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Last Updated: December 26, 2024

SALUTENSIN-DEMI Drug Patent Profile


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Which patents cover Salutensin-demi, and what generic alternatives are available?

Salutensin-demi is a drug marketed by Shire and is included in one NDA.

The generic ingredient in SALUTENSIN-DEMI is hydroflumethiazide; reserpine. There are two drug master file entries for this compound. Additional details are available on the hydroflumethiazide; reserpine profile page.

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Summary for SALUTENSIN-DEMI
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 74
DailyMed Link:SALUTENSIN-DEMI at DailyMed
Drug patent expirations by year for SALUTENSIN-DEMI

US Patents and Regulatory Information for SALUTENSIN-DEMI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire SALUTENSIN-DEMI hydroflumethiazide; reserpine TABLET;ORAL 012359-004 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

SALUTENSIN-DEMI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pharmaceutical Drugs: A Case Study Approach

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by a myriad of factors including regulatory changes, technological advancements, and shifting market demands. This article will delve into the market dynamics and financial trajectory of pharmaceutical drugs, using the broader industry context to illustrate key points.

The Pharmaceutical Market Overview

The global pharmaceutical market is projected to reach $1.15 trillion in 2024 and is expected to exceed $1.4 trillion by 2028. This growth is driven by the increasing global burden of chronic diseases, such as cancer, diabetes, and cardiovascular diseases[3].

Investment Trends in Pharmaceutical Research and Development

Investing in pharmaceutical research and development (R&D) is a high-risk, high-reward endeavor. The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. Despite these challenges, successful drugs can generate substantial revenue streams. For example, AbbVie's Humira, a monoclonal antibody for autoimmune diseases, generated over $20 billion in annual revenue at its peak[3].

Challenges in Pharmaceutical R&D

The return on investment (ROI) for pharmaceutical R&D has been declining in recent years. Deloitte's annual R&D returns analysis for 2022 revealed a forecasted ROI of just 1.2%, down from 1.9% in 2021. This decline is attributed to increasing regulatory hurdles, shorter exclusivity periods, and the introduction of generic or biosimilar competitors[3].

Impact of Generic and Biosimilar Drugs

When a drug loses patent protection, generic or biosimilar versions can enter the market, leading to a rapid decline in sales for the original brand-name drug. This significantly impacts a company's ability to recoup its R&D investment. For instance, Humira lost patent exclusivity in 2023, which will likely reduce its revenue substantially[3].

Market Segments and Opportunities

Oncology

The oncology market represents a significant opportunity due to the rising incidence of cancer worldwide. By 2040, cancer cases are projected to increase dramatically, driving investment in new cancer therapies[3].

Diabetes and Cardiovascular Diseases

Diabetes and cardiovascular diseases are other major areas of focus. Drugs like Sanofi's Toujeo and Novo Nordisk's Tresiba, which offer improved glycemic control and reduced risk of hypoglycemia, are gaining traction. GLP-1 receptor agonists and SGLT2 inhibitors are also popular due to their additional health benefits[3].

Financial Burden and Affordability

The financial burden of prescription drugs remains a significant issue, particularly for low-income groups and those with public insurance. Strategies to lower drug costs, such as the increased use of generic drugs, have shown some success but more needs to be done to ensure affordability and accessibility[2].

Precision Medicine and Next-Generation Sequencing

Precision medicine, which leverages genomic sequencing and molecular profiling, is becoming increasingly important. This approach optimizes treatment efficacy and minimizes adverse events, but it also raises concerns about the high cost of these therapies[3].

Lifestyle Drugs and Emerging Markets

Lifestyle drugs, such as those for obesity and erectile dysfunction, have seen significant growth. For example, Sildenafil Citrate (Viagra) has been a market leader in this segment. These drugs often have a strong market demand and can contribute substantially to a company's revenue[4].

Regulatory and Public Health Considerations

The emergence of new infectious diseases and the growing threat of antimicrobial resistance (AMR) highlight the need for increased investment in developing new antibiotics. However, this comes with significant financial risks and uncertainties. Initiatives like the AMR Action Fund aim to address these challenges by funding biotechnology companies developing new antibiotics[3].

Case Study: Synthetic Opioids and Overdose Deaths

In Ohio, there has been a rapid change in the illicit drug market, with a decline in heroin and a rise in synthetic opioids like fentanyl and carfentanil. This shift has been strongly correlated with an increase in overdose deaths. Crime lab data can serve as an early warning system to alert stakeholders about changes in the illicit opioid risk environment[1].

Balancing Profit and Public Health

Pharmaceutical companies must balance the need for profit with the imperative of public health. High-cost therapies, such as biologics, raise concerns about affordability and accessibility. Companies are exploring new economic models to incentivize investment in areas like antimicrobial resistance and neglected tropical diseases[3].

Key Takeaways

  • The global pharmaceutical market is expected to grow significantly, driven by chronic diseases.
  • High costs and long development timelines characterize pharmaceutical R&D.
  • Generic and biosimilar drugs significantly impact the revenue of brand-name drugs.
  • Precision medicine and next-generation sequencing are becoming crucial in optimizing treatment.
  • Regulatory and public health considerations play a vital role in shaping the industry.
  • Balancing profit with public health is a critical challenge for pharmaceutical companies.

FAQs

What is the projected global pharmaceutical market revenue by 2028?

The global pharmaceutical market revenue is forecasted to exceed $1.4 trillion by 2028[3].

How much does it cost to bring a new drug to market?

The average cost of bringing a new drug to market is approximately $2.6 billion[3].

What is the impact of generic and biosimilar drugs on brand-name drugs?

Generic and biosimilar drugs can lead to a rapid decline in sales for brand-name drugs after patent protection is lost[3].

Which market segments are seeing significant investment in pharmaceutical R&D?

Oncology, diabetes, and cardiovascular diseases are major areas of focus for pharmaceutical R&D[3].

How is precision medicine changing the pharmaceutical industry?

Precision medicine is optimizing treatment efficacy and minimizing adverse events through genomic sequencing and molecular profiling, but it also raises concerns about affordability[3].

What initiatives are being taken to address antimicrobial resistance?

Initiatives like the AMR Action Fund are funding biotechnology companies to develop new antibiotics to combat AMR[3].

Sources

  1. Rapidly Changing US Illicit Drug Market and Overdose Deaths: PubMed.
  2. Financial Burden from Prescription Drugs: PubMed.
  3. Investment Trends in Pharmaceutical Research: DrugBank Blog.
  4. Lifestyle Drug Market Booming: PubMed.
  5. Journal of the Florida Medical Association: Internet Archive.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.