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Oxaliplatin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for oxaliplatin?

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, Cipla Ltd, Gland Pharma Ltd, Mylan Labs Ltd, Sanofi Aventis Us, Teva Pharms, and Jiangsu Hengrui Med, and is included in twenty-two NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has five patent family members in four countries.

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

Summary for Generic Name: oxaliplatin

Tradenames:2
Patents:2
Applicants:15
NDAs:22
Drug Master File Entries: see list26
Suppliers / Packagers: see list17
Clinical Trials: see list496
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:oxaliplatin at DailyMed

Pharmacology for Ingredient: oxaliplatin

Tentative approvals for OXALIPLATIN

Applicant Application No. Form Dosage
► Subscribe► SubscribeINJECTABLE; INJECTION5MG/ML
► Subscribe► SubscribeINJECTABLE; INJECTION5MG/ML
► Subscribe► SubscribeINJECTABLE; IV (INFUSION)200MG/40ML
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078812-001Aug 7, 2009DISCNNoNo► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-002Aug 9, 2002DISCNYesNo5,420,319*PED► SubscribeY► Subscribe
Sun Pharma Global
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078818-002Aug 7, 2009RXNoYes► Subscribe► Subscribe
Sandoz
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078817-001Jan 24, 2011RXNoNo► Subscribe► Subscribe
Mylan Labs Ltd
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)091358-001Aug 7, 2012RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: oxaliplatin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-003Nov 17, 20065,338,874*PED► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-002Jan 31, 20055,338,874*PED► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-001Aug 9, 20025,290,961*PED► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-001Jan 31, 20055,716,988*PED► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-002Jan 31, 20055,420,319*PED► Subscribe
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International Patent Family for Ingredient: oxaliplatin

Country Document Number Estimated Expiration
Japan3025602► Subscribe
European Patent Office0625523► Subscribe
JapanH06329692► Subscribe
Spain2167328► Subscribe
Germany69331048► Subscribe
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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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