You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 13, 2024

~ Buy the APRETUDE (cabotegravir) Drug Profile, 2024 PDF Report in the Report Store ~

APRETUDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Apretude, and when can generic versions of Apretude launch?

Apretude is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and fifty-five patent family members in thirty-eight countries.

The generic ingredient in APRETUDE is cabotegravir. One supplier is listed for this compound. Additional details are available on the cabotegravir profile page.

DrugPatentWatch® Generic Entry Outlook for Apretude

Apretude will be eligible for patent challenges on January 21, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 15, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Try a Trial

Summary for APRETUDE
International Patents:155
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 53
Clinical Trials: 2
Patent Applications: 395
Drug Prices: Drug price information for APRETUDE
What excipients (inactive ingredients) are in APRETUDE?APRETUDE excipients list
DailyMed Link:APRETUDE at DailyMed
Drug patent expirations by year for APRETUDE
Drug Prices for APRETUDE

See drug prices for APRETUDE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for APRETUDE
Generic Entry Date for APRETUDE*:
Constraining patent/regulatory exclusivity:
NDA:
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 APRETUDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ViiV HealthcarePhase 4

See all APRETUDE clinical trials

US Patents and Regulatory Information for APRETUDE

APRETUDE is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of APRETUDE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting APRETUDE

N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a- -hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

(3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting APRETUDE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  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
Viiv Hlthcare APRETUDE cabotegravir SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 215499-001 Dec 20, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Viiv Hlthcare APRETUDE cabotegravir SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 215499-001 Dec 20, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare APRETUDE cabotegravir SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 215499-001 Dec 20, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
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
>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 APRETUDE

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 APRETUDE

When does loss-of-exclusivity occur for APRETUDE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 11302030
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013005907
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 10524
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 13000715
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3547266
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0161280
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18279
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 4924
Estimated Expiration: ⤷  Try a Trial

Patent: 1390233
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 31336
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5028
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 31385
Estimated Expiration: ⤷  Try a Trial

Patent: 14500849
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6193
Estimated Expiration: ⤷  Try a Trial

Patent: 13003037
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 520
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01600350
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 222
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1301766
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1938662
Estimated Expiration: ⤷  Try a Trial

Patent: 130116254
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 94557
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 77377
Estimated Expiration: ⤷  Try a Trial

Patent: 1223529
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 8250
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering APRETUDE around the world.

Country Patent Number Title Estimated Expiration
South Africa 200803423 Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase ⤷  Try a Trial
Philippines 12007502373 Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase ⤷  Try a Trial
Hungary S1400039 ⤷  Try a Trial
Portugal 2465580 ⤷  Try a Trial
Hungary E056603 ⤷  Try a Trial
Denmark 3045206 ⤷  Try a Trial
Cyprus 1115151 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for APRETUDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2465580 PA2021512 Lithuania ⤷  Try a Trial PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
1874117 2014C/038 Belgium ⤷  Try a Trial PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121
1874117 14C0041 France ⤷  Try a Trial 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 517 Finland ⤷  Try a Trial
2465580 122021000021 Germany ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1481 20201217
2465580 132021000000098 Italy ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR(VOCABRIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1481, 20201221
2465580 301109 Netherlands ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: EU/1/20/1481 20201217
>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.