Fludarabine Phosphate Patent Expiration

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 Fludarabine Phosphate, Oforta. 12 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.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Oforta US7148207 Oral fludara of high-purity formulation with quick release of active ingredient Dec 20, 2022

(Expired)

Sanofi Aventis Us
Oforta US7547776 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% Dec 10, 2018

(Expired)

Sanofi Aventis Us


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Fludarabine Phosphate Generics

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.


1. 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


2. 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


3. RISING

Rising Pharma Holdings Inc has filed for 1 generic 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/VIAL injectable Discontinued INJECTION N/A Oct 16, 2012


4. 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


5. 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


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


7. EXTROVIS

Extrovis Ag has filed for 1 generic for Fludarabine Phosphate. Given below are the details of the strengths of this generic introduced by Extrovis.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/2ML (25MG/ML) injectable Discontinued INJECTION N/A Dec 21, 2011


8. 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


9. 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.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/2ML (25MG/ML) injectable Prescription INJECTION AP1 Apr 28, 2004