Dexrazoxane Hydrochloride Patent Expiration

Dexrazoxane Hydrochloride is Used for managing extravasation caused by IV anthracycline chemotherapy. It was first introduced by Pfizer Inc in its drug Zinecard on May 26, 1995. Another drug containing Dexrazoxane Hydrochloride is Totect. 5 different companies have introduced drugs containing Dexrazoxane Hydrochloride.


Dexrazoxane Hydrochloride Patents

Given below is the list of patents protecting Dexrazoxane Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Totect US6727253 Treatment of accidental extravasation of anthracyclines Mar 13, 2020

(Expired)

Clinigen



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 Dexrazoxane Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Dexrazoxane Hydrochloride.

Activity Date Patent Number
Patent litigations
Mail-Petition Decision - Dismissed 05 Oct, 2016 US6727253
Petition Decision - Dismissed 05 Oct, 2016 US6727253
Petition Entered 04 Apr, 2016 US6727253
Change in Power of Attorney (May Include Associate POA) 17 Sep, 2013 US6727253
Correspondence Address Change 16 Sep, 2013 US6727253
Recordation of Patent Grant Mailed 27 Apr, 2004 US6727253
Patent Issue Date Used in PTA Calculation 27 Apr, 2004 US6727253
Issue Notification Mailed 08 Apr, 2004 US6727253
Receipt into Pubs 18 Mar, 2004 US6727253
Application Is Considered Ready for Issue 17 Mar, 2004 US6727253


Dexrazoxane Hydrochloride's Family Patents

Family Patents

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Dexrazoxane Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Dexrazoxane Hydrochloride. The first generic version for Dexrazoxane Hydrochloride was by Hikma Pharmaceuticals Usa Inc and was approved on Sep 28, 2004. And the latest generic version is by Gland Pharma Ltd and was approved on Dec 16, 2019.

Given below is the list of companies who have filed for Dexrazoxane Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 2 different strengths of generic version for Dexrazoxane Hydrochloride. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Oct 19, 2011
EQ 500MG BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Oct 19, 2011


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





2. GLAND

Gland Pharma Ltd has filed for 2 different strengths of generic version for Dexrazoxane Hydrochloride. Given below are the details of the strengths of this generic introduced by Gland.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL

injectable Prescription INJECTION AP Nov 28, 2016
EQ 250MG BASE/VIAL

injectable Prescription INJECTION AP Dec 16, 2019


Manufacturing Plant Locations
New

Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.

Country City Firm Name
India
Visakhapatnam Gland Pharma Limited
Malur Gland Chemicals Pvt Ltd.
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Aurangabad Gland Chemical Private Limited
Sriperumbudur Gland Chemical Private Limited
Hyderabad Gland Pharma Limited
Parawada, Visakhapatnam Gland Pharma Limited





3. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Dexrazoxane Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL

injectable Prescription INJECTION AP Sep 28, 2004
EQ 250MG BASE/VIAL

injectable Prescription INJECTION AP Sep 28, 2004


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC