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 Par Sterile Products, Teva Pharms Usa Inc, Baxter Hlthcare Corp, Apotex, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, and Zydus Pharms. and is included in ten 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.
Summary for MICAFUNGIN
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 35 |
| Clinical Trials: | 58 |
| Patent Applications: | 1,788 |
| Drug Prices: | Drug price information for MICAFUNGIN |
| What excipients (inactive ingredients) are in MICAFUNGIN? | MICAFUNGIN excipients list |
| DailyMed Link: | MICAFUNGIN at DailyMed |
Recent Clinical Trials for MICAFUNGIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University Health Sciences | Phase 4 |
| Scynexis, Inc. | Phase 3 |
| Yung Shin Pharm. Ind. Co., Ltd. | Phase 4 |
Pharmacology for MICAFUNGIN
| Drug Class | Echinocandin Antifungal |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Sterile Products | MICAFUNGIN | micafungin sodium | POWDER;INTRAVENOUS | 212156-001 | Jun 16, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Xellia Pharms Aps | MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 211713-001 | Jun 2, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Baxter Hlthcare Corp | MICAFUNGIN IN SODIUM CHLORIDE 0.9% | micafungin sodium | SOLUTION;INTRAVENOUS | 216142-003 | Sep 29, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Teva Pharms Usa Inc | MICAFUNGIN | micafungin sodium | POWDER;INTRAVENOUS | 212125-002 | Jul 30, 2021 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
