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Last Updated: December 22, 2024

GERIMAL Drug Patent Profile


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Which patents cover Gerimal, and what generic alternatives are available?

Gerimal is a drug marketed by Watson Labs and is included in three NDAs.

The generic ingredient in GERIMAL is ergoloid mesylates. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ergoloid mesylates profile page.

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Summary for GERIMAL
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 4
DailyMed Link:GERIMAL at DailyMed
Drug patent expirations by year for GERIMAL

US Patents and Regulatory Information for GERIMAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs GERIMAL ergoloid mesylates TABLET;ORAL 088207-001 Mar 22, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs GERIMAL ergoloid mesylates TABLET;SUBLINGUAL 086189-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs GERIMAL ergoloid mesylates TABLET;SUBLINGUAL 086188-001 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

GERIMAL Market Analysis and Financial Projection Experimental

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

Introduction

The generic drug market is a vital component of the global pharmaceutical industry, offering affordable alternatives to brand-name medications. This article will delve into the market dynamics and financial trajectory of generic drugs, using available data and trends to illustrate the sector's growth and challenges.

Global Market Size and Growth

The global market for generic drugs is experiencing significant growth. As of 2023, the market size was estimated at $435.3 billion, with projections to reach $655.8 billion by 2028, growing at a compound annual growth rate (CAGR) of 8.5% from 2023 to 2028[1].

Market Segments and Geographic Regions

The generic drug market is segmented by molecule type and geographic region. Key regions include North America, Europe, Asia-Pacific, and the Rest of the World. Countries such as the U.S., Canada, Mexico, Germany, the U.K., Italy, China, India, and Japan are significant players in this market[1].

Key Market Drivers

Several factors drive the growth of the generic drug market:

  • Increasing Demand for Affordable Medications: The need for cost-effective healthcare solutions is a major driver, especially in emerging markets like Brazil, China, India, Mexico, and Russia[1].
  • Patent Expirations: The expiration of patents on brand-name drugs allows generic manufacturers to enter the market, increasing competition and reducing prices[3].
  • Regulatory Support: Favorable regulatory environments in many countries facilitate the approval and marketing of generic drugs[3].

Competitive Landscape

The generic drug market is highly competitive, with multiple players vying for market share. Companies employ various strategies to stay competitive:

  • Mergers and Acquisitions: Consolidation is common, as companies seek to expand their product portfolios and geographical reach[1].
  • Cost Control: Efficient manufacturing and distribution processes help companies maintain profitability in a price-sensitive market[2].
  • Innovation: Some companies invest in research and development to create complex generics or biosimilars, which can offer higher margins[2].

Financial Performance of Generic Drug Companies

Companies specializing in generic drugs have shown robust financial performance:

  • Servier Group, for example, reported a 9.2% increase in consolidated revenue to €5.327 billion in the 2022-2023 financial year, with generics revenue growing by 8.8% to €1.286 billion[2].
  • EBITDA Margin: Servier's EBITDA margin increased to 19.1% in 2022-2023, driven by higher sales and tight cost control[2].

Price Dynamics in the Generic Drug Market

Generic drug prices are influenced by several factors:

  • Competition: Prices decline as more competitors enter the market. Studies have shown that prices approach long-run marginal costs when there are eight or more competitors[3].
  • Raw Material Shortages and Production Difficulties: These can lead to price increases due to supply chain disruptions[4].
  • Regulatory Backlog: Delays in the approval of new generic drugs can affect market dynamics and prices[4].

Impact of Medicare Part D on Generic Drug Prices

Under Medicare Part D, generic drug prices have generally declined:

  • Overall Decline: Generic drug prices fell by 59% from the first quarter of 2010 to the second quarter of 2015. However, some established generics experienced moderate decreases followed by slight increases[4].
  • Extraordinary Price Increases: Despite overall declines, some generic drugs saw extraordinary price increases of 100% or more, which persisted for at least a year[4].

Regional Market Trends

Different regions exhibit unique trends:

  • U.S. Market: The U.S. is a dominant market for generic drugs, with sales projected to grow at a CAGR of 10.4% from 2009 to 2014. The market is driven by high demand for affordable medications and a favorable regulatory environment[1].
  • Emerging Markets: Countries like India and China are seeing rapid growth in the generic drug market due to increasing healthcare needs and government support for generic medications[1].

Therapeutic Categories

Generic drugs span various therapeutic categories:

  • Cardiovascular Drugs: These represent a significant portion of the generic drug market, including hypolipidaemics and antihypertensives[1].
  • Respiratory Conditions: Generic drugs for asthma and COPD are also in high demand[1].
  • Central Nervous System and Anticancer Agents: These categories are experiencing major growth due to the expiration of patents on brand-name drugs[1].

Challenges and Opportunities

The generic drug market faces several challenges and opportunities:

  • Raw Material Shortages: Supply chain disruptions can impact production and prices[4].
  • Regulatory Hurdles: Delays in regulatory approvals can slow market entry for new generics[4].
  • Innovation: The development of complex generics and biosimilars offers opportunities for higher margins and market differentiation[2].

Key Takeaways

  • The global generic drug market is projected to grow significantly, driven by increasing demand for affordable medications and patent expirations.
  • Competition is a key driver of price dynamics, with prices declining as more competitors enter the market.
  • Regional markets, such as the U.S. and emerging economies, exhibit unique trends and growth opportunities.
  • Companies must navigate challenges like raw material shortages and regulatory backlogs while leveraging opportunities in innovation.

FAQs

What is the projected growth rate of the global generic drug market from 2023 to 2028?

The global generic drug market is expected to grow at a CAGR of 8.5% from 2023 to 2028[1].

Which regions are significant players in the generic drug market?

Key regions include North America, Europe, Asia-Pacific, and the Rest of the World, with countries such as the U.S., Canada, Mexico, Germany, the U.K., Italy, China, India, and Japan being major players[1].

How do patent expirations affect the generic drug market?

Patent expirations allow generic manufacturers to enter the market, increasing competition and reducing prices[3].

What are the main factors influencing generic drug prices?

Competition, raw material shortages, production difficulties, and regulatory backlogs are primary factors influencing generic drug prices[3][4].

How has Medicare Part D impacted generic drug prices in the U.S.?

Under Medicare Part D, generic drug prices have generally declined, although some established generics have experienced moderate decreases followed by slight increases[4].

Sources

  1. BCC Research: Global Markets for Generic Drugs - BCC Research
  2. Servier: Servier confirms its 2025 trajectory to achieve its 2030 ambition
  3. Federal Trade Commission: Generic Drug Industry Dynamics
  4. GAO: Part D Generic Drug Prices Declined Overall, but Some Had Significant Increases

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.