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Serving leading biopharmaceutical companies globally:

Julphar
Harvard Business School
Merck
Baxter
Cerilliant
Colorcon
US Army
Fuji
McKesson
Fish and Richardson

Generated: January 16, 2018

DrugPatentWatch Database Preview

ONDANSETRON - Generic Drug Details

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What are the generic 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 fourteen patent family members in ten 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
➤ Subscribe➤ SubscribeEQ 2MG BASE/MLINJECTABLE;INJECTION
➤ Subscribe➤ SubscribeEQ 2MG BASE/MLINJECTABLE;INJECTION
➤ Subscribe➤ Subscribe4MGTABLET, 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
Apotex ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077306-001 Jun 25, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 076972-001 Dec 26, 2006 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Luitpold ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077387-001 Dec 26, 2006 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Barr ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 076693-001 Jun 25, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078139-002 Jun 25, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077517-002 Jun 25, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077011-001 Dec 26, 2006 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077517-001 Jun 25, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 076876-001 Nov 22, 2006 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wockhardt ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077716-001 Dec 26, 2006 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ONDANSETRON

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Serving leading biopharmaceutical companies globally:

Citi
Novartis
Boehringer Ingelheim
McKesson
US Department of Justice
Medtronic
UBS
Daiichi Sankyo
Cipla

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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