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

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021759

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NDA 021759 describes ELOXATIN, which is a drug marketed by Sanofi Aventis Us and is included in two NDAs. It is available from one supplier. Additional details are available on the ELOXATIN profile page.

The generic ingredient in ELOXATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
Summary for 021759
Tradename:ELOXATIN
Applicant:Sanofi Aventis Us
Ingredient:oxaliplatin
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021759
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759 NDA AUTHORIZED GENERIC Winthrop U.S. 0955-1725 0955-1725-10 1 VIAL, GLASS in 1 CARTON (0955-1725-10) > 10 mL in 1 VIAL, GLASS
ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759 NDA AUTHORIZED GENERIC Winthrop U.S. 0955-1727 0955-1727-20 1 VIAL, GLASS in 1 CARTON (0955-1727-20) > 20 mL in 1 VIAL, GLASS
Paragraph IV (Patent) Challenges for 021759
Tradename Dosage Ingredient NDA Submissiondate
ELOXATIN INJECTABLE;INTRAVENOUS oxaliplatin 021759 2007-07-16
ELOXATIN INJECTABLE;INTRAVENOUS oxaliplatin 021759 2007-02-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/10ML (5MG/ML)
Approval Date:Jan 31, 2005TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/20ML (5MG/ML)
Approval Date:Jan 31, 2005TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 17, 2006TE:RLD:Yes

Expired US Patents for NDA 021759

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-002 Jan 31, 2005   Start Trial   Start Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-001 Jan 31, 2005   Start Trial   Start Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-001 Jan 31, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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