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Last Updated: March 19, 2024

Fludarabine phosphate - Generic Drug Details


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What are the generic sources for fludarabine phosphate and what is the scope of patent protection?

Fludarabine phosphate is the generic ingredient in three branded drugs marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Areva Pharms, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, and Sanofi Aventis Us, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for fludarabine phosphate. Five suppliers are listed for this compound.

Summary for fludarabine phosphate
Recent Clinical Trials for fludarabine phosphate

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

SponsorPhase
James Michael MartinPhase 1
InvectysPhase 1/Phase 2
Dana-Farber Cancer InstitutePhase 2

See all fludarabine phosphate clinical trials

Pharmacology 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
Mylan Labs Ltd FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 200648-001 Oct 16, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 200647-001 Dec 21, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 077790-001 Apr 6, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sagent Pharms Inc FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 076661-001 Apr 28, 2004 AP1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Llc FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 203738-001 Feb 28, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz FLUDARABINE PHOSPHATE fludarabine phosphate INJECTABLE;INJECTION 022137-001 Sep 21, 2007 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genzyme Corp FLUDARA fludarabine phosphate INJECTABLE;INJECTION 020038-001 Apr 18, 1991 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for fludarabine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme Corp FLUDARA fludarabine phosphate INJECTABLE;INJECTION 020038-001 Apr 18, 1991 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us OFORTA fludarabine phosphate TABLET;ORAL 022273-001 Dec 18, 2008 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us OFORTA fludarabine phosphate TABLET;ORAL 022273-001 Dec 18, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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