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Last Updated: October 26, 2021

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Ondansetron hydrochloride - Generic Drug Details

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What are the generic drug sources for ondansetron hydrochloride and what is the scope of freedom to operate?

Ondansetron hydrochloride is the generic ingredient in six branded drugs marketed by 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), Teva, Wockhardt, Am Regent, Emcure Pharms Ltd, Sun Pharm Inds Ltd, Taro Pharms Ireland, Novartis, Glaxosmithkline, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Chartwell Molecules, Dr Reddys Labs Ltd, Glenmark Generics, Hikma Intl Pharms, Ipca Labs Ltd, Mylan, and Natco Pharma Ltd, and is included in seventy-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for ondansetron hydrochloride. Sixty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ondansetron hydrochloride
Recent Clinical Trials for ondansetron hydrochloride

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 hydrochloride clinical trials

Generic filers with tentative approvals for ONDANSETRON HYDROCHLORIDE
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

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 hydrochloride
Paragraph IV (Patent) Challenges for ONDANSETRON HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ZOFRAN SOLUTION;ORAL ondansetron hydrochloride 020605 2004-12-20
ZOFRAN TABLET;ORAL ondansetron hydrochloride 020103
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER INJECTABLE;INJECTION ondansetron hydrochloride 020403
ZOFRAN INJECTABLE;INJECTION ondansetron hydrochloride 020007
ZOFRAN PRESERVATIVE FREE INJECTABLE;INJECTION ondansetron hydrochloride 020007

US Patents and Regulatory Information for ondansetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077343-001 Dec 26, 2006 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076930-002 Jun 25, 2007 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pliva Hrvatska Doo ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077112-003 Jun 25, 2007 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Labs Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 204906-001 Jul 31, 2017 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Glenmark Generics ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077535-001 Jun 25, 2007 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma Farmaceutica ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 076780-001 Dec 26, 2006 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Dr Reddys Labs Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 076183-002 Dec 26, 2006 AB 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 hydrochloride

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Baxter
Colorcon
AstraZeneca
Johnson and Johnson

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