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Last Updated: November 22, 2024

FLUDARABINE PHOSPHATE Drug Patent Profile


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Which patents cover Fludarabine Phosphate, and what generic alternatives are available?

Fludarabine Phosphate is a drug marketed by Actavis Llc, Actavis Totowa, Areva Pharms, Fresenius Kabi Usa, Hikma, Hospira, Rising, Sagent Pharms Inc, and Sandoz. and is included in eleven NDAs.

The generic ingredient in FLUDARABINE PHOSPHATE is fludarabine phosphate. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fludarabine phosphate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fludarabine Phosphate

A generic version of FLUDARABINE PHOSPHATE was approved as fludarabine phosphate by HIKMA on August 28th, 2003.

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Drug patent expirations by year for FLUDARABINE PHOSPHATE
Recent Clinical Trials for FLUDARABINE PHOSPHATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fred Hutchinson Cancer CenterPhase 2
National Cord Blood NetworkPhase 2
University Cancer Research Fund at Lineberger Comprehensive Cancer CenterPhase 1/Phase 2

See all FLUDARABINE PHOSPHATE clinical trials

Pharmacology for FLUDARABINE PHOSPHATE
Anatomical Therapeutic Chemical (ATC) Classes for FLUDARABINE PHOSPHATE

US Patents and Regulatory Information for FLUDARABINE PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Llc FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 203738-001 Feb 28, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 077790-001 Apr 6, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 078393-001 Oct 15, 2007 AP1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 200647-001 Dec 21, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Totowa FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 078610-001 Feb 11, 2009 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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