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Last Updated: December 26, 2024

ETIDRONATE DISODIUM - Generic Drug Details


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What are the generic drug sources for etidronate disodium and what is the scope of patent protection?

Etidronate disodium is the generic ingredient in two branded drugs marketed by Mgi Pharma Inc, Apil, and Norvium Bioscience, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for etidronate disodium.

Drug Prices for ETIDRONATE DISODIUM

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Recent Clinical Trials for ETIDRONATE DISODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
UMC UtrechtPhase 2
Netherlands Brain FoundationPhase 2

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US Patents and Regulatory Information for ETIDRONATE DISODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Norvium Bioscience ETIDRONATE DISODIUM etidronate disodium TABLET;ORAL 075800-001 Jan 24, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mgi Pharma Inc DIDRONEL etidronate disodium INJECTABLE;INJECTION 019545-001 Apr 20, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience ETIDRONATE DISODIUM etidronate disodium TABLET;ORAL 075800-002 Jan 24, 2003 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

Expired US Patents for ETIDRONATE DISODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil DIDRONEL etidronate disodium TABLET;ORAL 017831-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Mgi Pharma Inc DIDRONEL etidronate disodium INJECTABLE;INJECTION 019545-001 Apr 20, 1987 ⤷  Subscribe ⤷  Subscribe
Apil DIDRONEL etidronate disodium TABLET;ORAL 017831-002 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

ETIDRONATE DISODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Etidronate Disodium

Introduction to Etidronate Disodium

Etidronate disodium, a first-generation bisphosphonate, is used primarily in the treatment of osteoporosis and other bone-related disorders. It works by mimicking the action of pyrophosphate, a natural regulator of calcification and decalcification in the body[5].

Market Drivers

The etidronate disodium market is driven by several key factors:

Increasing Prevalence of Osteoporosis

The growing prevalence of osteoporosis, particularly among the elderly population, is a significant driver. As the global population ages, the demand for effective osteoporosis treatments increases, benefiting etidronate disodium and other related medications[1][4].

Rising Awareness About Bone Health

Increased awareness about the importance of bone health and the risks associated with osteoporosis is driving patient demand for preventive and treatment options. This heightened awareness contributes to the market's growth as more people seek medical interventions to manage bone health[1].

Growing Elderly Population

The aging population, especially in developed countries, is another crucial driver. The risk of bone-related disorders increases with age, making this demographic a key target for etidronate disodium and other osteoporosis treatments[1][4].

Market Restraints

Despite the positive drivers, the market faces several challenges:

Competition from Generic Drugs

The availability of generic versions of etidronate disodium and other bisphosphonates leads to price competition and margin pressure for manufacturers. This competition can reduce the market share and revenue of branded products[1].

Regulatory Hurdles

The approval process for new osteoporosis medications is lengthy and costly, posing significant challenges for companies seeking to enter the market with innovative products. Regulatory hurdles can delay market entry and increase development costs[1].

Market Opportunities

There are several opportunities for growth and expansion in the etidronate disodium market:

Product Innovation

Pharmaceutical companies can develop innovative formulations of etidronate disodium that offer improved efficacy, safety, and patient convenience. Such innovations can help differentiate products from generic alternatives and attract more patients[1].

Emerging Markets

Expanding into emerging markets with high unmet needs for osteoporosis treatments presents a significant opportunity for market growth. Regions such as Asia-Pacific, particularly China, offer robust domestic demand and supportive policies that can drive market expansion[1][4].

Regional Analysis

The etidronate disodium market varies significantly by region:

North America and Europe

These regions are experiencing steady growth driven by government initiatives and increasing consumer awareness about bone health. However, the market is more saturated, and competition from generic drugs is higher[4].

Asia-Pacific

This region, led by China, is a key growth area due to robust domestic demand, supportive policies, and a strong manufacturing base. The market in Asia-Pacific is expected to grow significantly over the forecast period[4].

Financial Trajectory

Market Size and Growth

The global etidronate disodium market was valued at a significant amount in 2023 and is forecast to grow at a compound annual growth rate (CAGR) through 2030. The market size is expected to increase driven by the factors mentioned above[4].

Revenue and Sales

The revenue generated from etidronate disodium sales is anticipated to rise, driven by increased demand in both developed and emerging markets. Sales quantity and consumption value are expected to grow across various regions, with Asia-Pacific leading the way[4].

Cost-Effectiveness

Etidronate disodium, while effective, must be cost-effective to remain competitive. Studies have shown that bisphosphonates, including etidronate disodium, can be cost-effective in achieving normocalcaemia and reducing skeletal morbidity, especially when considering the long-term benefits and reduced hospitalization costs[3].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the etidronate disodium market:

Initial Disruption

The initial disruption in healthcare services and reduced patient visits affected market growth. However, the increasing focus on preventive healthcare and the treatment of chronic conditions such as osteoporosis has led to new opportunities for market expansion[1].

Key Industry Developments

Several industry developments are shaping the market:

Partnerships and Collaborations

Pharmaceutical companies are entering into partnerships and collaborations to develop innovative formulations of etidronate disodium and other osteoporosis treatments. These collaborations aim to enhance product efficacy and safety[1].

Research and Development

Ongoing research and development in the field of osteoporosis treatments focus on developing new drugs and formulations that offer improved efficacy and safety profiles. This continuous innovation is crucial for maintaining market competitiveness[1].

Analyst Suggestions

To succeed in the etidronate disodium market, companies should:

Invest in Research and Development

Investing in research and development is essential for developing innovative formulations that can differentiate products from generic alternatives and address unmet needs in the market[1].

Market Diversification

Expanding into emerging markets with high unmet needs can help companies mitigate risks and capitalize on new growth opportunities. This diversification strategy can also help in reducing dependence on saturated markets[1].

Future Outlook

The future outlook for the etidronate disodium market is positive, driven by the increasing prevalence of osteoporosis, rising awareness about bone health, and the growing aging population. However, companies must address the challenges posed by competition from generic drugs and regulatory hurdles to sustain growth and remain competitive[1].

Key Takeaways

  • The etidronate disodium market is driven by the increasing prevalence of osteoporosis, rising awareness about bone health, and the growing elderly population.
  • Competition from generic drugs and regulatory hurdles are significant challenges.
  • Product innovation and expansion into emerging markets offer key opportunities for growth.
  • The market is expected to grow steadily, with Asia-Pacific leading the way.
  • Continuous investment in research and development and market diversification are crucial strategies for success.

FAQs

What are the primary drivers of the etidronate disodium market?

The primary drivers include the increasing prevalence of osteoporosis, rising awareness about bone health, and the growing elderly population.

How does competition from generic drugs affect the market?

Competition from generic drugs leads to price competition and margin pressure for manufacturers, reducing the market share and revenue of branded products.

What are the key opportunities for growth in the etidronate disodium market?

Key opportunities include product innovation and expansion into emerging markets with high unmet needs for osteoporosis treatments.

How has the COVID-19 pandemic impacted the etidronate disodium market?

The pandemic initially disrupted healthcare services but has led to new opportunities for market expansion due to the increased focus on preventive healthcare and chronic condition treatment.

What strategies should companies adopt to succeed in the etidronate disodium market?

Companies should invest in research and development to develop innovative formulations and diversify into emerging markets to mitigate risks and capitalize on new growth opportunities.

Cited Sources

  1. MarkWide Research: Etidronate Disodium Market 2024-2032 | Size, Share, Growth
  2. CMS: Evaluation of the Medicare Replacement Drug Demonstration
  3. NIHR: A systematic review of the role of bisphosphonates in metastatic bone disease
  4. Global Info Research: Global Etidronate Disodium Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030
  5. DrugBank Online: Etidronate disodium

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