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Details for Generic Name: oxaliplatin

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

There are twenty-four drug master file entries for oxaliplatin. Five suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: oxaliplatin

Drug Master File Entries: see list24
Suppliers: see list5
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

Oxaliplatin in Treating Patients With Metastatic Breast Cancer
Status: Active, not recruiting Condition: Stage IV Breast Cancer

Study of S-1 and Oxaliplatin (SOX) Versus Capecitabine and Oxaliplatin (COX) in Patients With Advanced Colorectal Cancer
Status: Completed Condition: Colorectal Cancer

Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
Status: Terminated Condition: Adenocarcinoma of the Pancreas; Adenocarcinoma of the Stomach; BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Ovarian Mucinous Cystadenocarcinoma; Recurrent Breast Cancer; Recurrent Colon Cancer; Recurrent Gastric Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Pancreatic Cancer; Recurrent Rectal Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Stage IV Colon Cancer; Stage IV Gastric Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Stage IV Pancreatic Cancer; Stage IV Rectal Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Safety of ON 01910.Na and Irinotecan or ON 01910.Na and Oxaliplatin in Patients With Hepatoma
Status: Completed Condition: Hepatoma; Advanced Solid Tumor

Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab
Status: Recruiting Condition: Advanced Cancers

Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL
Status: Completed Condition: Leukemia

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See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jiangsu Hengrui Med
INJECTABLE;IV (INFUSION)203869-002Jun 18, 2014RXNo<disabled><disabled>
Hospira Worldwide
INJECTABLE;IV (INFUSION)078813-001Aug 7, 2009RXNo<disabled><disabled>
Teva Pharms
INJECTABLE;IV (INFUSION)022160-002Aug 7, 2009RXYes<disabled><disabled>
Sanofi Aventis Us
INJECTABLE;IV (INFUSION)021759-003Nov 17, 2006RXYes5,716,988*PED<disabled>Y<disabled>
Sanofi Aventis Us
INJECTABLE;IV (INFUSION)021759-001Jan 31, 2005RXYes5,716,988*PED<disabled>Y<disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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