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Generated: July 19, 2018

DrugPatentWatch Database Preview

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 one supplier. There are twelve 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:	12
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	FOR SUSPENSION;IV (INFUSION)	021660	NDA	Abraxis BioScience, LLC	68817-134	N	68817-134-50

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;IV (INFUSION)			Strength	100MG/VIAL
Approval Date:	Jan 7, 2005	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 6, 2020
Regulatory Exclusivity Use:	TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS AS FIRST-LINE TREATMENT, IN COMBINATION WITH GEMCITABINE.
Patent:	➤ Sign Up	Patent Expiration:	Feb 21, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PANCREATIC CANCER
Patent:	➤ Sign Up	Patent Expiration:	Oct 27, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF BREAST CANCER

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	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005	➤ Sign Up	➤ Sign Up
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005	➤ Sign Up	➤ Sign Up
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005	➤ Sign Up	➤ Sign Up
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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