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Generated: December 14, 2018

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TIVICAY Drug Profile

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When do Tivicay patents expire, and what generic alternatives are available?

Tivicay is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seven patent family members in thirty-one countries.

The generic ingredient in TIVICAY is dolutegravir sodium. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.

Drug patent expirations by year for TIVICAY
Generic Entry Opportunity Date for TIVICAY
Generic Entry Date for TIVICAY*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Synonyms for TIVICAY
1051375-19-9
1Q1V9V5WYQ
AK174049
AKOS025396662
B5856
CHEBI:76007
CHEMBL1213165
CS-3496
D10113
Dolutegravir (sodium)
DOLUTEGRAVIR SODIUM
Dolutegravir sodium (JAN/USAN)
Dolutegravir sodium [USAN]
EX-A1694
FT-0697030
GSK 1349572A
GSK-1349572A
GSK1349572 sodiuM salt
GSK1349572A
HY-13238A
KS-00000T34
MolPort-039-136-625
s4642
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-3,4,6,8,12,12a-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-3,4,6
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 TIVICAY

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 204790-002 Jun 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-003 Jun 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-002 Jun 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-001 Aug 12, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-003 Jun 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-002 Jun 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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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Paragraph IV (Patent) Challenges for TIVICAY
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 10 mg, 25 mg and 50 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for TIVICAY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117/01 Switzerland ➤ Sign Up PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
0676 Netherlands ➤ Sign Up PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
2014021 Lithuania ➤ Sign Up PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
90036-9 Sweden ➤ Sign Up PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
2014 00032 Denmark ➤ Sign Up PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
2 50006-2014 Slovakia ➤ Sign Up PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Healthtrust
US Army
Moodys
Colorcon
QuintilesIMS
Deloitte
Johnson and Johnson
Cantor Fitzgerald

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