Cabotegravir sodium - Generic Drug Details

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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

Generic Entry Date for cabotegravir sodium^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for cabotegravir sodium

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

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

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Country	Patent Number	Title	Estimated Expiration
Australia	2006307101	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase	⤷ Sign Up
Denmark	2465580		⤷ Sign Up
Spain	2892304		⤷ Sign Up
Norway	339525		⤷ Sign Up
Slovenia	3187225		⤷ Sign Up
South Africa	200708970	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity	⤷ Sign Up
Canada	2606282	DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASEINHIBITORY ACTIVITY)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cabotegravir sodium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	C20140020 00130	Estonia	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
2465580	2021C/519	Belgium	⤷ Sign Up	PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
2465580	2021/013	Ireland	⤷ Sign Up	PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/20/1481 20201221
1874117	PA2014021,C1874117	Lithuania	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116
1874117	CR 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 20140121
1874117	2014/032	Ireland	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2465580	21C1023	France	⤷ Sign Up	PRODUCT NAME: CABOTEGRAVIR OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1481 20201221; FIRST REGISTRATION: - EU/1/20/1481 20201221
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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