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Last Updated: May 17, 2024

DOLUTEGRAVIR SODIUM; LAMIVUDINE - Generic Drug Details


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What are the generic sources for dolutegravir sodium; lamivudine and what is the scope of patent protection?

Dolutegravir sodium; lamivudine is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium; lamivudine has two hundred and eighty patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for DOLUTEGRAVIR SODIUM; LAMIVUDINE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DOLUTEGRAVIR SODIUM; LAMIVUDINE
Generic Entry Date for DOLUTEGRAVIR SODIUM; LAMIVUDINE*:
Constraining patent/regulatory exclusivity:
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.

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM; LAMIVUDINE
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 DOLUTEGRAVIR SODIUM; LAMIVUDINE

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 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

International Patents for DOLUTEGRAVIR SODIUM; LAMIVUDINE

Country Patent Number Title Estimated Expiration
Australia 2017268621 ANTIVIRAL THERAPY ⤷  Try a Trial
South Korea 101363875 ⤷  Try a Trial
Eurasian Patent Organization 032868 КОМБИНАЦИЯ ДЛЯ ЛЕЧЕНИЯ ВИЧ-ИНФЕКЦИИ (COMBINATION FOR TREATING HIV INFECTION) ⤷  Try a Trial
Colombia 6602152 En respuesta al requerimiento de pago de reivindicaciones adicionales a las 10 primeras,presenta nuevo capítulo reivindicatorio y paga. ⤷  Try a Trial
Eurasian Patent Organization 202190473 ПРОТИВОВИРУСНАЯ ТЕРАПИЯ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DOLUTEGRAVIR SODIUM; LAMIVUDINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 122014000066 Germany ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
2465580 PA2021512,C2465580 Lithuania ⤷  Try a Trial PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
1874117 SPC/GB14/041 United Kingdom ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
1874117 C201430032 Spain ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR O UNA SAL O SOLVATO DEL MISMO FARMACEUTICAMENTE ACEPTABLE, INCLUIDA LA SAL SODICA DE DOLUTEGRAVIR.; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2932970 C20180031 00270 Estonia ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIIR/RILPIVIRIIN;REG NO/DATE: EU/1/18/1282 18.05.2018
>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.