Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Johnson and Johnson
Dow
Merck
Boehringer Ingelheim

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020449

See Plans and Pricing

« Back to Dashboard

NDA 020449 describes TAXOTERE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from two suppliers. Additional details are available on the TAXOTERE profile page.

The generic ingredient in TAXOTERE is docetaxel. There are forty-one drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 020449
Tradename:TAXOTERE
Applicant:Sanofi Aventis Us
Ingredient:docetaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020449
Physiological EffectMicrotubule Inhibition
Suppliers and Packaging for NDA: 020449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAXOTERE docetaxel INJECTABLE;INJECTION 020449 NDA Sanofi-Aventis U.S. LLC 0075-8003 0075-8003-01 1 VIAL, GLASS in 1 CARTON (0075-8003-01) > 1 mL in 1 VIAL, GLASS
TAXOTERE docetaxel INJECTABLE;INJECTION 020449 NDA Sanofi-Aventis U.S. LLC 0075-8004 0075-8004-04 1 VIAL, GLASS in 1 CARTON (0075-8004-04) > 4 mL in 1 VIAL, GLASS
Paragraph IV (Patent) Challenges for 020449
Tradename Dosage Ingredient NDA Submissiondate
TAXOTERE INJECTABLE;INJECTION docetaxel 020449 2009-06-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 14, 1996TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Aug 3, 2010TE:APRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/4ML (20MG/ML)
Approval Date:Aug 2, 2010TE:APRLD:Yes

Expired US Patents for NDA 020449

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Johnson and Johnson
Colorcon
McKinsey
Baxter

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 verifification 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.