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Last Updated: April 28, 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	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	dolutegravir sodium	TABLET;ORAL	204790-003	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 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
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
>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
Australia	2006307101	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase	⤷ Try a Trial
Norway	2021018		⤷ Try a Trial
China	101346376	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase	⤷ Try a Trial
South Korea	101580310		⤷ Try a Trial
South Africa	200803423	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase	⤷ 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
1874117	PA2014021	Lithuania	⤷ Try a Trial	PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
1874117	C20140020 00130	Estonia	⤷ Try a Trial	PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
1874117	C201430032	Spain	⤷ Try a Trial	PRODUCT NAME: DOLUTEGRAVIR O UNA SAL O SOLVATO DEL MISMO FARMACEUTICAMENTE ACEPTABLE, INCLUIDA LA SAL SODICA DE DOLUTEGRAVIR.; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1874117	517	Finland	⤷ Try a Trial
2465580	C20210013 00397	Estonia	⤷ Try a Trial	PRODUCT NAME: KABOTEGRAVIIR;REG NO/DATE: EU/1/120/1481; 21.12.2020
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verification 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.