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Last Updated: December 25, 2024

HIPREX Drug Patent Profile


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When do Hiprex patents expire, and what generic alternatives are available?

Hiprex is a drug marketed by Esjay Pharma and is included in one NDA.

The generic ingredient in HIPREX is methenamine hippurate. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the methenamine hippurate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hiprex

A generic version of HIPREX was approved as methenamine hippurate by AUROBINDO PHARMA LTD on July 5th, 2016.

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Summary for HIPREX
Drug patent expirations by year for HIPREX
Drug Prices for HIPREX

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Recent Clinical Trials for HIPREX

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

SponsorPhase
University of Texas Southwestern Medical CenterPhase 4
University of PennsylvaniaN/A

See all HIPREX clinical trials

US Patents and Regulatory Information for HIPREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Esjay Pharma HIPREX methenamine hippurate TABLET;ORAL 017681-001 Approved Prior to Jan 1, 1982 AB RX Yes 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

HIPREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HIPREX (Methenamine Hippurate Tablets)

Overview of HIPREX

HIPREX, also known as methenamine hippurate, is a medication used for the prophylactic or suppressive treatment of frequently recurring urinary tract infections (UTIs). It works by hydrolyzing to formaldehyde in acid urine and maintaining the urine's acidity, which helps in inhibiting the growth of bacteria such as E. coli, enterococci, and staphylococci[5].

Market Size and Growth

The methenamine hippurate tablets market, which includes HIPREX, has been experiencing strong growth in recent years. As of 2023, the global market size for methenamine hippurate tablets was valued at $8.97 billion. This figure is expected to increase to $9.63 billion in 2024, reflecting a compound annual growth rate (CAGR) of 7.4%. By 2028, the market is projected to reach $12.83 billion, maintaining the same CAGR of 7.4%[1][4].

Key Drivers of Growth

Several factors are driving the growth of the methenamine hippurate tablets market:

Increasing Prevalence of UTIs

The rising incidence of urinary tract infections is a significant driver. UTIs are more common among certain demographics, such as the geriatric population, which is expected to increase in the coming years[1].

Concerns About Antibiotic Resistance

Growing concerns about antibiotic resistance have led to a preference for non-antibiotic treatments like methenamine hippurate. This shift is driven by the need to reduce the development of drug-resistant bacteria[1][4].

Advancements in UTI Management

Advancements in the management of UTIs, including preventive therapies and ongoing clinical trials, are also contributing to the market's growth. Healthcare's increasing focus on preventive measures rather than just treating infections is another key factor[1][4].

Geriatric Population

The anticipated increase in the geriatric population, who are more susceptible to UTIs, is poised to drive the growth of the methenamine hippurate tablets market in the coming years[1].

Regional Market Analysis

North America

North America was the largest region in the methenamine hippurate tablets market in 2023. This region includes countries like the USA and Canada, where the demand for non-antibiotic UTI treatments is high due to the prevalence of UTIs and concerns about antibiotic resistance[1][4].

Other Regions

Other significant regions include Asia-Pacific, Western Europe, Eastern Europe, South America, the Middle East, and Africa. Each of these regions has its own market dynamics, with varying levels of demand and growth rates[1][4].

Distribution Channels and End Users

Distribution Channels

The methenamine hippurate tablets market is segmented by distribution channels, including hospital pharmacies, online pharmacies, and retail pharmacies. Each channel plays a crucial role in making the medication accessible to patients[4].

End Users

The market is also segmented by end users, such as hospitals, homecare, specialty clinics, and others. Hospitals and homecare settings are significant end users due to the frequent need for UTI treatment and prevention in these environments[4].

Pricing and Affordability

The cost of HIPREX can vary depending on the pharmacy and the patient's insurance status. For cash-paying customers, a supply of 100 tablets of Hiprex (methenamine hippurate 1 g) can cost around $220. However, generic versions are available at significantly lower prices, starting from $29.58 for 30 tablets[2].

Clinical Validation and Safety

HIPREX has been clinically validated for its effectiveness in preventing and treating UTIs. It is generally active against a range of bacteria and is recommended for use after the eradication of the infection by other antimicrobial agents. However, it is important to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms. Periodic liver function studies are also recommended, especially for patients with liver dysfunction[5].

Future Trends and Opportunities

Increased Focus on Preventive Healthcare

The healthcare sector's increasing focus on preventive therapies is expected to continue driving the demand for methenamine hippurate tablets. This trend aligns with the broader shift towards preventive healthcare measures rather than just treating infections[1][4].

Research and Development

Ongoing clinical trials and research in UTI management are expected to introduce new and improved treatments, further boosting the market. The preference for non-antibiotic solutions will continue to grow as concerns about antibiotic resistance escalate[1][4].

Market Challenges

Despite the growth, the market faces challenges such as the high cost of development and the potential for generic or biosimilar competitors to enter the market once patent exclusivity is lost. These factors can impact the revenue and profitability of pharmaceutical companies involved in this market[3].

Key Takeaways

  • The methenamine hippurate tablets market, including HIPREX, is experiencing strong growth driven by increasing UTI prevalence, concerns about antibiotic resistance, and advancements in UTI management.
  • The market is expected to grow from $8.97 billion in 2023 to $12.83 billion by 2028 at a CAGR of 7.4%.
  • North America is the largest region in this market, with significant contributions from other regions globally.
  • The distribution channels include hospital pharmacies, online pharmacies, and retail pharmacies, catering to various end users such as hospitals and homecare settings.
  • The medication is clinically validated but requires careful use to maintain urine acidity and periodic monitoring of liver function.

FAQs

What is HIPREX used for?

HIPREX (methenamine hippurate) is used for the prophylactic or suppressive treatment of frequently recurring urinary tract infections (UTIs)[5].

How much does HIPREX cost?

The cost of HIPREX can vary, but for cash-paying customers, a supply of 100 tablets can cost around $220. Generic versions are available at lower prices, starting from $29.58 for 30 tablets[2].

What are the key drivers of the methenamine hippurate tablets market?

The key drivers include the increasing prevalence of UTIs, concerns about antibiotic resistance, advancements in UTI management, and the growing geriatric population[1][4].

Which region is the largest market for methenamine hippurate tablets?

North America is the largest region in the methenamine hippurate tablets market[1][4].

What are the potential challenges for the methenamine hippurate tablets market?

Challenges include the high cost of development, the potential for generic or biosimilar competitors, and the need to maintain urine acidity and monitor liver function during treatment[1][3][5].

How does HIPREX work?

HIPREX works by hydrolyzing to formaldehyde in acid urine and maintaining the urine's acidity, which helps in inhibiting the growth of bacteria[5].

Sources

  1. The Business Research Company: Methenamine Hippurate Tablets Global Market Report 2024
  2. Drugs.com: Hiprex Prices, Coupons, Copay Cards & Patient Assistance
  3. DrugBank Blog: Investment Trends in Pharmaceutical Research
  4. The Business Research Company: Methenamine Hippurate Tablets Global Market Report 2024
  5. FDA: HIPREX® (methenamine hippurate tablets USP) Label[5]

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