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Last Updated: August 13, 2020

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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, Hospira, Lannett Co Inc, Luitpold, Mylan Labs Ltd, Pliva Hrvatska Doo, Qilu, Sagent Pharms, Sandoz Inc, Sun Pharm Inds (in), Teva, West-ward Pharms Int, Wockhardt, Am Regent, Emcure Pharms Ltd, Sun Pharm Inds Ltd, Taro Pharms Ireland, Novartis, Glaxosmithkline, Amneal Pharms, Aurobindo Pharma, Hikma, 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.

Recent Clinical Trials for ondansetron hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rajesh DesharN/A
King Saud UniversityPhase 4
DAS-MG, IncPhase 2

See all ondansetron hydrochloride clinical trials

Generic filers with tentative approvals for ONDANSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
  Start Trial  Start 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
Hikma ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride SOLUTION;ORAL 076960-001 Dec 26, 2006 AA RX No No   Start Trial   Start Trial   Start Trial
Hospira ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 076696-001 Dec 26, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Qilu ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 203711-001 Sep 8, 2014 AP RX No Yes   Start Trial   Start Trial   Start Trial
West-ward Pharms Int ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 077011-001 Dec 26, 2006 AP 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 hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER ondansetron hydrochloride INJECTABLE;INJECTION 020403-001 Jan 31, 1995   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-001 Dec 31, 1992   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991   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:

Johnson and Johnson
Boehringer Ingelheim
Harvard Business School
Baxter
Mallinckrodt
McKinsey

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