VEKLURY Drug Patent Profile
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Which patents cover Veklury, and what generic alternatives are available?
Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are fourteen patents protecting this drug.
This drug has three hundred and twenty-four patent family members in forty-seven countries.
The generic ingredient in VEKLURY is remdesivir. One supplier is listed for this compound. Additional details are available on the remdesivir profile page.
DrugPatentWatch® Generic Entry Outlook for Veklury
Veklury will be eligible for patent challenges on October 22, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 29, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VEKLURY
International Patents: | 324 |
US Patents: | 14 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 5 |
Patent Applications: | 52 |
What excipients (inactive ingredients) are in VEKLURY? | VEKLURY excipients list |
DailyMed Link: | VEKLURY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VEKLURY
Generic Entry Date for VEKLURY*:
Constraining patent/regulatory exclusivity:
NDA:
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 VEKLURY
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mansoura University Hospital | Phase 4 |
PharmaMar | Phase 3 |
ASST Fatebenefratelli Sacco | Phase 3 |
Pharmacology for VEKLURY
Anatomical Therapeutic Chemical (ATC) Classes for VEKLURY
US Patents and Regulatory Information for VEKLURY
VEKLURY is protected by fourteen US patents and eight FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VEKLURY is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VEKLURY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating arenaviridae and coronaviridae virus infections
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating Arenaviridae and Coronaviridae virus infections
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Paramyxoviridae
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
1'-substituted carba-nucleoside analogs for antiviral treatment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
1'substituted carba-nucleoside analogs for antiviral treatment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating Filoviridae virus infections
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating Filoviridae virus infections
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
1'-substituted carba-nucleoside analogs for antiviral treatment
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting VEKLURY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
3-DAY DOSING REGIMEN FOR THE TREATMENT OF COVID-19 IN ADULTS AND PEDIATRIC PATIENTS (>12 YEARS AND WEIGHING AT LEAST 40 KG) WITH POSITIVE RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING, WHO ARE NOT HOSPITALIZED AND HAVE MILD-TO-MODERATE COVID-19, AND ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH
Exclusivity Expiration: ⤷ Try a Trial
CLINICAL STUDY INFORMATION ADDED TO LABEL ABOUT THE TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN PATIENTS WITH SEVERELY REDUCED RENAL FUNCTION (ESTIMATED GLOMERULAR FILTRATION RATE, EGFR < 30 ML/MIN)
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VEKLURY | remdesivir | SOLUTION;INTRAVENOUS | 214787-002 | Oct 22, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Gilead Sciences Inc | VEKLURY | remdesivir | SOLUTION;INTRAVENOUS | 214787-002 | Oct 22, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Gilead Sciences Inc | VEKLURY | remdesivir | SOLUTION;INTRAVENOUS | 214787-002 | Oct 22, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
EU/EMA Drug Approvals for VEKLURY
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 VEKLURY
When does loss-of-exclusivity occur for VEKLURY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2467
Estimated Expiration: ⤷ Try a Trial
Patent: 2468
Estimated Expiration: ⤷ Try a Trial
Patent: 9850
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 15339222
Estimated Expiration: ⤷ Try a Trial
Patent: 15339223
Estimated Expiration: ⤷ Try a Trial
Patent: 18253483
Estimated Expiration: ⤷ Try a Trial
Patent: 19201232
Estimated Expiration: ⤷ Try a Trial
Patent: 20203892
Estimated Expiration: ⤷ Try a Trial
Patent: 21201474
Estimated Expiration: ⤷ Try a Trial
Patent: 22283772
Estimated Expiration: ⤷ Try a Trial
Patent: 23202679
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015027413
Estimated Expiration: ⤷ Try a Trial
Patent: 2017007636
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 63832
Estimated Expiration: ⤷ Try a Trial
Patent: 63907
Estimated Expiration: ⤷ Try a Trial
Patent: 84285
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 17001040
Estimated Expiration: ⤷ Try a Trial
Patent: 17002693
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7073005
Estimated Expiration: ⤷ Try a Trial
Patent: 7074902
Estimated Expiration: ⤷ Try a Trial
Patent: 3549120
Estimated Expiration: ⤷ Try a Trial
Patent: 3620992
Estimated Expiration: ⤷ Try a Trial
Patent: 4191438
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17003960
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 170165
Estimated Expiration: ⤷ Try a Trial
Patent: 170483
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0181130
Estimated Expiration: ⤷ Try a Trial
Patent: 0200518
Estimated Expiration: ⤷ Try a Trial
Cuba
Patent: 170056
Estimated Expiration: ⤷ Try a Trial
Patent: 170145
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 20893
Estimated Expiration: ⤷ Try a Trial
Patent: 22946
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 12174
Estimated Expiration: ⤷ Try a Trial
Patent: 66295
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 017000103
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 17025261
Estimated Expiration: ⤷ Try a Trial
Patent: 17072474
Estimated Expiration: ⤷ Try a Trial
El Salvador
Patent: 17005424
Estimated Expiration: ⤷ Try a Trial
Patent: 17005561
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 2239
Estimated Expiration: ⤷ Try a Trial
Patent: 9561
Estimated Expiration: ⤷ Try a Trial
Patent: 1790597
Estimated Expiration: ⤷ Try a Trial
Patent: 1790630
Estimated Expiration: ⤷ Try a Trial
Patent: 1990021
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 12174
Estimated Expiration: ⤷ Try a Trial
Patent: 12175
Estimated Expiration: ⤷ Try a Trial
Patent: 66295
Estimated Expiration: ⤷ Try a Trial
Patent: 95844
Estimated Expiration: ⤷ Try a Trial
Patent: 36099
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 58795
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 39231
Estimated Expiration: ⤷ Try a Trial
Patent: 49192
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1707
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 20484
Estimated Expiration: ⤷ Try a Trial
Patent: 87547
Estimated Expiration: ⤷ Try a Trial
Patent: 71424
Estimated Expiration: ⤷ Try a Trial
Patent: 57294
Estimated Expiration: ⤷ Try a Trial
Patent: 58428
Estimated Expiration: ⤷ Try a Trial
Patent: 17186358
Estimated Expiration: ⤷ Try a Trial
Patent: 17533903
Estimated Expiration: ⤷ Try a Trial
Patent: 17534614
Estimated Expiration: ⤷ Try a Trial
Patent: 18172424
Estimated Expiration: ⤷ Try a Trial
Patent: 19048901
Estimated Expiration: ⤷ Try a Trial
Patent: 20090536
Estimated Expiration: ⤷ Try a Trial
Patent: 20097635
Estimated Expiration: ⤷ Try a Trial
Patent: 22065066
Estimated Expiration: ⤷ Try a Trial
Patent: 22068297
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 12174
Estimated Expiration: ⤷ Try a Trial
Patent: 66295
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 5823
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17005250
Estimated Expiration: ⤷ Try a Trial
Patent: 17005252
Estimated Expiration: ⤷ Try a Trial
Patent: 20012560
Estimated Expiration: ⤷ Try a Trial
Moldova, Republic of
Patent: 170046
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 070
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 867
Estimated Expiration: ⤷ Try a Trial
Patent: 872
Estimated Expiration: ⤷ Try a Trial
Patent: 201
Estimated Expiration: ⤷ Try a Trial
Patent: 506
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0803
Estimated Expiration: ⤷ Try a Trial
Patent: 0809
Estimated Expiration: ⤷ Try a Trial
Patent: 5328
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 171439
Estimated Expiration: ⤷ Try a Trial
Patent: 180202
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017500631
Estimated Expiration: ⤷ Try a Trial
Patent: 020551055
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 12174
Estimated Expiration: ⤷ Try a Trial
Patent: 12175
Estimated Expiration: ⤷ Try a Trial
Patent: 66295
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 12174
Estimated Expiration: ⤷ Try a Trial
Patent: 12175
Estimated Expiration: ⤷ Try a Trial
Patent: 66295
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 7381419
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 425
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 202008772U
Estimated Expiration: ⤷ Try a Trial
Patent: 201702903T
Estimated Expiration: ⤷ Try a Trial
Patent: 201702904R
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 12174
Estimated Expiration: ⤷ Try a Trial
Patent: 12175
Estimated Expiration: ⤷ Try a Trial
Patent: 66295
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1800414
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1822348
Estimated Expiration: ⤷ Try a Trial
Patent: 2337664
Estimated Expiration: ⤷ Try a Trial
Patent: 2453808
Estimated Expiration: ⤷ Try a Trial
Patent: 170066665
Estimated Expiration: ⤷ Try a Trial
Patent: 170067898
Estimated Expiration: ⤷ Try a Trial
Patent: 170077167
Estimated Expiration: ⤷ Try a Trial
Patent: 210152015
Estimated Expiration: ⤷ Try a Trial
Patent: 220140656
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 74806
Estimated Expiration: ⤷ Try a Trial
Patent: 85034
Estimated Expiration: ⤷ Try a Trial
Patent: 04298
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 87432
Estimated Expiration: ⤷ Try a Trial
Patent: 98444
Estimated Expiration: ⤷ Try a Trial
Patent: 40546
Estimated Expiration: ⤷ Try a Trial
Patent: 67201
Estimated Expiration: ⤷ Try a Trial
Patent: 1629076
Estimated Expiration: ⤷ Try a Trial
Patent: 1630925
Estimated Expiration: ⤷ Try a Trial
Patent: 2039526
Estimated Expiration: ⤷ Try a Trial
Patent: 2115098
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1809518
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 1485
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 376
Estimated Expiration: ⤷ Try a Trial
Patent: 464
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering VEKLURY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 032239 | СПОСОБЫ ЛЕЧЕНИЯ ВИРУСНЫХ ИНФЕКЦИЙ FILOVIRIDAE (METHODS FOR TREATING FILOVIRIDAE VIRUS INFECTIONS) | ⤷ Try a Trial |
Denmark | 3349758 | ⤷ Try a Trial | |
Slovenia | 2268642 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VEKLURY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2595980 | C02595980/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68043 25.11.2020 |
2595980 | 301084 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: REMDESIVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/20/1459 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |