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Last Updated: December 22, 2024

FLOWTUSS Drug Patent Profile


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Which patents cover Flowtuss, and what generic alternatives are available?

Flowtuss is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in FLOWTUSS is guaifenesin; hydrocodone bitartrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.

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US Patents and Regulatory Information for FLOWTUSS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx FLOWTUSS guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 022424-001 May 14, 2015 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

FLOWTUSS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory in the Pharmacy Industry: Implications for Drugs Like FLOWTUSS

Introduction

The pharmacy market has undergone significant transformations in recent years, influenced by consolidation, technological advancements, and regulatory changes. Understanding these dynamics is crucial for navigating the financial trajectory of prescription drugs, including those like FLOWTUSS.

Pharmacy Market Consolidation

The pharmacy market has seen substantial consolidation over the past two decades. This includes both vertical and horizontal integration, where larger pharmacy chains and pharmacy benefit managers (PBMs) acquire smaller entities, including independent pharmacies[1].

  • Impact on Competition: Consolidation can reduce competition, potentially leading to higher drug prices and reduced access to pharmacy services, especially in rural areas.
  • Economies of Scale: Larger entities can negotiate better prices with drug manufacturers, but this may not always translate to lower costs for consumers.

Challenges Facing Independent Pharmacies

Independent pharmacies face numerous challenges, including increased competition from chain pharmacies and online platforms, as well as regulatory pressures and reimbursement issues[1].

  • Survival Strategies: Many independent pharmacies are adapting by offering additional services such as immunizations, health clinics, and personalized care to differentiate themselves.
  • Financial Strains: Independent pharmacies often struggle with lower profit margins due to competitive pricing and reimbursement rates.

Growth of Specialty Pharmacies

Specialty pharmacies have emerged as a significant segment, focusing on high-cost, complex medications. These pharmacies often require specialized handling and patient support[1].

  • Market Demand: The demand for specialty drugs is increasing, driven by advancements in biotechnology and the need for treatments for chronic and rare diseases.
  • Financial Implications: Specialty drugs are typically more expensive, contributing to higher overall drug spending.

Role of Mail-Order Pharmacies and E-Commerce

Mail-order pharmacies and e-commerce platforms have become more prevalent, offering convenience and sometimes lower costs to consumers[1].

  • Convenience and Accessibility: These platforms can improve access to medications, especially for those with mobility issues or living in remote areas.
  • Regulatory Oversight: There is a need for stringent regulatory oversight to ensure the quality and safety of medications dispensed through these channels.

Recent and Forecasted Trends in Prescription Drug Spending

Prescription drug spending has seen significant growth over the past few decades. However, recent forecasts suggest a moderation in spending growth through the next decade[3].

  • Historical Context: Spending on retail prescription drugs accelerated in the 1990s and continued to rise, with a notable increase in 2021 following a slight decrease in 2020.
  • Future Projections: The National Health Expenditure Accounts (NHEA) project moderate growth in per capita drug spending through 2031, with provisions from the Inflation Reduction Act expected to reduce out-of-pocket drug spending.

Impact of the Inflation Reduction Act

The Inflation Reduction Act includes several provisions aimed at reducing drug costs, such as drug price negotiations and inflation rebates[3].

  • Drug Price Negotiations: The Act allows Medicare to negotiate prices for certain high-cost drugs, which is expected to reduce aggregate drug costs by 20%.
  • Inflation Rebates: Manufacturers will be required to pay rebates if drug prices increase faster than inflation, further reducing costs.

Medicare Drug Price Negotiation Program

The Medicare Drug Price Negotiation Program, part of the Inflation Reduction Act, targets high-cost drugs used by a significant number of Medicare enrollees[4].

  • Selected Drugs: The program focuses on drugs that have been on the market for a certain number of years, with total Medicare spending for these drugs exceeding $46 billion in 2022.
  • Financial Impact: The program is expected to reduce the federal deficit by $237 billion over 10 years.

Financial Trajectory for Prescription Drugs

The financial trajectory for prescription drugs like FLOWTUSS will be influenced by these market dynamics and regulatory changes.

  • Cost Containment: Efforts to contain drug costs, such as price negotiations and inflation rebates, could reduce the revenue generated by these drugs.
  • Market Competition: Increased competition from generic or biosimilar alternatives could also impact the financial performance of branded drugs.

Illustrative Statistics

  • Per Capita Spending: Retail prescription drug spending per capita in the U.S. increased from $101 in 1960 to $1,147 in 2021[3].
  • Medicare Spending: Total Medicare spending for selected high-cost drugs more than doubled from $20 billion in 2018 to $46 billion in 2022[4].

Expert Insights

"Consolidation in the pharmacy market can lead to reduced competition and higher prices, but it also allows for better negotiation power with drug manufacturers," says a pharmacy industry expert. "The key is to balance these forces to ensure affordability and access to essential medications."

Key Takeaways

  • The pharmacy market is undergoing significant changes due to consolidation, the growth of specialty pharmacies, and the rise of mail-order and e-commerce platforms.
  • Regulatory changes, such as the Inflation Reduction Act, are aimed at reducing drug costs through price negotiations and inflation rebates.
  • The financial trajectory for prescription drugs will be influenced by these market dynamics and regulatory efforts to contain costs.

FAQs

Q: How has consolidation affected the pharmacy market? A: Consolidation has reduced competition, potentially leading to higher drug prices, but it also allows larger entities to negotiate better prices with manufacturers.

Q: What is the impact of the Inflation Reduction Act on drug spending? A: The Act is expected to reduce aggregate drug costs by 20% through price negotiations and inflation rebates, and to reduce the federal deficit by $237 billion over 10 years.

Q: How are specialty pharmacies changing the market? A: Specialty pharmacies are growing due to the increasing demand for high-cost, complex medications, contributing to higher overall drug spending.

Q: What role do mail-order pharmacies and e-commerce platforms play? A: These platforms improve access to medications, especially for those with mobility issues or living in remote areas, but require stringent regulatory oversight.

Q: How will the Medicare Drug Price Negotiation Program affect drug costs? A: The program targets high-cost drugs used by a significant number of Medicare enrollees, aiming to reduce costs through price negotiations.

Cited Sources:

  1. Commonwealth Fund - "Competition, Consolidation, and Evolution in the Pharmacy Market"[1]
  2. Health System Tracker - "What are the recent and forecasted trends in prescription drug spending?"[3]
  3. ASPE - "Medicare Drug Price Negotiation Program: Understanding the Program"[4]

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