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Generated: May 27, 2017

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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?

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, 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, 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-seven suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: ondansetron

Drug Master File Entries: see list28
Suppliers / Packagers: see list37
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. Strength Dosage Form
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma
TABLET, ORALLY DISINTEGRATING;ORAL090469-001Apr 12, 2010ABRXNoNo► Subscribe► Subscribe
Aurobindo Pharma
ondansetron hydrochloride
TABLET;ORAL078539-001Jul 31, 2007ABRXNoNo► Subscribe► Subscribe
Chartwell Molecules
ondansetron hydrochloride
TABLET;ORAL077303-004Jun 25, 2007DISCNNoNo► Subscribe► Subscribe
Mylan Labs Ltd
ondansetron hydrochloride
INJECTABLE;INJECTION078257-001Apr 23, 2008APRXNoNo► Subscribe► Subscribe
Aurobindo Pharma
TABLET, ORALLY DISINTEGRATING;ORAL090469-002Apr 12, 2010ABRXNoNo► Subscribe► Subscribe
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