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Viiv Hlthcare Company Profile

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What is the competitive landscape for VIIV HLTHCARE, and when can generic versions of VIIV HLTHCARE drugs launch?

VIIV HLTHCARE has nineteen approved drugs.

There are seventeen US patents protecting VIIV HLTHCARE drugs.

There are eight hundred and sixty-three patent family members on VIIV HLTHCARE drugs in sixty-seven countries and one hundred and twenty-six supplementary protection certificates in fifteen countries.

Summary for Viiv Hlthcare

International Patents:	863
US Patents:	17
Tradenames:	12
Ingredients:	12
NDAs:	19

Drugs and US Patents for Viiv Hlthcare

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	AA	RX	Yes	Yes	6,294,540*PED				Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	8,129,385		Y	Y
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998	AB	RX	Yes	Yes	6,294,540*PED				Y
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes	7,368,460
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	8,101,629		Y
Viiv Hlthcare	RESCRIPTOR	delavirdine mesylate	TABLET;ORAL	020705-002	Jul 14, 1999		RX	Yes	Yes	6,177,101

Expired US Patents for Viiv Hlthcare

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003	6,436,989*PED
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	4,828,838*PED
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990	4,724,232
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	6,113,920*PED
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	6,180,639
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	7,119,202*PED

Paragraph IV (Patent) Challenges for VIIV HLTHCARE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	150 mg and 300 mg		2007-10-16
	Tablets	150 mg and 300 mg		2011-08-08
	Oral Solution	20 mg/ml		2012-12-27
	Tablets	150 mg/300 mg		2007-06-26
	Tablets	10 mg, 25 mg and 50 mg		2017-08-14
	Tablets	300 mg/150 mg/300 mg		2011-03-22
	Oral Solution	10 mg/mL		2011-11-22
	Tablets	300 mg		2009-01-28
	Tablets	700 mg		2012-01-18
	Tablets	600 mg/300 mg		2007-09-27
	Tablets	600 mg/50 mg/300 mg		2017-08-14

Non-Orange Book US Patents for Viiv Hlthcare

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
9,273,065	Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors
6,586,431	3,3-Biarylpiperidine and 2,2-biarylmorpholine derivatives
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
8,624,023	Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
7,108,864	Tablet formation
7,858,788	Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity

International Patents for Viiv Hlthcare Drugs

Country	Document Number	Estimated Expiration
Malaysia	156920
Japan	5539927
Slovakia	762001
Canada	2452217
Mexico	2007002595
World Intellectual Property Organization (WIPO)	2006024668

Supplementary Protection Certificates for Viiv Hlthcare Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016000111	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
001	Luxembourg		92001, EXPIRES: 20261128
0768	Netherlands		PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2012 00019	Denmark		PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
0150040 00167	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA), TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
2 50006-2014	Slovakia		PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Viiv Hlthcare