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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Colorcon
Daiichi Sankyo
Accenture
Express Scripts
QuintilesIMS
Chinese Patent Office
Harvard Business School
Julphar

Generated: July 16, 2018

DrugPatentWatch Database Preview

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 seven patent family members in thirty-one countries.

The generic ingredient in TIVICAY is dolutegravir sodium. There are fifteen 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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
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 TIVICAY dolutegravir sodium TABLET;ORAL 204790-002 Jun 9, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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 ➤ 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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Paragraph IV (Patent) Challenges for TIVICAY
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 10 mg, 25 mg and 50 mg ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for TIVICAY

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,051,337 Substituted 10-hydroxy-9,11-dioxo-2,3,4a,5,9,11,13,13a-octahydro-1h-pyrido[1,2-a]pyrr- olo[1',2':3,4]imidazo[1,2-d]pyrazine-8-carboxamides ➤ Try a Free Trial
9,273,065 Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors ➤ Try a Free Trial
7,858,788 Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity ➤ Try a Free Trial
8,624,023 Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for TIVICAY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140020 00130 Estonia ➤ Try a Free Trial PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
2014021,C1874117 Lithuania ➤ Try a Free 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
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
14/032 Ireland ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Mallinckrodt
Federal Trade Commission
Chubb
Daiichi Sankyo
Colorcon
Fish and Richardson
Boehringer Ingelheim

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.