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Last Updated: December 9, 2019

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. Ten 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 EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for 021660
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 68817-134-50 1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) > 20 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 021660
Tradename Dosage Ingredient NDA Submissiondate
ABRAXANE FOR SUSPENSION;IV (INFUSION) paclitaxel 021660 2015-12-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;IV (INFUSION)Strength100MG/VIAL
Approval Date:Jan 7, 2005TE: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:  Start TrialPatent Expiration:Feb 21, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PANCREATIC CANCER
Patent:  Start TrialPatent Expiration:Oct 27, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF BREAST CANCER

Expired US Patents for NDA 021660

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

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