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
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 84 |
Clinical Trials: | 34 |
Patent Applications: | 6,572 |
What excipients (inactive ingredients) are in zanamivir? | zanamivir excipients list |
DailyMed Link: | zanamivir at DailyMed |
Recent Clinical Trials for zanamivir
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Oxford | Phase 2 |
Naval Medical Research Center | Early Phase 1 |
George Washington University | Early Phase 1 |
Pharmacology for zanamivir
Drug Class | Neuraminidase Inhibitor |
Mechanism of Action | Neuraminidase Inhibitors |
Medical Subject Heading (MeSH) Categories for zanamivir
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | RELENZA | zanamivir | POWDER;INHALATION | 021036-001 | Jul 26, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | RELENZA | zanamivir | POWDER;INHALATION | 021036-001 | Jul 26, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | RELENZA | zanamivir | POWDER;INHALATION | 021036-001 | Jul 26, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>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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