Myfortic is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 3 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 27, 2018. Details of Myfortic'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). | |||
| US6306900 | Enteric coated pharmaceutical compositions |
Feb, 2018
(6 years ago) |
Expired
|
| US6025391 | Enteric-coated pharmaceutical compositions of mycophenolate |
Apr, 2017
(7 years ago) |
Expired
|
| US6172107 | Entric-coated pharmaceutical compositions |
Apr, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Myfortic 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 Myfortic's family patents as well as insights into ongoing legal events on those patents.
Myfortic's Family Patents
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Generic Launch
Generic Release Date:
Myfortic's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 27, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Myfortic Generic API suppliers:
Mycophenolic Sodium is the generic name for the brand Myfortic. 11 different companies have already filed for the generic of Myfortic, with Biocon Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Myfortic's generic
How can I launch a generic of Myfortic before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Myfortic's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Myfortic'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 Myfortic -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 180 mg | 03 Jun, 2009 | 1 | 08 Jan, 2014 | 10 Apr, 2017 | Extinguished |
| 360 mg | 02 Feb, 2009 | 1 | 08 Jan, 2014 | 10 Apr, 2017 | Non-Forfeiture |
About Myfortic
Myfortic is a drug owned by Novartis Pharmaceuticals Corp. It is used for preventing organ rejection in patients who have received allogeneic renal transplants. Myfortic uses Mycophenolic Sodium as an active ingredient. Myfortic was launched by Novartis in 2004.
Approval Date:
Myfortic was approved by FDA for market use on 27 February, 2004.
Active Ingredient:
Myfortic uses Mycophenolic Sodium as the active ingredient. Check out other Drugs and Companies using Mycophenolic Sodium ingredient
Treatment:
Myfortic is used for preventing organ rejection in patients who have received allogeneic renal transplants.
Dosage:
Myfortic is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 180MG BASE | TABLET, DELAYED RELEASE | Prescription | ORAL |
| EQ 360MG BASE | TABLET, DELAYED RELEASE | Prescription | ORAL |