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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
QuintilesIMS
Julphar
US Army
Healthtrust
Accenture
Chinese Patent Office
Moodys
Colorcon

Generated: October 19, 2017

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.

This drug has one hundred patent family members in thirty-one countries and fourteen supplementary protection certificates in eleven countries.

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

Summary for Tradename: TIVICAY

US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list41
Clinical Trials: see list19
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TIVICAY at DailyMed
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;ORAL204790-002Jun 9, 2016RXYesNo► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-002Jun 9, 2016RXYesNo► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-002Jun 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: 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
9,051,337Substituted 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► Subscribe
7,858,788Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity► Subscribe
8,754,214Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► Subscribe
9,365,587Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► Subscribe
8,410,103(3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent► Subscribe
8,778,943Substituted 10-hydroxy-9,11-dioxo-2,3,4a,5,9,11,13,13a-octahydro-1h-pyrido[1,2-.alpha- .]pyrrolo[1',2':3,4]imidazo[1,2-d]pyrazine-8-carboxamides► Subscribe
9,273,065Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors► Subscribe
8,188,271Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity► Subscribe
8,624,023Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: TIVICAY

Country Document Number Estimated Expiration
European Patent Office2527007► Subscribe
European Patent Office2465580► Subscribe
Spain2567197► Subscribe
Denmark1874117► Subscribe
South Korea20160003889► Subscribe
Mexico2011006241► Subscribe
Japan5317257► Subscribe
World Intellectual Property Organization (WIPO)2007049675► Subscribe
China101346376► Subscribe
Norway20075165► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TIVICAY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014021Lithuania► SubscribePRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
/2014Austria► SubscribePRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DELUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121
0140020 00130Estonia► SubscribePRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
1874117/01Switzerland► SubscribePRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
2014000066Germany► SubscribePRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
90036-9Sweden► SubscribePRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
2014 00032Denmark► SubscribePRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116
14/032Ireland► SubscribePRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
C0041France► SubscribePRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2 50006-2014Slovakia► SubscribePRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Chubb
McKesson
Cipla
Accenture
Teva
Fish and Richardson
Fuji
McKinsey
Johnson and Johnson

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.

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