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: | 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*:
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 |
---|---|
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 |
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 | ⤷ 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 | 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 | Y | Y | ⤷ 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
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 | ⤷ 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 |
Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | 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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200524612 | Combinations of a pyrimidine containing NNRTI with RT inhibitors | ⤷ Try a Trial |
China | 1541215 | 抑制HIV的嘧啶衍生物 (HIV inhibiting pyrimidines derivatives) | ⤷ Try a Trial |
Hungary | E025576 | ⤷ Try a Trial | |
African Regional IP Organization (ARIPO) | 2618 | Aqueous suspensions of TMC278 | ⤷ Try a Trial |
European Patent Office | 2040671 | SUSPENSIONS AQUEUSES DE TMC278 (AQUEOUS SUSPENSIONS OF TMC278) | ⤷ Try a Trial |
Norway | 337142 | ⤷ Try a Trial | |
Mexico | 2008005137 | DERIVADO DE CARBAMOILPIRIDONA POLICICLICA QUE TIENE ACTIVIDAD INHIBIDORA EN VIH INTEGRASA. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CABOTEGRAVIR; RILPIVIRINE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1419152 | 92001 | Luxembourg | ⤷ Try a Trial | 92001, EXPIRES: 20261128 |
1874117 | 14C0041 | France | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
1663240 | 132016000024751 | Italy | ⤷ Try a Trial | PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO E EMTRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128 |
1419152 | 12C0036 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE RILPIVIRINE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE ET DE TENOFOVIR, EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001 20111128 |
1663240 | 92854 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE, ET TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL |
1632232 | 93384 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE |
1874117 | C 2014 024 | Romania | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |