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
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.
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
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 6/20/2002 | ||
Authorised | 5/22/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
STARFLU-75 CAPSULES 75 MG | SIN15685P | CAPSULE | 75 mg | 5/14/2019 | |
NATFLU OSELTAMIVIR PHOSPHATE USP CAPSULES 75 MG | SIN16242P | CAPSULE | 75 mg | 6/21/2021 | |
FLUVIR OSELTAMIVIR PHOSPHATE CAPSULES 75MG | SIN16307P | CAPSULE | 75mg | 8/24/2021 | |
Tamiflu capsule 30mg | SIN13506P | CAPSULE | 30mg | 7/31/2008 | |
NATFLU OSELTAMIVIR PHOSPHATE USP CAPSULES 30 MG | SIN16240P | CAPSULE | 30 mg | 6/21/2021 | |
SELTAVIR CAPSULE 75MG | SIN16667P | CAPSULE | 75mg | 1/5/2023 | |
NATFLU OSELTAMIVIR PHOPHATE USP CAPSULES 45 MG | SIN16241P | CAPSULE | 45 mg | 6/21/2021 | |
Tamiflu capsule 45mg | SIN13507P | CAPSULE | 45mg | 7/31/2008 | |
SELTAVIR 45 CAPSULE 45MG | SIN16668P | CAPSULE | 45mg | 1/5/2023 | |
TAMIFLU CAPSULE 75 mg | SIN11403P | CAPSULE | 75 mg | 10/14/2000 |
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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
OSMIVIR oseltamivir (as phosphate) 45 mg capsule blister pack | 329878 | Medicine | A | 3/4/2022 | |
OSELTAMIVIR STRIDES oseltamivir (as phosphate) 45 mg capsule blister pack | 329881 | Medicine | A | 3/4/2022 | |
Oseltamivir Lupin Oseltamivir (as phosphate) 75 mg capsule blister pack | 328428 | Medicine | A | 12/3/2020 | |
TAMIFLU oseltamivir (as phosphate) 6 mg/mL powder for oral suspension | 188016 | Medicine | A | 5/11/2012 | |
OSELTAMIVIR STRIDES oseltamivir (as phosphate) 30 mg capsule blister pack | 329883 | Medicine | A | 3/4/2022 | |
TALMINEX oseltamivir (as phosphate) 45 mg capsule blister pack | 312889 | Medicine | A | 2/25/2020 | |
ALEMVIR oseltamivir (as phosphate) 30 mg hard capsule blister pack | 377313 | Medicine | A | 11/17/2022 | |
OSELTAMIVIR STR oseltamivir (as phosphate) 75 mg capsule blister pack | 329882 | Medicine | A | 3/4/2022 | |
TALMINEX oseltamivir (as phosphate) 30 mg capsule blister pack | 312888 | Medicine | A | 2/25/2020 | |
OSMIVIR oseltamivir (as phosphate) 75 mg capsule blister pack | 329877 | Medicine | A | 3/4/2022 |
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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