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Dolutegravir sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dolutegravir sodium?

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

Dolutegravir sodium has eighty-one patent family members in thirty countries.

There are nine drug master file entries for dolutegravir sodium. Three suppliers are listed for this compound.

Summary for Generic Name: dolutegravir sodium

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packagers: see list3
Clinical Trials: see list957
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dolutegravir sodium at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date 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
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-002Jun 9, 2016RXYesNo8,129,385► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-001Aug 12, 2013RXYesYes8,129,385► SubscribeYY ► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-003Jun 9, 2016RXYesNo► Subscribe► Subscribe
Viiv Hlthcare
TIVICAY
dolutegravir sodium
TABLET;ORAL204790-001Aug 12, 2013RXYesYes► Subscribe► 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
7,858,788Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity► Subscribe
9,273,065Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors► Subscribe
9,365,587Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► Subscribe
8,754,214Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► Subscribe
8,188,271Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity► 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
Cyprus1115151► Subscribe
Eurasian Patent Organization200801144► Subscribe
Taiwan201030010► Subscribe
European Patent Office1950212► Subscribe
China101212903► 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
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
/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
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
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
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
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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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