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Oxaliplatin - Generic Drug Details

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Oxaliplatin is the generic ingredient in two branded drugs marketed by Actavis Totowa, Fresenius Kabi Oncol, Sandoz Inc, Hospira Worldwide, Hospira Inc, Qilu Pharm Co Ltd, Sandoz, Sun Pharma Global, Fresenius Kabi Usa, Mylan Labs Ltd, Sanofi Aventis Us, Teva Pharms, and Jiangsu Hengrui Med, and is included in nineteen NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-four patent family members in fifteen countries.

There are twenty-six drug master file entries for oxaliplatin. Thirteen suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: oxaliplatin

Tradenames:2
Patents:2
Applicants:13
NDAs:19
Drug Master File Entries: see list26
Suppliers / Packaging: see list13
Formulation / Manufacturing:see details

Pharmacology for Ingredient: oxaliplatin

Tentative approvals for OXALIPLATIN

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION5MG/ML
<disabled><disabled>INJECTABLE; INJECTION5MG/ML
<disabled><disabled>INJECTABLE; IV (INFUSION)200MG/40ML

Clinical Trials for: oxaliplatin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira Worldwide
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078813-002Aug 7, 2009RXNo<disabled><disabled>
Hospira Inc
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078815-001Sep 30, 2009RXNo<disabled><disabled>
Teva Pharms
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)022160-002Aug 7, 2009RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: oxaliplatin

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-002Jan 31, 20055,338,874*PED<disabled>
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-003Nov 17, 20065,716,988*PED<disabled>
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-002Jan 31, 20055,290,961*PED<disabled>
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International Patent Family for Ingredient: oxaliplatin

Country Document Number Estimated Expiration
Australia2989695<disabled in preview>
Australia731981<disabled in preview>
Czech Republic286714<disabled in preview>
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