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Last Updated: July 21, 2024

ONDANSETRON - Generic Drug Details


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What are the generic drug sources for ondansetron and what is the scope of patent protection?

Ondansetron is the generic ingredient in nine branded drugs marketed by Aquestive, Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Pharms Ltd, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Molecular, 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, Steriscience, Sun Pharm Inds (in), Wockhardt, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Dr Reddys Labs Ltd, Hikma Intl Pharms, and Natco Pharma Ltd, 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 eighteen patent family members in fourteen countries.

There are twenty-eight drug master file entries for ondansetron. Thirty-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
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Adwia Pharma, EgyptPhase 3
Purdue UniversityPhase 4

See all ONDANSETRON clinical trials

Generic filers with tentative approvals for ONDANSETRON
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 2MG BASE/MLINJECTABLE;INJECTION
⤷  Sign Up⤷  Sign UpEQ 2MG BASE/MLINJECTABLE;INJECTION
⤷  Sign Up⤷  Sign Up8MGTABLET, 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
Hikma Intl Pharms ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077545-001 Sep 6, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Barr ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 076693-002 Jun 25, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076930-001 Jun 25, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lannett Co Inc ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 090883-001 Aug 5, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride SOLUTION;ORAL 091483-001 Jan 31, 2011 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma Farmaceutica ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 076781-001 Dec 26, 2006 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Am Regent ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077387-001 Dec 26, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
Sandoz ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ONDANSETRON

Country Patent Number Title Estimated Expiration
Germany 202007019476 ⤷  Sign Up
New Zealand 575900 NON-MUCOADHESIVE FILM DOSAGE FORMS ⤷  Sign Up
South Korea 20090080037 NON-MUCOADHESIVE FILM DOSAGE FORMS ⤷  Sign Up
Brazil PI0719840 FORMAS DE DOSAGEM DE PELÍCULAS NÃO-MUCOADESIVA ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2008040534 ⤷  Sign Up
European Patent Office 2076251 FORMES PHARMACEUTIQUES À BASE DE FILM NON MUCO-ADHÉSIF (NON-MUCOADHESIVE FILM DOSAGE FORMS) ⤷  Sign Up
Canada 2664986 FORMES PHARMACEUTIQUES A BASE DE FILM NON MUCO-ADHESIF (NON-MUCOADHESIVE FILM DOSAGE FORMS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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