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Last Updated: December 23, 2024

RENOVUE-65 Drug Patent Profile


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When do Renovue-65 patents expire, and when can generic versions of Renovue-65 launch?

Renovue-65 is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in RENOVUE-65 is iodamide meglumine. There is one drug master file entry for this compound. Additional details are available on the iodamide meglumine profile page.

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Summary for RENOVUE-65
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 11
Patent Applications: 34
DailyMed Link:RENOVUE-65 at DailyMed
Drug patent expirations by year for RENOVUE-65

US Patents and Regulatory Information for RENOVUE-65

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco RENOVUE-65 iodamide meglumine INJECTABLE;INJECTION 017902-001 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

RENOVUE-65 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Generic Drugs: A Case Study on the Impact of Patent Expiries

Introduction

The generic drugs market is poised for significant growth, driven by several key factors including patent expiries, increasing demand for affordable healthcare, and evolving market dynamics. This article will delve into the market dynamics and financial trajectory of the generic drugs sector, using the context of drugs like those that could replace branded versions post-patent expiry, such as the hypothetical 'RENOVUE-65'.

Global Generic Drugs Market Overview

The global generic drugs market is expected to reach nearly $497 billion by 2025, growing at a compound annual growth rate (CAGR) of 5.4%[1].

Demand for Generics

The demand for generic drugs continues to rise due to increasing healthcare costs and the need for affordable alternatives. In countries like Japan, generics penetration has significantly increased, from 30% to 68% over the last decade, and is expected to reach 80% by the end of 2020[1].

Patent Expiries and Market Opportunities

Patent expiries of blockbuster drugs create substantial opportunities for generics manufacturers. Over the next few years, several high-value drugs are set to go off-patent, including drugs like Sprycel, Zytiga, and Tecfidera, among others. These expiries will open up significant market share for generic versions[1].

Therapeutic Areas with High Potential

Certain therapeutic areas offer more potential for generics than others. For instance, oncology treatments, central nervous system drugs, and systemic anti-infectives are expected to see significant generic penetration due to their high value and widespread use[1].

Economic and Supply Challenges

Despite the growing demand, the generics industry faces several challenges. These include deteriorating economics, supply constraints, and increased price pressure from consolidated buyers. When generic drugs first enter the market, they are typically priced between 30% and 90% of the branded drug's price, but this pricing power is often eroded by consolidated buyers exerting price pressure[1].

Buyer Consolidation and Pricing Power

In the U.S., buyer groups such as CVS Caremark, Express Scripts, and OptumRx hold significant market share and exert considerable influence over pricing. This consolidation limits the pricing power of generics manufacturers, impacting their profitability[1].

Global Pharmaceutical Market Context

The global pharmaceutical market, which includes both branded and generic drugs, is expected to exceed $1.5 trillion by 2023, growing at a CAGR of 3-6%[3].

Regional Market Dynamics

  • United States: Driven by new product uptake and brand pricing, but offset by patent expiries and generics.
  • Pharmerging Markets: Expected to grow at 5-8% CAGR.
  • Japan: Medicine spending is expected to decline due to the uptake of generics and exchange rates.
  • Europe: Slower growth due to cost-containment measures and less growth from new products[3].

Financial Trajectory of Generic Drugs

The financial trajectory of generic drugs is influenced by several factors:

Revenue Growth

The generics market is projected to grow significantly, with sales expected to reach $497 billion by 2025. This growth is driven by the increasing demand for generics and the upcoming patent expiries of high-value drugs[1].

Profitability Challenges

Despite revenue growth, generics manufacturers face profitability challenges due to supply constraints, deteriorating economics, and price pressure from buyers. The ability to maintain pricing power is crucial for profitability in this sector[1].

Case Study: Hypothetical 'RENOVUE-65'

If we consider a hypothetical drug like 'RENOVUE-65' that is set to replace a branded version post-patent expiry, several factors would influence its market dynamics and financial trajectory:

Market Entry and Pricing

Upon market entry, 'RENOVUE-65' would likely be priced between 30% and 90% of the branded drug's price. However, this pricing would be subject to pressure from consolidated buyers, which could reduce the drug's profitability over time[1].

Market Penetration

The market penetration of 'RENOVUE-65' would depend on factors such as the therapeutic area it belongs to, the level of competition, and the acceptance by healthcare providers and patients. For instance, if 'RENOVUE-65' is an oncology treatment, it would have a higher potential for market penetration due to the high demand and value of such treatments[1].

Financial Projections

Given the expected growth rate of the generics market, 'RENOVUE-65' could contribute significantly to the revenue of its manufacturer. However, the financial projections would need to account for the challenges in maintaining profitability, such as supply constraints and buyer consolidation[1].

Illustrative Statistics

  • Global Generics Market: Expected to reach $497 billion by 2025, growing at a CAGR of 5.4%[1].
  • Patent Expiries: The number of small-molecule drugs going off-patent is expected to nearly double by 2026, creating significant opportunities for generics[1].
  • Generics Penetration: In Japan, generics penetration rose from 30% to 68% over the last decade and is expected to reach 80% by the end of 2020[1].

Quotes from Industry Experts

"The generics industry faces two opposing forces that complicate profitability and growth. On the one hand, demand for generics continues to rise. At the same time, there are increasing barriers: supply constraints and deteriorating economics."[1]

Conclusion

The generics market is poised for significant growth driven by patent expiries, increasing demand, and evolving market dynamics. However, manufacturers face challenges such as supply constraints, deteriorating economics, and buyer consolidation. For a hypothetical drug like 'RENOVUE-65', understanding these market dynamics is crucial for predicting its financial trajectory and market penetration.

Key Takeaways

  • The global generics market is expected to reach $497 billion by 2025.
  • Patent expiries of blockbuster drugs create substantial opportunities for generics.
  • Therapeutic areas like oncology and central nervous system drugs offer high potential for generics.
  • Buyer consolidation and supply constraints impact profitability.
  • Regional market dynamics vary, with the U.S. and pharmerging markets driving growth.

FAQs

1. What is the projected growth rate of the global generics market? The global generics market is expected to grow at a CAGR of 5.4% and reach $497 billion by 2025[1].

2. Which therapeutic areas offer the most potential for generic drugs? Oncology treatments, central nervous system drugs, and systemic anti-infectives offer significant potential for generic drugs due to their high value and demand[1].

3. How do buyer groups influence the pricing of generic drugs? Buyer groups, such as CVS Caremark and Express Scripts, exert considerable influence over pricing, limiting the pricing power of generics manufacturers and impacting their profitability[1].

4. What are the main challenges faced by generics manufacturers? Generics manufacturers face challenges such as supply constraints, deteriorating economics, and price pressure from consolidated buyers[1].

5. How does the global pharmaceutical market context impact the generics sector? The global pharmaceutical market context, including regional dynamics and the impact of new product launches and cost-containment measures, influences the growth and profitability of the generics sector[3].

Sources

  1. KPMG International - Generics 2030[1]
  2. FINRA.org - Annual Renewal Program (Not relevant to the topic)
  3. IQVIA - The Global Use of Medicine in 2019 and Outlook to 2023[3]
  4. MarketsandMarkets - Pharmaceutical Drug Delivery Market Growth, Drivers & Opportunities (Not directly relevant to the topic)[4]

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