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Last Updated: February 26, 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 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-three 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
Laval UniversityPhase 3
CHU de Quebec-Universite LavalPhase 3
Instituto Nacional de Cancer, BrazilPhase 2/Phase 3

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
Hospira ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 077840-001 Jan 19, 2007 AP RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 078539-003 Jul 31, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride SOLUTION;ORAL 078776-001 Nov 28, 2007 AA RX No No   Start Trial   Start Trial   Start Trial
Teva ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076252-001 Jun 25, 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 020781-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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