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Serving leading biopharmaceutical companies globally:

Medtronic
Daiichi Sankyo
McKesson
Queensland Health
Deloitte
Argus Health
Express Scripts
Farmers Insurance
US Department of Justice
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Generated: October 20, 2017

DrugPatentWatch Database Preview

Abacavir sulfate; dolutegravir sodium; lamivudine - Generic Drug Details

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

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

Abacavir sulfate; dolutegravir sodium; lamivudine has two hundred and eighty-one patent family members in sixty-one countries and twenty-nine supplementary protection certificates in fifteen countries.

There are eleven drug master file entries for abacavir sulfate; dolutegravir sodium; lamivudine. One supplier is listed for this compound.

Summary for Generic Name: abacavir sulfate; dolutegravir sodium; lamivudine

US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list11
Suppliers / Packagers: see list1
Clinical Trials: see list3,632
Drug Prices:see low prices
DailyMed Link:abacavir sulfate; dolutegravir sodium; lamivudine 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
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: abacavir sulfate; dolutegravir sodium; lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014► Subscribe► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: abacavir sulfate; dolutegravir sodium; lamivudine

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: abacavir sulfate; dolutegravir sodium; lamivudine

Country Document Number Estimated Expiration
BrazilPI0923217► Subscribe
Germany69232387► Subscribe
Indonesia24910► Subscribe
Israel190879► Subscribe
Austria516026► Subscribe
JapanH10511682► Subscribe
Japan2001525840► Subscribe
Canada2955957► Subscribe
Denmark2465580► Subscribe
Argentina012702► 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: ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8Finland► Subscribe
0195Netherlands► Subscribe300195, 20160328, EXPIRES: 20191216
90028Netherlands► SubscribePRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
0028Netherlands► SubscribePRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
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
90036-9Sweden► SubscribePRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
99C0033Belgium► SubscribePRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
/2005Austria► SubscribePRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217
2014000066Germany► SubscribePRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 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 20140121
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Serving leading biopharmaceutical companies globally:

Accenture
Julphar
Medtronic
UBS
Citi
Colorcon
Queensland Health
Healthtrust
Fish and Richardson
Cerilliant

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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