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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.

Background

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

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2021/10/19
Phase 1
Completed
2021/08/19
Phase 4
Active, not recruiting
2021/08/17
Not Applicable
UNKNOWN
2021/01/15
Phase 2
Recruiting
2020/12/24
Phase 3
Completed
Guangdong Raynovent Biotech Co., Ltd
2020/12/24
Phase 4
UNKNOWN
2020/09/22
Phase 3
UNKNOWN
2020/09/02
Phase 4
Completed
2020/08/18
Phase 2
Completed
2020/07/07
Phase 1
UNKNOWN

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Preferred Pharmaceuticals Inc.
68788-8123
ORAL
6 mg in 1 mL
8/22/2023
Macleods Pharmaceuticals Limited
33342-258
ORAL
75 mg in 1 1
9/5/2022
Zydus Lifesciences Limited
70771-1711
ORAL
45 mg in 1 1
10/31/2022
Zydus Lifesciences Limited
70771-1710
ORAL
30 mg in 1 1
10/31/2022
NuCare Pharmaceuticals,Inc.
68071-2612
ORAL
75 mg in 1 1
1/5/2022
Amneal Pharmaceuticals NY LLC
60219-1265
ORAL
45 mg in 1 1
9/26/2022
Amneal Pharmaceuticals NY LLC
69238-1273
ORAL
6 mg in 1 mL
12/30/2023
Strides Pharma Science Limited
64380-797
ORAL
30 mg in 1 1
12/8/2022
NuCare Pharmaceuticals,Inc.
68071-2528
ORAL
75 mg in 1 1
11/22/2021
Cadila Healthcare Limited
70771-1598
ORAL
6 mg in 1 mL
8/5/2021

EMA Drug Approvals

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Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SELTAVIR 30 CAPSULE 30MG
SIN16669P
CAPSULE
30mg
1/5/2023

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Oseltamivir Phosphate Capsules
国药准字H20249291
化学药品
胶囊剂
11/5/2024
Oseltamivir Phosphate Capsules
国药准字H20253123
化学药品
胶囊剂
1/8/2025
Oseltamivir Phosphate Capsules
国药准字H20243972
化学药品
胶囊剂
6/11/2024
Oseltamivir Phosphate Capsules
国药准字H20249360
化学药品
胶囊剂
11/15/2024
Oseltamivir Phosphate Capsules
国药准字H20249330
化学药品
胶囊剂
11/15/2024
Oseltamivir Phosphate Capsules
国药准字H20244551
化学药品
胶囊剂
7/30/2024
Oseltamivir Phosphate Capsules
国药准字H20223173
化学药品
胶囊剂
3/29/2022
Oseltamivir Phosphate Capsules
国药准字H20243537
化学药品
胶囊剂
6/4/2024
Oseltamivir Phosphate Capsules
国药准字H20244552
化学药品
胶囊剂
7/30/2024
Oseltamivir Phosphate Capsules
国药准字H20243988
化学药品
胶囊剂
6/11/2024

PPB Drug Approvals

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