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Last Updated: December 22, 2024

LOW-QUEL Drug Patent Profile


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When do Low-quel patents expire, and what generic alternatives are available?

Low-quel is a drug marketed by Halsey and is included in one NDA.

The generic ingredient in LOW-QUEL is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.

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Summary for LOW-QUEL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 7
Patent Applications: 60
DailyMed Link:LOW-QUEL at DailyMed
Drug patent expirations by year for LOW-QUEL

US Patents and Regulatory Information for LOW-QUEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey LOW-QUEL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085211-001 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

LOW-QUEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory in the Pharmaceutical Industry: Lessons for Drugs Like LOW-QUEL

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by a myriad of factors including regulatory policies, market competition, technological advancements, and financial constraints. For a drug like LOW-QUEL, understanding these market dynamics and financial trajectories is crucial for its success. Here, we delve into the key aspects that shape the pharmaceutical market and how they impact the financial performance of drugs.

Global Trends in the Pharmaceutical Industry

The global pharmaceutical sector is undergoing significant changes driven by various trends:

Pricing Pressure and Regulatory Measures

Governments worldwide are implementing pricing regulations to curb healthcare costs, which affects the profit margins of pharmaceutical companies. This trend is particularly evident in the Middle East and North Africa (MENA) region, where countries like Jordan face strict pricing regulations that impact both local and export markets[1].

Industry 4.0 and Cost Efficiency

The adoption of Industry 4.0 technologies is transforming the manufacturing process, making it more streamlined and cost-efficient. This shift is crucial for pharmaceutical companies looking to maintain profitability in a competitive market[1].

Artificial Intelligence in R&D

Artificial Intelligence (AI) is revolutionizing the research and development (R&D) process by enhancing efficiency and decision-making. AI helps in aggregating data sets, identifying patterns, and generating insights, which can accelerate drug development[1].

Mergers and Acquisitions

The pharmaceutical sector is witnessing a wave of mergers and acquisitions (M&A) aimed at consolidating the market and simplifying the supply chain. This trend is driven by the need for larger, integrated suppliers and the availability of low-cost finance[1].

Competition in Prescription Drug Markets

Competition plays a vital role in shaping the pharmaceutical market:

Impact on Pricing

The level of competition in the prescription drug market directly influences pricing. Drugs with multiple manufacturers tend to have lower prices compared to those with a single manufacturer. This is a key factor in the U.S. prescription drug market, where high prices are often attributed to a lack of competition[4].

Policy Solutions

To foster innovation and improve affordability, policymakers are exploring tailored policy solutions. For instance, the Inflation Reduction Act in the U.S. includes provisions for Medicare drug price negotiation, which is expected to save billions in Medicare spending over the next decade[5].

Trade-Off Between Lower Drug Prices and Innovation

There is a fundamental dilemma in prescription drug policy:

Balancing Affordability and Innovation

High drug prices are necessary to incentivize innovation, but they also strain consumers' and taxpayers' ability to afford these drugs. Policies aimed at controlling drug prices, such as H.R.3, may save public sector funds but could result in fewer new drugs being developed over time[3].

Role of Smaller Bio-Pharmaceutical Companies

Smaller emerging bio-pharmaceutical companies are increasingly responsible for late-stage R&D and new drug launches. However, these firms face challenges in securing the necessary capital for risky and expensive new ventures[3].

Financial Trajectory of Pharmaceutical Companies

The financial health of pharmaceutical companies is influenced by several factors:

Revenue and Profit Margins

Pharmaceutical companies are restructuring to reduce costs and maintain profitability. This includes reducing staff, refocusing R&D, closing manufacturing plants, and divesting underperforming businesses. These savings are often used to replenish pipelines with promising new drug candidates[1].

Impact of Regulatory Policies

Regulatory policies, such as those related to drug pricing and patent expirations, significantly impact company revenues. For example, the Inflation Reduction Act's drug pricing provisions are expected to have a modest impact on the number of new drugs coming to market, but they will also reduce Medicare spending substantially[5].

Case Study: Jordan's Pharmaceutical Sector

Jordan's pharmaceutical industry offers valuable insights into the complexities of the sector:

Market Dominance of Generics

Generics dominate the market in Jordan, both in volume and export value. Despite their lower prices, generics account for a significant portion of the industry's revenue due to their high volume sales[1].

Export-Oriented Industry

Jordan's pharmaceutical industry is highly export-oriented, with approximately 70% of its production being exported. This export focus is crucial for the industry's financial health and cash flow[1].

Regulatory Challenges

Local manufacturers in Jordan face challenges such as slow drug registration periods and unified pricing regulations. These issues affect the industry's ability to streamline local and foreign drug sales and maintain a healthy cash flow[1].

Key Takeaways

  • Regulatory Environment: Strict pricing regulations and slow drug registration processes can significantly impact the financial trajectory of pharmaceutical companies.
  • Technological Advancements: Adopting Industry 4.0 technologies and AI in R&D can enhance efficiency and profitability.
  • Competition: The level of competition in the market directly influences drug prices and the financial health of pharmaceutical companies.
  • Innovation vs. Affordability: Balancing the need for innovation with the necessity of affordability is a critical challenge in the pharmaceutical industry.
  • Export Market: For countries like Jordan, a strong export-oriented strategy is vital for maintaining financial stability.

FAQs

Q: How do regulatory policies impact the pharmaceutical industry? A: Regulatory policies, such as pricing regulations and drug registration processes, can significantly affect the profit margins and cash flow of pharmaceutical companies. These policies can streamline or hinder the industry's operations depending on their nature.

Q: What role does AI play in pharmaceutical R&D? A: AI enhances the efficiency of R&D by aggregating data sets, identifying patterns, and generating insights. This helps companies make smarter, faster, and more strategic decisions.

Q: How does competition influence drug prices? A: The level of competition in the prescription drug market directly influences pricing. Drugs with multiple manufacturers tend to have lower prices compared to those with a single manufacturer.

Q: What are the financial implications of mergers and acquisitions in the pharmaceutical sector? A: Mergers and acquisitions help pharmaceutical companies consolidate the market, simplify the supply chain, and reduce costs. This can lead to increased financial stability and profitability.

Q: How do smaller bio-pharmaceutical companies contribute to innovation? A: Smaller emerging bio-pharmaceutical companies are responsible for a significant portion of late-stage R&D and new drug launches. However, they often face challenges in securing the necessary capital for their ventures.

Sources

  1. Value Chain Analysis of the Pharmaceutical Sector in Jordan. GIZ.
  2. Stanford-Lancet report calls for sweeping reforms to mitigate opioid crisis. Stanford Medicine.
  3. Addressing the Trade-Off Between Lower Drug Prices and Incentives for Pharmaceutical Innovation. Brookings.
  4. Competition in Prescription Drug Markets, 2017-2022. ASPE.
  5. Explaining the Prescription Drug Provisions in the Inflation Reduction Act. KFF.

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