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Last Updated: March 28, 2024

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VEKLURY Drug Patent Profile


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When do Veklury patents expire, and what generic alternatives are available?

Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen 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

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Summary for VEKLURY
International Patents:324
US Patents:13
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
Drug patent expirations by year for VEKLURY
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

SponsorPhase
Mansoura University HospitalPhase 4
PharmaMarPhase 3
ASST Fatebenefratelli SaccoPhase 3

See all VEKLURY clinical trials

Pharmacology for VEKLURY

US Patents and Regulatory Information for VEKLURY

VEKLURY is protected by thirteen 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

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
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
Croatia P20180572 ⤷  Try a Trial
Croatia P20220740 ⤷  Try a Trial
Japan 7158428 ⤷  Try a Trial
Slovenia 2280973 ⤷  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 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 132020000000176 Italy ⤷  Try a Trial 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 Lithuania ⤷  Try a Trial PRODUCT NAME: REMDESIVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1459 20200703
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
>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.