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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
Formulation / Manufacturing:see details

Pharmacology for Ingredient: zanamivir

Clinical Trials for: zanamivir

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

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Status: Withdrawn Condition: Healthy Subjects

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

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: Recruiting 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, 1999RXYes6,294,572<disabled>YY<disabled>
Glaxosmithkline
RELENZA
zanamivir
POWDER;INHALATION021036-001Jul 26, 1999RXYes5,648,379<disabled><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
Spain2113881May 16, 1998
United Kingdom9325841Feb 23, 1994
Greece3035681Jun 29, 2001
South Korea100403256Apr 30, 2004
China1036849Dec 31, 1997
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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.

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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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