Clofarabine Patent Expiration

Clofarabine is Used for treating pediatric patients aged 1 to 21 years with relapsed or refractory acute lymphoblastic leukemia. It was first introduced by Genzyme Corp in its drug Clolar on Dec 28, 2004. 12 different companies have introduced drugs containing Clofarabine.


Clofarabine Patents

Given below is the list of patents protecting Clofarabine, 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
Clolar US5661136

(Pediatric)

2-halo-2'-fluoro ARA adenosines as antinoplastic agents Jul 14, 2018

(Expired)

Genzyme
Clolar US5661136 2-halo-2'-fluoro ARA adenosines as antinoplastic agents Jan 14, 2018

(Expired)

Genzyme



Clofarabine's Family Patents

Family Patents

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Clofarabine Generic API Manufacturers

Several generic applications have been filed for Clofarabine. The first generic version for Clofarabine was by Abon Pharmaceuticals Llc and was approved on May 9, 2017. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Oct 3, 2022.

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


1. ABON PHARMS LLC

Abon Pharmaceuticals Llc has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Abon Pharms Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Prescription INTRAVENOUS AP May 9, 2017





2. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Prescription INTRAVENOUS AP Feb 22, 2019





3. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Prescription INTRAVENOUS AP Nov 6, 2017


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Piscataway Amneal Pharmaceuticals, LLC
Branchburg Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





4. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Prescription INTRAVENOUS AP Nov 6, 2017





5. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Clofarabine. 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
20MG/20ML (1MG/ML)

solution Discontinued INTRAVENOUS N/A Oct 3, 2022


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
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited





6. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Prescription INTRAVENOUS AP Oct 31, 2018





7. HOSPIRA

Hospira Inc has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Discontinued INTRAVENOUS N/A Dec 27, 2018


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Rocky Mount Hospira, Inc.
Clayton Hospira, Inc.
Morgan Hill Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
Lake Forest Hospira Inc
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





8. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Prescription INTRAVENOUS AP Oct 23, 2020





9. MSN

Msn Laboratories Private Ltd has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Prescription INTRAVENOUS AP Dec 6, 2017


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Yadadri Bhuvanagiri District MSN Organics Private Limited
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Sangareddy MSN Laboratories Private Ltd.
Rangareddy District MSN Laboratories Private Limited
Isnapur MSN Laboratories Private Limited, Unit-II
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Sangareddy MSN Laboratories Private Limited, R&D Center
Sangareddy MSN Pharmachem Private Limited
Kamareddy MSN Life Sciences Private Limited
United States
Piscataway MSN PHARMACEUTICALS INC





10. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Prescription INTRAVENOUS AP Nov 6, 2017





11. NOVAST LABS

Novast Laboratories Ltd has filed for 1 generic for Clofarabine. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG/20ML (1MG/ML)

solution Discontinued INTRAVENOUS N/A Sep 14, 2018