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-five 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: | 325 |
| 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
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for treating arenaviridae and coronaviridae virus infections
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for treating Arenaviridae and Coronaviridae virus infections
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Paramyxoviridae
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
1'-substituted carba-nucleoside analogs for antiviral treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
1'substituted carba-nucleoside analogs for antiviral treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for treating Filoviridae virus infections
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for treating Filoviridae virus infections
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
1'-substituted carba-nucleoside analogs for antiviral treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting VEKLURY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ||||
| 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 | SOLUTION;INTRAVENOUS | 214787-002 | Oct 22, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| 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 | 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 | Y | ⤷ Sign Up | |||
| Gilead Sciences Inc | VEKLURY | remdesivir | POWDER;INTRAVENOUS | 214787-001 | Oct 22, 2020 | 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 |
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: ⤷ Sign Up
Patent: 2468
Estimated Expiration: ⤷ Sign Up
Patent: 9850
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 15339222
Estimated Expiration: ⤷ Sign Up
Patent: 15339223
Estimated Expiration: ⤷ Sign Up
Patent: 18253483
Estimated Expiration: ⤷ Sign Up
Patent: 19201232
Estimated Expiration: ⤷ Sign Up
Patent: 20203892
Estimated Expiration: ⤷ Sign Up
Patent: 21201474
Estimated Expiration: ⤷ Sign Up
Patent: 22283772
Estimated Expiration: ⤷ Sign Up
Patent: 23202679
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015027413
Estimated Expiration: ⤷ Sign Up
Patent: 2017007636
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 63832
Estimated Expiration: ⤷ Sign Up
Patent: 63907
Estimated Expiration: ⤷ Sign Up
Patent: 84285
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 17001040
Estimated Expiration: ⤷ Sign Up
Patent: 17002693
Estimated Expiration: ⤷ Sign Up
China
Patent: 7073005
Estimated Expiration: ⤷ Sign Up
Patent: 7074902
Estimated Expiration: ⤷ Sign Up
Patent: 3549120
Estimated Expiration: ⤷ Sign Up
Patent: 3620992
Estimated Expiration: ⤷ Sign Up
Patent: 4191438
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 17003960
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 170165
Estimated Expiration: ⤷ Sign Up
Patent: 170483
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0181130
Estimated Expiration: ⤷ Sign Up
Patent: 0200518
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 170056
Estimated Expiration: ⤷ Sign Up
Patent: 170145
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20893
Estimated Expiration: ⤷ Sign Up
Patent: 22946
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 12174
Estimated Expiration: ⤷ Sign Up
Patent: 66295
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 017000103
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 17025261
Estimated Expiration: ⤷ Sign Up
Patent: 17072474
Estimated Expiration: ⤷ Sign Up
El Salvador
Patent: 17005424
Estimated Expiration: ⤷ Sign Up
Patent: 17005561
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2239
Estimated Expiration: ⤷ Sign Up
Patent: 9561
Estimated Expiration: ⤷ Sign Up
Patent: 1790597
Estimated Expiration: ⤷ Sign Up
Patent: 1790630
Estimated Expiration: ⤷ Sign Up
Patent: 1990021
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 12174
Estimated Expiration: ⤷ Sign Up
Patent: 12175
Estimated Expiration: ⤷ Sign Up
Patent: 66295
Estimated Expiration: ⤷ Sign Up
Patent: 95844
Estimated Expiration: ⤷ Sign Up
Patent: 36099
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 58795
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 39231
Estimated Expiration: ⤷ Sign Up
Patent: 49192
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1707
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 20484
Estimated Expiration: ⤷ Sign Up
Patent: 87547
Estimated Expiration: ⤷ Sign Up
Patent: 71424
Estimated Expiration: ⤷ Sign Up
Patent: 57294
Estimated Expiration: ⤷ Sign Up
Patent: 58428
Estimated Expiration: ⤷ Sign Up
Patent: 17186358
Estimated Expiration: ⤷ Sign Up
Patent: 17533903
Estimated Expiration: ⤷ Sign Up
Patent: 17534614
Estimated Expiration: ⤷ Sign Up
Patent: 18172424
Estimated Expiration: ⤷ Sign Up
Patent: 19048901
Estimated Expiration: ⤷ Sign Up
Patent: 20090536
Estimated Expiration: ⤷ Sign Up
Patent: 20097635
Estimated Expiration: ⤷ Sign Up
Patent: 22065066
Estimated Expiration: ⤷ Sign Up
Patent: 22068297
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 12174
Estimated Expiration: ⤷ Sign Up
Patent: 66295
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 5823
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 17005250
Estimated Expiration: ⤷ Sign Up
Patent: 17005252
Estimated Expiration: ⤷ Sign Up
Patent: 20012560
Estimated Expiration: ⤷ Sign Up
Moldova, Republic of
Patent: 170046
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 070
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 867
Estimated Expiration: ⤷ Sign Up
Patent: 872
Estimated Expiration: ⤷ Sign Up
Patent: 201
Estimated Expiration: ⤷ Sign Up
Patent: 506
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0803
Estimated Expiration: ⤷ Sign Up
Patent: 0809
Estimated Expiration: ⤷ Sign Up
Patent: 5328
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 171439
Estimated Expiration: ⤷ Sign Up
Patent: 180202
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 017500631
Estimated Expiration: ⤷ Sign Up
Patent: 020551055
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 12174
Estimated Expiration: ⤷ Sign Up
Patent: 12175
Estimated Expiration: ⤷ Sign Up
Patent: 66295
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 12174
Estimated Expiration: ⤷ Sign Up
Patent: 12175
Estimated Expiration: ⤷ Sign Up
Patent: 66295
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 7381419
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 425
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202008772U
Estimated Expiration: ⤷ Sign Up
Patent: 201702903T
Estimated Expiration: ⤷ Sign Up
Patent: 201702904R
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 12174
Estimated Expiration: ⤷ Sign Up
Patent: 12175
Estimated Expiration: ⤷ Sign Up
Patent: 66295
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1800414
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1822348
Estimated Expiration: ⤷ Sign Up
Patent: 2337664
Estimated Expiration: ⤷ Sign Up
Patent: 2453808
Estimated Expiration: ⤷ Sign Up
Patent: 170066665
Estimated Expiration: ⤷ Sign Up
Patent: 170067898
Estimated Expiration: ⤷ Sign Up
Patent: 170077167
Estimated Expiration: ⤷ Sign Up
Patent: 210152015
Estimated Expiration: ⤷ Sign Up
Patent: 220140656
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 74806
Estimated Expiration: ⤷ Sign Up
Patent: 85034
Estimated Expiration: ⤷ Sign Up
Patent: 04298
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 87432
Estimated Expiration: ⤷ Sign Up
Patent: 98444
Estimated Expiration: ⤷ Sign Up
Patent: 40546
Estimated Expiration: ⤷ Sign Up
Patent: 67201
Estimated Expiration: ⤷ Sign Up
Patent: 1629076
Estimated Expiration: ⤷ Sign Up
Patent: 1630925
Estimated Expiration: ⤷ Sign Up
Patent: 2039526
Estimated Expiration: ⤷ Sign Up
Patent: 2115098
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1809518
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 1485
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 376
Estimated Expiration: ⤷ Sign Up
Patent: 464
Estimated Expiration: ⤷ Sign Up
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) | ⤷ Sign Up |
| Poland | 3785717 | ⤷ Sign Up | |
| European Patent Office | 3212174 | MÉTHODES POUR LE TRAITEMENT D'INFECTIONS VIRALES À FILOVIRIDAE (METHODS FOR TREATING FILOVIRIDAE VIRUS INFECTIONS) | ⤷ Sign Up |
| Australia | 2009240630 | Carba-nucleoside analogs for antiviral treatment | ⤷ Sign Up |
| New Zealand | 730803 | Methods for the preparation of ribosides | ⤷ Sign Up |
| Portugal | 2280973 | ⤷ Sign Up | |
| Lithuania | C2937350 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VEKLURY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2595980 | 53/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: REMDESIVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER ESTER DAVON; REGISTRATION NO/DATE: EU/1/20/1459 (MITTEILUNG) 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 | LUC00193 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/20/1459 20200703 |
| 2595980 | C202030068 | Spain | ⤷ Sign Up | 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 |
| 2595980 | 20C1065 | France | ⤷ Sign Up | PRODUCT NAME: REMDESIVIR OU UN SEL OU UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1459 20200703 |
| 2595980 | 2090055-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: REMDESIVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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