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Last Updated: March 19, 2024

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, 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, Sandoz, Steriscience, Sun Pharm Inds (in), Teva, Wockhardt, Am Regent, Sun Pharm Inds Ltd, Taro Pharms Ireland, 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, and Natco Pharma Ltd, and is included in seventy-two NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for ondansetron hydrochloride. Sixty-two 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
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Immune Oncology Research InstitutePhase 3
American Heart AssociationPhase 4

See all ondansetron hydrochloride clinical trials

Generic filers with tentative approvals for ONDANSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 2MG BASE/MLINJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
ZOFRAN Oral Solution ondansetron hydrochloride 4 mg/5 mL 020605 1 2004-12-20

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
Aurobindo Pharma ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 078539-002 Jul 31, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077729-003 Mar 28, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-001 Dec 31, 1992 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 076696-001 Dec 26, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Sandoz ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-003 Aug 27, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991 ⤷  Try a Trial ⤷  Try a Trial
Sandoz ZOFRAN ondansetron hydrochloride TABLET;ORAL 020103-002 Dec 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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