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Last Updated: January 2, 2025

Bendroflumethiazide - Generic Drug Details


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

Bendroflumethiazide is the generic ingredient in five branded drugs marketed by Apothecon, King Pharms Llc, Impax Labs, and Natco Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for bendroflumethiazide.

Summary for bendroflumethiazide
Recent Clinical Trials for bendroflumethiazide

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SponsorPhase
Yale UniversityPhase 1
Mylan PharmaceuticalsPhase 1
Steno Diabetes CenterPhase 4

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Medical Subject Heading (MeSH) Categories for bendroflumethiazide
Anatomical Therapeutic Chemical (ATC) Classes for bendroflumethiazide

US Patents and Regulatory Information for bendroflumethiazide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
King Pharms Llc CORZIDE bendroflumethiazide; nadolol TABLET;ORAL 018647-002 May 25, 1983 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
King Pharms Llc CORZIDE bendroflumethiazide; nadolol TABLET;ORAL 018647-001 May 25, 1983 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon NATURETIN-5 bendroflumethiazide TABLET;ORAL 012164-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco Pharma NADOLOL AND BENDROFLUMETHIAZIDE bendroflumethiazide; nadolol TABLET;ORAL 078688-002 Feb 15, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco Pharma NADOLOL AND BENDROFLUMETHIAZIDE bendroflumethiazide; nadolol TABLET;ORAL 078688-001 Feb 15, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon NATURETIN-10 bendroflumethiazide TABLET;ORAL 012164-003 Approved Prior to Jan 1, 1982 DISCN 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

Bendroflumethiazide Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Bendroflumethiazide

Introduction

Bendroflumethiazide, a thiazide diuretic, is widely used in the treatment of hypertension, edema, and other conditions. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, healthcare providers, and investors.

Market Overview

Global Generic Drug Market

The global generic drug market, which includes bendroflumethiazide, was valued at around $244.5 billion in 2017, representing about 17% of the global pharmaceuticals market. This segment is growing, driven by the need to improve access to drugs for patients with chronic conditions and to allocate resources for newer, innovative treatments[3].

Competitive Landscape

Market Concentration

The market for oral diuretics, including thiazides like bendroflumethiazide, has historically shown a high degree of concentration. In the 1970s, for example, the four-firm concentration in the oral diuretic market was around 67%, indicating that a few major firms dominated the market[4].

Product Differentiation and Promotion

Despite the dominance of a few firms, the market for oral diuretics is characterized by significant promotional expenditures. However, it has been observed that leading firms in this market tend to spend a smaller percentage of their sales on promotion compared to non-leading firms. The success of early entrants in the market, such as the introduction of thiazide diuretics in 1957, has been a key factor in their market dominance. These early entrants often achieved substantial sales advantages that were difficult for later entrants to overcome, even with heavy promotional efforts[4].

Financial Aspects

Pricing and Reimbursement

In many healthcare systems, the price of generic drugs like bendroflumethiazide is set by the reference price of the generic medicinal product (GMP). This means that the use of a branded drug (BD) or a GMP does not affect the budget impact, as the healthcare system reimburses only the reference price. In some countries, the prices of BDs and GMPs are the same, eliminating any financial advantage of choosing one over the other[3].

Cost and Pricing Information

Bendroflumethiazide is available in various dosage forms, and its pricing varies depending on the manufacturer and the specific product. For example, the cost of bendroflumethiazide tablets can range from $3.23 to $4.29 per tablet, depending on the strength and the manufacturer[5].

Regulatory and Safety Considerations

Safety Profile and Regulatory Updates

Bendroflumethiazide, like other thiazide diuretics, has a known safety profile that includes potential adverse reactions such as hypercalcaemia. Recent regulatory updates have emphasized the need to include hypercalcaemia as an adverse reaction in the product information for bendroflumethiazide and bendroflumethiazide/potassium chloride products. Additionally, healthcare professionals are advised to discontinue thiazide diuretics before conducting parathyroid function tests due to potential interference[1].

Market Trends and Future Outlook

Growing Demand for Generic Drugs

The demand for generic drugs, including bendroflumethiazide, is expected to continue growing as healthcare systems seek to manage costs and improve patient access to essential medications. A consolidated generic drug industry with multiple manufacturers can help maintain competitive pricing and ensure the sustainability of healthcare systems[3].

Comparative Efficacy and Clinical Outcomes

Studies comparing different thiazide diuretics, such as chlorthalidone and hydrochlorothiazide, have shown varying outcomes in terms of cardiovascular events and mortality. These studies highlight the importance of selecting the most appropriate diuretic based on patient-specific factors and clinical history. For instance, chlorthalidone may offer better outcomes in certain patient subgroups compared to hydrochlorothiazide[2].

Impact of Market Dynamics on Financial Trajectory

Revenue Stability

The financial trajectory of bendroflumethiazide is influenced by its stable market position as a generic drug. The drug's inclusion in various treatment guidelines for hypertension and edema ensures a consistent demand, which in turn stabilizes revenue streams for manufacturers.

Competitive Pressures

Despite the stability, manufacturers face competitive pressures from other generic and branded diuretics. The need to invest in promotional activities and product differentiation to maintain market share can impact profit margins. However, early entrants in the market, such as those who introduced thiazide diuretics, often enjoy a long-term sales advantage that can mitigate these pressures[4].

Key Takeaways

  • Market Size and Growth: The global generic drug market, including bendroflumethiazide, is significant and growing.
  • Competitive Landscape: The market is concentrated, with leading firms enjoying a long-term sales advantage.
  • Pricing and Reimbursement: Prices are often set by reference prices, eliminating financial advantages between branded and generic options.
  • Regulatory Considerations: Safety profiles and regulatory updates are crucial for maintaining market authorization.
  • Market Trends: Growing demand for generic drugs and comparative efficacy studies influence market dynamics.

FAQs

What is bendroflumethiazide used for?

Bendroflumethiazide is used to treat hypertension, edema, and other conditions by increasing urine production and reducing blood pressure[5].

How does bendroflumethiazide affect calcium levels?

Bendroflumethiazide can cause a slight increase in calcium serum levels by decreasing tubular calcium excretion, which can be a signal of hypercalcaemia[1].

What are the potential adverse reactions of bendroflumethiazide?

Potential adverse reactions include hypercalcaemia, increased potassium excretion, and elevated serum uric acid levels[1][5].

How does the market concentration affect the financial trajectory of bendroflumethiazide?

Market concentration can lead to stable revenue streams for leading firms but also necessitates significant promotional expenditures to maintain market share[4].

What is the impact of regulatory updates on bendroflumethiazide?

Regulatory updates, such as the addition of hypercalcaemia as an adverse reaction, are crucial for maintaining market authorization and ensuring patient safety[1].

Sources

  1. CMDh Scientific Conclusions and Grounds for the Variation to the Terms of the Marketing Authorisation(s) for Bendroflumethiazide/Bendroflumethiazide Potassium Chloride. European Medicines Agency.
  2. Chlorthalidone vs Hydrochlorothiazide for Hypertension Treatment. JAMA Network Open.
  3. Low-quality of some generic medicinal products represents a matter of concern. Open Access SGUL.
  4. Sales, Promotion, and Product Differentiation in Two Prescription Drug Markets. Federal Trade Commission.
  5. Bendroflumethiazide: Uses, Interactions, Mechanism of Action. DrugBank.

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