Totect is a drug owned by Clinigen Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 13, 2020. Details of Totect'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). | |||
| US6727253 | Treatment of accidental extravasation of anthracyclines |
Mar, 2020
(5 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 Totect's patents.
Latest Legal Activities on Totect's Patents
Given below is the list of recent legal activities going on the following patents of Totect.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail-Petition Decision - Dismissed
Critical | 05 Oct, 2016 | US6727253 |
| Petition Decision - Dismissed
Critical | 05 Oct, 2016 | US6727253 |
| Petition Entered | 04 Apr, 2016 | US6727253 |
| Change in Power of Attorney (May Include Associate POA)
Critical | 17 Sep, 2013 | US6727253 |
| Correspondence Address Change
Critical | 16 Sep, 2013 | US6727253 |
| Recordation of Patent Grant Mailed
Critical | 27 Apr, 2004 | US6727253 |
| Patent Issue Date Used in PTA Calculation
Critical | 27 Apr, 2004 | US6727253 |
| Issue Notification Mailed
Critical | 08 Apr, 2004 | US6727253 |
| Receipt into Pubs | 18 Mar, 2004 | US6727253 |
| Application Is Considered Ready for Issue
Critical | 17 Mar, 2004 | US6727253 |
FDA has granted several exclusivities to Totect. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Totect, 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
Totect.
Exclusivity Information
Totect holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Totect's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Sep 06, 2014 |
US patents provide insights into the exclusivity only within the United States, but
Totect 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 Totect's family patents as well as insights into
ongoing legal events
on those patents.
Totect's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Totect's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 13, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Totect Generic API suppliers:
Dexrazoxane Hydrochloride is the generic name for the brand Totect. 4 different companies have already filed for the generic of Totect, with Eugia Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Totect's generic
About Totect
Totect is a drug owned by Clinigen Inc. It is used for managing extravasation caused by IV anthracycline chemotherapy. Totect uses Dexrazoxane Hydrochloride as an active ingredient. Totect was launched by Clinigen in 2007.
Approval Date:
Totect was approved by FDA for market use on 06 September, 2007.
Active Ingredient:
Totect uses Dexrazoxane Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dexrazoxane Hydrochloride ingredient
Treatment:
Totect is used for managing extravasation caused by IV anthracycline chemotherapy.
Dosage:
Totect is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |