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Last Updated: September 27, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205934

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NDA 205934 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis Llc, Amneal, Apotex Inc, Cipla, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Pfizer Labs, Sandoz, Shilpa Medicare Ltd, Teikoku Pharma, Teva Pharms Usa, and Sun Pharma Global, and is included in twenty-one NDAs. It is available from twelve suppliers. There are three patents protecting this drug. Additional details are available on the DOCETAXEL profile page.

The generic ingredient in DOCETAXEL is docetaxel. There are forty-one drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 205934
Tradename:DOCETAXEL
Applicant:Teikoku Pharma
Ingredient:docetaxel
Patents:3
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Dec 22, 2015TE:APRLD:No
Patent:  Start TrialPatent Expiration:Sep 30, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION
Patent:  Start TrialPatent Expiration:Sep 30, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 30, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ADVANCED GASTRIC ADENOCARCINOMA IN COMBINATION WITH CISPLATIN AND FLUOROURACIL IN PATIENTS THAT HAVE NOT RECEIVED PRIOR CHEMOTHERAPY

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