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Last Updated: January 27, 2023

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 seven 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-two patent family members in thirty-four 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.

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
See Plans and PricingSee Plans and Pricing50MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing50MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing50MGTABLET;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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-003 Jun 9, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare TIVICAY PD dolutegravir sodium TABLET, FOR SUSPENSION;ORAL 213983-001 Jun 12, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-002 Jun 9, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Country Patent Number Title Estimated Expiration
Singapore 171308 SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES See Plans and Pricing
Eurasian Patent Organization 200801144 ПОЛИЦИКЛИЧЕСКОЕ КАРБАМОИЛПИРИДОНОВОЕ ПРОИЗВОДНОЕ, ОБЛАДАЮЩЕЕ ИНГИБИТОРНОЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ ИНТЕГРАЗЫ ВИЧ See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006116764 See Plans and Pricing
Spain 2743531 See Plans and Pricing
Luxembourg C00210 See Plans and Pricing
Norway 340111 See Plans and Pricing
Netherlands 300676 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dolutegravir sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2932970 18C1043 France See Plans and Pricing PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
2465580 LUC00210 Luxembourg See Plans and Pricing PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
1874117 C01874117/01 Switzerland See Plans and Pricing PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
2932970 PA2018013,C2932970 Lithuania See Plans and Pricing PRODUCT NAME: DERINYS, APIMANTIS DOLUTEGRAVIRA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., DOLUTEGRAVIRO NATRIO DRUSKA) IR RILPIVIRINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., RILPIVIRINO HIDROCHLORIDA); REGISTRATION NO/DATE: EU/1/18/1282/001-002 20180516
2932970 CR 2018 00036 Denmark See Plans and Pricing PRODUCT NAME: KOMBINATION AF DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. DOLUTEGRAVIRNATRIUM, OG RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. RILPIVIRINHYDROCHLORID; REG. NO/DATE: EU/1/18/1282/001-002 20180518
1874117 14C0041 France See Plans and Pricing PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117 CA 2014 00032 Denmark See Plans and Pricing PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
Johnson and Johnson
AstraZeneca
Merck
Moodys

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