Generated: December 18, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 021660
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, which is a drug marketed by Abraxis Bioscience and is included in one NDA. It is available from one supplier. There are thirteen 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-seven 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
|Formulation / Manufacturing:||see details|
Pharmacology for NDA: 021660
Medical Subject Heading (MeSH) Categories for 021660
Suppliers and Packaging for NDA: 021660
||National Drug Code
||FOR SUSPENSION;IV (INFUSION)
||Abraxis BioScience, LLC
||1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) > 20 mL in 1 VIAL, SINGLE-USE
|Complete Access Available with Subscription
Summary 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, 2016
|Regulatory Exclusivity Use:||FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARACINOMA OF THE PANCREAS, IN COMBINATION WITH GEMCITABINE|
|Regulatory Exclusivity Expiration:||Sep 6, 2020
|Regulatory Exclusivity Use:||ORPHAN DRUG EXCLUSIVITY|
|Patent:||► Subscribe||Patent Expiration:||Feb 21, 2026||Product Flag?||Substance Flag?||Delist Request?|
|Patented Use:||TREATMENT OF PANCREATIC CANCER|
Expired Orange Book Patents for NDA: 021660
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