MICAFUNGIN SODIUM Drug Patent 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, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, and Zydus Pharms. and is included in eight NDAs.
The generic ingredient in MICAFUNGIN SODIUM 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 Sodium
A generic version of MICAFUNGIN SODIUM was approved as micafungin sodium by FRESENIUS KABI USA on May 17th, 2019.
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Questions you can ask:
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Summary for MICAFUNGIN SODIUM
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 5 |
| Patent Applications: | 52 |
| 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. | |
| Seoul National University Hospital | Phase 2 |
Pharmacology for MICAFUNGIN SODIUM
| Drug Class | Echinocandin Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes for MICAFUNGIN SODIUM
Paragraph IV (Patent) Challenges for MICAFUNGIN SODIUM
| 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 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 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 213261-001 | Jul 9, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Biocon Pharma | MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 216438-002 | May 29, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
