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Generated: November 18, 2017

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 Sun Pharm Inds Ltd, Chartwell Molecules, Teva, Nesher Pharms, Midatech Pharma Us, Mylan, Sandoz, Glenmark Generics, Sun Pharm Inds, Aurobindo Pharma, Novartis Pharms Corp, Barr, Aurobindo Pharma Ltd, Glaxosmithkline, Mylan Labs Ltd, Apotex, Taro, Qilu Pharm Co Ltd, West-ward Pharms Int, Pliva Hrvatska Doo, Taro Pharms Ireland, Lannett, Wockhardt, Emcure Pharms, Gland Pharma Ltd, Sandoz Inc, Luitpold, Hospira, Silarx, Apotex Inc, Accord Hlthcare, Emcure Pharms Ltd, Hikma Intl Pharms, Sun Pharm Inds (in), Natco Pharma Ltd, Fresenius Kabi Usa, Ipca Labs Ltd, Sagent Pharms, Hikma Farmaceutica, Amneal Pharms, Dr Reddys Labs Ltd, and Baxter Hlthcare Corp, 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-six 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
u► SubscribeEQ 2MG BASE/MLINJECTABLE;INJECTION
u► SubscribeEQ 2MG BASE/MLINJECTABLE;INJECTION
u► Subscribe4MGTABLET, ORALLY DISINTEGRATING;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipca Labs Ltd
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL203761-001Jan 23, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL076183-001Dec 26, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
ONDANSETRON
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL078050-002Aug 13, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL078539-002Jul 31, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
ONDANSETRON
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL077557-002Aug 2, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Hikma Intl Pharms
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL077545-001Sep 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
ondansetron hydrochloride
INJECTABLE;INJECTION076978-001Feb 26, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz
ONDANSETRON
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL078050-001Aug 13, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN
ondansetron hydrochloride
INJECTABLE;INJECTION020007-001Jan 4, 1991DISCNYesNo► Subscribe► Subscribe► Subscribe
Teva
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ondansetron hydrochloride
INJECTABLE;INJECTION076759-001Nov 22, 2006APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ondansetron

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-001Jan 27, 1999► Subscribe► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 1999► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,682,037Non-mucoadhesive film dosage forms► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ondansetron

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2008040534► Subscribe
Mexico2009003372► Subscribe
South Korea101448050► Subscribe
European Patent Office2248519► Subscribe
European Patent Office2076251► Subscribe
BrazilPI0719840► Subscribe
China101626756► Subscribe
South Korea20090080037► Subscribe
Australia2007304425► Subscribe
European Patent Office2444072► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Cipla
Federal Trade Commission
Chubb
Merck
Accenture
McKinsey
QuintilesIMS
Chinese Patent Office
Dow
Farmers Insurance

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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