Details for New Drug Application (NDA): 021660

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NDA 021660 describes ABRAXANE, which is a drug marketed by Abraxis Bioscience and is included in one NDA. It is available from three suppliers. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ABRAXANE profile page.

The generic ingredient in ABRAXANE is paclitaxel. There are sixty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

Summary for 021660

Tradename:	ABRAXANE
Applicant:	Abraxis Bioscience
Ingredient:	paclitaxel
Patents:	11
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021660

Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 021660

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Suppliers and Packaging for NDA: 021660

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660	NDA AUTHORIZED GENERIC	TWi Pharmaceuticals, Inc.	24979-710	24979-710-51	1 VIAL, SINGLE-USE in 1 CARTON (24979-710-51) > 20 mL in 1 VIAL, SINGLE-USE
ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660	NDA AUTHORIZED GENERIC	Apotex Corp.	60505-6230	60505-6230-4	1 VIAL, SINGLE-USE in 1 CARTON (60505-6230-4) > 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	Jan 7, 2005	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 6, 2022
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Regulatory Exclusivity Expiration:	Jun 6, 2023
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	See Plans and Pricing	Patent Expiration:	Aug 21, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021660

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	See Plans and Pricing	See Plans and Pricing
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	See Plans and Pricing	See Plans and Pricing
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	See Plans and Pricing	See Plans and Pricing
Abraxis Bioscience	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.