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Details for Generic Name: zanamivir

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Zanamivir is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seventeen patent family members in forty-seven countries.

Three suppliers are listed for this compound.

Summary for Generic Name: zanamivir

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packaging: see list3
Therapeutic Class:Antivirals

Pharmacology for Ingredient: zanamivir

Clinical Trials for: zanamivir

A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
Status: Completed Condition: Influenza, Human

Pharmacokinetics of Zanamivir After Single and Repeated Dose Infusion Administration in Healthy Chinese Adults
Status: Completed Condition: Influenza, Human

A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects
Status: Withdrawn Condition: Healthy Subjects

A Study of Intravenous Zanamivir in the Treatment of Hospitalized Patients With Influenza Infection
Status: Completed Condition: Influenza, Human

Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital
Status: Completed Condition: Influenza, Human

A Study to Evaluate the Effect of Intravenous Zanamivir on Cardiac Conduction in Healthy Volunteers
Status: Completed Condition: Influenza, Human

Evaluation of Efficacity and Safety of Oseltamivir and Zanamivir
Status: Terminated Condition: Gastric Influenza

Long Term Influenza Prophylaxis With Inhaled Zanamivir or Oral Oseltamivir
Status: Completed Condition: Influenza

Zanamivir Versus Trivalent Split Virus Influenza Vaccine
Status: Completed Condition: Influenza

Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)
Status: Completed Condition: Influenza, Human

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
RELENZA
zanamivir
POWDER;INHALATION021036-001Jul 26, 1999RXYes5,648,379<disabled> <disabled>
Glaxosmithkline
RELENZA
zanamivir
POWDER;INHALATION021036-001Jul 26, 1999RXYes6,294,572<disabled>YY <disabled>
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Expired Orange Book Patents for Generic Ingredient: zanamivir

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
RELENZA
zanamivir
POWDER;INHALATION021036-001Jul 26, 19995,360,817<disabled>
Glaxosmithkline
RELENZA
zanamivir
POWDER;INHALATION021036-001Jul 26, 19994,627,432<disabled>
Glaxosmithkline
RELENZA
zanamivir
POWDER;INHALATION021036-001Jul 26, 1999D379506<disabled>
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Non-Orange Book Patents for Generic Ingredient: zanamivir

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,360,817 Derivatives and analogues of 2-deoxy-2,3-didehydro-N-acetyl neuraminic acid and their use as antiviral agents<disabled in preview>
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International Patent Family for Ingredient: zanamivir

Country Document Number Publication Date
Germany19975068Oct 10, 2002
Brazil1100548KNov 01, 2011
Portugal97460Jan 29, 1999
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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