You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Merck
Mallinckrodt
Dow
Harvard Business School

Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021246


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 021246 describes TAMIFLU, which is a drug marketed by Roche and is included in two NDAs. It is available from two suppliers. Additional details are available on the TAMIFLU profile page.

The generic ingredient in TAMIFLU is oseltamivir phosphate. There are eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 021246
Tradename:TAMIFLU
Applicant:Roche
Ingredient:oseltamivir phosphate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021246
Suppliers and Packaging for NDA: 021246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246 NDA Genentech, Inc. 0004-0822 0004-0822-05 1 BOTTLE, GLASS in 1 CARTON (0004-0822-05) > 60 mL in 1 BOTTLE, GLASS
Paragraph IV (Patent) Challenges for 021246
Tradename Dosage Ingredient NDA Submissiondate
TAMIFLU FOR SUSPENSION;ORAL oseltamivir phosphate 021246 2015-06-18

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 12MG BASE/ML
Approval Date:Dec 14, 2000TE:RLD:No
Regulatory Exclusivity Expiration:Aug 2, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING INFLUENZA VIRUS RESISTANCE TO OSELTAMIVIR IN IMMUNOCOMPROMISED PATIENTS

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 6MG BASE/ML
Approval Date:Mar 21, 2011TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Aug 2, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING INFLUENZA VIRUS RESISTANCE TO OSELTAMIVIR IN IMMUNOCOMPROMISED PATIENTS

Expired US Patents for NDA 021246

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-002 Mar 21, 2011   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:

Colorcon
Mallinckrodt
Harvard Business School
McKesson
McKinsey
Johnson and Johnson

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 verification 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.