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: | 21 |
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*:
Constraining patent/regulatory exclusivity:
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 |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 1/Phase 2 |
National Institute of Mental Health (NIMH) | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for cabotegravir; rilpivirine
US Patents and Regulatory Information for cabotegravir; rilpivirine
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 | 212888-001 | 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 | 212888-001 | 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 | ⤷ Sign Up | |||
Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | 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 |
Expired US Patents for cabotegravir; rilpivirine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2662068 | ⤷ Sign Up | |
Ukraine | 92467 | ГІДРОХЛОРИД 4-[[4-[[4-(2-ЦІАНОЕТЕНІЛ)-2,6-ДИМЕТИЛФЕНІЛ]АМІНО]-2-ПІРИМІДИНІЛ]АМІНО]БЕНЗОНІТРИЛУ[ГИДРОХЛОРИД 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА (HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL]AMINO]-2-PYRIMIDINYL] AMINO]BENZONITRILE) | ⤷ Sign Up |
Jordan | 3429 | مشتقات برميدينات مثبطة فيروس الايدز (HIV INHIBITING PYRIMIDINES DERIVATIVES) | ⤷ Sign Up |
Norway | 20071745 | ⤷ Sign Up | |
Australia | 2006307101 | Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase | ⤷ Sign Up |
Taiwan | I413521 | ⤷ Sign Up | |
Israel | 160328 | PYRIMIDINE DERIVATIVES, PROCESS AND INTERMEDIATES FOR PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM FOR INHIBITING HIV | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cabotegravir; rilpivirine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1419152 | CA 2012 00021 | Denmark | ⤷ Sign Up | |
1874117 | C20140020 00130 | Estonia | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014 |
1663240 | PA2016045 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RILPIVIRINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
1874117 | C201430032 | Spain | ⤷ Sign Up | 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 |
1663240 | 300850 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN: -RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
1663240 | 15C0071 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1419152 | 125 5007-2012 | Slovakia | ⤷ Sign Up | PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |