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Last Updated: May 29, 2024

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DOVATO Drug Patent Profile


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

Dovato is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eighty patent family members in forty-nine countries.

The generic ingredient in DOVATO is dolutegravir sodium; lamivudine. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; lamivudine profile page.

DrugPatentWatch® Generic Entry Outlook for Dovato

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2031. This may change due to patent challenges or generic licensing.

There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for DOVATO
International Patents:280
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 45
Clinical Trials: 7
Patent Applications: 49
Formulation / Manufacturing:see details
Drug Prices: Drug price information for DOVATO
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for DOVATO
What excipients (inactive ingredients) are in DOVATO?DOVATO excipients list
DailyMed Link:DOVATO at DailyMed
Drug patent expirations by year for DOVATO
Drug Prices for DOVATO

See drug prices for DOVATO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DOVATO
Generic Entry Date for DOVATO*:
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Constraining patent/regulatory exclusivity:
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NDA:
211994
Dosage:
TABLET;ORAL

*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 DOVATO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ViiV HealthcarePhase 1
Saint Michael's Medical CenterPhase 4
Societa' Italiana Di Malattie Infettive E TropicaliPhase 3

See all DOVATO clinical trials

Pharmacology for DOVATO
Drug ClassHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of ActionHIV Integrase Inhibitors
Multidrug and Toxin Extrusion Transporter 1 Inhibitors
Nucleoside Reverse Transcriptase Inhibitors
Organic Cation Transporter 2 Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for DOVATO
J05AF Nucleoside and nucleotide reverse transcriptase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J05AJ Integrase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
Paragraph IV (Patent) Challenges for DOVATO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DOVATO Tablets dolutegravir sodium; lamivudine 50 mg/300 mg 211994 1 2019-07-30

US Patents and Regulatory Information for DOVATO

DOVATO is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DOVATO 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 DOVATO

Antiviral therapy
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 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

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International Patents for DOVATO

When does loss-of-exclusivity occur for DOVATO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 51
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 11209788
Estimated Expiration: ⤷  Sign Up

Patent: 14202404
Estimated Expiration: ⤷  Sign Up

Patent: 14202405
Estimated Expiration: ⤷  Sign Up

Patent: 14202406
Estimated Expiration: ⤷  Sign Up

Patent: 16204987
Estimated Expiration: ⤷  Sign Up

Patent: 17268621
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012018670
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 87691
Estimated Expiration: ⤷  Sign Up

Patent: 67453
Estimated Expiration: ⤷  Sign Up

Patent: 03988
Estimated Expiration: ⤷  Sign Up

Patent: 60290
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 12002080
Estimated Expiration: ⤷  Sign Up

China

Patent: 2791129
Estimated Expiration: ⤷  Sign Up

Patent: 5311033
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 02152
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 120423
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0150770
Estimated Expiration: ⤷  Sign Up

Patent: 0180855
Estimated Expiration: ⤷  Sign Up

Patent: 0181531
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 16509
Estimated Expiration: ⤷  Sign Up

Patent: 20457
Estimated Expiration: ⤷  Sign Up

Patent: 21040
Estimated Expiration: ⤷  Sign Up

Patent: 18029
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 31027
Estimated Expiration: ⤷  Sign Up

Patent: 32970
Estimated Expiration: ⤷  Sign Up

Patent: 27542
Estimated Expiration: ⤷  Sign Up

Patent: 94972
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 012000205
Estimated Expiration: ⤷  Sign Up

Patent: 021000147
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 12012106
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 5176
Estimated Expiration: ⤷  Sign Up

Patent: 2868
Estimated Expiration: ⤷  Sign Up

Patent: 7601
Estimated Expiration: ⤷  Sign Up

Patent: 1290583
Estimated Expiration: ⤷  Sign Up

Patent: 1690872
Estimated Expiration: ⤷  Sign Up

Patent: 1892277
Estimated Expiration: ⤷  Sign Up

Patent: 2190473
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 31027
Estimated Expiration: ⤷  Sign Up

Patent: 32970
Estimated Expiration: ⤷  Sign Up

Patent: 27542
Estimated Expiration: ⤷  Sign Up

Patent: 51249
Estimated Expiration: ⤷  Sign Up

Patent: 94972
Estimated Expiration: ⤷  Sign Up

Patent: 16599
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 94972
Estimated Expiration: ⤷  Sign Up

France

Patent: C1043
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 79522
Estimated Expiration: ⤷  Sign Up

Patent: 09629
Estimated Expiration: ⤷  Sign Up

Patent: 50335
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 26849
Estimated Expiration: ⤷  Sign Up

Patent: 37812
Estimated Expiration: ⤷  Sign Up

Patent: 40554
Estimated Expiration: ⤷  Sign Up

Patent: 800042
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1007
Estimated Expiration: ⤷  Sign Up

Patent: 5182
Estimated Expiration: ⤷  Sign Up

Patent: 7267
Estimated Expiration: ⤷  Sign Up

Patent: 7658
Estimated Expiration: ⤷  Sign Up

Patent: 1959
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 68386
Estimated Expiration: ⤷  Sign Up

Patent: 13518107
Estimated Expiration: ⤷  Sign Up

Patent: 16145204
Estimated Expiration: ⤷  Sign Up

Patent: 17008087
Estimated Expiration: ⤷  Sign Up

Patent: 18127473
Estimated Expiration: ⤷  Sign Up

Patent: 19167371
Estimated Expiration: ⤷  Sign Up

Patent: 21091705
Estimated Expiration: ⤷  Sign Up

Patent: 22071126
Estimated Expiration: ⤷  Sign Up

Patent: 23085431
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 932970
Estimated Expiration: ⤷  Sign Up

Patent: 2018013
Estimated Expiration: ⤷  Sign Up

Patent: 32970
Estimated Expiration: ⤷  Sign Up

Patent: 27542
Estimated Expiration: ⤷  Sign Up

Patent: 94972
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0090
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 8334
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 6891
Estimated Expiration: ⤷  Sign Up

Patent: 7937
Estimated Expiration: ⤷  Sign Up

Patent: 7938
Estimated Expiration: ⤷  Sign Up

Patent: 12008774
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 182
Estimated Expiration: ⤷  Sign Up

Patent: 058
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 002
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 1319
Estimated Expiration: ⤷  Sign Up

Patent: 7824
Estimated Expiration: ⤷  Sign Up

Patent: 7826
Estimated Expiration: ⤷  Sign Up

Patent: 7827
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 18036
Estimated Expiration: ⤷  Sign Up

Patent: 32970
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 121524
Estimated Expiration: ⤷  Sign Up

Patent: 160180
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 016500195
Estimated Expiration: ⤷  Sign Up

Patent: 018502489
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 31027
Estimated Expiration: ⤷  Sign Up

Patent: 32970
Estimated Expiration: ⤷  Sign Up

Patent: 27542
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 31027
Estimated Expiration: ⤷  Sign Up

Patent: 32970
Estimated Expiration: ⤷  Sign Up

Patent: 27542
Estimated Expiration: ⤷  Sign Up

Patent: 94972
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01500177
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 123
Estimated Expiration: ⤷  Sign Up

Patent: 323
Estimated Expiration: ⤷  Sign Up

Patent: 728
Estimated Expiration: ⤷  Sign Up

Patent: 183
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 2614
Estimated Expiration: ⤷  Sign Up

Patent: 201509476R
Estimated Expiration: ⤷  Sign Up

Patent: 201707183T
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 31027
Estimated Expiration: ⤷  Sign Up

Patent: 32970
Estimated Expiration: ⤷  Sign Up

Patent: 27542
Estimated Expiration: ⤷  Sign Up

Patent: 94972
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1205586
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1830715
Estimated Expiration: ⤷  Sign Up

Patent: 1883750
Estimated Expiration: ⤷  Sign Up

Patent: 1964923
Estimated Expiration: ⤷  Sign Up

Patent: 120128640
Estimated Expiration: ⤷  Sign Up

Patent: 160111536
Estimated Expiration: ⤷  Sign Up

Patent: 170078868
Estimated Expiration: ⤷  Sign Up

Patent: 180078358
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 43066
Estimated Expiration: ⤷  Sign Up

Patent: 70811
Estimated Expiration: ⤷  Sign Up

Patent: 88925
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 12000376
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1807704
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 5556
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 DOVATO around the world.

Country Patent Number Title Estimated Expiration
South Korea 20080009733 POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY ⤷  Sign Up
South Korea 101847887 ⤷  Sign Up
Cyprus 1120345 ⤷  Sign Up
Slovenia 3127542 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for DOVATO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2932970 PA2018013 Lithuania ⤷  Sign Up PRODUCT NAME: DERINYS, APIMANTIS DOLUTEGRAVIRA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., DOLUTEGRAVIRO NATRI) IR RILPIVIRINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., RILPIVIRINO HIDROCHLORIDA); REGISTRATION NO/DATE: EU/1/18/1282/001-002 20180516
1874117 CR 2014 00032 Denmark ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
2465580 2190020-4 Sweden ⤷  Sign Up PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221
1874117 1490036-9 Sweden ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
>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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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