ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE - Generic Drug Details

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What are the generic 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 two branded drugs marketed by Viiv Hlthcare and is included in two NDAs. 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 fifty-five patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

International Patents:	155
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product 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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Generic Entry Dates for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL
Generic Entry Dates for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET, FOR SUSPENSION;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.

Pharmacology for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 1A1 Inhibitors HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIUMEQ PD	Tablets for Oral Suspension	abacavir sulfate; dolutegravir sodium; lamivudine	60 mg/5 mg/30 mg	215413	1	2023-03-31
TRIUMEQ	Tablets	abacavir sulfate; dolutegravir sodium; lamivudine	600 mg/50 mg/ 300 mg	205551	5	2017-08-14

US Patents and Regulatory Information for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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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	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	⤷ Sign Up	⤷ Sign Up
>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	Title	Estimated Expiration
Norway	2021018		⤷ Sign Up
European Patent Office	3284519	DÉRIVÉS DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉS D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)	⤷ Sign Up
Australia	2006239177	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity	⤷ Sign Up
South Africa	200708970	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity	⤷ Sign Up
>Country	>Patent Number	>Title	>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
1874117	CA 2014 00032	Denmark	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116
2465580	2021C/519	Belgium	⤷ Sign Up	PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
2465580	CA 2021 00010	Denmark	⤷ Sign Up	PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221
0817637	C00817637/01	Switzerland	⤷ Sign Up	PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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