You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 14, 2024

Cabotegravir - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
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

SponsorPhase
Wits Health Consortium (Pty) LtdPhase 3
Desmond Tutu HIV FoundationPhase 3
Ministry of Health, UgandaPhase 3

See all cabotegravir clinical trials

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 CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 RX Yes Yes 11,389,447 ⤷  Subscribe ⤷  Subscribe
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 RX Yes Yes 10,927,129 ⤷  Subscribe Y Y ⤷  Subscribe
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 RX Yes Yes 11,224,597 ⤷  Subscribe Y ⤷  Subscribe
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Viiv Hlthcare VOCABRIA cabotegravir sodium TABLET;ORAL 212887-001 Jan 21, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Viiv Hlthcare APRETUDE cabotegravir SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 215499-001 Dec 20, 2021 RX Yes Yes 10,927,129 ⤷  Subscribe Y Y ⤷  Subscribe
>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
Spain 2667868 ⤷  Subscribe
Spain 2446324 ⤷  Subscribe
Canada 2810524 COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS) ⤷  Subscribe
Norway 2023042 ⤷  Subscribe
Norway 20075165 ⤷  Subscribe
Netherlands 301109 ⤷  Subscribe
China 101212903 Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cabotegravir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 300676 Netherlands ⤷  Subscribe PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
1874117 517 Finland ⤷  Subscribe
2465580 2021C/519 Belgium ⤷  Subscribe PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
1874117 PA2014021,C1874117 Lithuania ⤷  Subscribe 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 C202130021 Spain ⤷  Subscribe PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217
1874117 CR 2014 00032 Denmark ⤷  Subscribe PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
1874117 C300676 Netherlands ⤷  Subscribe PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.