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Last Updated: March 18, 2024

Dolutegravir sodium - Generic Drug Details


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

Dolutegravir sodium is the generic ingredient in four branded drugs marketed by Viiv Hlthcare and is included in four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium has one hundred and fifty-three patent family members in thirty-five countries.

There are seventeen drug master file entries for dolutegravir sodium. Two suppliers are listed for this compound. There are eight tentative approvals for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium
Generic Entry Dates for dolutegravir sodium*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, FOR SUSPENSION;ORAL
Generic Entry Dates for dolutegravir sodium*:
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.

Recent Clinical Trials for dolutegravir sodium

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

SponsorPhase
St Stephens Aids TrustPhase 4

See all dolutegravir sodium clinical trials

Generic filers with tentative approvals for DOLUTEGRAVIR SODIUM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial50MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial50MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial50MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TIVICAY PD Tablets for Suspension dolutegravir sodium 5 mg 213983 1 2021-07-21
TIVICAY Tablets dolutegravir sodium 10 mg, 25 mg and 50 mg 204790 4 2017-08-14

US Patents and Regulatory Information for dolutegravir sodium

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 JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-002 Jun 9, 2016 DISCN Yes No ⤷  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

Supplementary Protection Certificates for dolutegravir sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 C 2014 024 Romania ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2932970 2018C/041 Belgium ⤷  Try a Trial PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD DOLUTEGRAVIRNATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD RILPIVIRINEHYDROCHLORIDE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
1874117 PA2014021,C1874117 Lithuania ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 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.