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Last Updated: May 1, 2024

CABOTEGRAVIR; RILPIVIRINE - Generic Drug Details

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

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

Cabotegravir; rilpivirine has three hundred and ninety-two patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for CABOTEGRAVIR; RILPIVIRINE

International Patents:	392
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CABOTEGRAVIR; RILPIVIRINE
DailyMed Link:	CABOTEGRAVIR; RILPIVIRINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CABOTEGRAVIR; RILPIVIRINE

Generic Entry Date for CABOTEGRAVIR; RILPIVIRINE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

^*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; RILPIVIRINE

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

Sponsor	Phase
National Institute of Mental Health (NIMH)	Phase 1/Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 3

See all CABOTEGRAVIR; RILPIVIRINE clinical trials

US Patents and Regulatory Information for CABOTEGRAVIR; RILPIVIRINE

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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	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

Expired US Patents for CABOTEGRAVIR; RILPIVIRINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CABOTEGRAVIR; RILPIVIRINE

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Country	Patent Number	Title	Estimated Expiration
Portugal	2040671		⤷ Try a Trial
South Korea	20130133061	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY	⤷ Try a Trial
Eurasian Patent Organization	200702080	ПОЛИЦИКЛИЧЕСКОЕ КАРБОМОИЛПИРИДОНОВОЕ ПРОИЗВОДНОЕ, ОБЛАДАЮЩЕЕ ИНГИБИТОРНОЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ ИНТЕГРАЗЫ ВИЧ	⤷ Try a Trial
Netherlands	301109		⤷ Try a Trial
Australia	2002329238		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CABOTEGRAVIR; RILPIVIRINE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	1590057-4	Sweden	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
1663240	PA2015035	Lithuania	⤷ Try a Trial	PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1663240	SPC/GB15/064	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTERED: UK EU/1/11/737/001-002 20111128
1663240	375 5032-2016	Slovakia	⤷ Try a Trial	PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/EMTRICITABIN/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2465580	PA2021512,C2465580	Lithuania	⤷ Try a Trial	PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
>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.

Summary for CABOTEGRAVIR; RILPIVIRINE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CABOTEGRAVIR; RILPIVIRINE

Recent Clinical Trials for CABOTEGRAVIR; RILPIVIRINE

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CABOTEGRAVIR; RILPIVIRINE