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Last Updated: September 29, 2020

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Fludarabine phosphate - Generic Drug Details

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What are the generic drug 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, 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

SponsorPhase
Sumithira VasuPhase 1
Northwestern UniversityPhase 1
Agios PharmaceuticalsPhase 1

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
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

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   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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Serving leading biopharmaceutical companies globally:

Medtronic
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Boehringer Ingelheim
Harvard Business School

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