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
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 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 |
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 |
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. 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 |
5. 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 |
6. 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 |
7. 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 |
8. 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 |
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 |