Last Updated: August 2, 2026

FLUDARA Drug Patent Profile

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When do Fludara patents expire, and when can generic versions of Fludara launch?

Fludara is a drug marketed by Genzyme Corp, Actavis Llc, Actavis Totowa, Areva Pharms, Caplin One Labs, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Rising, and Sagent Pharms Inc. and is included in twelve NDAs.

The generic ingredient in FLUDARA 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 Fludara

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

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Summary for FLUDARA

US Patents:	0
Applicants:	11
NDAs:	12

US Patents and Regulatory Information for FLUDARA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme Corp	FLUDARA	fludarabine phosphate	INJECTABLE;INJECTION	020038-001	Apr 18, 1991		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Fresenius Kabi Usa	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	078393-001	Oct 15, 2007	AP1	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Areva Pharms	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	090724-001	Sep 27, 2010	AP1	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sagent Pharms Inc	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	076661-001	Apr 28, 2004	AP1	RX	No	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

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