Remdesivir - Generic Drug Details
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What are the generic drug sources for remdesivir and what is the scope of freedom to operate?
Remdesivir
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Remdesivir has three hundred and fourteen patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for remdesivir
International Patents: | 314 |
US Patents: | 13 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 132 |
Patent Applications: | 63 |
What excipients (inactive ingredients) are in remdesivir? | remdesivir excipients list |
DailyMed Link: | remdesivir at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for remdesivir
Generic Entry Date for remdesivir*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for remdesivir
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | N/A |
Hangzhou Hospital of Traditional Chinese Medicine | N/A |
The First Affiliated Hospital of Zhejiang Chinese Medical University | N/A |
Pharmacology for remdesivir
Drug Class | SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor |
US Patents and Regulatory Information for remdesivir
EU/EMA Drug Approvals for remdesivir
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Ireland UC | Veklury | remdesivir | EMEA/H/C/005622 Veklury is indicated for the treatment of coronavirus disease 2019 (COVID 19) in:adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 |
Authorised | no | no | no | 2020-07-03 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for remdesivir
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 111093627 | 用于治疗病毒感染的包含RNA聚合酶抑制剂和环糊精的组合物 (COMPOSITIONS COMPRISING AN RNA POLYMERASE INHIBITOR AND CYCLODEXTRIN FOR TREATING VIRAL INFECTIONS) | ⤷ Try a Trial |
South Korea | 101821680 | ⤷ Try a Trial | |
Taiwan | 202039526 | Methods for treating Filoviridae virus infections | ⤷ Try a Trial |
South Africa | 201008008 | CARBA-NUCLEOSIDE ANALOGS FOR ANTIVIRAL TREATMENT | ⤷ Try a Trial |
Lithuania | 3349758 | ⤷ Try a Trial | |
Cyprus | 1120366 | ⤷ Try a Trial | |
Netherlands | 301084 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for remdesivir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2595980 | C202030068 | Spain | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIR O UNA SAL O UN ESTER FARMACEUTICAMENTE ACEPTABLES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1459; DATE OF AUTHORISATION: 20200703; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1459; DATE OF FIRST AUTHORISATION IN EEA: 20200703 |
2937350 | CR 2020 00060 | Denmark | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1459 20200703 |
2595980 | 2020C/554 | Belgium | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703 |
2595980 | 122020000084 | Germany | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIR ODER PHARMAZEUTISCH AKZEPTABLES SALZ ODER PHARMAZEUTISCH AKZEPTABLER ESTER DAVON; REGISTRATION NO/DATE: EU/1/20/1459 20200703 |
2937350 | PA2020539,C2937350 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703 |
2937350 | PA2020539 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703 |
2595980 | 20C1065 | France | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIR OU UN SEL OU UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1459 20200703 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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