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 |
|---|---|
| Desmond Tutu HIV Foundation | Phase 3 |
| Ministry of Health, Uganda | Phase 3 |
| Assistance Publique - Hôpitaux de Paris | 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 | VOCABRIA | cabotegravir sodium | TABLET;ORAL | 212887-001 | Jan 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Viiv Hlthcare | VOCABRIA | cabotegravir sodium | TABLET;ORAL | 212887-001 | Jan 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Viiv Hlthcare | VOCABRIA | cabotegravir sodium | TABLET;ORAL | 212887-001 | 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 | ||
| >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 |
|---|---|---|---|
| Poland | 3045206 | ⤷ Sign Up | |
| Brazil | 112013005907 | composição farmacêutica parenteral, métodos para o tratamento e para prevenção de uma infecção por hiv, e, uso de uma composição farmacêutica | ⤷ Sign Up |
| Poland | 2616076 | ⤷ Sign Up | |
| South Africa | 201301766 | PHARMACEUTICAL COMPOSITIONS | ⤷ 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 | 2014/032 | Ireland | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
| 1874117 | 30/2014 | Austria | ⤷ Sign Up | 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 | 14C0041 | France | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
| 1874117 | CR 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 20140121 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
