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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
Drug Prices:see low prices

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
Fresenius Kabi Oncol
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078811-002Jun 10, 2010RXNo
Mylan Labs Ltd
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)200979-002Aug 8, 2012RXNo
Sun Pharma Global
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078818-001Aug 7, 2009RXYes
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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, 20055,290,961*PED<disabled>
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-001Aug 9, 20025,290,961*PED<disabled>
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-001Jan 31, 20055,290,961*PED<disabled>
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International Patent Family for Ingredient: oxaliplatin

Country Document Number Estimated Expiration
JapanH06329692<disabled in preview>
Canada2196922<disabled in preview>
South Korea100365171<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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.

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