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
*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 |
| 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 | 212888-002 | 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 | 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 | ⤷ 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 | ⤷ 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 | 212888-001 | 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
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 1419152 | ⤷ Sign Up | |
| Japan | 2009079058 | POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY | ⤷ Sign Up |
| Eurasian Patent Organization | 200700534 | ФУМАРАТ 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА | ⤷ Sign Up |
| Argentina | 102104 | COMBINACIONES DE UNA PIRIMIDINA QUE CONTIENEN NNRTI CON INHIBIDORES DE LA RT | ⤷ Sign Up |
| Japan | WO2006088173 | ＨＩＶインテグラーゼ阻害活性を有する２環性カルバモイルピリドン誘導体 | ⤷ Sign Up |
| Croatia | P20110563 | ⤷ Sign Up | |
| Norway | 2017063 | ⤷ 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 | SPC/GB12/022 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF.; REGISTERED: UK EU/1/11/736/001 20111128 |
| 1632232 | 93384 | Luxembourg | ⤷ Sign Up | 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 |
| 1632232 | 122016000110 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
| 1632232 | 132016000129226 | Italy | ⤷ Sign Up | PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA CLORIDRATO O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, EMTRICITABINA E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623 |
| 2465580 | SPC/GB21/030 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221 |
| 1419152 | 125 5007-2012 | Slovakia | ⤷ Sign Up | PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128 |
| 1663240 | 379 5033-2016 | Slovakia | ⤷ Sign Up | PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
