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Dolutegravir sodium - Generic Drug Details

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What are the generic drug sources for dolutegravir sodium and what is the scope of patent protection?

Dolutegravir sodium is the generic ingredient in four branded drugs marketed by Viiv Hlthcare and is included in four NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium has one hundred and thirty-five patent family members in thirty-three countries.

There are seventeen drug master file entries for dolutegravir sodium. Four suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for dolutegravir sodium

International Patents:	135
US Patents:	7
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	1
Patent Applications:	4
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dolutegravir sodium
What excipients (inactive ingredients) are in dolutegravir sodium?	dolutegravir sodium excipients list
DailyMed Link:	dolutegravir sodium at DailyMed

Recent Clinical Trials for dolutegravir sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
St Stephens Aids Trust	Phase 4

See all dolutegravir sodium clinical trials

Generic filers with tentative approvals for DOLUTEGRAVIR SODIUM

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET;ORAL
		50MG	TABLET;ORAL
		50MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dolutegravir sodium

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
TIVICAY PD	TABLET, FOR SUSPENSION;ORAL	dolutegravir sodium	213983	2021-07-21
TIVICAY	TABLET;ORAL	dolutegravir sodium	204790	2017-08-14

US Patents and Regulatory Information for dolutegravir sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes			Y	Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes			Y	Y

International Patents for dolutegravir sodium

Country	Patent Number	Estimated Expiration
Viet Nam	34404
Cyprus	1115151
Poland	1874117

Supplementary Protection Certificates for dolutegravir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	517	Finland
1874117	C01874117/01	Switzerland		PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
1874117	202 50006-2014	Slovakia		PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121