MYCAMINE Drug Patent Profile
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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 17th, 2019.
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- What is the 5 year forecast for MYCAMINE?
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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 |
Recent Clinical Trials for MYCAMINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University Health Sciences | Phase 4 |
| St. Antonius Hospital | Phase 4 |
| Radboud University | Phase 4 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | AP | RX | Yes | Yes | ⤷ 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-002 | Mar 16, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-002 | Mar 16, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MYCAMINE
See the table below for patents covering MYCAMINE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 024634 | COMPOSICION FARMACEUTICA ESTABILIZADA EN FORMA LIOFILIZADA | ⤷ Sign Up |
| China | 1203089 | ⤷ Sign Up | |
| Japan | 2002363097 | STABILIZED AND LYOPHILIZED TYPE PHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
| European Patent Office | 0729974 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MYCAMINE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0788511 | 91452 | Luxembourg | ⤷ Sign Up | 91452, EXPIRES: 20200929 |
| 0788511 | 300352 | Netherlands | ⤷ Sign Up | 300352, 20150929, EXPIRES: 20200928 |
| 0788511 | SPC/GB08/036 | United Kingdom | ⤷ Sign Up | 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 | SPC022/2008 | Ireland | ⤷ Sign Up | SPC022/2008: 20090219, EXPIRES: 20200928 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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