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Last Updated: March 28, 2024

Zanamivir - Generic Drug Details


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What are the generic sources for zanamivir and what is the scope of freedom to operate?

Zanamivir is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for zanamivir
Recent Clinical Trials for zanamivir

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of OxfordPhase 2
George Washington UniversityEarly Phase 1
Hospital Infantil de Niño Jesús de Barranquilla (HINJ)Early Phase 1

See all zanamivir clinical trials

Pharmacology for zanamivir
Drug ClassNeuraminidase Inhibitor
Mechanism of ActionNeuraminidase Inhibitors
Medical Subject Heading (MeSH) Categories for zanamivir

US Patents and Regulatory Information for zanamivir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for zanamivir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for zanamivir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GlaxoSmithKline Trading Services Limited Dectova Zanamivir EMEA/H/C/004102
Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when:The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/orOther anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.Dectova should be used in accordance with official guidance.
Authorised no no no 2019-04-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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