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 |
---|---|
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 |
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Phase 3 |
US Patents and Regulatory Information for cabotegravir
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 |
---|---|---|---|
Israel | 225206 | נגזרת של קרבאמוילפירידון רב-טבעתי, הרכב רוקחי המכיל אותה והשימוש בה (Polycyclic carbamoylpyridone derivative, pharmaceutical composition comprising the same and use thereof) | ⤷ Try a Trial |
Norway | 20075165 | ⤷ Try a Trial | |
Brazil | PI0617842 | composto ou um sal farmaceuticamente aceitável ou um solvato do mesmo, e, composição farmacêutica | ⤷ Try a Trial |
Australia | 2006307101 | Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase | ⤷ Try a Trial |
Taiwan | 200800988 | Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity | ⤷ Try a Trial |
European Patent Office | 3372281 | DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY) | ⤷ 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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cabotegravir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2465580 | 2021/013 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/20/1481 20201221 |
1874117 | 30/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121 |
1874117 | C20140020 00130 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014 |
1874117 | PA2014021,C1874117 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116 |
2465580 | 21C1023 | France | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1481 20201221; FIRST REGISTRATION: - EU/1/20/1481 20201221 |
1874117 | 517 | Finland | ⤷ Try a Trial | |
2465580 | 132021000000098 | Italy | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR(VOCABRIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1481, 20201221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |