Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Boehringer Ingelheim
McKesson
Johnson and Johnson
Medtronic

Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020007

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 020007 describes ZOFRAN PRESERVATIVE FREE, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the ZOFRAN PRESERVATIVE FREE profile page.

The generic ingredient in ZOFRAN PRESERVATIVE FREE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
Summary for 020007
Tradename:ZOFRAN PRESERVATIVE FREE
Applicant:Novartis
Ingredient:ondansetron hydrochloride
Patents:0
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 020007
Tradename Dosage Ingredient NDA Submissiondate
ZOFRAN PRESERVATIVE FREE INJECTABLE;INJECTION ondansetron hydrochloride 020007
ZOFRAN INJECTABLE;INJECTION ondansetron hydrochloride 020007

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 4, 1991TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 10, 1993TE:RLD:Yes

Expired US Patents for NDA 020007

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991   Start Trial   Start Trial
Novartis ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993   Start Trial   Start Trial
Novartis ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991   Start Trial   Start Trial
Novartis ZOFRAN ondansetron hydrochloride INJECTABLE;INJECTION 020007-001 Jan 4, 1991   Start Trial   Start Trial
Novartis ZOFRAN PRESERVATIVE FREE ondansetron hydrochloride INJECTABLE;INJECTION 020007-003 Dec 10, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
Colorcon
Merck
Mallinckrodt
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.