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Last Updated: December 22, 2024

TEGOPEN Drug Patent Profile


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Which patents cover Tegopen, and when can generic versions of Tegopen launch?

Tegopen is a drug marketed by Apothecon and is included in two NDAs.

The generic ingredient in TEGOPEN is cloxacillin sodium. There are twenty-three drug master file entries for this compound. Additional details are available on the cloxacillin sodium profile page.

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Summary for TEGOPEN
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 34
Patent Applications: 5,076
DailyMed Link:TEGOPEN at DailyMed
Drug patent expirations by year for TEGOPEN

US Patents and Regulatory Information for TEGOPEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon TEGOPEN cloxacillin sodium FOR SOLUTION;ORAL 061453-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon TEGOPEN cloxacillin sodium FOR SOLUTION;ORAL 050192-001 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

TEGOPEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Generic Drugs: A Case Study

Introduction

Understanding the market dynamics and financial trajectory of generic drugs is crucial for both pharmaceutical companies and investors. This article will delve into the key aspects of the generic drug market, using examples and data to illustrate the dynamics and financial implications.

The Generic Drug Industry: An Overview

The generic drug industry is characterized by unique institutional and regulatory features that make it an interesting case study for market competition and pricing strategies. Generic drugs enter the market after the patent expiration of their branded counterparts, offering a more cost-effective alternative[1].

Market Entry and Competition

When a generic drug enters the market, it typically faces a period of monopoly pricing before other generic competitors join. The number of competitors significantly affects the pricing and profitability of generic drugs. Research indicates that generic drug prices fall as the number of competitors increases, but these prices remain above long-run marginal costs until there are at least 8 or more competitors[1].

Impact of Number of Competitors on Pricing

The relationship between the number of competitors and pricing is a critical factor in the generic drug market. For instance, the initial generic monopolist can charge prices 35% to 50% above long-run marginal costs. As more firms enter the market, prices decline and approach long-run marginal costs when the number of producers reaches 8 or more[1].

Entry and Expected Rents

The decision to enter a generic drug market is heavily influenced by the expected rents or profits. More firms enter, and enter more quickly, in markets with greater expected rents. This is because higher expected profits justify the costs associated with entering the market, such as the cost of obtaining an Abbreviated New Drug Application (ANDA)[1].

Regulatory Influences

Government policies and regulatory changes can significantly impact the generic drug market. For example, the FDA's increased scrutiny of generic drug applications in the late 1980s raised the cost of obtaining an ANDA, which in turn affected the entry of new generic firms and the resulting prices[1].

Economic Implications of Precision Medicines

The shift towards precision medicines, which target small patient populations, has economic ramifications for the generic drug market. These drugs often have higher prices due to their value to specific patient groups, but they also face limited generic competition due to the small market size and high fixed costs of entry[3].

Case Study: Penicillin Drug Market

The penicillin drug market provides a practical example of how generic drugs influence market dynamics. The global penicillin drug market is projected to grow from $8.4 billion in 2022 to $12.1 billion by 2032, driven by the increasing demand for affordable and generic penicillin medications. The availability of multiple manufacturers producing generic penicillin has led to increased market competition, resulting in lower prices and a steady supply of medications[4].

Market Growth Drivers

  • Surge in Demand for Generic Medications: Patients and healthcare systems increasingly seek cost-effective alternatives to brand-name medications.
  • Increased Market Competition: Multiple manufacturers producing generic penicillin lead to lower prices and a stable supply.
  • Online Providers: Online platforms offer flexibility and a diverse selection of penicillin drugs, contributing to market growth[4].

Regional Analysis

The Asia-Pacific region is a significant market for penicillin drugs, driven by the growing population, increasing healthcare expenditures, and improving healthcare infrastructure. This region is expected to grow at the fastest rate during the forecast period[4].

Financial Trajectory of Generic Drugs

The financial trajectory of generic drugs is closely tied to the number of competitors and the market size.

Revenue and Profit Trends

Generic drug revenues and profits are affected by the number of firms in the market. Initially, revenues and profits increase as more firms enter, but they begin to fall after five to eight months as more entrants compete away price-cost margins[1].

Cost Structure

The cost structure for generic drugs includes the cost of obtaining regulatory approvals, manufacturing costs, and marketing expenses. Higher regulatory scrutiny can increase these costs, affecting the financial viability of entering the market[1].

Illustrative Statistics

  • Price Reduction: Generic drug prices decline by 35% to 50% as the number of competitors increases from one to eight or more[1].
  • Market Size: The global penicillin drug market is expected to grow from $8.4 billion in 2022 to $12.1 billion by 2032, a CAGR of 3.7%[4].
  • Regional Growth: The Asia-Pacific region is expected to grow at the fastest rate, driven by increasing healthcare expenditures and improving infrastructure[4].

Quotes from Industry Experts

"The ability to create products that target small patient populations changes optimal pricing policies and decisions about which drugs to prioritize in the development process." - Amitabh Chandra, discussing the economic implications of precision medicines[3].

Analogies and Metaphors

The generic drug market can be likened to a marathon where multiple runners (competitors) enter the race. Initially, the first runner (the initial generic monopolist) sets a high pace (price), but as more runners join, the pace slows down (prices decrease), and the race becomes more competitive.

Key Takeaways

  • Competition and Pricing: The number of competitors significantly affects generic drug prices, with prices approaching long-run marginal costs as the number of competitors increases.
  • Regulatory Impact: Government policies and regulatory changes can influence the cost of entry and the resulting market dynamics.
  • Market Growth: The demand for affordable and generic medications drives market growth, especially in regions with increasing healthcare expenditures.
  • Financial Trajectory: Revenues and profits initially increase with more firms entering the market but decline as competition intensifies.

FAQs

What is the impact of the number of competitors on generic drug prices?

Generic drug prices fall as the number of competitors increases, but they remain above long-run marginal costs until there are at least 8 or more competitors.

How do regulatory changes affect the generic drug market?

Regulatory changes, such as increased scrutiny of generic drug applications, can raise the cost of entry and affect the number of firms entering the market, thereby influencing prices.

What drives the growth of the penicillin drug market?

The growth of the penicillin drug market is driven by the increasing demand for affordable and generic medications, increased market competition, and the rise in online providers offering a diverse selection of penicillin drugs.

How do precision medicines affect the generic drug market?

Precision medicines, targeting small patient populations, often have higher prices but face limited generic competition due to high fixed costs of entry and the small market size.

What is the projected growth rate of the penicillin drug market?

The global penicillin drug market is projected to grow at a CAGR of 3.7% from 2022 to 2032.

Sources

  1. Federal Trade Commission - Generic Drug Industry Dynamics[1]
  2. National Bureau of Economic Research - The Economics of Drug Development: Pricing and Innovation in a Changing Market[3]
  3. Allied Market Research - Penicillin Drug Market Size, Share & Growth Report, 2032[4]

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