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Chinese Patent Office
Federal Trade Commission
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Covington
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Cerilliant
US Department of Justice
Citi
Accenture
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Ondansetron - Generic Drug Details

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

Ondansetron
is the generic ingredient in nine branded drugs marketed by Midatech Pharma Us, Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Generics, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Novartis Pharms Corp, Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Lannett, Luitpold, Mylan Labs Ltd, Pliva Hrvatska Doo, Qilu Pharm Co Ltd, Sagent Pharms, Sandoz Inc, Sun Pharm Inds (in), West-ward Pharms Int, Wockhardt, Emcure Pharms Ltd, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Apotex, Silarx, Taro, Dr Reddys Labs Ltd, Hikma Intl Pharms, Ipca Labs Ltd, 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 fifteen patent family members in eleven countries.

There are twenty-eight drug master file entries for ondansetron. Thirty-eight suppliers are listed for this compound. There are three tentative approvals for this compound.
Pharmacology for ondansetron
Medical Subject Heading (MeSH) Categories for ondansetron
Tentative approvals for ONDANSETRON
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
➤ Try a Free Trial➤ Try a Free TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
➤ Try a Free Trial➤ Try a Free Trial4MGTABLET, ORALLY DISINTEGRATING;ORAL

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
Emcure Pharms Ltd ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 078945-001 Jan 3, 2013 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078139-001 Jun 25, 2007 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076930-001 Jun 25, 2007 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 204906-001 Jul 31, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 202600-001 Dec 21, 2012 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Ipca Labs Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 203761-001 Jan 23, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Chartwell Molecules ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 076506-002 Dec 26, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Taro ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077729-003 Mar 28, 2011 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 090469-002 Apr 12, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078050-002 Aug 13, 2007 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ondansetron

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ondansetron

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,682,037 Non-mucoadhesive film dosage forms ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for ondansetron

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
QuintilesIMS
Baxter
McKesson
Accenture
Fuji
Cerilliant
Colorcon
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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