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Serving leading biopharmaceutical companies globally:

Argus Health
Colorcon
Farmers Insurance
McKesson
McKinsey
Johnson and Johnson
Medtronic
Teva
US Army
Daiichi Sankyo

Generated: October 18, 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. 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. Three suppliers are listed for this compound.

Summary for Generic Name: dolutegravir sodium

US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list15
Suppliers / Packagers: see list3
Clinical Trials: see list2,494
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dolutegravir sodium 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;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► Subscribe► 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;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► Subscribe► 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► Subscribe► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-002Jun 9, 2016RXYesNo► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-003Jun 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
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 Ingredient: dolutegravir sodium

Country Document Number Estimated Expiration
Norway20075165► Subscribe
JapanWO2006088173► Subscribe
Norway20081892► Subscribe
European Patent Office1852434► Subscribe
World Intellectual Property Organization (WIPO)2007049675► Subscribe
China101346376► Subscribe
SloveniaEP2465580► Subscribe
Morocco29460► Subscribe
BrazilPI0923217► Subscribe
Israel190879► 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
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
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
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
2014000066Germany► SubscribePRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
1874117/01Switzerland► SubscribePRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
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
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
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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Fuji
Colorcon
Cerilliant
Healthtrust
Farmers Insurance
Moodys
Accenture
Citi
Federal Trade Commission

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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