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

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Cipla
Colorcon
Fuji
US Department of Justice

Generated: September 17, 2019

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TIVICAY Drug Profile

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Which patents cover Tivicay, and when can generic versions of Tivicay launch?

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 twenty patent family members in thirty-three countries.

The generic ingredient in TIVICAY is dolutegravir sodium. There are seventeen drug master file entries for this compound. Four 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
(3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-
(3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.0^{3,8}]tetradeca-10,13-diene-13-carboxamide
(4R,12aS)-N-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-[1,3]oxazino[3,2-a]pyrido[1,2-d]pyrazine-9-carboxamide
(4R,12aS)-N-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1,2:4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide
(4r,12as)-N-(2,4-Difluorobenzyl)-7-Hydroxy-4-Methyl-6,8-Dioxo-3,4,6,8,12,12a-Hexahydro-2h-Pyrido[1',2':4,5]pyrazino[2,1-B][1,3]oxazine-9-Carboxamide
(4R,12aS)-N-[(2,4-Difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1 ,3]oxazine-9-carboxamide
(4R,12aS)-N-[(2,4-Difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide
(4R,12aS)-N-[(2,4-difluorophenyl)methyl]-7-hydroxy-4-methyl-6,8-dioxo-3,4,12,12a-tetrahydro-2H-pyrido[[?]:[?]]pyrazino[[?]][1,3]oxazine-9-carboxamide
(4R,12aS)-N-[(2,4-difluorophenyl)methyl]-7-hydroxy-4-methyl-6,8-dioxo-3,4,12,12a-tetrahydro-2H-pyrido[5,6]pyrazino[2,6-b][1,3]oxazine-9-carboxamide
1051375-16-6
1172581-47-3
3s3m
3s3n
3s3o
A4074
AB0033823
ABP000915
AC-28371
AKOS025396657
AOB87150
API0013713
BC638753
BCP9000620
BDBM50062551
C20H19F2N3O5
cc-13
CHEBI:76010
CHEMBL1229211
CS-0454
D10066
DB08930
diazatricyclo[8.4.0.0?,?]tetradeca-10,13-diene-13-
DKO1W9H7M1
DLU
Dolutegravir
Dolutegravir (GSK1349572)
Dolutegravir (USAN)
Dolutegravir [USAN:INN]
Dolutegravir Sodium ( API)
EX-A1695
FT-0701265
GSK 1349572
GSK 1349572; Soltegravir; Tivicay
GSK-1349572
GSK1349572
GTPL7365
HSDB 8152
HY-13238
J-501471
KB-76707
methyl-9,12-dioxo-4-oxa-1,8-
MLS006011137
MolPort-023-293-507
NCGC00346629-01
PB33506
Q-4931
QCR-34
RHWKPHLQXYSBKR-BMIGLBTASA-N
RL00238
S-349572
S-GSK1349572
S/GSK-1349572
S/GSK1349572
S/GSK1349572,GSK1349572
s2667
SC-85939
SCHEMBL82071
SMR004702915
Tivicay (TN)
UNII-DKO1W9H7M1
X7595
ZINC58581064

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 204790-001 Aug 12, 2013 RX Yes Yes ➤ 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 Y Y ➤ Sign Up
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-001 Aug 12, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ 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
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-002 Jun 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 1490036-9 Sweden ➤ Sign Up PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
1874117 517 Finland ➤ Sign Up
1874117 122014000066 Germany ➤ Sign Up PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
1874117 2014C/038 Belgium ➤ Sign Up PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121
1874117 300676 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
1874117 2014/032 Ireland ➤ Sign Up PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
McKesson
Queensland Health
Mallinckrodt
Moodys
Teva

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.