APRETUDE Drug Patent Profile
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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-seven 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
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Summary for APRETUDE
| International Patents: | 157 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 4 |
| Patent Applications: | 319 |
| Drug Prices: | Drug price information for APRETUDE |
| What excipients (inactive ingredients) are in APRETUDE? | APRETUDE excipients list |
| DailyMed Link: | APRETUDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for APRETUDE
*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
| Sponsor | Phase |
|---|---|
| PPD | Phase 3 |
| GlaxoSmithKline | Phase 3 |
| ViiV Healthcare | Phase 3 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
(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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting APRETUDE
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | Y | ⤷ Sign Up | ||
| Viiv Hlthcare | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499-001 | Dec 20, 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 | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499-001 | Dec 20, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 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
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013005907
Patent: composição farmacêutica parenteral, métodos para o tratamento e para prevenção de uma infecção por hiv, e, uso de uma composição farmacêutica
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 10524
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 13000715
Patent: 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.
Estimated Expiration: ⤷ Sign Up
China
Patent: 3547266
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0161280
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 18279
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 16076
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 4924
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 1390233
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 16076
Patent: COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 31336
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 5028
Patent: תכשיר רוקחי פרנטרלי לשימוש בטיפול בזיהום על ידי hiv באדם (Parenteral pharmaceutical composition for use in the treatment of an hiv infection in a human)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 31385
Estimated Expiration: ⤷ Sign Up
Patent: 14500849
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 16076
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 6193
Patent: COMPOSICIONES FARMACEUTICAS. (PHARMACEUTICAL COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up
Patent: 13003037
Patent: COMPOSICIONES FARMACEUTICAS. (PHARMACEUTICAL COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 520
Patent: FARMACEUTSKE KOMPOZICIJE (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 16076
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 16076
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 01600350
Patent: COMPOSIZIONI FARMACEUTICHE
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 222
Patent: FARMACEUTSKE KOMPOZICIJE (PHARMACEUTICAL COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 16076
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1301766
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1938662
Estimated Expiration: ⤷ Sign Up
Patent: 130116254
Patent: PHARMACEUTICAL COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 94557
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 77377
Estimated Expiration: ⤷ Sign Up
Patent: 1223529
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 8250
Patent: ПАРЕНТЕРАЛЬНА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЇЇ ЗАСТОСУВАННЯ ТА СПОСОБИ ЛІКУВАННЯ АБО ПОПЕРЕДЖЕННЯ ВІЛ-ІНФЕКЦІЇ У ЛЮДИНИ
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Australia | 2006307101 | Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase | ⤷ Sign Up |
| Denmark | 2465580 | ⤷ Sign Up | |
| Spain | 2892304 | ⤷ Sign Up | |
| Eurasian Patent Organization | 024924 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for APRETUDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1874117 | C20140020 00130 | Estonia | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014 |
| 2465580 | 2021C/519 | Belgium | ⤷ Sign Up | PRODUCT NAME: VOCABRIA-CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221 |
| 2465580 | 2021/013 | Ireland | ⤷ Sign Up | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/20/1481 20201221 |
| 1874117 | PA2014021,C1874117 | Lithuania | ⤷ Sign Up | 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 |
| >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.
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