Oxybutynin - Generic Drug Details

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

Oxybutynin is the generic ingredient in eight branded drugs marketed by Barr Labs Div Teva, Allergan, 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 forty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for oxybutynin. One supplier is listed for this compound.

Summary for oxybutynin

US Patents:	3
Tradenames:	8
Applicants:	34
NDAs:	42
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	98
Patent Applications:	6,530
Drug Prices:	Drug price trends for oxybutynin
Drug Sales Revenues:	Drug sales revenues for oxybutynin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxybutynin
What excipients (inactive ingredients) are in oxybutynin?	oxybutynin excipients list
DailyMed Link:	oxybutynin at DailyMed

See drug prices for oxybutynin

See drug sales revenues for oxybutynin

Recent Clinical Trials for oxybutynin

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

Sponsor	Phase
Reinier de Graaf Groep	Phase 3
Seoul National University Hospital	Phase 2
Il-Yang Pharm. Co., Ltd.	Phase 2

See all oxybutynin clinical trials

Pharmacology for oxybutynin

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for oxybutynin

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

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
Pharmobedient Cnsltg	OXYBUTYNIN CHLORIDE	oxybutynin chloride	SYRUP;ORAL	074868-001	Feb 12, 1997		DISCN	No	No
Usl Pharma	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	070746-001	Mar 10, 1988		DISCN	No	No
Pharm Assoc	OXYBUTYNIN CHLORIDE	oxybutynin chloride	SYRUP;ORAL	075137-001	Dec 18, 1998		DISCN	No	No
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011		DISCN	Yes	No
Accord Hlthcare	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	207138-003	Feb 29, 2016	AB	RX	No	Yes
Pharm Assoc	OXYBUTYNIN CHLORIDE	oxybutynin chloride	SYRUP;ORAL	074997-001	Oct 15, 1997		DISCN	No	No
Rubicon	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	214415-003	Oct 27, 2020	AB	RX	No	No

Expired US Patents for oxybutynin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013
Abbvie	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan	GELNIQUE 3%	oxybutynin	GEL, METERED;TRANSDERMAL	202513-001	Dec 7, 2011

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

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].