Cabenuva Kit is a drug owned by Viiv Healthcare Co. It is protected by 10 US drug patents filed from 2021 to 2025. Out of these, 7 drug patents are active and 3 have expired. Cabenuva Kit's patents have been open to challenges since 21 January, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 18, 2038. Details of Cabenuva Kit's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10927129 | 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 |
Apr, 2026
(1 year, 6 days from now) | Active |
| US8410103 | (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 |
Apr, 2026
(1 year, 6 days from now) | Active |
| US7125879 | HIV inhibiting pyrimidines derivatives |
Apr, 2025
(18 hours ago) |
Expired
|
| US8080551 | HIV inhibiting pyrimidines derivatives |
Apr, 2023
(2 years ago) |
Expired
|
| US6838464 | 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents |
Feb, 2021
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12178815 | Regimens for treating HIV infections and aids |
Jul, 2038
(13 years from now) | Active |
| USRE50189 | NA |
Nov, 2031
(6 years from now) | Active |
| US11224597 | Pharmaceutical compositions |
Sep, 2031
(6 years from now) | Active |
| US12138264 | Pharmaceutical compositions |
Sep, 2031
(6 years from now) | Active |
| US11389447 | Aqueous suspensions of TMC278 |
Jun, 2027
(2 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Cabenuva Kit's patents.
Latest Legal Activities on Cabenuva Kit's Patents
Given below is the list of recent legal activities going on the following patents of Cabenuva Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eCofC Notification | 28 May, 2024 | US11389447 |
| Recordation of Patent eCertificate of Correction | 28 May, 2024 | US11389447 |
| Email Notification Critical | 28 May, 2024 | US11389447 |
| Patent eCofC Notification | 28 May, 2024 | US11389447 |
| Email Notification Critical | 23 Apr, 2024 | US11389447 |
| Mail Pub Notice re 312 amendment | 23 Apr, 2024 | US11389447 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 18 Apr, 2024 | US11389447 |
| transaction for FDA Determination of Regulatory Review Period | 25 Jan, 2024 | US8410103 |
| Expire Patent Critical | 22 Jan, 2024 | US8080551 |
| Maintenance Fee Reminder Mailed Critical | 07 Aug, 2023 | US8080551 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Cabenuva Kit and ongoing litigations to help you estimate the early arrival of Cabenuva Kit generic.
Cabenuva Kit's Litigations
Cabenuva Kit been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 26, 2020, against patent number US11389447. The petitioner , challenged the validity of this patent, with JANSSEN SCIENCES IRELAND UC as the respondent. Click below to track the latest information on how companies are challenging Cabenuva Kit's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11389447 | October, 2020 |
Decision
(02 Aug, 2021) | JANSSEN SCIENCES IRELAND UC | |
FDA has granted some exclusivities to Cabenuva Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cabenuva Kit, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Cabenuva Kit.
Exclusivity Information
Cabenuva Kit holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Cabenuva Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-184) | Jan 31, 2025 |
| New Patient Population(NPP) | Mar 29, 2025 |
| New Chemical Entity Exclusivity(NCE) | Jan 21, 2026 |
Several oppositions have been filed on Cabenuva Kit's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Cabenuva Kit's generic, the next section provides detailed information on ongoing and past EP oppositions related to Cabenuva Kit patents.
Cabenuva Kit's Oppositions Filed in EPO
Cabenuva Kit has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 09, 2012, by Hamm, Volker. This opposition was filed on patent number EP05108086A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP17195280A | Feb, 2020 | Gilead Sciences, Inc. | Opposition rejected |
| EP16154531A | Dec, 2018 | Gilead Sciences, Inc. | Patent maintained as amended |
| EP07786802A | Oct, 2018 | HGF Limited | Opposition rejected |
| EP06822311A | Nov, 2016 | Zwicker Schnappauf & Partner PartG mbB | Opposition procedure closed |
| EP04787096A | Jan, 2016 | Page White & Farrer Limited | Patent maintained as amended |
| EP06758843A | May, 2014 | Ahrens, Gabriele | Opposition procedure closed |
| EP05108086A | Feb, 2012 | Hamm, Volker | The patent has been limited |
US patents provide insights into the exclusivity only within the United States, but Cabenuva Kit is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Cabenuva Kit's family patents as well as insights into ongoing legal events on those patents.
Cabenuva Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cabenuva Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 18, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cabenuva Kit Generics:
There are no approved generic versions for Cabenuva Kit as of now.
Alternative Brands for Cabenuva Kit
Cabenuva Kit which is used for treating HIV-1 infection in adults and adolescents aged 12 years and older., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Viiv Hlthcare |
| |||
About Cabenuva Kit
Cabenuva Kit is a drug owned by Viiv Healthcare Co. It is used for treating HIV-1 infection in adults and adolescents aged 12 years and older. Cabenuva Kit uses Cabotegravir; Rilpivirine as an active ingredient. Cabenuva Kit was launched by Viiv Hlthcare in 2021.
Approval Date:
Cabenuva Kit was approved by FDA for market use on 21 January, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Cabenuva Kit is 21 January, 2021, its NCE-1 date is estimated to be 21 January, 2025.
Active Ingredient:
Cabenuva Kit uses Cabotegravir; Rilpivirine as the active ingredient. Check out other Drugs and Companies using Cabotegravir; Rilpivirine ingredient
Treatment:
Cabenuva Kit is used for treating HIV-1 infection in adults and adolescents aged 12 years and older.
Dosage:
Cabenuva Kit is available in suspension, extended release form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |
| 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML) | SUSPENSION, EXTENDED RELEASE | Prescription | INTRAMUSCULAR |