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Last Updated: December 22, 2024

MICAFUNGIN Drug Patent Profile


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

Micafungin is a drug marketed by Endo Operations, Teva Pharms Usa Inc, Baxter Hlthcare Corp, Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, and Zydus Pharms. and is included in eleven NDAs.

The generic ingredient in MICAFUNGIN is micafungin sodium. There are eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Micafungin

A generic version of MICAFUNGIN was approved as micafungin sodium by FRESENIUS KABI USA on May 17th, 2019.

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Summary for MICAFUNGIN
Drug patent expirations by year for MICAFUNGIN
Drug Prices for MICAFUNGIN

See drug prices for MICAFUNGIN

Recent Clinical Trials for MICAFUNGIN

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

SponsorPhase
Wake Forest University Health SciencesPhase 4
Scynexis, Inc.Phase 3
Yung Shin Pharm. Ind. Co., Ltd.Phase 4

See all MICAFUNGIN clinical trials

Pharmacology for MICAFUNGIN

US Patents and Regulatory Information for MICAFUNGIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations MICAFUNGIN micafungin sodium POWDER;INTRAVENOUS 212156-001 Jun 16, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Meitheal MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 215381-001 Sep 28, 2022 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare Corp MICAFUNGIN IN SODIUM CHLORIDE 0.9% micafungin sodium SOLUTION;INTRAVENOUS 216142-003 Sep 29, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa Inc MICAFUNGIN micafungin sodium POWDER;INTRAVENOUS 212125-002 Jul 30, 2021 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 207344-001 May 17, 2019 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xellia Pharms Aps MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 211713-001 Jun 2, 2021 AP RX 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

MICAFUNGIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Micafungin

Introduction to Micafungin

Micafungin, an echinocandin antifungal drug, is widely used to treat and prevent invasive fungal infections, including candidemia, abscesses, and esophageal candidiasis. Its efficacy and safety profile have made it a critical component in the antifungal treatment landscape, particularly in hospital settings.

Market Size and Forecast

The Micafungin Sodium for Injection market has been experiencing significant growth. As of 2023, the market size was valued at USD 3.49 billion and is projected to reach USD 6.38 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.2% during the forecast period of 2024 to 2031[1].

Key Drivers of Market Growth

Regulatory Approvals and Market Expansion

New approvals and indications for Micafungin are opening up additional market opportunities, especially in regions with rising healthcare access. Regulatory environments, particularly in the EU, facilitate drug approval processes, which is beneficial for the expansion of Micafungin in markets like Germany, France, and the UK[1].

Shift Towards Parenteral Administration

The preference for injectable formulations in hospital settings is driving the market for Micafungin, as it is available in this form. This shift is crucial because hospital settings often require rapid and effective antifungal treatments to manage severe infections[1].

Increased Investment in Research and Development

Ongoing research to develop new antifungal agents and combinations is enhancing the market for existing treatments like Micafungin. Innovations in pharmaceutical formulations and delivery methods are further contributing to the growth of the Micafungin Sodium market[1].

Healthcare Infrastructure Development

Improvements in healthcare infrastructure, especially in developing regions, are leading to increased accessibility to antifungal treatments. This development is particularly significant in the Asia-Pacific region, where countries like India and China are investing heavily in healthcare improvements[1][3].

Geographic Market Dynamics

North America

North America, particularly the United States, is a significant market for Micafungin due to the high demand driven by an increase in immunocompromised patients and a robust healthcare system that supports advanced antifungal treatments. The region's advanced healthcare infrastructure and high levels of research and development contribute to its dominance in the Micafungin market[1][3].

Europe

The European market mirrors the trends seen in North America, with countries like Germany, France, and the UK actively adopting innovative treatments against emerging fungal pathogens. EU regulations that facilitate drug approval processes also support the growth of the Micafungin market in this region[1].

Asia-Pacific

The Asia-Pacific region is witnessing rapid growth driven by rising healthcare expenditures, increased awareness of fungal infections, and an expanding patient population at risk due to changing demographics and rising cases of comorbidities. Countries like Japan and Australia are showing significant growth, while emerging economies such as India and China face challenges but are gradually improving their healthcare access[1][3].

Economic Factors and Cost Considerations

Competitive Pricing

Micafungin Sodium is positioned favorably in a cost-sensitive environment due to its competitive pricing compared to other antifungal agents. This pricing strategy makes it an attractive option for hospitals and clinics seeking cost-effective yet effective treatment options[3].

Generic Versions

The increasing adoption of generic versions of Micafungin Sodium is anticipated to further drive market growth, providing more accessible treatment options for healthcare providers and patients alike[3].

Cost-Effectiveness Studies

Studies have shown that Micafungin is cost-equivalent to other antifungal agents like caspofungin. For instance, a study demonstrated that Micafungin had a lower total cost compared to caspofungin, primarily due to the lower cost associated with alternative antifungal treatments. This cost-effectiveness is a significant factor in its market appeal[5].

Future Projections

Rising Global Incidences of Fungal Infections

The global antifungal market, including Micafungin, is expected to grow significantly due to the rising global incidences of fungal infections. This growth is particularly driven by the increasing awareness of antifungal treatments and the growing threat of invasive fungal diseases, especially in immunocompromised patients[3].

Shift Towards Outpatient Care and Personalized Medicine

The shift towards outpatient care and the growing trend of personalized medicine are further enhancing the prospects for Micafungin. Hospitals are increasingly adopting antifungal stewardship programs to optimize treatment protocols, which enhances patient outcomes and reduces resistance rates[3].

Regional Growth

Geographically, while North America remains a dominant player, the Asia-Pacific region is expected to witness a compound annual growth rate (CAGR) of over 7% in the coming years. This growth is driven by both demand and supply-side factors, including increasing healthcare access and rising awareness of fungal infections in countries like India and China[3].

Market Segmentation and Competitive Landscape

Product Types

The Micafungin market is segmented based on product types, including 50 mg and 100 mg single-use vials. These different formulations cater to various treatment needs and patient populations[4].

Application and Regional Trends

The market is also segmented based on applications and regional trends. The comprehensive analysis includes consumption, revenue, market share, and growth rate across different regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[4].

Competitive Analysis

The competitive landscape of the Micafungin market involves key players and their market share, strategies, and competitive advantages. This analysis helps in understanding the market dynamics and identifying growth opportunities[4].

Challenges and Opportunities

Barriers to Market Growth

Despite the growth potential, the Micafungin market faces challenges such as limited access to advanced medical treatments in some emerging economies. However, these challenges also present opportunities for market expansion as governments invest in healthcare improvements[3].

Potential Opportunities

The increasing burden of fungal infections in developing regions is gradually prompting governments to invest in healthcare improvements. This trend bodes well for future market expansion and presents significant opportunities for the Micafungin market[3].

Key Takeaways

  • Market Growth: The Micafungin Sodium for Injection market is projected to grow from USD 3.49 billion in 2023 to USD 6.38 billion by 2031, with a CAGR of 8.2%.
  • Geographic Dynamics: North America and Europe are dominant markets, while the Asia-Pacific region is emerging as a significant growth area.
  • Economic Factors: Competitive pricing and the increasing adoption of generic versions are driving market growth.
  • Future Projections: Rising global incidences of fungal infections and shifts towards outpatient care and personalized medicine are expected to enhance market prospects.
  • Market Segmentation: The market is segmented by product types, applications, and regional trends, with a competitive landscape involving key players.

FAQs

What is the current market size of Micafungin Sodium for Injection?

The Micafungin Sodium for Injection market was valued at USD 3.49 billion in 2023[1].

What is the projected growth rate of the Micafungin market?

The Micafungin market is projected to grow at a CAGR of 8.2% from 2024 to 2031[1].

Which regions are driving the growth of the Micafungin market?

North America and Europe are currently dominant, but the Asia-Pacific region is emerging as a significant growth area due to increasing healthcare access and awareness of fungal infections[1][3].

How does Micafungin compare to other antifungal agents in terms of cost?

Micafungin is cost-equivalent to other antifungal agents like caspofungin and has been shown to have a lower total cost in some studies[5].

What are the key drivers of the Micafungin market growth?

Key drivers include regulatory approvals, the shift towards parenteral administration, increased investment in research and development, and improvements in healthcare infrastructure[1].

Sources

  1. Verified Market Research: Micafungin Sodium For Injection Market Size And Forecast[1].
  2. Open Forum Infectious Diseases: A 15-Year FUNGINOS Survey[2].
  3. PMarketResearch: Worldwide Micafungin Sodium Drug Market Research 2024 by Type, Application, Participants, and Countries Forecast to 2030[3].
  4. River Country News Channel Nebraska: Global Micafungin Drug Market Report Offering Dynamic Business Growth 2024-2032[4].
  5. PubMed: Economic evaluation of micafungin versus caspofungin for the treatment of candidemia and invasive candidiasis[5].

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