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Ondansetron - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ondansetron?

Ondansetron is the generic ingredient in nine branded drugs marketed by Sun Pharm Inds Ltd, Chartwell Pharms Llc, Teva, Nesher Pharms, Midatech Pharma Us, Mylan, Sandoz, Glenmark Generics, Sun Pharm Inds, Aurobindo Pharma, Novartis Pharms Corp, Barr, Aurobindo Pharma Ltd, Glaxosmithkline, Chartwell Molecules, Apotex, Taro, Qilu Pharm Co Ltd, West-ward Pharms Int, Pliva Hrvatska Doo, Taro Pharms Ireland, Lannett, Wockhardt, Emcure Pharms, Gland Pharma Ltd, Luitpold, Hospira, Silarx, Apotex Inc, Mylan Labs Ltd, 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 Claris, and is included in eighty-four NDAs. There are three 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 two tentative approvals for this compound.

Summary for Generic Name: ondansetron

Tradenames:9
Patents:3
Applicants:42
NDAs:84
Drug Master File Entries: see list28
Suppliers / Packagers: see list36
Bulk Api Vendors: see list77
Clinical Trials: see list146
Patent Applications: see list7,447
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ondansetron at DailyMed

Pharmacology for Ingredient: ondansetron

Tentative approvals for ONDANSETRON

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORALEQ 16MG
► Subscribe► SubscribeTABLET; ORAL16MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Midatech Pharma Us
ZUPLENZ
ondansetron
FILM;ORAL022524-002Jul 2, 2010RXYesYes8,580,830► SubscribeY ► Subscribe
Chartwell Molecules
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL077303-004Jun 25, 2007DISCNNoNo► Subscribe► Subscribe
Glenmark Generics
ONDANSETRON
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL078152-001Jun 27, 2007RXNoNo► Subscribe► Subscribe
Sun Pharm Inds (in)
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
TABLET;ORAL077050-001Jun 25, 2007RXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride
INJECTABLE;INJECTION202599-001Dec 21, 2012RXNoNo► 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;ORAL020781-001Jan 27, 19994,695,578*PED► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 19996,063,802*PED► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 19994,695,578*PED► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 19995,955,488*PED► Subscribe
Novartis Pharms Corp
ZOFRAN ODT
ondansetron
TABLET, ORALLY DISINTEGRATING;ORAL020781-002Jan 27, 19995,578,628*PED► Subscribe
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International Patent Family for Ingredient: ondansetron

Country Document Number Estimated Expiration
China105168186► Subscribe
European Patent Office2076251► Subscribe
New Zealand575900► Subscribe
BrazilPI0719840► Subscribe
Germany202007019476► 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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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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