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Last Updated: August 13, 2020

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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 patent protection?

Ondansetron is the generic ingredient in nine branded drugs marketed by Fortovia, 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, Hospira, Lannett Co Inc, Luitpold, Mylan Labs Ltd, Pliva Hrvatska Doo, Qilu, Sagent Pharms, Sandoz Inc, Sun Pharm Inds (in), West-ward Pharms Int, Wockhardt, Am Regent, Emcure Pharms Ltd, Taro Pharms Ireland, Glaxosmithkline, Amneal Pharms, Hikma, 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
Rajesh DesharN/A
King Saud UniversityPhase 4
DAS-MG, IncPhase 2

See all ONDANSETRON clinical trials

Generic filers with tentative approvals for ONDANSETRON
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
  Start Trial  Start TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
  Start Trial  Start 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
Glenmark Generics ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077535-001 Jun 25, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 077365-001 Dec 26, 2006 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 076695-001 Dec 26, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Taro ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077729-001 Mar 28, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Sagent Pharms ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 078180-001 Mar 26, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 078050-002 Aug 13, 2007 AB RX No No   Start Trial   Start Trial   Start 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 020781-002 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-001 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ODT ondansetron TABLET, ORALLY DISINTEGRATING;ORAL 020781-002 Jan 27, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Medtronic
Colorcon
Mallinckrodt
Express Scripts

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 verification 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.