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Last Updated: March 18, 2024

ONDANSETRON - Generic Drug Details


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What are the generic drug sources for ondansetron and what is the scope of patent protection?

Ondansetron is the generic ingredient in nine branded drugs marketed by Aquestive, Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Generics, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Accord Hlthcare, 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, Am Regent, 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-four 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
Genuine Research Center, EgyptPhase 3
Adwia Pharma, EgyptPhase 3

See all ONDANSETRON clinical trials

Generic filers with tentative approvals for ONDANSETRON
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a Trial8MGTABLET, 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
Teva ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 076876-001 Nov 22, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078139-001 Jun 25, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Intl Pharms ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077545-001 Sep 6, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Steriscience ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 078257-001 Apr 23, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078050-002 Aug 13, 2007 AB 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 ONDANSETRON

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

International Patents for ONDANSETRON

Country Patent Number Title Estimated Expiration
Hungary E038022 ⤷  Try a Trial
New Zealand 575900 NON-MUCOADHESIVE FILM DOSAGE FORMS ⤷  Try a Trial
European Patent Office 2248519 Formes galéniques de film non mucoadhésifs (Non-mucoadhesive film dosage forms) ⤷  Try a Trial
Canada 2664986 FORMES PHARMACEUTIQUES A BASE DE FILM NON MUCO-ADHESIF (NON-MUCOADHESIVE FILM DOSAGE FORMS) ⤷  Try a Trial
Poland 2248519 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated 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.