FLAVOXATE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for flavoxate hydrochloride and what is the scope of freedom to operate?

Flavoxate hydrochloride is the generic ingredient in two branded drugs marketed by Epic Pharma, Impax Pharms, Padagis Us, and Ortho Mcneil Janssen, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for flavoxate hydrochloride. Three suppliers are listed for this compound.

Summary for FLAVOXATE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
Patent Applications:	1,816
What excipients (inactive ingredients) are in FLAVOXATE HYDROCHLORIDE?	FLAVOXATE HYDROCHLORIDE excipients list
DailyMed Link:	FLAVOXATE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for FLAVOXATE HYDROCHLORIDE

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

Sponsor	Phase
University of Calgary	Phase 4
Mahidol University	Phase 4
Padagis LLC	Phase 1

See all FLAVOXATE HYDROCHLORIDE clinical trials

Pharmacology for FLAVOXATE HYDROCHLORIDE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for FLAVOXATE HYDROCHLORIDE

Parasympatholytics

Urological Agents

Anatomical Therapeutic Chemical (ATC) Classes for FLAVOXATE HYDROCHLORIDE

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

US Patents and Regulatory Information for FLAVOXATE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Pharms	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076234-001	Aug 28, 2003		DISCN	No	No
Padagis Us	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076831-001	Dec 16, 2004	AB	RX	No	Yes
Epic Pharma	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076835-001	Nov 30, 2005	AB	RX	No	No
Ortho Mcneil Janssen	URISPAS	flavoxate hydrochloride	TABLET;ORAL	016769-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Flavoxate Hydrochloride

Last updated: July 28, 2025

Introduction

Flavoxate hydrochloride, a derivative of oxybutynin, is primarily used as an antispasmodic agent to treat urinary bladder spasms and symptomatic relief of urinary frequency, urgency, and pain associated with inflammatory or neurological conditions. Despite its longstanding clinical application, the drug's market dynamics and financial trajectory are shaped by evolving healthcare landscapes, regulatory pathways, and competitive shifts within the pharmaceutical industry. This report dissects these factors, providing an analytical framework for stakeholders aiming to navigate the flavoxate hydrochloride segment effectively.

Pharmaceutical Market Overview: Focus on Bladder Spasm Therapeutics

The global urinary antispasmodic market, incorporating flavoxate hydrochloride, is a niche segment within urology therapeutics. As of 2022, the market was valued at approximately USD 1.3 billion, with a compounded annual growth rate (CAGR) of around 4.2% projected through 2027[1]. Key drivers include rising incidences of urinary incontinence, overactive bladder, and neurogenic bladder conditions, especially among aging populations.

Market Dynamics Driving Flavoxate Hydrochloride

Epidemiological Factors and Demographic Shifts

An aging demographic globally fosters increased prevalence of urinary disorders. Data indicates that over 50% of individuals aged 65 and above suffer from urinary incontinence or bladder dysfunctions[2]. Flavoxate hydrochloride, being a prescribed therapeutic, benefits from this demographic trend. However, the demand depends significantly on the medication’s positioning among newer therapies and the approval landscape.

Therapeutic Landscape and Competition

While flavoxate hydrochloride enjoys a historical presence, its market share faces consolidation from newer agents such as beta-3 adrenergic agonists (e.g., mirabegron), which offer improved side-effect profiles[3]. As a result, the drug’s relevance may diminish unless it gains novel indications or demonstrates superiority in specific subpopulations.

Regulatory Considerations and Patent Status

Currently, flavoxate hydrochloride remains off-patent in many jurisdictions, leading to increased generic competition. The lack of patent protection constrains pricing power, putting pressure on margins. Regulatory pathways for new formulations or delivery systems (e.g., extended-release forms) could open niche markets, though such developments require significant investment.

Manufacturing and Supply Chain Factors

The production of flavoxate hydrochloride involves complex synthesis processes with regulatory oversight for quality assurance. Supply chain disruptions, as experienced globally, could impact availability, influencing market stability.

Pricing and Reimbursement Dynamics

Reimbursement policies greatly influence the market trajectory. High-cost therapeutics with better efficacy profiles are favored, whereas older, generic drugs like flavoxate hydrochloride often face reimbursement barriers. Payers emphasize cost-effectiveness, which could pressure price reductions unless clinical benefits justify premium positioning.

Financial Trajectory and Revenue Projections

Historical Revenue and Market Share

Historically, flavoxate hydrochloride has generated modest revenues proportional to its limited market penetration—estimated at approximately USD 50-100 million annually globally[4]. Its market share is heavily concentrated in certain regions, notably Latin America, parts of Asia, and Eastern Europe where it remains a key prescription option.

Forecasted Growth and Potential Revenue Streams

In the short term, global revenues are expected to plateau or decline marginally due to competitive pressures. However, niche adoption in specific patient populations (e.g., patients intolerant to newer agents) might sustain niche revenues.

Long-term growth prospects hinge on:

• Formulation innovations: development of sustained-release or transdermal formulations could rejuvenate interest.
• New indications: exploring off-label uses or combination therapies.
• Geographic expansion: entering emerging markets with increasing healthcare infrastructure investments.

Global revenues for flavoxate hydrochloride could remain steady at approximately USD 50-80 million annually over the next 5 years unless significant market disruptors emerge.

Impact of Generic Competition

Major generics manufacturers dominate the landscape, suppressing prices and squeezing profit margins. Companies with established manufacturing facilities may capitalize on economies of scale to sustain profitability, though new entrants will likely face steep price erosion[5].

Market Challenges and Opportunities

Challenges

• Limited clinical innovation: reliance on a decades-old molecule limits growth potential.
• Evolving treatment paradigms: shift toward more tolerable, targeted therapies.
• Regulatory barriers: approval of new formulations or indications may face delays.

Opportunities

• Reformulation strategies: sustained-release or combination formulations increasing compliance.
• Biomarker-driven therapy: personalized medicine approaches could identify responsive subpopulations.
• Strategic partnerships: collaborations with biotech firms exploring novel delivery systems.

Conclusion

The market dynamics for flavoxate hydrochloride reflect a mature, highly commodified segment influenced by demographic shifts, competing therapies, and regulatory forces. Financially, its trajectory suggests stability with modest growth potential, primarily through niche applications and formulation innovations. Stakeholders must navigate a landscape marked by patent expirations, generic competition, and evolving treatment standards. Strategic positioning around formulation development, market expansion, and collaboration will determine the drug’s long-term financial viability.

---

Key Takeaways

• Flavoxate hydrochloride faces a mature market with limited growth, with revenues plateauing around USD 50-80 million annually.
• The aging global population drives demand, but competition from newer drugs like mirabegron reduces market share.
• Patent expiration and generic proliferation exert downward pressure on prices and margins.
• Innovation in formulations and exploring new indications are vital for market sustenance.
• Geographic expansion into emerging markets offers growth opportunities, contingent on regulatory approvals and local healthcare policies.

---

FAQs

1. What factors influence the pricing of flavoxate hydrochloride globally?
Pricing is affected by patent status, competition from generics, regulatory obligations, healthcare payer policies, and the availability of more effective or tolerable alternatives.

2. Are there any ongoing clinical trials investigating new uses for flavoxate hydrochloride?
Current data indicate minimal ongoing research, primarily limited to formulation improvements rather than novel therapeutic indications.

3. How does the patent landscape impact flavoxate hydrochloride's market share?
Patent expirations have led to widespread generic manufacturing, reducing exclusivity and pricing power, which constrains revenue growth.

4. What regulatory hurdles exist for developing new formulations of flavoxate hydrochloride?
Regulatory agencies require demonstration of bioequivalence, safety, and efficacy for reformulated versions, which involves substantial clinical testing and approval processes.

5. Which regions offer the most promising markets for flavoxate hydrochloride expansion?
Emerging markets in Asia, Latin America, and Eastern Europe present opportunities due to increasing healthcare infrastructure and unmet demand for urological treatments, provided regulatory pathways are navigated successfully.

---

Sources:

[1] Research and Markets, “Global Urinary Antispasmodic Market Report,” 2022.

[2] World Health Organization, “Urinary Incontinence: Epidemiology and Burden,” 2021.

[3] NICE Guidance, “Treatment options for overactive bladder,” 2020.

[4] IQVIA, “Global Pharmaceutical Sales Data,” 2022.

[5] EvaluatePharma, “Generic Drug Market Analysis,” 2022.