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: | 46 |
| 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
*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 |
|---|---|
| Ministry of Health, Uganda | Phase 3 |
| Assistance Publique - Hôpitaux de Paris | Phase 3 |
| PPD | 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 | ⤷ Sign Up | ⤷ Sign Up | 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 | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499-001 | Dec 20, 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 | ||||
| >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 |
|---|---|---|---|
| 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. | ⤷ Sign Up |
| South Africa | 200803423 | Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase | ⤷ Sign Up |
| Hong Kong | 1249742 | 具有HIV整合酶抑制活性的多環氨甲酰吡啶酮衍生物 (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY) | ⤷ Sign Up |
| Denmark | 2465580 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cabotegravir
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1874117 | PA2014021 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116 |
| 2465580 | 2021C/519 | Belgium | ⤷ Sign Up | PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221 |
| 2465580 | CR 2021 00010 | Denmark | ⤷ Sign Up | PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221 |
| 1874117 | CA 2014 00032 | Denmark | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
