Cabotegravir sodium - Generic Drug Details

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

Cabotegravir sodium is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for cabotegravir sodium

International Patents:	125
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	1
Patent Applications:	7
What excipients (inactive ingredients) are in cabotegravir sodium?	cabotegravir sodium excipients list
DailyMed Link:	cabotegravir sodium at DailyMed

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

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 cabotegravir sodium

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

Sponsor	Phase
ViiV Healthcare	Phase 1

See all cabotegravir sodium clinical trials

Pharmacology for cabotegravir sodium

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors

US Patents and Regulatory Information for cabotegravir 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	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes			Y	Y
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes			Y	Y

International Patents for cabotegravir sodium

Country	Patent Number	Title	Estimated Expiration
China	101212903	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Hong Kong	1107227	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY
Israel	186555	(4r,9as)-5-הידרוקסי-4-מתיל-6,10-דיאוקסו-10,9a,9,6,4,3 -הקסאהידרו-2h-1-אוקסא-8a,4a -דיאזא אנטרצן-7-חומצה קרבוקסילית 4,2-דיפלואורו-בנזילאמיד או מלח רוקחי שלו, תכשיר המכיל אותו ושימוש בו בטיפול או מניעת hiv ((4 r,9as)-5-hydroxy-4-methyll-6,1 0-dioxo-3,4,6,9,9a ,10-hexahydro-2h-1-oxa-4a, 8a-diaza-anthracene-7 -carboxylic acid 2,4-difluoro-benzylamide or a pharmaceutically acceptable salt thereof, composition comprising it and uses thereof in the treatment and prophylaxis of hiv)
Japan	WO2006088173	ＨＩＶインテグラーゼ阻害活性を有する２環性カルバモイルピリドン誘導体
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)
Portugal	3284520

Supplementary Protection Certificates for cabotegravir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	300676	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
1874117	C01874117/01	Switzerland		PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
2465580	C02465580/01	Switzerland		PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67740 08.10.2021
2465580	CR 2021 00010	Denmark		PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221
1874117	C201430032	Spain		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	14C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121