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, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Rising, 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

US Patents:	0
Tradenames:	3
Applicants:	12
NDAs:	13
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	484
Patent Applications:	4,763
What excipients (inactive ingredients) are in FLUDARABINE PHOSPHATE?	FLUDARABINE PHOSPHATE excipients list
DailyMed Link:	FLUDARABINE PHOSPHATE at DailyMed

Recent Clinical Trials for FLUDARABINE PHOSPHATE

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

Sponsor	Phase
National Cord Blood Network	Phase 2
Fred Hutchinson Cancer Center	Phase 2
University Cancer Research Fund at Lineberger Comprehensive Cancer Center	Phase 1/Phase 2

See all FLUDARABINE PHOSPHATE clinical trials

Pharmacology for FLUDARABINE PHOSPHATE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FLUDARABINE PHOSPHATE

L01BB	Purine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for FLUDARABINE PHOSPHATE

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Glossary

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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
Hospira	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	077790-001	Apr 6, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms Inc	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	076661-001	Apr 28, 2004	AP1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	OFORTA	fludarabine phosphate	TABLET;ORAL	022273-001	Dec 18, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	076349-001	Aug 28, 2003	AP	RX	No	No	⤷ 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

Expired US Patents for FLUDARABINE PHOSPHATE

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

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