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:	101
Clinical Trials:	3
Patent Applications:	1,622
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
Paddock Laboratories, Inc.	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
Ortho Mcneil Janssen	URISPAS	flavoxate hydrochloride	TABLET;ORAL	016769-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Epic Pharma	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076835-001	Nov 30, 2005	AB	RX	No	No
Padagis Us	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076831-001	Dec 16, 2004	AB	RX	No	Yes
Impax Pharms	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076234-001	Aug 28, 2003		DISCN	No	No

FLAVOXATE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Flavoxate Hydrochloride

Introduction to Flavoxate Hydrochloride

Flavoxate hydrochloride is a muscle relaxant with urinary antispasmodic properties, widely used in the treatment of various urinary tract conditions. It works by binding to muscarinic receptors, suppressing the micturition reflex, and increasing the capacity of the urinary bladder. This medication is marketed under several brand names, with Urispas being one of the most well-known.

Market Drivers

Several factors are driving the growth of the global flavoxate hydrochloride tablets market:

Increasing Incidence of Lower Urinary Tract Dysfunction

The rising incidence of lower urinary tract dysfunction, such as prolonged micturition, incomplete bladder emptying, and other related symptoms, is a significant driver. For instance, around 10% of the geriatric population globally suffers from urine incontinence, and this number is expected to increase to 20% by 2050[1].

Generic Market Expansion

The expiration of the patent for Urispas in 2004 led to the entry of several generic players into the market. Companies like Epic Pharma LLC and Paddock Laboratories LLC have launched generic versions of flavoxate hydrochloride tablets, which are cheaper than the branded products. This has increased accessibility and affordability for patients[1].

Regional Demand

North America is expected to hold a dominant position in the global flavoxate hydrochloride tablets market due to its large customer base and increasing incidence of lower urinary tract dysfunction. Similar trends are observed in Europe and Asia, where a significant portion of the population over 40 years old suffers from mild to severe lower urinary tract symptoms[1].

Market Restraints

Despite the growth drivers, there are several factors that could restrain the market growth:

Emergence of New Medications

The introduction of new medicines belonging to different chemical classes could pose a challenge. For example, the approval of Recabrio by the U.S. FDA in 2019, which is a multifunctional drug for treating urinary tract infections, may divert some market share away from flavoxate hydrochloride[1].

Competition from Alternative Treatments

The availability of alternative treatments for urinary tract conditions could also impact the demand for flavoxate hydrochloride. Patients and healthcare providers may opt for newer or more effective treatments, reducing the reliance on flavoxate hydrochloride[1].

Financial Trajectory

Market Size and Projections

The global flavoxate hydrochloride tablets market was valued at USD 1.23 billion in 2023 and is projected to reach USD 2.34 billion by 2031, growing at a compound annual growth rate (CAGR) of 5%[4].

Revenue and Consumption

In the U.S., the consumption of flavoxate hydrochloride tablets was significant, with around USD 8,800 million spent by patients in 2017 alone, according to the Central Medicare and Medicaid Services (CMS)[1].

Regional Analysis

North America

North America is expected to dominate the market due to the high prevalence of lower urinary tract dysfunction. For instance, 291,000 individuals in the U.S. suffer from lower urinary tract dysfunction due to spinal cord injuries[1].

Europe

In Europe, a significant percentage of women suffer from lower urinary tract dysfunction, primarily due to nocturia, urgency, and urinary tract infections. This demand is expected to support the market growth in the region[1].

Asia

Asia also presents a substantial market, with a high percentage of men and women over 40 years old experiencing mild to severe lower urinary tract symptoms. This demographic trend is expected to drive the market in this region[1].

Key Players

Several key players are operating in the global flavoxate hydrochloride tablets market, including:

• Epic Pharma LLC
• Perrigo Company PLC
• Manus Aktteva Biopharma LLP
• Recordati S.p.A
• Taj Pharmaceuticals Ltd.
• Trumac Healthcare
• Zhejiang CONBA Pharmaceutical Co., Ltd.
• Walter Bushnell
• Cipla Inc.[1]

Market Taxonomy

The market can be segmented by:

Medicine Type

• Branded
• Generic

Distribution Channel

• Retail Pharmacies
• Hospital Pharmacies
• Online Pharmacies

Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa[1]

Clinical Efficacy and Safety

Flavoxate hydrochloride has been proven to be effective in treating overactive bladder and associated symptoms through various clinical trials. It significantly increases bladder volume capacity and improves symptoms such as diurnal and night frequency, urgency, and urinary incontinence. The medication also has a favorable safety profile compared to other competitors[3].

Common Uses of Flavoxate Tablets

Flavoxate tablets are used to manage several urinary tract conditions, including:

Relief from Dysuria

Flavoxate helps in relieving painful or difficult urination by relaxing the muscles of the urinary tract[5].

Management of Cystitis

It reduces the frequency and urgency of urination associated with cystitis by calming the bladder muscles[5].

Treatment of Urethritis

Flavoxate alleviates symptoms of urethritis, such as painful urination and burning sensation, by acting as a muscle relaxant[5].

Alleviation of Nocturia

It helps in reducing the frequency of nighttime urination, improving sleep quality[5].

Post-Surgical Bladder Spasms

Flavoxate is prescribed to manage bladder spasms following surgical procedures involving the urinary tract[5].

Treatment of Overactive Bladder

It manages the symptoms of overactive bladder, such as frequent or urgent urination and incontinence, by relaxing the bladder muscles[5].

Side Effects and Precautions

While generally well-tolerated, flavoxate tablets can cause side effects such as dry mouth, dizziness, blurred vision, and gastrointestinal disturbances. It is crucial to consult a healthcare provider if any side effects become severe or persistent. Flavoxate is not recommended during pregnancy due to limited safety data and potential risks[5].

Key Takeaways

• The global flavoxate hydrochloride tablets market is driven by the increasing incidence of lower urinary tract dysfunction and the expansion of generic market offerings.
• North America is expected to dominate the market due to its large customer base and high prevalence of lower urinary tract dysfunction.
• The market is projected to grow at a CAGR of 5%, reaching USD 2.34 billion by 2031.
• Flavoxate hydrochloride is effective in treating various urinary tract conditions, including overactive bladder, cystitis, and urethritis.
• The medication has a favorable safety profile but may cause side effects such as dry mouth and dizziness.

Frequently Asked Questions

What is flavoxate hydrochloride used for?

Flavoxate hydrochloride is used to treat various urinary tract conditions, including overactive bladder, cystitis, urethritis, and post-surgical bladder spasms[5].

Is flavoxate hydrochloride an antibiotic?

No, flavoxate hydrochloride is not an antibiotic; it belongs to a class of medications called antispasmodics[5].

How does flavoxate hydrochloride work?

Flavoxate hydrochloride works by binding to muscarinic receptors, suppressing the micturition reflex, and increasing the capacity of the urinary bladder[1].

What are the common side effects of flavoxate hydrochloride?

Common side effects include dry mouth, dizziness, blurred vision, and gastrointestinal disturbances[5].

Can flavoxate hydrochloride be taken during pregnancy?

Flavoxate hydrochloride is not recommended during pregnancy due to limited safety data and potential risks. It is categorized as FDA Category C[5].

Sources

1. Coherent Market Insights: Flavoxate Hydrochloride Tablets Market Size By 2028
2. Central Drugs Standard Control Organisation: Annual Report 2021-22
3. PubMed: Flavoxate: present and future
4. Market Research Intellect: Global Flavoxate Hydrochloride Tablets Sales Market
5. Medicover Hospitals: 6 Common Uses of Flavoxate Tablets