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Last Updated: October 16, 2021

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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 freedom to operate?

Ondansetron is the generic ingredient in nine branded drugs marketed by Aquestive, Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Generics, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Novartis, Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hikma Pharms, Hospira, Lannett Co Inc, Luitpold, Mylan Labs Ltd, Pliva Hrvatska Doo, Qilu, Sagent Pharms, Sandoz Inc, Sun Pharm Inds (in), Wockhardt, Am Regent, Emcure Pharms Ltd, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Dr Reddys Labs Ltd, Hikma Intl Pharms, Ipca Labs Ltd, and Natco Pharma Ltd, and is included in eighty-four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ondansetron has eighteen patent family members in fourteen countries.

There are twenty-eight drug master file entries for ondansetron. Twenty-five suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for ondansetron

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Drug Sales Revenue Trends for ondansetron

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Recent Clinical Trials for ondansetron

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tel-Aviv Sourasky Medical CenterN/A
CHU de Quebec-Universite LavalPhase 3
Laval UniversityPhase 3

See all ondansetron clinical trials

Generic filers with tentative approvals for ONDANSETRON
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
⤷  Free Forever Trial⤷  Free Forever TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
⤷  Free Forever Trial⤷  Free Forever Trial8MGTABLET, ORALLY DISINTEGRATING;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ondansetron
Medical Subject Heading (MeSH) Categories for ondansetron
Paragraph IV (Patent) Challenges for ONDANSETRON
Tradename Dosage Ingredient NDA Submissiondate
ZOFRAN ODT TABLET, ORALLY DISINTEGRATING;ORAL ondansetron 020781

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
Fresenius Kabi Usa ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 076972-001 Dec 26, 2006 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076252-002 Jun 25, 2007 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Luitpold ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077387-001 Dec 26, 2006 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Aurobindo Pharma ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 078539-003 Jul 31, 2007 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Taro ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077729-002 Mar 28, 2011 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi Usa ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 202253-001 Jul 19, 2013 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ondansetron

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
McKesson
Merck
Moodys
Boehringer Ingelheim

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