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Last Updated: March 30, 2020

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Dolutegravir sodium - Generic Drug Details

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What are the generic drug sources for dolutegravir sodium and what is the scope of freedom to operate?

Dolutegravir sodium is the generic ingredient in three branded drugs marketed by Viiv Hlthcare and is included in three NDAs. There are eight 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 thirty patent family members in thirty-three countries.

There are seventeen drug master file entries for dolutegravir sodium. Three suppliers are listed for this compound. There are five 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

Recent Litigation for dolutegravir sodium

Identify potential future generic entrants

District Court Litigation
Case NameDate
ViiV Healthcare Company v. Gilead Sciences, Inc.2018-02-07
ViiV Healthcare Company v. Sandoz Inc.2017-12-11
ViiV Healthcare Company v. Cipla Limited2017-12-04

See all dolutegravir sodium litigation

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

Synonyms for dolutegravir sodium
1051375-19-9
1Q1V9V5WYQ
AK174049
AKOS025396662
AS-57143
B5856
BCP11890
CHEBI:76007
CHEMBL1213165
CS-3496
D10113
Dolutegravir (sodium)
Dolutegravir Sodium ( API)
Dolutegravir sodium (JAN/USAN)
Dolutegravir sodium [USAN]
dolutegravir-sodium
EX-A1694
FT-0697030
GSK 1349572A
GSK-1349572A
GSK1349572 sodiuM salt
GSK1349572A
GSK1349572sodiuMsalt;DOLUTEGRAVIRSODIUM;GSK1349572A;Dolutegravir sodiuM salt;Dolutegravir SodiuM ( API)
HY-13238A
KS-00000T34
Q27145679
s4642
SCHEMBL19859120
Sodium (4R,12aS)-9-((2,4-difluorobenzyl)carbamoyl)-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate;Sodium (4R,12aS)-9-((2,4-difluorobenzyl)carbamoyl)-4-methyl-6,8-dioxo-3,
sodium (4R,12aS)-9-[(2,4-difluorobenzyl)carbamoyl]-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate
Tivicay (TN)
UNII-1Q1V9V5WYQ
Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM
Tradename Dosage Ingredient NDA Submissiondate
TIVICAY TABLET;ORAL dolutegravir sodium 204790 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 JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-003 Jun 9, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-001 Aug 12, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   Start 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
2932970 2018C/041 Belgium   Start 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 122014000066 Germany   Start Trial PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
1874117 2014/032 Ireland   Start Trial PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117 C20140020 00130 Estonia   Start Trial PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
1874117 PA2014021,C1874117 Lithuania   Start 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
1874117 C 2014 024 Romania   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Mallinckrodt
Colorcon
Moodys
Dow

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