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Oseltamivir

Generic Name
Oseltamivir
Brand Names
Ebilfumin, Tamiflu
Drug Type
Small Molecule
Chemical Formula
C16H28N2O4
CAS Number
196618-13-0
Unique Ingredient Identifier
20O93L6F9H

Overview

Oseltamivir (marketed as the product TamifluⓇ), is an antiviral neuraminidase inhibitor used for the treatment and prophylaxis of infection with influenza viruses A (including pandemic H1N1) and B. Oseltamivir exerts its antiviral activity by inhibiting the activity of the viral neuraminidase enzyme found on the surface of the virus, which prevents budding from the host cell, viral replication, and infectivity. The clinical benefit of use of oseltamivir is greatest when administered within 48 hours of the onset of influenza symptoms since effectiveness decreases significantly after that point in time; there is generally no benefit in use beyond 48 hours for healthy, low-risk individuals as influenza is a self-limiting illness. However, antiviral treatment might be beneficial when initiated after 48 hours for patients with severe, complicated or progressive illness or for hospitalized patients. According to the CDC, data from clinical trials and observational studies have demonstrated that early antiviral treatment can shorten the duration of fever and illness symptoms, and may reduce the risk of some complications (including pneumonia and respiratory failure). They recommend the use of oseltamivir in people with a higher risk of developing complications including children younger than 2 years, people over 65 years, people with some chronic conditions or immunosuppression, pregnant women, residents of long term care facilities, and indigenous communities for example. The benefits of oseltamivir use are controversial; a 2014 Cochrane Review of the evidence found that oseltamivir treatment had limited benefit. The authors concluded that oseltamivir use in healthy adults had small, non-specific effects on symptoms (where the time to first alleviation of symptoms was only reduced from 7 to 6.3 days), it had no effect on hospitalizations, and that there was no evidence for any reductions in complications of influenza such as pneumonia. Due to the risk of adverse effects such as nausea, vomiting, psychiatric effects and renal adverse events in adults and vomiting in children, the harms are generally considered to outweigh the small clinical benefit of use of oseltamivir. Notably, in 2017, the World Health Organization downgraded oseltamivir from its essential medicines list from a "core" drug to a "complementary" drug, due to limited cost-effectiveness. Yearly vaccination with the influenza vaccine is still considered the best preventative measure.

Indication

According to FDA prescribing information, oseltamivir is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours . In particular, this agent is indicated in adults and children including full-term neonates who present with symptoms typical of influenza when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of the first onset of symptoms. Oseltamivir is also indicated for the prophylaxis of influenza in patients one year and older . Specifically, post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community qualifies for such prophylactic therapy. Oseltamivir would only be indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak.

Associated Conditions

  • Flu caused by Influenza
  • Influenza A Virus Infection
  • Influenza A, Influenza B
  • Influenza Type B

Research Report

Published: Jul 18, 2025

Oseltamivir (DB00198): A Comprehensive Pharmacological and Clinical Monograph

I. Introduction and Drug Profile

1.1. Overview & Historical Context

Oseltamivir (DrugBank ID: DB00198) is an orally administered, small-molecule antiviral drug belonging to the class of neuraminidase inhibitors.[1] It stands as a cornerstone therapy for both the treatment and prophylaxis of infections caused by influenza A and influenza B viruses.[1] Marketed globally under the well-known brand name Tamiflu®, among others, oseltamivir was the first neuraminidase inhibitor to be made available in a convenient oral pill form.[4] Its development was a collaborative effort between Gilead Sciences, which led the initial discovery, and Hoffmann-La Roche, which guided it through late-stage clinical trials and commercialization, culminating in its first approval by the U.S. Food and Drug Administration (FDA) in 1999.[4]

The history of oseltamivir is characterized by immense commercial success, particularly during periods of heightened public health concern, such as the 2009 H1N1 influenza pandemic. These events prompted massive government-led stockpiling initiatives worldwide, cementing the drug's status as a primary tool in pandemic preparedness plans.[6] This widespread adoption was predicated on the belief that oseltamivir could not only shorten the duration of illness but also reduce the incidence of severe complications, hospitalizations, and mortality.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/08
Not Applicable
Not yet recruiting
Jiangxi Kerui Pharmaceutical Co., Ltd
2025/07/31
Not Applicable
Not yet recruiting
Nanjing Zenshine Pharmaceuticals
2025/01/14
Phase 3
Completed
2025/01/07
Not Applicable
Not yet recruiting
Capital Medical University
2024/07/18
Phase 3
Recruiting
Jiaxing AnDiCon Biotech Co.,Ltd
2023/09/28
Phase 1
Completed
Nanjing Zenshine Pharmaceuticals
2023/04/18
Phase 1
Completed
2023/03/29
Phase 1
Completed
2022/12/13
Phase 2
Recruiting
2022/03/28
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
RPK Pharmaceuticals, Inc.
53002-3387
ORAL
75 mg in 1 1
9/5/2022
A-S Medication Solutions
50090-4159
ORAL
75 mg in 1 1
4/27/2018
Preferred Pharmaceuticals Inc.
68788-7600
ORAL
6 mg in 1 mL
8/22/2023
Asclemed USA, Inc.
76420-290
ORAL
45 mg in 1 1
9/22/2022
Ajanta Pharma USA Inc.
27241-139
ORAL
6 mg in 1 mL
5/31/2023
Teva Pharmaceuticals USA, Inc.
0093-8180
ORAL
6 mg in 1 mL
10/18/2022
Alembic Pharmaceuticals Inc.
62332-414
ORAL
45 mg in 1 1
12/22/2021
Proficient Rx LP
71205-417
ORAL
45 mg in 1 1
2/1/2020
Zydus Pharmaceuticals USA Inc.
70710-1009
ORAL
45 mg in 1 1
12/27/2022
EPIC PHARMA, LLC
42806-553
ORAL
30 mg in 1 1
9/18/2023

EMA Drug Approvals

HSA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
TAMIFLU 12 mg/ml POLVO PARA SUSPENSION ORAL
02222002
POLVO PARA SUSPENSIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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