CABENUVA KIT Drug Patent Profile
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When do Cabenuva Kit patents expire, and what generic alternatives are available?
Cabenuva Kit is a drug marketed by Viiv Hlthcare and is included in one NDA. There are five patents protecting this drug.
This drug has three hundred and ninety-two patent family members in fifty-one countries.
The generic ingredient in CABENUVA KIT is cabotegravir; rilpivirine. One supplier is listed for this compound. Additional details are available on the cabotegravir; rilpivirine profile page.
DrugPatentWatch® Generic Entry Outlook for Cabenuva Kit
Cabenuva Kit 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.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Summary for CABENUVA KIT
| International Patents: | 392 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CABENUVA KIT |
| DailyMed Link: | CABENUVA KIT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CABENUVA KIT
*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 CABENUVA KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Phase 3 |
| ViiV Healthcare | Phase 4 |
US Patents and Regulatory Information for CABENUVA KIT
CABENUVA KIT is protected by five US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of CABENUVA KIT 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 CABENUVA KIT
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
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG
Aqueous suspensions of TMC278
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG BY MONTHLY ADMINISTRATION OF RILPIVIRINE SUSPENSION AS PART OF COMBINATION THERAPY
HIV inhibiting pyrimidines derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG
(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
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG
FDA Regulatory Exclusivity protecting CABENUVA KIT
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
NEW DOSING SCHEDULE FOR CABOTEGRAVIR/RILPIVRINE INJECTION EVERY 2 MONTHS
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 | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-002 | Jan 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for CABENUVA KIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-002 | Jan 21, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-002 | Jan 21, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CABENUVA KIT
When does loss-of-exclusivity occur for CABENUVA KIT?
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 CABENUVA KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 021700 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛ (ТМС278) В ФОРМЕ СУСПЕНЗИИ МИКРО- ИЛИ НАНОЧАСТИЦ, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ЕЕ ПРИМЕНЕНИЕ ДЛЯ ДЛИТЕЛЬНОГО ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ ВИЧ-ИНФЕКЦИИ (PHARMACEUTICAL COMPOSITION, COMPRISING 4-[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL]AMINO]-2-PYRIMIDINYL]AMINO]BENZONITRILE (TMC278) IN THE FORM OF A SUSPENSION OF MICRO- OR NANOPARTICLES, PROCESS FOR PREPARING SAME AND USE THEREOF FOR THE LONG-TERM TREATMENT OR PROPHYLAXIS OF HIV INFECTION) | ⤷ Sign Up |
| Japan | 5247661 | ⤷ Sign Up | |
| Spain | 2667868 | ⤷ Sign Up | |
| European Patent Office | 2298761 | DERIVES D'UNE PYRIMIDINE EN TANT QU'INHIBITEUR DU VIH (HIV INHIBITING PYRIMIDINES DERIVATIVES) | ⤷ Sign Up |
| Taiwan | I413521 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CABENUVA KIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1632232 | CA 2016 00065 | Denmark | ⤷ Sign Up | PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623 |
| 2465580 | 301109 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: EU/1/20/1481 20201217 |
| 1419152 | 22/2012 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRIN UND PHARMAZEUTISCH ANNEHMBAREN ADDITIONSSALZEN VON RILPIVIRIN, EINSCHLIESSLICH DEM HYDROCHLORID VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 1419152 | 132012902054377 | Italy | ⤷ Sign Up | PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128 |
| 1663240 | PA2016045 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RILPIVIRINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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