CABOTEGRAVIR; RILPIVIRINE - Generic Drug Details

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What are the generic sources for cabotegravir; rilpivirine and what is the scope of patent protection?

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:	22
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Gilead Sciences	Phase 4
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2

See all CABOTEGRAVIR; RILPIVIRINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CABOTEGRAVIR; RILPIVIRINE

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	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 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	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	⤷ Sign Up	⤷ Sign Up
>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
Mexico	346193	COMPOSICIONES FARMACEUTICAS. (PHARMACEUTICAL COMPOSITIONS.)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006024667		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012037320		⤷ Sign Up
China	101478950	Aqueous suspensions of TMC278	⤷ Sign Up
Japan	6231385		⤷ Sign Up
>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
2465580	C202130021	Spain	⤷ Sign Up	PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217
1663240	58/2015	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	C01663240/03	Switzerland	⤷ Sign Up	FORMER OWNER: JANSSEN SCIENCES IRELAND UC, IE
1663240	2016/058	Ireland	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; NAT REGISTRATION NO/DATE: EU/1/16/1112 20160621; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2457)
1419152	C01419152/02	Switzerland	⤷ Sign Up	PRODUCT NAME: RILPIVIRIN UND TENOFOVIR; REGISTRATION NO/DATE: SWISSMEDIC 62155 12.03.2013
>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

Anatomical Therapeutic Chemical (ATC) Classes for CABOTEGRAVIR; RILPIVIRINE

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

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