REMDESIVIR - Generic Drug Details
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What are the generic drug sources for remdesivir and what is the scope of patent protection?
Remdesivir
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Remdesivir has three hundred and twenty-five patent family members in forty-seven countries.
One supplier is listed for this compound.
Summary for REMDESIVIR
International Patents: | 325 |
US Patents: | 16 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 133 |
Patent Applications: | 67 |
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 |
---|---|
University of Derby | Phase 4 |
Peninsula Clinical Trials Unit | Phase 4 |
University of Exeter | Phase 4 |
Pharmacology for REMDESIVIR
Drug Class | SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor |
Anatomical Therapeutic Chemical (ATC) Classes for REMDESIVIR
US Patents and Regulatory Information for REMDESIVIR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VEKLURY | remdesivir | SOLUTION;INTRAVENOUS | 214787-002 | Oct 22, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | VEKLURY | remdesivir | POWDER;INTRAVENOUS | 214787-001 | Oct 22, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | VEKLURY | remdesivir | POWDER;INTRAVENOUS | 214787-001 | Oct 22, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | VEKLURY | remdesivir | POWDER;INTRAVENOUS | 214787-001 | Oct 22, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Gilead Sciences Inc | VEKLURY | remdesivir | POWDER;INTRAVENOUS | 214787-001 | Oct 22, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 |
---|---|---|---|
Denmark | 2937350 | ⤷ Sign Up | |
Chile | 2017001040 | Métodos para tratar infecciones por el virus filoviridae | ⤷ Sign Up |
China | 113549120 | 制备核糖核苷的方法 (Method for preparing ribonucleoside) | ⤷ Sign Up |
Denmark | 3349758 | ⤷ Sign Up | |
Serbia | 54008 | 1`-SUPSTITUISANI KARBA-NUKLEOZIDNI ANALOZI ZA ANTIVIRUSNU TERAPIJU (1' -SUBSTITUTED CARBA-NUCLEOSIDE ANALOGS FOR ANTIVIRAL TREATMENT) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for REMDESIVIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2937350 | PA2020539 | Lithuania | ⤷ Sign Up | PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703 |
2595980 | 132020000000176 | Italy | ⤷ Sign Up | PRODUCT NAME: REMDESIVIR O SALE O ESTERE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO(VEKLURY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1459, 20200703 |
2937350 | PA2020539,C2937350 | Lithuania | ⤷ Sign Up | PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703 |
2595980 | 2020C/554 | Belgium | ⤷ Sign Up | PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703 |
2595980 | 122020000084 | Germany | ⤷ Sign Up | PRODUCT NAME: REMDESIVIR ODER PHARMAZEUTISCH AKZEPTABLES SALZ ODER PHARMAZEUTISCH AKZEPTABLER ESTER DAVON; REGISTRATION NO/DATE: EU/1/20/1459 20200703 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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