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Last Updated: May 16, 2024

Dolutegravir sodium - Generic Drug Details

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

Dolutegravir sodium is the generic ingredient in four branded drugs marketed by Viiv Hlthcare and is included in four NDAs. There are five 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 fifty-five patent family members in thirty-five countries.

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

Summary for dolutegravir sodium

International Patents:	155
US Patents:	5
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	1
Patent Applications:	96
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium

Generic Entry Dates for dolutegravir sodium^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET, FOR SUSPENSION;ORAL
Generic Entry Dates for dolutegravir sodium^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
⤷ Try a Trial	⤷ Try a Trial	50MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	50MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

Anatomical Therapeutic Chemical (ATC) Classes for dolutegravir sodium

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIVICAY PD	Tablets for Suspension	dolutegravir sodium	5 mg	213983	1	2021-07-21
TIVICAY	Tablets	dolutegravir sodium	10 mg, 25 mg and 50 mg	204790	4	2017-08-14

US Patents and Regulatory Information for dolutegravir sodium

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Glossary

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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	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for dolutegravir sodium

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Country	Patent Number	Title	Estimated Expiration
Luxembourg	C00210		⤷ Try a Trial
Portugal	3045206		⤷ Try a Trial
European Patent Office	3045206	DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTE D'UNE ACTIVITE INHIBITRICE DE L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)	⤷ Try a Trial
South Korea	20080009733	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY	⤷ Try a Trial
South Korea	101363875		⤷ Try a Trial
European Patent Office	3284520	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dolutegravir sodium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	C 2021 017	Romania	⤷ Try a Trial	PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF NATIONAL AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217
2932970	SPC/GB18/041	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
2932970	CR 2018 00036	Denmark	⤷ Try a Trial	PRODUCT NAME: KOMBINATION AF DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. DOLUTEGRAVIRNATRIUM, OG RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. RILPIVIRINHYDROCHLORID; REG. NO/DATE: EU/1/18/1282/001-002 20180518
2932970	LUC00090	Luxembourg	⤷ Try a Trial	PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
1874117	30/2014	Austria	⤷ Try a Trial	PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121
1874117	202 50006-2014	Slovakia	⤷ Try a Trial	PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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