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Last Updated: December 22, 2024

URISPAS Drug Patent Profile


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

Urispas is a drug marketed by Ortho Mcneil Janssen and is included in one NDA.

The generic ingredient in URISPAS is flavoxate hydrochloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the flavoxate hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Urispas

A generic version of URISPAS was approved as flavoxate hydrochloride by PADAGIS US on December 16th, 2004.

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Summary for URISPAS
Drug patent expirations by year for URISPAS
Recent Clinical Trials for URISPAS

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

SponsorPhase
Mahidol UniversityPhase 4
Padagis LLCPhase 1
Paddock Laboratories, Inc.Phase 1

See all URISPAS clinical trials

US Patents and Regulatory Information for URISPAS

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 URISPAS flavoxate hydrochloride TABLET;ORAL 016769-001 Approved Prior to Jan 1, 1982 DISCN 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

URISPAS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Urispas (Flavoxate Hydrochloride)

Introduction to Urispas

Urispas, known generically as flavoxate hydrochloride, is a synthetic urinary tract spasmolytic used to treat various bladder symptoms such as painful urination, frequent or urgent urination, increased nighttime urination, bladder pain, and incontinence. These symptoms often arise from conditions like cystitis, prostatitis, urethritis, and urethrotrigonitis[2][4].

Market Overview

The global urological disorders drugs market, within which Urispas operates, is experiencing significant growth. As of 2023, this market is valued at approximately USD 8.94 billion and is projected to reach USD 11.93 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of 5.94% during the forecast period[3].

Key Drivers of Market Growth

  1. Increasing Geriatric Population: The rising number of elderly individuals is a major driver, as this demographic is more prone to urological disorders such as prostate and bladder cancer, and other urinary tract issues[3].

  2. Changing Lifestyles and Environmental Factors: Changes in lifestyle, dietary habits, and exposure to environmental toxins contribute to the increasing prevalence of urological disorders, thereby driving the demand for drugs like Urispas[3].

  3. Advanced Treatment Options: The adoption of advanced therapies, including targeted therapies, immunotherapies, and gene therapies, is a significant growth factor in the urological disorders drugs market[3].

Market Challenges

  1. High Drug Costs: One of the primary challenges is the high cost of drugs, which can limit access to essential medications, particularly in developing countries[3].

  2. Regulatory Frameworks: Strict regulatory frameworks pose challenges for pharmaceutical companies seeking to introduce new drugs to the market, which can impact the financial trajectory of existing drugs like Urispas[3].

Segmentation and Distribution

The urological disorders drugs market is segmented based on drug type, indication, distribution channel, and geography. Urispas falls under the urinary antispasmodics category, which is a significant segment within this market.

  • Distribution Channels: Hospital pharmacies are the dominant distribution channels due to the need for medical supervision for many urological disorders[3].

  • Geography: The Americas region is expected to lead the market, while the Asia-Pacific region is projected to witness significant growth due to the rising geriatric population and increasing incidence of urological disorders[3].

Financial Trajectory

Given the discontinuation of the Urispas brand name in the U.S. and the availability of generic equivalents, the financial trajectory of Urispas is influenced by several factors:

  1. Generic Competition: The availability of generic versions of flavoxate hydrochloride can reduce the market share and revenue of the original branded product, impacting its financial performance[1][2].

  2. Market Demand: Despite the challenges, the increasing demand for urological disorder treatments due to demographic and lifestyle changes ensures a steady market for drugs like Urispas.

  3. Pricing and Accessibility: The high cost of drugs can affect sales, especially in regions where affordability is a concern. However, the overall growth of the urological disorders market suggests that there is still a significant financial opportunity for Urispas and similar drugs[3].

Competitive Landscape

The global urological disorders drugs market is competitive, with major players such as AbbVie, Inc., AstraZeneca PLC, Merck & Co., Inc., Novartis AG, and Pfizer, Inc. These companies are continually developing new treatments and therapies, which can impact the market share of existing drugs like Urispas. However, the specific financial performance of Urispas would depend on its generic status, pricing, and the strategies employed by its manufacturers and distributors[3].

Key Takeaways

  • Growing Market: The urological disorders drugs market is growing rapidly, driven by demographic and lifestyle changes.
  • Generic Competition: The availability of generic versions of flavoxate hydrochloride affects the financial performance of Urispas.
  • Regulatory and Cost Challenges: High drug costs and strict regulatory frameworks are significant challenges.
  • Geographical Variations: The market is geographically diverse, with the Americas and Asia-Pacific regions being key segments.

FAQs

  1. What is Urispas used for? Urispas is used for the symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency, and incontinence associated with conditions like cystitis, prostatitis, and urethritis[2][4].

  2. Is Urispas available in generic form? Yes, the Urispas brand name has been discontinued in the U.S., but generic versions of flavoxate hydrochloride are available[1][2].

  3. What are the common side effects of Urispas? Common side effects include nausea, vomiting, dry mouth, vertigo, headache, mental confusion, drowsiness, and blurred vision[1][4].

  4. Can Urispas be used during pregnancy? Urispas should be used during pregnancy only if clearly needed, as there are no well-controlled studies in pregnant women[1][4].

  5. How is Urispas administered? Urispas is administered orally, typically one tablet three times a day for as long as required, and should be taken after a meal to prevent nausea[4].

Cited Sources

  1. Drugs.com - Urispas: Package Insert / Prescribing Information
  2. Drugs.com - Urispas Uses, Side Effects & Warnings
  3. BusinessWire - $11.93 Billion Urological Disorders Drugs Market Analysis, 2023-2028
  4. Medicines.org.uk - Urispas 200mg Film-coated Tablets - (emc)
  5. RxList - Urispas (Flavoxate Hydrochloride Tablets)

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