Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Federal Trade Commission
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Cantor Fitzgerald
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Generated: September 18, 2019

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Dolutegravir sodium - Generic Drug Details

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

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

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

Synonyms for dolutegravir sodium
1051375-19-9
1Q1V9V5WYQ
AK174049
AKOS025396662
B5856
BCP11890
CHEBI:76007
CHEMBL1213165
CS-3496
D10113
Dolutegravir (sodium)
Dolutegravir Sodium ( API)
Dolutegravir sodium (JAN/USAN)
Dolutegravir sodium [USAN]
Dolutegravir sodium(GSK1349572)
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
MolPort-039-136-625
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
Tivicay (TN)
UNII-1Q1V9V5WYQ

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 TIVICAY dolutegravir sodium TABLET;ORAL 204790-003 Jun 9, 2016 RX Yes No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-001 Aug 12, 2013 RX Yes Yes   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-001 Aug 12, 2013 RX Yes Yes   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
>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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Supplementary Protection Certificates for dolutegravir sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 14C0041 France   Try a Free Trial 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 C 2014 024 Romania   Try a Free 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
1874117 202 50006-2014 Slovakia   Try a Free Trial PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
1874117 300676 Netherlands   Try a Free Trial PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
1874117 2014C/038 Belgium   Try a Free Trial PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121
1874117 122014000066 Germany   Try a Free 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 CR 2014 00032 Denmark   Try a Free Trial PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
>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 verifification 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.