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Last Updated: July 20, 2024

Ondansetron - Generic Drug Details


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

Ondansetron is the generic ingredient in nine branded drugs marketed by Aquestive, Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Pharms Ltd, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Steriscience, Sun Pharm Inds (in), Wockhardt, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Dr Reddys Labs Ltd, Hikma Intl Pharms, and Natco Pharma Ltd, and is included in eighty-five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ondansetron has eighteen patent family members in fourteen countries.

There are twenty-eight drug master file entries for ondansetron. Thirty-five suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for ondansetron

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Drug Sales Revenue Trends for ondansetron

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Recent Clinical Trials for ondansetron

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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Adwia Pharma, EgyptPhase 3
Purdue UniversityPhase 4

See all ondansetron clinical trials

Generic filers with tentative approvals for ONDANSETRON
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 2MG BASE/MLINJECTABLE;INJECTION
⤷  Sign Up⤷  Sign UpEQ 2MG BASE/MLINJECTABLE;INJECTION
⤷  Sign Up⤷  Sign Up8MGTABLET, ORALLY DISINTEGRATING;ORAL

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 ondansetron
Medical Subject Heading (MeSH) Categories for ondansetron

US Patents and Regulatory Information for ondansetron

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avet Lifesciences ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 090424-001 Apr 16, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aquestive ZUPLENZ ondansetron FILM;ORAL 022524-001 Jul 2, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Dr Reddys Labs Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076183-004 Dec 26, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride SOLUTION;ORAL 077009-001 Nov 30, 2007 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078139-002 Jun 25, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ondansetron

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
>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.