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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
McKesson
UBS
Teva
Medtronic
AstraZeneca
Accenture
Novartis
Citi

Generated: December 18, 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 and one Paragraph IV challenge.

This drug has one hundred and two patent family members in thirty-one countries and fifteen supplementary protection certificates in twelve 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-002Jun 9, 2016RXYesNo► Subscribe► SubscribeYY► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► SubscribeYY► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► SubscribeYY► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► SubscribeYY► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-002Jun 9, 2016RXYesNo► Subscribe► SubscribeYY► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-002Jun 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► SubscribeYY► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for TIVICAY

Drugname Dosage Strength RLD Submissiondate
dolutegravir sodiumTablets10 mg, 25 mg and 50 mgTivicay8/14/2017

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
9,365,587Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► Subscribe
7,858,788Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity► Subscribe
8,624,023Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► Subscribe
9,273,065Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors► 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
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
8,188,271Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity► Subscribe
8,754,214Synthesis 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
Spain2569357► Subscribe
Taiwan201030010► Subscribe
European Patent Office3187225► Subscribe
Eurasian Patent Organization014162► Subscribe
Canada2955957► Subscribe
Eurasian Patent Organization200801144► Subscribe
South Korea20080064182► Subscribe
Japan5848595► Subscribe
Netherlands300676► Subscribe
South Korea101733625► 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
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
2014021Lithuania► SubscribePRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
90036-9Sweden► SubscribePRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
7Finland► Subscribe
2014021,C1874117Lithuania► SubscribePRODUCT 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
1874117/01Switzerland► SubscribePRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
/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
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
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
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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Serving leading biopharmaceutical companies globally:

Deloitte
Julphar
Novartis
Daiichi Sankyo
AstraZeneca
Colorcon
McKinsey
Express Scripts
Teva
QuintilesIMS

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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