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Last Updated: December 22, 2024

DITROPAN Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Ditropan

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

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Summary for DITROPAN
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 89
Clinical Trials: 22
Patent Applications: 3,945
Drug Prices: Drug price information for DITROPAN
What excipients (inactive ingredients) are in DITROPAN?DITROPAN excipients list
DailyMed Link:DITROPAN at DailyMed
Drug patent expirations by year for DITROPAN
Drug Prices for DITROPAN

See drug prices for DITROPAN

Recent Clinical Trials for DITROPAN

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

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

See all DITROPAN clinical trials

US Patents and Regulatory Information for DITROPAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Janssen DITROPAN oxybutynin chloride SYRUP;ORAL 018211-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-002 Dec 16, 1998 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Janssen Pharms DITROPAN oxybutynin chloride TABLET;ORAL 017577-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-001 Dec 16, 1998 DISCN Yes 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

DITROPAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DITROPAN (Oxybutynin)

Market Overview

The market for DITROPAN (oxybutynin), a medication primarily used to treat overactive bladder (OAB), is characterized by several key dynamics that influence its growth and financial performance.

Prevalence of Overactive Bladder

The prevalence of OAB is a significant driver of the market. According to the National Institute of Health (NIH), the national prevalence of OAB in the United States is 16.5%, with similar rates in both men and women[1]. This high prevalence ensures a steady demand for treatments like DITROPAN.

Market Growth

The global overactive bladder treatment market, which includes DITROPAN, was valued at USD 3.20 billion in 2022 and is expected to grow at a CAGR of 3.90% to reach USD 4.69 billion by 2032[4]. This growth is driven by increasing patient awareness, the high disease burden, and an expanding elderly population.

Geographical Analysis

North America dominates the overactive bladder treatment market, holding a 47.38% market share in 2022. This is due to the high prevalence of OAB in the geriatric population and substantial healthcare expenditure in the region. However, the Asia Pacific region is expected to grow the fastest during the forecast period due to rising healthcare expenditure and increasing awareness of OAB[4].

Pharmacotherapy Segment

DITROPAN falls under the anticholinergics segment, which dominated the pharmacotherapy market with a 21.19% share and a revenue of $0.67 billion in 2022. Anticholinergics are widely used due to their efficacy in treating OAB and other bladder conditions[4].

Financial Trajectory

Revenue and Expenditure

The financial trajectory of DITROPAN is influenced by several factors, including total income, expenditure, and profitability. Here are some key financial aspects:

  • Total Income: The market for oxybutynin is driven by increasing healthcare spending and expanded insurance coverage. In 2022, retail prescription drug spending increased by 8.4% to $405.9 billion, indicating a robust market for prescription medications like DITROPAN[1].
  • Total Expenditure: The operating expenditure for manufacturing DITROPAN includes costs such as raw material procurement, manufacturing process costs, and regulatory compliance. A detailed analysis of these costs is crucial for understanding the profitability of the drug[1].

Profitability Analysis

A comprehensive profitability analysis includes gross profit, gross margin, net profit, and net margin. For a DITROPAN manufacturing plant, this analysis would involve:

  • Gross Profit and Margin: These are calculated based on the total income and total expenditure. A higher gross margin indicates better profitability.
  • Net Profit and Margin: These are calculated after deducting all expenses, including taxation and depreciation. A higher net margin suggests higher profitability[1].

Project Economics

Setting up a DITROPAN manufacturing plant involves significant capital expenditure (CapEx) and operating expenditure (OpEx). A detailed project report would include:

  • Capital Expenditure: This includes the initial investment required for setting up the plant, such as land acquisition, equipment, and infrastructure.
  • Operating Expenditure: This includes ongoing costs such as raw materials, labor, and maintenance.
  • Income Projections: These are based on market demand and pricing strategies.
  • Taxation and Depreciation: These are crucial for calculating the net profit.
  • Liquidity Analysis and Profitability Analysis: These help in understanding the financial health and sustainability of the project[1].

Regulatory Environment

A favorable regulatory environment is crucial for the financial success of DITROPAN. Regulatory approvals and compliance with quality assurance criteria are essential for maintaining market presence. The report on DITROPAN manufacturing includes detailed information on regulatory procedures and necessary certifications[1].

Competitive Landscape

Compliance and Persistence

DITROPAN competes with other anticholinergic medications like tolterodine ER. Studies have shown that tolterodine ER has comparable compliance to oxybutynin ER but a longer duration of use. This indicates that while DITROPAN is effective, it faces competition in terms of patient compliance and treatment duration[2].

Adverse Events and Side Effects

Common side effects of DITROPAN include dry mouth, constipation, somnolence, and dry eyes. These side effects can impact patient compliance and overall market performance. For instance, the discontinuation rate for all adverse events was 6.8% in clinical trials, with nausea being a significant cause[3].

Market Trends and Analysis

Increasing Healthcare Spending

The increasing healthcare spending globally, particularly in the United States, where health care spending grew 4.1% to reach $4.5 trillion in 2022, is a positive trend for the DITROPAN market. Expanded insurance coverage and higher enrollment in health insurance programs also contribute to increased accessibility and usage of prescription medications like DITROPAN[1].

Technological Advancements

Advancements in medical technology and the development of new instruments are expected to drive market growth. The presence of a strong drug pipeline and the entry of efficient drugs into the market are also positive indicators for the future of DITROPAN[4].

Awareness and Education

Government initiatives and private organizations' awareness campaigns about early disorder diagnosis are crucial for market growth. However, the lack of awareness about the prevalence of OAB and the availability of alternative therapies can act as restraining factors[4].

Key Takeaways

  • Market Growth: The DITROPAN market is driven by the high prevalence of OAB, increasing patient awareness, and expanding healthcare expenditure.
  • Financial Performance: The profitability of DITROPAN is influenced by total income, expenditure, and regulatory compliance.
  • Competitive Landscape: DITROPAN faces competition from other anticholinergic medications in terms of compliance and treatment duration.
  • Regulatory Environment: A favorable regulatory environment is crucial for the financial success of DITROPAN.
  • Market Trends: Increasing healthcare spending, technological advancements, and awareness campaigns are positive trends for the market.

FAQs

Q: What is the current market size of the overactive bladder treatment market?

The global overactive bladder treatment market was valued at USD 3.20 billion in 2022[4].

Q: What is the expected CAGR of the overactive bladder treatment market from 2022 to 2032?

The market is expected to grow at a CAGR of 3.90% from 2022 to 2032[4].

Q: Which region dominates the overactive bladder treatment market?

North America dominates the market with a 47.38% market share in 2022[4].

Q: What are the common side effects of DITROPAN?

Common side effects include dry mouth, constipation, somnolence, and dry eyes[3].

Q: How does DITROPAN compare to other anticholinergic medications in terms of compliance?

DITROPAN has comparable compliance to tolterodine ER but a shorter duration of use compared to tolterodine ER[2].

Sources

  1. IMARC Group: Oxybutynin (Ditropan) Manufacturing Plant Project Report 2024.
  2. PubMed: Economic impact of extended-release tolterodine versus immediate-release and extended-release oxybutynin.
  3. Health Canada: DITROPAN XL.
  4. The Brainy Insights: Overactive Bladder Treatment Market Size [2032].

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