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Last Updated: March 19, 2024

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, Actavis Totowa, Am Regent, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hospira Inc, Hospira Worldwide, Kindos, Mylan Labs Ltd, Novast Labs, Qilu Pharm Hainan, Sandoz, Sun Pharm, and Teva Pharms, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for oxaliplatin

See drug prices for oxaliplatin

Recent Clinical Trials for oxaliplatin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Institut Cancerologie de l'OuestPhase 3
Grünenthal GmbHPhase 3
Mansoura UniversityPhase 1/Phase 2

See all oxaliplatin clinical trials

Generic filers with tentative approvals for OXALIPLATIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial5MG/MLINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a Trial100MG/20ML (5MG/ML)INJECTABLE;INTRAVENOUS
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
ELOXATIN Injection oxaliplatin 5 mg/mL, 40 mL vials 021759 1 2007-07-16
ELOXATIN Injection oxaliplatin 5 mg/mL, 10 mL and 20 mL vials 021759 11 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
Sun Pharm OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 202922-002 Apr 8, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kindos OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 217348-002 Jan 11, 2024 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 207325-001 Feb 10, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Qilu Pharm Hainan OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 204368-001 Jun 7, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 204880-002 Mar 5, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis OXALIPLATIN oxaliplatin INJECTABLE;INTRAVENOUS 204880-001 Mar 5, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 021492-002 Aug 9, 2002 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021492-001 Aug 9, 2002 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-003 Nov 17, 2006 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-001 Jan 31, 2005 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-003 Nov 17, 2006 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-003 Nov 17, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.