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Last Updated: February 19, 2020

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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 patent protection?

Oxaliplatin is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Actavis Llc, Actavis Totowa, Am Regent, Cipla, Eugia Pharma, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira Inc, Hospira Worldwide, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Qilu, Sandoz, Sandoz Inc, Sun Pharm, and Teva Pharms, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for oxaliplatin

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Recent Clinical Trials for oxaliplatin

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SponsorPhase
Zhongshan Hospital Xiamen UniversityPhase 1/Phase 2
Yanhong DengPhase 3
IpsenPhase 3

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Recent Litigation for oxaliplatin

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District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. SANDOZ, INC.2007-06-14

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Generic filers with tentative approvals for OXALIPLATIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MG/MLINJECTABLE; INJECTION
  Start Trial  Start Trial100MG/20ML (5MG/ML)INJECTABLE;INTRAVENOUS
  Start Trial  Start Trial50MG/10ML (5MG/ML)INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for oxaliplatin
Paragraph IV (Patent) Challenges for OXALIPLATIN
Tradename Dosage Ingredient NDA Submissiondate
ELOXATIN INJECTABLE;INTRAVENOUS oxaliplatin 021759 2007-07-16
ELOXATIN INJECTABLE;INTRAVENOUS oxaliplatin 021759 2007-02-09
ELOXATIN INJECTABLE;INTRAVENOUS oxaliplatin 021492 2007-02-09

US Patents and Regulatory Information for oxaliplatin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jiangsu Hengrui Med OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 203869-001 Jun 18, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 078819-002 Jun 2, 2010 AP RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 207474-003 Mar 21, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Sandoz OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 090849-001 Apr 28, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira Worldwide OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 078813-001 Aug 7, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for oxaliplatin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-002 Jan 31, 2005   Start Trial   Start Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-003 Nov 17, 2006   Start Trial   Start Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021492-001 Aug 9, 2002   Start Trial   Start Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-001 Jan 31, 2005   Start Trial   Start Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021492-002 Aug 9, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
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McKinsey

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.