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Serving leading biopharmaceutical companies globally:

Baxter
Queensland Health
Argus Health
Dow
Novartis
Accenture
Chubb
Boehringer Ingelheim
Harvard Business School
Medtronic

Generated: December 16, 2017

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Dolutegravir sodium - Generic Drug Details

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What are the generic sources for dolutegravir sodium and what is the scope of dolutegravir sodium patent protection?

Dolutegravir sodium
is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are fifteen drug master file entries for dolutegravir sodium. Two suppliers are listed for this compound.
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;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► SubscribeYY► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► SubscribeYY► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-003Jun 9, 2016RXYesNo► 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;ORAL204790-002Jun 9, 2016RXYesNo► Subscribe► SubscribeYY► Subscribe
Viiv HlthcareTIVICAYdolutegravir sodiumTABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► SubscribeYY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: dolutegravir sodium

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
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
8,624,023Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► Subscribe
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
9,273,065Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors► 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
7,858,788Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity► Subscribe
8,188,271Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity► Subscribe
9,365,587Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► 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 Ingredient: dolutegravir sodium

Country Document Number Estimated Expiration
European Patent Office1852434► Subscribe
Japan5086478► Subscribe
Eurasian Patent Organization200801144► Subscribe
Mexico302718► Subscribe
Eurasian Patent Organization014162► Subscribe
JapanWO2006088173► Subscribe
Eurasian Patent Organization200702080► Subscribe
Portugal2465580► Subscribe
Austria516026► Subscribe
Spain2569357► 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: DOLUTEGRAVIR SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00032Denmark► SubscribePRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
/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
2 50006-2014Slovakia► SubscribePRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 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
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
0140020 00130Estonia► SubscribePRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
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
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
2014021Lithuania► SubscribePRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
00676Netherlands► SubscribePRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
Citi
Chubb
Fish and Richardson
Teva
Cerilliant
Healthtrust
Boehringer Ingelheim
AstraZeneca

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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