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Last Updated: December 22, 2024

OXYBUTYNIN Drug Patent Profile


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

Oxybutynin is a drug marketed by Barr Labs Div Teva, 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-five NDAs.

The generic ingredient in OXYBUTYNIN 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

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

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Drug patent expirations by year for OXYBUTYNIN
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Recent Clinical Trials for OXYBUTYNIN

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SponsorPhase
Reinier de Graaf GroepPhase 3
Seoul National University HospitalPhase 2
Il-Yang Pharm. Co., Ltd.Phase 2

See all OXYBUTYNIN clinical trials

Paragraph IV (Patent) Challenges for OXYBUTYNIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OXYTROL Transdermal System Extended-release oxybutynin 3.9 mg/24 hrs 021351 1 2008-08-19

US Patents and Regulatory Information for OXYBUTYNIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Beximco Pharms Usa OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 213550-001 Jul 14, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rubicon OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 214415-003 Oct 27, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 075079-001 Oct 31, 1997 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novitium Pharma OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 209823-001 Oct 23, 2017 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for OXYBUTYNIN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Teva B.V.  Kentera (previously Oxybutynin Nicobrand) oxybutynin EMEA/H/C/000532
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.
Authorised no no no 2004-06-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

OXYBUTYNIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxybutynin

Introduction to Oxybutynin

Oxybutynin is a medication primarily used to treat overactive bladder (OAB) symptoms, including frequent urination, urgent need to urinate, and incontinence. It is available in various forms, including oral tablets, extended-release tablets, and transdermal systems.

Market Size and Growth

The oxybutynin market, particularly the oxybutynin transdermal system market, is experiencing significant growth. As of 2023, the oxybutynin transdermal system market was valued at USD 7.48 billion and is projected to reach USD 10.97 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.9% from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the oxybutynin market:

Increasing Prevalence of Overactive Bladder

The rising prevalence of OAB, especially among the elderly population, is a major driver. As the global population ages, the incidence of OAB is increasing, leading to higher demand for effective treatments like oxybutynin[1][3].

Technological Advancements

Advancements in transdermal patch design have improved the efficacy and comfort of oxybutynin delivery. These improvements include better adherence and controlled drug release, making transdermal systems more appealing to patients[1].

Patient Preference for Non-Invasive Treatments

Patients are increasingly opting for non-invasive and comfortable treatment solutions, which has boosted the demand for oxybutynin transdermal systems. This preference is driven by the desire for treatments that do not involve oral medications or invasive procedures[1].

Healthcare Infrastructure and Regulatory Approvals

Investments in healthcare infrastructure and favorable regulatory approvals are also contributing to the market's growth. These factors enable better access to and adoption of oxybutynin treatments[1].

Market Segmentation

The oxybutynin market is segmented based on several criteria:

By Type

The market is segmented into patches, gels, and films. Transdermal patches are a significant segment due to their ease of use and controlled drug delivery[1].

By Application

The primary application of oxybutynin is in the treatment of overactive bladder. This segment is driven by the increasing need for effective OAB treatments[1].

By Region

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Asia-Pacific is expected to be one of the fastest-growing regions due to increasing healthcare expenditure and a rising elderly population[1][3].

Financial Trajectory

Cost Effectiveness

Oxybutynin is known for its cost-effectiveness, which is a significant factor in its market growth. The total yearly cost for generic oxybutynin can range from $494 to $1,452, making it a more affordable option compared to some other OAB medications[5].

Revenue Projections

The global overactive bladder treatment market, which includes oxybutynin, was valued at USD 3.20 billion in 2022 and is expected to reach USD 4.69 billion by 2032, growing at a CAGR of 3.90%[3].

Regional Revenue

North America and Europe are currently significant markets for oxybutynin, but the Asia-Pacific region is expected to grow rapidly due to increasing healthcare infrastructure and a growing elderly population[1][3].

Competitive Landscape

The oxybutynin market is part of the broader overactive bladder treatment market, which includes other medications like tolterodine, trospium, solifenacin, and mirabegron. Oxybutynin has been estimated to propel market growth globally due to its cost-effectiveness, good efficiency, and lower adherence rate in OAB treatment[2].

Key Players

The market is competitive, with several key players involved in the development and distribution of oxybutynin. These companies are investing in research and development to improve the efficacy and comfort of oxybutynin treatments[2][3].

Market Trends

Emerging Technologies

New emerging technologies and drug developments are driving the market. The advent of combination therapies and rising drug approvals are expected to bolster the overactive bladder treatment market, including oxybutynin[2].

Increasing Patient Awareness

Rising patient awareness and the high disease burden of OAB are driving the demand for effective treatments. Public knowledge of the treatments for overactive bladder syndrome is increasing, which is helping to propel market growth[3].

Healthcare Expenditure

The increasing healthcare expenditure and efforts by government organizations to improve healthcare infrastructure are also contributing to the market's growth. Technological advancements and innovations in medical instruments are offering lucrative market growth opportunities[3].

Challenges and Restraints

Cost and Accessibility

Despite its cost-effectiveness, oxybutynin can still be expensive for some patients, especially those without adequate insurance coverage. Out-of-pocket costs for Medicare beneficiaries and the uninsured can be significant, affecting accessibility[5].

Regulatory and Utilization Management

Some plans require prior authorization or step therapy for oxybutynin, which can create barriers to access. These utilization management requirements can impact the market's growth by limiting the availability of the medication to some patients[5].

Conclusion

The oxybutynin market is poised for significant growth driven by the increasing prevalence of overactive bladder, technological advancements, patient preference for non-invasive treatments, and favorable regulatory approvals. Despite challenges related to cost and accessibility, the market's financial trajectory indicates a strong future for oxybutynin as a key treatment for OAB.

Key Takeaways

  • The oxybutynin transdermal system market is expected to grow from USD 7.48 billion in 2023 to USD 10.97 billion by 2031.
  • Technological advancements in transdermal patch design are driving market growth.
  • Patient preference for non-invasive treatments is increasing demand for oxybutynin.
  • The Asia-Pacific region is expected to be one of the fastest-growing markets.
  • Oxybutynin is cost-effective compared to other OAB medications.
  • Increasing healthcare expenditure and patient awareness are driving market growth.

FAQs

Q: What is the projected growth rate of the oxybutynin transdermal system market?

The oxybutynin transdermal system market is projected to grow at a CAGR of 4.9% from 2024 to 2031[1].

Q: What are the main drivers of the oxybutynin market?

The main drivers include the increasing prevalence of overactive bladder, technological advancements in transdermal systems, patient preference for non-invasive treatments, and favorable regulatory approvals[1].

Q: How does oxybutynin compare to other OAB medications in terms of cost?

Oxybutynin is generally more cost-effective, with total yearly costs ranging from $494 to $1,452 for generic versions, compared to other medications[5].

Q: Which region is expected to grow the fastest in the oxybutynin market?

The Asia-Pacific region is expected to be one of the fastest-growing markets due to increasing healthcare expenditure and a growing elderly population[1][3].

Q: What are the challenges facing the oxybutynin market?

Challenges include out-of-pocket costs for patients, regulatory and utilization management requirements, and accessibility issues for some patients[5].

Sources

  1. Market Research Intellect: Oxybutynin Transdermal System Market Size, Share and Trends[1].
  2. PR Newswire: Overactive Bladder (OAB) Treatment Market Analysis, 2014-2024[2].
  3. The Brainy Insights: Overactive Bladder Treatment Market Size [2032][3].
  4. Cognitive Market Research: Oxybutynin Transdermal System Market Report 2024 (Global Edition)[4].
  5. PubMed: Analyzing Access and Costs of Oral Medications for Overactive Bladder[5].

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