUTYNIN CHLORIDE

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Recent Clinical Trials for OXYBUTYNIN CHLORIDE

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

SponsorPhase
Il-Yang Pharm. Co., Ltd.Phase 2
Seoul National University HospitalPhase 2
Alliance for Clinical Trials in OncologyPhase 2

See all OXYBUTYNIN CHLORIDE clinical trials

Pharmacology for OXYBUTYNIN CHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for OXYBUTYNIN CHLORIDE
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
Hibrow Hlthcare OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 211062-001 Feb 6, 2019 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Unique OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 206121-001 May 27, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 208165-001 Dec 17, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Quantum Pharmics OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 072296-001 Dec 8, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 071655-001 Nov 14, 1988 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Osmotica Pharm Us OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 078503-003 Feb 4, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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