Last Updated: September 28, 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, Hisun Pharm Hangzhou, Hospira, Rising, and Sagent Pharms Inc. and is included in thirteen NDAs.

The generic ingredient in FLUDARA is fludarabine phosphate. Six 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:	12
NDAs:	13

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
Rising	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	200648-001	Oct 16, 2012		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Fresenius Kabi Usa	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	078544-001	Oct 15, 2007	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Actavis Llc	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	203738-001	Feb 28, 2017		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Actavis Totowa	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	078610-001	Feb 11, 2009	AP	RX	No	Yes	⤷ 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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