Cabotegravir - Generic Drug Details
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What are the generic sources for cabotegravir and what is the scope of patent protection?
Cabotegravir
is the generic ingredient in three branded drugs marketed by Viiv Hlthcare and is included in three NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cabotegravir has one hundred and fifty-seven patent family members in thirty-eight countries.
One supplier is listed for this compound.
Summary for cabotegravir
International Patents: | 157 |
US Patents: | 5 |
Tradenames: | 3 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 53 |
Clinical Trials: | 40 |
Patent Applications: | 757 |
What excipients (inactive ingredients) are in cabotegravir? | cabotegravir excipients list |
DailyMed Link: | cabotegravir at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cabotegravir
Generic Entry Date for cabotegravir*:
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
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 |
Anatomical Therapeutic Chemical (ATC) Classes for cabotegravir
US Patents and Regulatory Information for cabotegravir
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499-001 | Dec 20, 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 | 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 | VOCABRIA | cabotegravir sodium | TABLET;ORAL | 212887-001 | 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 | 212888-001 | 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 |
EU/EMA Drug Approvals for cabotegravir
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
ViiV Healthcare B.V. | Vocabria | cabotegravir | EMEA/H/C/004976 Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA |
Authorised | no | no | no | 2020-12-17 | |
ViiV Healthcare B.V. | Apretude | cabotegravir | EMEA/H/C/005756 Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1). |
Authorised | no | no | no | 2023-09-15 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for cabotegravir
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101848819 | ⤷ Try a Trial | |
Hungary | E031336 | ⤷ Try a Trial | |
Norway | 20075165 | ⤷ Try a Trial | |
Chile | 2013000715 | Composicion farmaceutica que comprende (3s,11ar)-n-[(2,4-difluorofenil)metil]-2,3,5,7,11,11a-hexahidro-6-hidroxi-3-metil-5,7-dioxo-oxazolo[3,2-a]pirido[1,2-d]pirazin-8-carboxamida y un sistema de agente tensoactivo de polisorbato y polietilenglicol; metodo de tratamiento; y su uso para tratar o prevenir una infeccion por vih. | ⤷ Try a Trial |
European Patent Office | 2465580 | Dérivés de carbamoylpyridone polycyclique dotés d'une activité inhibitrice de l'intégrase du VIH (Polycyclic carbamoylpyridone derivatives having hiv integrase inhibitory activity) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cabotegravir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2465580 | C20210013 00397 | Estonia | ⤷ Try a Trial | PRODUCT NAME: KABOTEGRAVIIR;REG NO/DATE: EU/1/120/1481; 21.12.2020 |
1874117 | PA2014021 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116 |
2465580 | LUC00210 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221 |
2465580 | 17/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR UND SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1481 (MITTEILUNG) 20201221 |
2465580 | C 2021 017 | Romania | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF NATIONAL AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |