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Last Updated: January 2, 2025

THEOCLEAR-80 Drug Patent Profile


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When do Theoclear-80 patents expire, and when can generic versions of Theoclear-80 launch?

Theoclear-80 is a drug marketed by Cent Pharms and is included in one NDA.

The generic ingredient in THEOCLEAR-80 is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Theoclear-80

A generic version of THEOCLEAR-80 was approved as theophylline by RHODES PHARMS on September 1st, 1982.

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Summary for THEOCLEAR-80
Drug patent expirations by year for THEOCLEAR-80

US Patents and Regulatory Information for THEOCLEAR-80

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cent Pharms THEOCLEAR-80 theophylline SYRUP;ORAL 087095-001 Mar 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

THEOCLEAR-80 Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Drug Industry: A Comprehensive Analysis

Introduction

The pharmaceutical industry, including drugs like THEOCLEAR-80, is a complex and dynamic sector influenced by a myriad of factors. This article delves into the market dynamics, financial trajectories, and key trends that shape the industry.

The Evolving Pharmacy Market

The pharmacy market has undergone significant changes over the past few decades. Vertical and horizontal consolidation have led to a market dominated by large chain pharmacies, supermarkets, and mass retailers like Walmart. This consolidation affects competition, drug prices, and access to pharmacy services[1].

Drug Formulation Market Growth

The global drug formulation market is experiencing robust growth, driven by biopharmaceutical innovation, patient-centric drug development, and regulatory support for orphan drugs. The market is expected to grow from $1780.87 billion in 2023 to $1931.05 billion in 2024, with a compound annual growth rate (CAGR) of 8.4%[3].

Segmentation by Dosage Form

The market is segmented into oral formulations, parenteral formulations, topical formulations, and inhalation formulations. Each segment has its own growth trajectory, with oral formulations being the largest due to their ease of administration and high patient compliance[3].

Segmentation by Formulation

The market is also segmented by formulation types such as tablets, capsules, injectables, sprays, suspensions, and powders. Advanced drug delivery systems, including nanotechnology and biological drug delivery, are driving innovation in this area[3].

Therapy Areas

Drug formulations are used across various therapy areas, including cardiovascular diseases, pain management, diabetes, cancer, and respiratory diseases. The growth in these areas is driven by increasing prevalence of chronic diseases and advancements in treatment options[3].

Impact of Major Health Events

Significant health events, such as the COVID-19 pandemic, have a profound impact on the pharmaceutical industry. These events can drive stock prices up during the initial phase due to increased demand for certain drugs and vaccines, but may also lead to volatility as the event unfolds[5].

Temporal Influence on Stock Prices

The study on the impact of major health events on pharmaceutical stock performance reveals distinct patterns. During the beginning phase of a health crisis, stock prices often surge due to market reactions to the initial news. As the event peaks, stock prices may stabilize or decline, and during the resolution phase, they may return to pre-crisis levels or even rise if the company has developed effective treatments or vaccines[5].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the financial trajectory of drugs. For instance, the Inflation Reduction Act (IRA) in the U.S. requires the government to negotiate prices for certain Medicare-covered drugs, which can impact the pricing strategy and profitability of pharmaceutical companies[4].

Price Negotiations and Rebates

The IRA mandates that manufacturers pay rebates to Medicare if prices of single-source drugs increase faster than the consumer price index. This provision can reduce brand prices but may also disincentivize generic manufacturers from entering the market, potentially undermining robust generic competition[4].

Financial Incentives and Generic Competition

Generic drugs require a sufficiently discounted price relative to branded drugs to attract market share. However, the IRA's price-control provisions could reduce the pricing advantage of generics, making it less financially viable for generic manufacturers to enter the market. This could lead to a contraction in generic competition, which is already a concern given the current market dynamics[4].

Advanced Drug Delivery Systems

The future of the drug formulation market is heavily influenced by advancements in drug delivery systems. Technologies such as 3D printing, biological drug delivery systems, and the integration of artificial intelligence (AI) are expected to drive growth and innovation in the industry[3].

Personalized Medicine

Personalized medicine and individualized formulations are becoming increasingly important. This approach tailors drug treatments to individual patients based on their genetic profiles, medical histories, and other factors, which can improve efficacy and reduce side effects[3].

Regional and Country Analysis

The global drug formulation market varies significantly by region and country. The Asia-Pacific region, for example, is expected to see strong growth due to government initiatives, regulatory support, and increasing investments in healthcare infrastructure[3].

Key Trends and Future Outlook

Several key trends are expected to shape the future of the drug formulation market:

  • Biopharmaceuticals and Biologics: These will continue to dominate the market due to their efficacy and the growing demand for targeted therapies.
  • Advanced Drug Delivery Systems: Innovations in drug delivery will enhance patient compliance and treatment outcomes.
  • Personalized Medicine: Individualized formulations will become more prevalent, driven by advancements in genomics and AI.
  • Regulatory Support: Governments will continue to play a crucial role in regulating prices and promoting innovation through incentives for orphan drugs and other niche areas[3].

Impact on THEOCLEAR-80 and Similar Drugs

For a drug like THEOCLEAR-80, the market dynamics and financial trajectory will be influenced by the broader trends in the pharmaceutical industry. Here are some key points:

  • Market Competition: The drug will face competition from both branded and generic versions, with the IRA's price-control provisions potentially affecting its pricing strategy.
  • Regulatory Environment: Compliance with regulatory requirements, such as those set by the IRA, will be crucial for maintaining profitability.
  • Innovation: Investing in advanced drug delivery systems and personalized medicine could enhance the drug's market position and patient outcomes.
  • Health Events: The impact of major health events on stock performance and market demand must be carefully managed to ensure stability and growth.

Key Takeaways

  • The pharmacy market is undergoing significant changes due to consolidation and the rise of new pharmacy types.
  • The drug formulation market is growing strongly, driven by biopharmaceutical innovation and regulatory support.
  • Major health events can significantly impact pharmaceutical stock performance.
  • The regulatory environment, particularly the IRA, influences pricing strategies and generic competition.
  • Advanced drug delivery systems and personalized medicine are key trends shaping the future of the industry.

FAQs

What is the current trend in the pharmacy market?

The pharmacy market is experiencing vertical and horizontal consolidation, leading to a market dominated by large chain pharmacies and supermarkets. This trend affects competition, drug prices, and access to pharmacy services[1].

How does the Inflation Reduction Act impact pharmaceutical prices?

The IRA requires the government to negotiate prices for certain Medicare-covered drugs and mandates rebates if prices increase faster than the consumer price index. This can reduce brand prices but may also disincentivize generic manufacturers from entering the market[4].

What are the key drivers of growth in the drug formulation market?

The growth in the drug formulation market is driven by biopharmaceutical innovation, patient-centric drug development, regulatory support for orphan drugs, and increased R&D investment. Advanced drug delivery systems and personalized medicine are also significant drivers[3].

How do major health events affect pharmaceutical stock performance?

Major health events can drive stock prices up during the initial phase due to increased demand, stabilize or decline during the peak phase, and return to pre-crisis levels or rise during the resolution phase. Macroeconomic and market indicators also play a crucial role in these dynamics[5].

What is the future outlook for the drug formulation market?

The market is expected to grow strongly, driven by advancements in 3D printing, focus on pediatric formulations, biological drug delivery systems, and the integration of AI. Biopharmaceuticals and biologics will continue to dominate, and personalized medicine will become more prevalent[3].

Sources

  1. Competition, Consolidation, and Evolution in the Pharmacy Market - The Commonwealth Fund.
  2. Medical Implications Elective - California Department of Social Services.
  3. Drug Formulation Global Market Report 2024 - The Business Research Company.
  4. Mitigating the Inflation Reduction Act's Adverse Impacts on the Prescription Drug Market - USC Health Policy.
  5. Impact of Major Health Events on Pharmaceutical Stocks - arXiv.

More… ↓

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