APRETUDE Drug Patent Profile
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Which patents cover Apretude, and what generic alternatives are available?
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
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: | 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 |
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
Sponsor | Phase |
---|---|
ViiV Healthcare | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for APRETUDE
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 | ||
>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 | 200708970 | Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity | ⤷ Try a Trial |
Norway | 2023042 | ⤷ Try a Trial | |
Slovenia | 3187225 | ⤷ 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 | SPC/GB21/030 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221 |
2465580 | 2021/013 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/20/1481 20201221 |
2465580 | 21C1023 | France | ⤷ Try a Trial | PRODUCT NAME: CABOTEGRAVIR OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1481 20201221; FIRST REGISTRATION: - EU/1/20/1481 20201221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |