Istodax is a drug owned by Bristol-myers Squibb Co. It is protected by 3 US drug patents filed in 2013 out of which all have expired. Istodax's patents have been open to challenges since 05 November, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 22, 2021. Details of Istodax'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). | |||
| US7611724 | Method of producing FR901228 |
Aug, 2021
(3 years ago) |
Expired
|
| US7608280 | Method of producing FR901228 |
Aug, 2021
(3 years ago) |
Expired
|
| US4977138 | FR901228 substance and preparation thereof |
Aug, 2013
(11 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 Istodax's patents.
Latest Legal Activities on Istodax's Patents
Given below is the list of recent legal activities going on the following patents of Istodax.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Apr, 2021 | US7611724 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Apr, 2021 | US7608280 (Litigated) |
| Workflow - Request for CPA - Begin | 15 May, 2015 | US7608280 (Litigated) |
| Workflow - Request for CPA - Begin | 15 May, 2015 | US7611724 |
| Mail-Record Petition Decision of Granted to Make Special | 30 Nov, 2009 | US7611724 |
| Patent Issue Date Used in PTA Calculation Critical | 03 Nov, 2009 | US7611724 |
| Recordation of Patent Grant Mailed Critical | 03 Nov, 2009 | US7611724 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Oct, 2009 | US7608280 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 27 Oct, 2009 | US7608280 (Litigated) |
| Email Notification Critical | 15 Oct, 2009 | US7611724 |
FDA has granted several exclusivities to Istodax. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Istodax, 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 Istodax.
Exclusivity Information
Istodax holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Istodax's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 05, 2014 |
| Orphan Drug Exclusivity(ODE) | Jun 16, 2018 |
| Orphan Drug Exclusivity(ODE-12) | Jun 16, 2018 |
US patents provide insights into the exclusivity only within the United States, but Istodax 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 Istodax's family patents as well as insights into ongoing legal events on those patents.
Istodax's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Istodax's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 22, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Istodax Generic API suppliers:
Romidepsin is the generic name for the brand Istodax. 1 company has already filed for the generic of Istodax. Check out the entire list of companies who have already received approval for Istodax's generic
How can I launch a generic of Istodax before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Istodax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Istodax'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 Istodax -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/vial | 05 Nov, 2013 | 1 | 12 Oct, 2021 | 22 Aug, 2021 | Extinguished |
About Istodax
Istodax is a drug owned by Bristol-Myers Squibb Co. Istodax uses Romidepsin as an active ingredient. Istodax was launched by Bristol-Myers in 2009.
Approval Date:
Istodax was approved by FDA for market use on 05 November, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Istodax is 05 November, 2009, its NCE-1 date is estimated to be 05 November, 2013.
Active Ingredient:
Istodax uses Romidepsin as the active ingredient. Check out other Drugs and Companies using Romidepsin ingredient
Dosage:
Istodax is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG/VIAL | POWDER | Prescription | INTRAVENOUS |