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Last Updated: May 31, 2020

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Abacavir sulfate; dolutegravir sodium; lamivudine - Generic Drug Details

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What are the generic drug sources for abacavir sulfate; dolutegravir sodium; lamivudine and what is the scope of freedom to operate?

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 two 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 one hundred and thirty patent family members in thirty-three countries.

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

Summary for abacavir sulfate; dolutegravir sodium; lamivudine

International Patents:	130
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	12
Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for abacavir sulfate; dolutegravir sodium; lamivudine
DailyMed Link:	abacavir sulfate; dolutegravir sodium; lamivudine at DailyMed

Recent Litigation for abacavir sulfate; dolutegravir sodium; lamivudine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ViiV Healthcare Company v. Gilead Sciences, Inc.	2018-02-07
ViiV Healthcare Company v. Sandoz Inc.	2017-12-11
ViiV Healthcare Company v. Cipla Limited	2017-12-04

See all abacavir sulfate; dolutegravir sodium; lamivudine litigation

PTAB Litigation

Petitioner	Date
	2015-01-08
	2014-06-02

See all abacavir sulfate; dolutegravir sodium; lamivudine litigation

Pharmacology for abacavir sulfate; dolutegravir sodium; lamivudine

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
TRIUMEQ	TABLET;ORAL	abacavir sulfate; dolutegravir sodium; lamivudine	205551	2017-08-14

US Patents and Regulatory Information for abacavir sulfate; dolutegravir sodium; lamivudine

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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;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for abacavir sulfate; dolutegravir sodium; lamivudine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	Start Trial	Start Trial
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	Start Trial	Start Trial
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for abacavir sulfate; dolutegravir sodium; lamivudine

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Country	Patent Number	Estimated Expiration
Hong Kong	1172282	Start Trial
Israel	225207	Start Trial
Slovenia	1874117	Start Trial
Japan	5086478	Start Trial
Brazil	PI0610030	Start Trial
South Korea	101363875	Start Trial
Portugal	2465580	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for abacavir sulfate; dolutegravir sodium; lamivudine

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0434450	C990028	Netherlands	Start Trial	PRODUCT 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
1874117	122014000066	Germany	Start Trial	PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
0434450	990028	Netherlands	Start Trial	PRODUCT 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
0434450	SPC/GB99/032	United Kingdom	Start Trial	PRODUCT NAME: ABACAVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE INCLUDING ABACAVIR SULPHATE; REGISTERED: CH CH 55048 001 19990628; CH CH 55049 002 19990628; UK EU/1/99/112/001 19990708; UK EU/1/99/112/002 19990708
1874117	300676	Netherlands	Start Trial	PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
1874117	SPC/GB14/041	United Kingdom	Start Trial	PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
1874117	C20140020 00130	Estonia	Start Trial	PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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