Fludarabine Phosphate is Used for treating patients with B-cell chronic lymphocytic leukemia (CLL). It was first introduced by Genzyme Corp in its drug Fludara on Apr 18, 1991. Other drugs containing Fludarabine Phosphate are Oforta, Fludarabine Phosphate. 11 different companies have introduced drugs containing Fludarabine Phosphate.
Fludarabine Phosphate Patents
Given below is the list of patents protecting Fludarabine Phosphate, along
with the drug name that holds that patent and the company name owning that
drug.
Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5%
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Fludarabine Phosphate Generic API Manufacturers
Several generic applications have been filed for Fludarabine Phosphate. The first generic version for Fludarabine Phosphate was by Hikma Pharmaceuticals Usa Inc and was approved on Aug 28, 2003. And the latest generic version is by Actavis Llc and was approved on Feb 28, 2017.
Given below is the list of companies who have filed for
Fludarabine Phosphate generic, along with the locations of their manufacturing plants worldwide.
1. ACTAVIS LLC
Actavis Llc has filed for 1 generic for Fludarabine Phosphate. Given below are the
details of the strengths of this generic introduced by
Actavis Llc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/2ML (25MG/ML)
injectable
Discontinued
INJECTION
N/A
Feb 28, 2017
Manufacturing Plant Locations
New
Actavis Llc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Llc as present at those locations.
Country
City
Firm Name
United States
Edison
Actavis LLC
2. ACTAVIS TOTOWA
Actavis Totowa Llc has filed for 1 generic for Fludarabine Phosphate. Given below are the
details of the strengths of this generic introduced by
Actavis Totowa.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/VIAL
(reference standard)
injectable
Prescription
INJECTION
AP
Feb 11, 2009
Manufacturing Plant Locations
New
Actavis Totowa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Totowa as present at those locations.
Country
City
Firm Name
United States
Totowa
Actavis Totowa LLC
Little Falls
Actavis Totowa LLC
3. AREVA PHARMS
Areva Pharmaceuticals Inc has filed for 1 generic for Fludarabine Phosphate. Given below are the
details of the strengths of this generic introduced by
Areva Pharms.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/2ML (25MG/ML)
injectable
Prescription
INJECTION
AP1
Sep 27, 2010
4. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 2 different strengths of generic version for Fludarabine Phosphate. Given below are the
details of the strengths of this generic introduced by
Fresenius Kabi Usa.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/2ML (25MG/ML)
injectable
Prescription
INJECTION
AP1
Oct 15, 2007
50MG/VIAL
injectable
Prescription
INJECTION
AP
Oct 15, 2007
Manufacturing Plant Locations
New
Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.
Country
City
Firm Name
United States
Bensenville
Fresenius Kabi USA LLC (FK USA)
Skokie
Fresenius Kabi USA LLC
North Andover
Fresenius Kabi USA, LLC
Melrose Park
Fresenius Kabi USA LLC
Melrose Park
Fresenius Kabi USA, LLC
Lake Zurich
Fresenius Kabi USA, LLC
Wilson
Fresenius Kabi USA, LLC
Grand Island
Fresenius Kabi USA, LLC
5. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Fludarabine Phosphate. Given below are the
details of the strengths of this generic introduced by
Hikma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/VIAL
injectable
Prescription
INJECTION
AP
Aug 28, 2003
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
Dayton
Hikma Injectables USA Inc
Cherry Hill
Hikma Pharmaceuticals USA Inc.
Eatontown
Hikma Pharmaceuticals USA, Inc.
Carlsbad
Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt
Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman
Hikma Pharmaceuticals LLC
6. HOSPIRA
Hospira Worldwide, Inc has filed for 1 generic for Fludarabine Phosphate. Given below are the
details of the strengths of this generic introduced by
Hospira.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/VIAL
injectable
Discontinued
INJECTION
N/A
Apr 6, 2007
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
Lake Forest
Hospira Inc
Clayton
Hospira, Inc.
Pleasant Prairie
Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Morgan Hill
Hospira Inc
Mcpherson
Hospira, Inc., A Pfizer Company
Rocky Mount
Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal
Hospira, Ltd.
7. RISING
Rising Pharma Holdings Inc has filed for 2 different strengths of generic version for Fludarabine Phosphate. Given below are the
details of the strengths of this generic introduced by
Rising.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
50MG/2ML (25MG/ML)
injectable
Discontinued
INJECTION
N/A
Dec 21, 2011
50MG/VIAL
injectable
Discontinued
INJECTION
N/A
Oct 16, 2012
Manufacturing Plant Locations
New
Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.
Country
City
Firm Name
United States
Phoenix
Rising Sun Farms Inc
Fort Bragg
Rising Tide Sea Vegetables
Saddle Brook
Rising Pharmaceuticals, Inc.
Decatur
Rising Pharma Holdings, Inc
Livingston
Risingsun Iodine Products Corp.
East Brunswick
Rising Pharma Holding, Inc.
Mount Morris
Rising Creek Bakery LLC
Rising Sun
Rising Sun Veterinary Clinic
Flagstaff
Rising High Enterprises, LLC (DBA RisingHy)
Mexico
Pueblo San Clemente
RISING FARMS SAPI DE CV
India
Ahmedabad
Rising Retina Clinic
8. SAGENT PHARMS INC
Sagent Pharmaceuticals Inc has filed for 1 generic for Fludarabine Phosphate. Given below are the
details of the strengths of this generic introduced by
Sagent Pharms Inc.
