Mycamine is a drug owned by Astellas Pharma Us Inc. It is protected by 4 US drug patents filed from 2013 to 2019 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 20, 2023. Details of Mycamine's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6774104 (Pediatric) | Stabilized pharmaceutical composition in lyophilized form |
Jul, 2021
(3 years ago) |
Expired
|
| US6774104 | Stabilized pharmaceutical composition in lyophilized form |
Jan, 2021
(3 years ago) |
Expired
|
| US6107458 | Cyclic hexapeptides having antibiotic activity |
Mar, 2019
(5 years ago) |
Expired
|
| US6265536 | Cyclic hexapeptides having antibiotic activity |
Sep, 2015
(9 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Mycamine's patents.
Latest Legal Activities on Mycamine's Patents
Given below is the list of recent legal activities going on the following patents of Mycamine.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 07 Dec, 2004 | US6774104 |
| Patent Issue Date Used in PTA Calculation Critical | 10 Aug, 2004 | US6774104 |
| Recordation of Patent Grant Mailed Critical | 10 Aug, 2004 | US6774104 |
| Issue Notification Mailed Critical | 22 Jul, 2004 | US6774104 |
| Receipt into Pubs | 07 Jul, 2004 | US6774104 |
| Dispatch to FDC | 01 Jul, 2004 | US6774104 |
| Receipt into Pubs | 30 Jun, 2004 | US6774104 |
| Receipt into Pubs | 24 May, 2004 | US6774104 |
| Application Is Considered Ready for Issue Critical | 21 May, 2004 | US6774104 |
| Receipt into Pubs | 14 May, 2004 | US6774104 |
FDA has granted several exclusivities to Mycamine. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mycamine, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Mycamine.
Exclusivity Information
Mycamine holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Mycamine's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-821) | Dec 20, 2022 |
| Pediatric Exclusivity(PED) | Jun 20, 2023 |
US patents provide insights into the exclusivity only within the United States, but Mycamine is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Mycamine's family patents as well as insights into ongoing legal events on those patents.
Mycamine's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mycamine's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 20, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mycamine Generic API suppliers:
Micafungin Sodium is the generic name for the brand Mycamine. 8 different companies have already filed for the generic of Mycamine, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mycamine's generic
How can I launch a generic of Mycamine before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mycamine's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mycamine's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Mycamine -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/vial 100 mg/vial | 16 Jun, 2014 | 1 | 17 May, 2019 | 08 Jan, 2021 | Eligible |
About Mycamine
Mycamine is a drug owned by Astellas Pharma Us Inc. It is used for treating candidiasis infections in various settings, including esophageal candidiasis, candidemia, and candida peritonitis. Mycamine uses Micafungin Sodium as an active ingredient. Mycamine was launched by Astellas in 2005.
Approval Date:
Mycamine was approved by FDA for market use on 16 March, 2005.
Active Ingredient:
Mycamine uses Micafungin Sodium as the active ingredient. Check out other Drugs and Companies using Micafungin Sodium ingredient
Treatment:
Mycamine is used for treating candidiasis infections in various settings, including esophageal candidiasis, candidemia, and candida peritonitis.
Dosage:
Mycamine is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE/VIAL | INJECTABLE | Prescription | INTRAVENOUS |
| EQ 50MG BASE/VIAL | INJECTABLE | Prescription | INTRAVENOUS |