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Last Updated: December 22, 2024

HYPAQUE-76 Drug Patent Profile


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When do Hypaque-76 patents expire, and what generic alternatives are available?

Hypaque-76 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in HYPAQUE-76 is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

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Summary for HYPAQUE-76
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 4
DailyMed Link:HYPAQUE-76 at DailyMed
Drug patent expirations by year for HYPAQUE-76
Recent Clinical Trials for HYPAQUE-76

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

SponsorPhase
Institute of Liver and Biliary Sciences, IndiaN/A
Spectrum Pharmaceuticals, IncPhase 2
CephalonPhase 2

See all HYPAQUE-76 clinical trials

US Patents and Regulatory Information for HYPAQUE-76

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare HYPAQUE-76 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 086505-001 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

HYPAQUE-76 Market Analysis and Financial Projection Experimental

Understanding the Market Dynamics and Financial Trajectory of HYPAQUE-76

Introduction

HYPAQUE-76, a brand-name prescription drug, is part of a broader landscape of pharmaceuticals that have experienced significant price fluctuations. To grasp the market dynamics and financial trajectory of HYPAQUE-76, it is essential to delve into the factors influencing its pricing and the broader trends in the prescription drug market.

Background on Brand-Name Prescription Drugs

Brand-name prescription drugs, including HYPAQUE-76, are FDA-approved products that often enjoy patent protection and market exclusivity. These protections allow drug companies to recoup their research and development costs and earn a return on their investment[1][4].

Patent Protection and Market Exclusivity

Patent protection and market exclusivity play crucial roles in the pricing of brand-name drugs like HYPAQUE-76. These mechanisms limit competition, enabling drug companies to maintain higher prices. For instance, two of the six case study drugs with extraordinary price increases were still under patent at the time of the price hike[1][4].

Impact of Consolidation and Ownership Transfers

The pharmaceutical industry has seen an increase in consolidation through mergers and acquisitions, as well as transfers of drug ownership rights. This trend can lead to fewer drug options and reduced competition, contributing to extraordinary price increases. For example, the rights to several case-study drugs, including some that experienced significant price hikes, were transferred to new companies shortly before the price increases[1][4].

Therapeutic Classes and Market Segments

HYPAQUE-76 falls within specific therapeutic classes, such as those treating central nervous system, anti-infective, or cardiovascular conditions. These classes have seen a disproportionate number of extraordinary price increases. The drug's niche market position can further exacerbate price hikes due to limited competition and high demand[1][4].

Pricing Mechanisms in the Health Care Market

Unlike other consumer markets, the health care market does not respond to price changes in the same way. Health care providers, rather than patients, often make purchasing decisions, and patients may be unaware of the costs due to third-party payers. This dynamic can insulate drug companies from the usual market discipline that would otherwise curb price increases[1][4].

Extraordinary Price Increases

The period between 2000 and 2008 saw a significant rise in extraordinary price increases for brand-name drugs, including HYPAQUE-76. Most of these increases ranged from 100% to 499%, with a median increase of about 158%. However, some drugs experienced price hikes of over 1,000%, with the largest increase being around 4,200%[1][4].

Specific Case of HYPAQUE-76

HYPAQUE-76, an iodinated contrast agent, is used in medical imaging procedures. Its pricing trajectory can be influenced by several factors:

  • Limited Competition: If there are few therapeutically equivalent drugs available, HYPAQUE-76 may experience higher prices due to reduced competition.
  • Patent and Market Exclusivity: If HYPAQUE-76 was under patent or had market exclusivity at the time of its price increase, this would have limited competition and allowed the drug company to maintain higher prices.
  • Consolidation and Ownership: If the rights to HYPAQUE-76 were transferred to a new company, this could have led to a price increase shortly after the transfer[1][4].

Repackaging and Resale

Some brand-name drugs, including those in the same therapeutic classes as HYPAQUE-76, are repackaged and resold in smaller quantities to health care providers. This practice can contribute to higher prices due to the additional costs associated with repackaging and distribution[4].

Market Trends and Future Outlook

The pharmaceutical industry is shifting towards specialty drugs that target niche markets. This trend, combined with increased consolidation, suggests that market domination by a few large companies could continue, potentially leading to further price increases for drugs like HYPAQUE-76[1][4].

Regulatory Incentives

Incentives such as tax credits, FDA fee waivers, and research grants for developing drugs for rare diseases can influence the pricing and development of certain pharmaceuticals. While these incentives are not directly related to HYPAQUE-76, they reflect the broader regulatory environment that can impact drug pricing[1][4].

Consumer and Health Care Provider Impact

The extraordinary price increases of brand-name drugs like HYPAQUE-76 have significant implications for consumers and health care providers. Patients may face higher out-of-pocket costs or reduced access to necessary medications, while health care providers must navigate the complexities of drug pricing to ensure patient care[1][4].

Key Takeaways

  • Patent Protection and Market Exclusivity: These mechanisms significantly influence the pricing of brand-name drugs.
  • Consolidation and Ownership Transfers: These can lead to reduced competition and higher prices.
  • Therapeutic Classes: Drugs in certain classes, like central nervous system or cardiovascular, are more prone to extraordinary price increases.
  • Health Care Market Dynamics: The health care market does not respond to price changes in the same way as other consumer markets.
  • Regulatory Environment: Incentives and regulatory policies can impact drug development and pricing.

FAQs

  1. What role do patents and market exclusivity play in drug pricing? Patents and market exclusivity limit competition, allowing drug companies to recoup research and development costs and maintain higher prices.

  2. How does consolidation in the pharmaceutical industry affect drug prices? Consolidation through mergers and acquisitions can reduce competition, leading to higher prices for drugs like HYPAQUE-76.

  3. Why are health care providers influential in drug pricing? Health care providers make purchasing decisions on behalf of patients, often without patients being aware of the costs, which can insulate drug companies from market discipline.

  4. What are the implications of extraordinary price increases for consumers? Consumers may face higher out-of-pocket costs or reduced access to necessary medications due to extraordinary price increases.

  5. How do regulatory incentives impact drug development and pricing? Regulatory incentives such as tax credits and FDA fee waivers can encourage the development of certain drugs but may also influence pricing strategies.

Sources

  1. GAO-10-201 Brand-Name Prescription Drug Pricing - U.S. Government Accountability Office.
  2. GAO-10-201, Brand-Name Prescription Drug Pricing - U.S. Government Accountability Office.
  3. DRUGS AND DRIVING: A SELECTED BIBLIOGRAPHY - ROSA P.
  4. GAO-10-201, Brand-Name Prescription Drug Pricing - U.S. Government Accountability Office.

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