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Micafungin sodium - Generic Drug Details
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What are the generic sources for micafungin sodium and what is the scope of patent protection?
Micafungin sodium
is the generic ingredient in two branded drugs marketed by Apotex, Fresenius Kabi Usa, and Astellas, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Micafungin sodium has forty patent family members in twenty-eight countries.
There are eight drug master file entries for micafungin sodium. Three suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for micafungin sodium
International Patents: | 40 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 8 |
Suppliers / Packagers: | 3 |
Bulk Api Vendors: | 28 |
Clinical Trials: | 4 |
Patent Applications: | 2 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for micafungin sodium |
What excipients (inactive ingredients) are in micafungin sodium? | micafungin sodium excipients list |
DailyMed Link: | micafungin sodium at DailyMed |
Recent Clinical Trials for micafungin sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Astellas Pharma China, Inc. | N/A |
Seoul National University Hospital | Phase 2 |
Yonsei University | Phase 2 |
Generic filers with tentative approvals for MICAFUNGIN SODIUM
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS |
Start Trial | Start Trial | EQ 50MG BASE/VIAL | INJECTABLE;INTRAVENOUS |
Start Trial | Start Trial | EQ 100MG BASE/VIAL | INJECTABLE;INTRAVENOUS |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for micafungin sodium
Drug Class | Echinocandin Antifungal |
Paragraph IV (Patent) Challenges for MICAFUNGIN SODIUM
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MYCAMINE | INJECTABLE;INTRAVENOUS | micafungin sodium | 021506 | 2014-06-16 |
US Patents and Regulatory Information for micafungin sodium
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 | Start Trial | Start Trial | Start Trial | |||
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-002 | Mar 16, 2005 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-002 | Mar 16, 2005 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Fresenius Kabi Usa | MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 207344-001 | May 17, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Apotex | MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 208366-002 | Nov 5, 2020 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Fresenius Kabi Usa | MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 207344-002 | May 17, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>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 micafungin sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-002 | Mar 16, 2005 | Start Trial | Start Trial |
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | Start Trial | Start Trial |
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | Start Trial | Start Trial |
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-002 | Mar 16, 2005 | Start Trial | Start Trial |
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | Start Trial | Start Trial |
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-002 | Mar 16, 2005 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for micafungin sodium
Country | Patent Number | Estimated Expiration |
---|---|---|
Hungary | 0103740 | Start Trial |
New Zealand | 510290 | Start Trial |
Spain | 2225161 | Start Trial |
Brazil | 0006823 | Start Trial |
Japan | 3381722 | Start Trial |
Portugal | 1107777 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for micafungin sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0788511 | C00788511/01 | Switzerland | Start Trial | PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012 |
0788511 | SPC/GB08/036 | United Kingdom | Start Trial | PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425 |
0788511 | 08C0028 | France | Start Trial | PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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