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MICAFUNGIN SODIUM Drug Profile
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When do Micafungin Sodium patents expire, and what generic alternatives are available?
Micafungin Sodium is a drug marketed by Apotex and Fresenius Kabi Usa and is included in two NDAs.
The generic ingredient in MICAFUNGIN SODIUM is micafungin sodium. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Micafungin Sodium
A generic version of MICAFUNGIN SODIUM was approved as micafungin sodium by FRESENIUS KABI USA on May 17th, 2019.
Summary for MICAFUNGIN SODIUM
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 5 |
| Patent Applications: | 2 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MICAFUNGIN SODIUM |
| DailyMed Link: | MICAFUNGIN SODIUM at DailyMed |
Recent Clinical Trials for MICAFUNGIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shandong Provincial Hospital | Phase 4 |
| Astellas Pharma China, Inc. | N/A |
| Seoul National University Hospital | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 208366-001 | 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 | |||
| 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 | 207344-001 | 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 |
