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Last Updated: December 22, 2024

THEOBID Drug Patent Profile


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When do Theobid patents expire, and what generic alternatives are available?

Theobid is a drug marketed by Whitby and is included in two NDAs.

The generic ingredient in THEOBID 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 Theobid

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

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Summary for THEOBID
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 171
Patent Applications: 6,129
DailyMed Link:THEOBID at DailyMed
Drug patent expirations by year for THEOBID

US Patents and Regulatory Information for THEOBID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Whitby THEOBID theophylline CAPSULE, EXTENDED RELEASE;ORAL 085983-001 Mar 20, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Whitby THEOBID JR. theophylline CAPSULE, EXTENDED RELEASE;ORAL 087854-001 Mar 20, 1985 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

THEOBID 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 various factors including regulatory changes, market competition, and economic trends. To understand the market dynamics and financial trajectory of a pharmaceutical drug, it is crucial to analyze several key aspects. Here, we will use a general approach to explain these dynamics, though the specific drug "THEOBID" is not mentioned in the provided sources, we can infer relevant insights from similar pharmaceutical products.

The Pharmaceutical Market Landscape

The global pharmaceutical market is projected to reach $1.15 trillion in 2024 and is expected to exceed $1.4 trillion by 2028, driven primarily by the increasing global burden of chronic diseases[3].

Drug Development Costs and Risks

Bringing a new drug to market is a costly and risky endeavor. The average cost is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved[3].

Pricing Dynamics and Cost-Effectiveness

Drug pricing plays a critical role in the financial trajectory of pharmaceuticals. Studies have shown that drug price dynamics significantly influence cost-effectiveness analyses. For instance, a study on the cost-effectiveness of biologic treatments found that yearly price increases during the exclusivity period and subsequent price decreases after the loss of exclusivity can have varied impacts on the cost per quality-adjusted life-year (QALY) gained[1].

Exclusivity Period and Price Increases

During the exclusivity period, drugs often experience yearly price increases. For example, a 2% yearly price increase can lead to a significant rise in the cost per QALY gained over time. However, post-exclusivity price reductions can mitigate these costs. A 25% to 40% price reduction after the loss of exclusivity can result in a more favorable cost-effectiveness ratio[1].

Impact on Cost-Effectiveness

The magnitude of pre-exclusivity price increases and post-exclusivity price decreases can counterbalance each other. For drugs like tezepelumab and targeted immune modulators, these dynamics can lead to varying cost-effectiveness outcomes depending on whether the comparator drugs also experience similar price changes[1].

Competitive Entry and Market Dynamics

The pharmaceutical market is highly competitive, with the period of marketing exclusivity for breakthrough drugs decreasing over time. This has led to faster entry of follow-on drugs into the market. Approximately one-third of follow-on drugs receive a priority rating from the US FDA, indicating their potential to provide significant therapeutic benefits and inject price competition into the marketplace[4].

Follow-On Drugs and Market Competition

Follow-on drugs, often termed 'me-too' drugs, are not merely duplicative but provide needed therapeutic options and enhance market competition. The development histories of these drugs suggest that they are often in clinical development before the approval of the breakthrough drug, indicating a development race rather than post hoc imitation[4].

Financial Projections and Growth Forecasts

Pharmaceutical companies with promising drug pipelines can exhibit significant financial growth. For example, companies like Tobii, although not directly related to the drug in question, are forecast to grow earnings and revenue substantially. Tobii is expected to grow earnings by 107.7% and revenue by 14% per annum, with EPS growth projected at 107% per annum[2].

Revenue and Earnings Growth

The revenue growth rate for pharmaceutical companies can be influenced by the success of their drug portfolios. A strong pipeline of drugs addressing unmet medical needs can drive revenue growth, as seen in the expanding markets for oncology, diabetes, and cardiovascular diseases[3].

Return on Equity and Profitability

The return on equity (ROE) for pharmaceutical companies can vary, but successful drug development and market penetration can lead to significant returns. For instance, Tobii's ROE is forecast to be 3.6% in three years, indicating a positive financial trajectory despite initial challenges[2].

Investment Trends in Pharmaceutical Research

Investing in pharmaceutical research and development is a high-risk, high-reward endeavor. The potential for blockbuster drugs to generate large revenue streams makes this sector attractive to investors. Strategic alignment of R&D investments to address unmet medical needs is crucial for shaping the future of healthcare innovation[3].

Oncology, Diabetes, and Cardiovascular Markets

The oncology market, for example, represents a vast opportunity due to the rising incidence of cancer worldwide. Similarly, the markets for diabetes and cardiovascular drugs are significant, with new drugs offering improved therapeutic outcomes and driving market growth[3].

Regulatory and Economic Factors

Regulatory changes and economic factors can significantly impact the financial trajectory of pharmaceutical drugs. The speed of competitive entry, the timing of development milestones, and the impact of regulatory approvals all play critical roles in shaping the market dynamics[4].

Key Takeaways

  • Drug Pricing Dynamics: Yearly price increases during exclusivity and post-exclusivity price reductions significantly impact cost-effectiveness analyses.
  • Competitive Market: The pharmaceutical market is highly competitive, with decreasing exclusivity periods and rapid entry of follow-on drugs.
  • Financial Growth: Successful drug development can lead to substantial revenue and earnings growth, as well as positive returns on equity.
  • Investment Trends: High-risk, high-reward investments in pharmaceutical R&D are driven by the potential for blockbuster drugs and addressing unmet medical needs.
  • Regulatory and Economic Factors: These factors influence the speed of competitive entry and the overall market dynamics.

FAQs

Q: What is the average cost of bringing a new drug to market?

The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years[3].

Q: How do price dynamics affect the cost-effectiveness of pharmaceutical drugs?

Price dynamics, including yearly price increases during exclusivity and subsequent price decreases after the loss of exclusivity, can significantly impact the cost per QALY gained, influencing the cost-effectiveness ratio[1].

Q: What role do follow-on drugs play in the pharmaceutical market?

Follow-on drugs provide needed therapeutic options, inject price competition into the marketplace, and are often in clinical development before the approval of the breakthrough drug, indicating a development race rather than post hoc imitation[4].

Q: How is the global pharmaceutical market projected to grow?

The global pharmaceutical market is projected to reach $1.15 trillion in 2024 and exceed $1.4 trillion by 2028, driven by the increasing global burden of chronic diseases[3].

Q: What factors influence the financial growth of pharmaceutical companies?

Factors such as successful drug development, market penetration, and strategic alignment of R&D investments to address unmet medical needs influence the financial growth of pharmaceutical companies[3].

Sources

  1. The Influence of US Drug Price Dynamics on Cost-Effectiveness Analyses - PubMed
  2. Tobii (OTCPK:TBII.F) Stock Forecast & Analyst Predictions - Simply Wall St
  3. Investment Trends in Pharmaceutical Research - DrugBank Blog
  4. The economics of follow-on drug research and development - PubMed

More… ↓

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