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Last Updated: January 30, 2023

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, Baxter Hlthcare Corp, Chartwell Molecular, Emcure Pharms, 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 Inc, Steriscience, 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, 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-three 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
General Hospital of Ningxia Medical UniversityN/A
Premier Research Group plcPhase 2/Phase 3
Amicus CD LLCPhase 2/Phase 3

See all ondansetron hydrochloride clinical trials

Generic filers with tentative approvals for ONDANSETRON HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 2MG BASE/MLINJECTABLE;INJECTION
See Plans and PricingSee Plans and PricingEQ 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
Luitpold ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 079039-001 Nov 18, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma Intl Pharms ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077545-003 Sep 6, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Natco Pharma Ltd ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077851-002 Jun 25, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride TABLET;ORAL 077729-003 Mar 28, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 076876-001 Nov 22, 2006 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTABLE;INJECTION 076695-001 Dec 26, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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