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Abacavir sulfate; dolutegravir sodium; lamivudine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for abacavir sulfate; dolutegravir sodium; lamivudine?

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. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and fifty-five patent family members in sixty countries.

There are eleven drug master file entries for abacavir sulfate; dolutegravir sodium; lamivudine. Two suppliers are listed for this compound.

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

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list11
Suppliers / Packagers: see list2
Clinical Trials: see list1,347
Drug Prices:see low prices
DailyMed Link:abacavir sulfate; dolutegravir sodium; lamivudine 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
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes8,129,385► SubscribeYY ► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes5,905,082*PED► Subscribe ► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes► Subscribe► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes6,294,540*PED► SubscribeY► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 2014RXYesYes9,242,986► SubscribeYY ► 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, 20145,905,082*PED► Subscribe
Viiv Hlthcare
TRIUMEQ
abacavir sulfate; dolutegravir sodium; lamivudine
TABLET;ORAL205551-001Aug 22, 20146,417,191*PED► 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
9,273,065Substituted 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
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
8,754,214Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates► 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
Japan5848595► Subscribe
Taiwan254939► Subscribe
South Africa200708970► Subscribe
African Regional IP Organization (ARIPO)9701089► Subscribe
South Korea20080009733► 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
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
0817637/01Switzerland► SubscribePRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
/1999Austria► SubscribePRODUCT NAME: ''ABACAVIR'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS, EINSCHLIESSLICH ABACAVIR-SULFAT.; NAT. REGISTRATION NO/DATE: EU/1/99/112/001 EU/1/99/112/002 19990708; FIRST REGISTRATION: LI 55048 001, 55049 002 19990628
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
1874117/01Switzerland► SubscribePRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
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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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