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Last Updated: December 8, 2022

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, Atlantide, Baxter Hlthcare Corp, Chartwell Molecular, Emcure Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Sandoz Inc, Steriscience, Sun Pharm Inds (in), 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-eight 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
General Hospital of Ningxia Medical UniversityN/A
Premier Research Group plcPhase 2/Phase 3
Amicus CD LLCPhase 2/Phase 3

See all ondansetron clinical trials

Generic filers with tentative approvals for ONDANSETRON
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 2MG BASE/MLINJECTABLE;INJECTION
See Plans and PricingSee Plans and PricingEQ 2MG BASE/MLINJECTABLE;INJECTION
See Plans and PricingSee Plans and Pricing8MGTABLET, 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

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
Teva ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 076810-002 Jun 25, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eugia Pharma ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 202599-001 Dec 21, 2012 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Am Regent ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 079032-001 Nov 18, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 090469-002 Apr 12, 2010 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride SOLUTION;ORAL 076960-001 Dec 26, 2006 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 See Plans and Pricing See Plans and Pricing
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 See Plans and Pricing See Plans and Pricing
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 See Plans and Pricing See Plans and Pricing
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 See Plans and Pricing See Plans and Pricing
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ondansetron

Country Patent Number Title Estimated Expiration
China 101626756 Non-mucoadhesive film dosage forms See Plans and Pricing
Brazil PI0719840 FORMAS DE DOSAGEM DE PELÍCULAS NÃO-MUCOADESIVA See Plans and Pricing
Poland 2248519 See Plans and Pricing
Hungary E038022 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008040534 See Plans and Pricing
Denmark 2248519 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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