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Fludarabine phosphateis the generic ingredient in three branded drugs marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Areva Pharms, Custopharm Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, and Sanofi Aventis Us, and is included in thirteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.
Fludarabine phosphate has thirty-seven patent family members in thirty countries.
There are ten drug master file entries for fludarabine phosphate. Six suppliers are listed for this compound.
Summary for fludarabine phosphate
Recent Clinical Trials for fludarabine phosphate
Identify potential brand extensions & 505(b)(2) entrants
|Sumithira Vasu||Phase 1|
|Northwestern University||Phase 1|
|Agios Pharmaceuticals||Phase 1|
Pharmacology for fludarabine phosphate
|Drug Class||Nucleoside Metabolic Inhibitor |
|Mechanism of Action||Nucleic Acid Synthesis Inhibitors |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Sagent Pharms Inc||FLUDARABINE PHOSPHATE||fludarabine phosphate||INJECTABLE;INJECTION||076661-001||Apr 28, 2004||AP||RX||No||No||Start Trial||Start Trial||Start Trial|
|Hospira||FLUDARABINE PHOSPHATE||fludarabine phosphate||INJECTABLE;INJECTION||077790-001||Apr 6, 2007||AP||RX||No||Yes||Start Trial||Start Trial||Start Trial|
|Mylan Labs Ltd||FLUDARABINE PHOSPHATE||fludarabine phosphate||INJECTABLE;INJECTION||200647-001||Dec 21, 2011||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Genzyme Corp||FLUDARA||fludarabine phosphate||INJECTABLE;INJECTION||020038-001||Apr 18, 1991||DISCN||Yes||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Genzyme Corp||FLUDARA||fludarabine phosphate||INJECTABLE;INJECTION||020038-001||Apr 18, 1991||Start Trial||Start Trial|
|Sanofi Aventis Us||OFORTA||fludarabine phosphate||TABLET;ORAL||022273-001||Dec 18, 2008||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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