MYCAMINE Drug Patent Profile

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

Mycamine is a drug marketed by Astellas and is included in one NDA.

The generic ingredient in MYCAMINE 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 Mycamine

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

Summary for MYCAMINE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	27
Patent Applications:	1,419
Drug Prices:	Drug price information for MYCAMINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYCAMINE
What excipients (inactive ingredients) are in MYCAMINE?	MYCAMINE excipients list
DailyMed Link:	MYCAMINE at DailyMed

See drug prices for MYCAMINE

Recent Clinical Trials for MYCAMINE

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Radboud University	Phase 4
St. Antonius Hospital	Phase 4

See all MYCAMINE clinical trials

Pharmacology for MYCAMINE

Drug Class

Echinocandin Antifungal

Paragraph IV (Patent) Challenges for MYCAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYCAMINE	For Injection	micafungin sodium	50 mg/vial 100 mg/vial	021506	1	2014-06-16

US Patents and Regulatory Information for MYCAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	AP	RX	Yes	Yes
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	AP	RX	Yes	Yes

Expired US Patents for MYCAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	6,107,458
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	5,376,634
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	6,265,536
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	5,376,634
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	6,265,536

International Patents for MYCAMINE

See the table below for patents covering MYCAMINE around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	295720	Stabilizovaný farmaceutický prostředek a způsob jeho výroby (Stabilized pharmaceutical composition and process for its preparation)
Norway	328483
Japan	2897427
Austria	229541
Norway	2010016

Supplementary Protection Certificates for MYCAMINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788511	SPC022/2008	Ireland		SPC022/2008: 20090219, EXPIRES: 20200928
0788511	08C0028	France		PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
0788511	CA 2008 00030	Denmark
0788511	C00788511/01	Switzerland		PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
0788511	300352	Netherlands		300352, 20150929, EXPIRES: 20200928

MYCAMINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MYCAMINE (Micafungin Sodium)

Overview of MYCAMINE

MYCAMINE, also known as micafungin sodium or Funguard in Japan, is a systemic antifungal agent that belongs to the echinocandin class. It is used to treat various fungal infections, including candidemia and invasive candidiasis.

Market Size and Growth

The global antifungal drugs market, which includes MYCAMINE, was estimated to be USD 15.8 billion in 2023 and is projected to grow at a CAGR of 3.8% from 2024 to 2030[1].

Specifically, the Micafungin Sodium for Injection market was valued at USD 3.49 billion in 2023 and is expected to reach USD 6.38 billion by 2031, growing at a CAGR of 8.2% during the forecast period[4].

Recent Transactions and Strategic Moves

In a significant move, Sandoz acquired the worldwide brand rights for MYCAMINE from Astellas in August 2023. This acquisition is part of Astellas' strategy to optimize resource allocation and achieve sustainable growth. The deal included an upfront payment of USD 62.5-75 million and potential sales-based milestone payments[2][5].

This transaction reinforces Sandoz's global hospital offerings and anti-infectives portfolio, aligning with their commitment to responsible access to critical antimicrobial medicines. Sandoz CEO Richard Saynor emphasized the importance of this acquisition in ensuring patients have access to the right medicine at the right time[5].

Financial Performance

Prior to the acquisition, MYCAMINE generated significant revenue for Astellas. For the fiscal year ending March 31, 2022, MYCAMINE sales were JPY 18.9 billion (approximately USD 170 million). In the year ending March 31, 2023, sales were JPY 14.2 billion (USD 105 million)[2][5].

The financial terms of the asset purchase agreement will be recorded as a gain on divestiture of intangible assets for Astellas, reflecting the strategic financial implications of this transaction[2].

Regulatory Environment

The antifungal drugs market, including MYCAMINE, is subject to stringent regulatory scrutiny. Regulatory approvals and compliance standards are crucial for ensuring product safety and efficacy. For instance, the FDA approval process for antifungal drugs is rigorous, as seen with recent approvals such as REZZAYO (rezafungin for injection) for treating candidemia and invasive candidiasis[1].

Market Drivers

Several factors drive the market for MYCAMINE:

• Increasing Prevalence of Fungal Infections: The rise in immunocompromised patients, particularly those undergoing chemotherapy, organ transplants, or suffering from HIV/AIDS, increases the demand for effective antifungal treatments[4].
• Advancements in Pharmaceutical Formulations: Innovations in drug delivery methods, such as the preference for injectable formulations in hospital settings, contribute to the growth of the Micafungin Sodium market[4].
• Healthcare Infrastructure Development: Improvements in healthcare infrastructure, especially in developing regions, enhance accessibility to antifungal treatments like MYCAMINE[4].

Market Challenges

Despite the positive trends, the market for MYCAMINE faces several challenges:

• Regulatory Hurdles: Navigating complex approval processes set by authorities like the FDA or EMA can be a significant barrier[4].
• Limited Awareness: In some regions, healthcare professionals may not be fully aware of the benefits and applications of MYCAMINE, leading to underutilization[4].
• Market Saturation: The antifungal market is saturated with multiple alternatives, making it challenging for MYCAMINE to differentiate itself[4].
• Healthcare System Constraints: Inadequate healthcare infrastructure and limited access to advanced treatment options in low-income areas can restrict the market potential of MYCAMINE[4].

Geographic Market Dynamics

The market for MYCAMINE is strategically segmented across various geographic regions:

• North America: This region, particularly the United States, has a significant demand for MYCAMINE due to a robust healthcare system and an increase in immunocompromised patients[4].
• Europe: Countries like Germany, France, and the UK are actively adopting innovative antifungal treatments, supported by EU regulations that facilitate drug approval processes[4].
• Asia-Pacific: This region is experiencing 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 comorbidities[4].

Key Takeaways

• The global antifungal drugs market, including MYCAMINE, is expected to grow significantly over the next few years.
• The acquisition of MYCAMINE by Sandoz from Astellas is a strategic move to strengthen Sandoz's anti-infectives portfolio.
• Regulatory approvals and compliance are critical for the market success of antifungal drugs.
• Market drivers include the increasing prevalence of fungal infections, advancements in pharmaceutical formulations, and improvements in healthcare infrastructure.
• Challenges such as regulatory hurdles, limited awareness, market saturation, and healthcare system constraints need to be addressed.

FAQs

1. What is MYCAMINE used for?

   • MYCAMINE (micafungin sodium) is used to treat various fungal infections, including candidemia and invasive candidiasis.

2. Who acquired the rights for MYCAMINE?

   • Sandoz acquired the worldwide brand rights for MYCAMINE from Astellas in August 2023.

3. What is the projected growth rate of the Micafungin Sodium for Injection market?

   • The Micafungin Sodium for Injection market is projected to grow at a CAGR of 8.2% from 2024 to 2031.

4. What are the key drivers of the MYCAMINE market?

   • Key drivers include the increasing prevalence of fungal infections, advancements in pharmaceutical formulations, and improvements in healthcare infrastructure.

5. What are the main challenges facing the MYCAMINE market?

   • Challenges include regulatory hurdles, limited awareness, market saturation, and healthcare system constraints.

Sources

1. Grand View Research - Antifungal Drugs Market Size, Share & Growth Report, 2030
2. Astellas - Astellas Transfers MYCAMINE ® Product Worldwide News
3. Synapse - Micafungin Sodium - Drug Targets, Indications, Patents
4. Verified Market Research - Micafungin Sodium For Injection Market Size And Forecast
5. Novartis - Sandoz completes acquisition of leading antifungal agent Mycamine ...