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Generated: October 21, 2017

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Oxaliplatin - Generic Drug Details

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What are the generic drug sources for oxaliplatin and what is the scope of oxaliplatin freedom to operate?

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, Sanja Pharms Co, Mylan Labs Ltd, Sanofi Aventis Us, Teva Pharms, Jiangsu Hengrui Med, Accord Hlthcare, and Luitpold Pharms Inc, and is included in twenty-six NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxaliplatin has five patent family members in four countries.

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

Summary for Generic Name: oxaliplatin

US Patents:1
Tradenames:2
Applicants:18
NDAs:26
Drug Master File Entries: see list26
Suppliers / Packagers: see list22
Clinical Trials: see list1,271
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. Strength Dosage Form
u► Subscribe5MG/MLINJECTABLE; INJECTION
u► Subscribe100MG/20ML (5MG/ML)INJECTABLE;IV (INFUSION)
u► Subscribe50MG/10ML (5MG/ML)INJECTABLE;IV (INFUSION)
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Oncol
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078810-001Aug 7, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Jiangsu Hengrui Med
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)203869-002Jun 18, 2014APRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Totowa
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078803-002Aug 8, 2012APRXNoNo► Subscribe► Subscribe► Subscribe
Gland Pharma Ltd
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)207325-001Feb 10, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharma Global
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078818-001Aug 7, 2009APRXNoYes► Subscribe► Subscribe► Subscribe
Teva Pharms
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)022160-001Aug 7, 2009APRXYesYes► Subscribe► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-002Jan 31, 2005APRXYesYes► Subscribe► SubscribeY► Subscribe
Fresenius Kabi Usa
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)090030-001Jan 31, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Oncol
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078811-002Jun 10, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION)078819-001Jun 2, 2010APRXNoNo► Subscribe► 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)021759-002Jan 31, 2005► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-002Aug 9, 2002► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-001Aug 9, 2002► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-001Aug 9, 2002► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-001Jan 31, 2005► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-002Jan 31, 2005► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-001Aug 9, 2002► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-003Nov 17, 2006► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021492-002Aug 9, 2002► Subscribe► Subscribe
Sanofi Aventis Us
ELOXATIN
oxaliplatin
INJECTABLE;IV (INFUSION)021759-001Jan 31, 2005► Subscribe► Subscribe
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International Patent Family for Ingredient: oxaliplatin

Country Document Number Estimated Expiration
Germany69331048► Subscribe
JapanH06329692► Subscribe
Japan3025602► Subscribe
European Patent Office0625523► Subscribe
Spain2167328► 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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Serving leading biopharmaceutical companies globally:

Julphar
Healthtrust
Baxter
Chubb
Medtronic
McKinsey
Covington
Chinese Patent Office
Federal Trade Commission
Boehringer Ingelheim

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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