CABENUVA KIT Drug Patent Profile

When do Cabenuva Kit patents expire, and when can generic versions of Cabenuva Kit launch?

Cabenuva Kit is a drug marketed by Viiv Hlthcare and is included in one NDA. There are eight patents protecting this drug.

This drug has four hundred and fifty-eight patent family members in fifty-three 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 was eligible for patent challenges on January 21, 2025.

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

Summary for CABENUVA KIT

International Patents:	458
US Patents:	8
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

Constraining patent/regulatory exclusivity:

11,224,597

NDA:

212888

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 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

See all CABENUVA KIT clinical trials

US Patents and Regulatory Information for CABENUVA KIT

CABENUVA KIT is protected by eight US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,224,597.

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

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	12,178,815
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	11,389,447
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes	7,125,879		Y	Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes	11,224,597		Y

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	6,838,464
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	8,080,551
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	6,838,464
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	8,080,551

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

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Montenegro

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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
Norway	20075165
South Korea	20080085194	LONG TERM TREATMENT OF HIV-INFECTION WITH TCM278
Slovenia	1981506
Japan	2014500849

Supplementary Protection Certificates for CABENUVA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	628	Finland
1419152	125 5007-2012	Slovakia		PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
3808743	301190	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, MET INBEGRIP VAN HET HYDROCHLORIDE-ZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1632232	300853	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623

Market Dynamics and Financial Trajectory for Cabenuva Kit

Introduction

Cabenuva, a long-acting injectable antiretroviral treatment (ART) for HIV, has been making significant waves in the pharmaceutical industry. Developed by ViiV Healthcare, a global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, Cabenuva has shown promising results in clinical trials and market performance.

Clinical Efficacy and Market Approval

Cabenuva, which combines cabotegravir and rilpivirine, has demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy, particularly in individuals with a history of adherence challenges to antiretroviral therapy (ART)[1][4].

Market Performance and Sales Growth

Quarterly and Annual Sales

In the second quarter of 2024, Cabenuva sales were £245 million, reflecting a significant growth trajectory. This growth is part of a broader trend where long-acting medicines, including Cabenuva and Apretude, now represent 18% of the total HIV portfolio for ViiV Healthcare, up from 13% in Q2 2023[2].

For the full year 2023, Cabenuva sales were £223 million in the fourth quarter, driven by strong patient demand, high levels of market access, and reimbursement in the US and EU[5].

Contribution to HIV Portfolio

Cabenuva and other long-acting medicines have become a crucial component of ViiV Healthcare's HIV portfolio. In Q2 2024, long-acting medicines contributed more than 50% of the total HIV growth, with Cabenuva being a key driver of this growth[2].

Financial Trajectory

Revenue Growth

The revenue from Cabenuva is part of ViiV Healthcare's overall strong financial performance in the HIV segment. In Q2 2024, HIV sales grew by 11% at constant exchange rates (CER), with long-acting medicines like Cabenuva playing a significant role in this growth[2].

Market Projections

Shionogi Inc. projects significant growth in the long-acting (LA) formulations market, aiming for annual sales of £2 billion for LA formulations by the late 2020s. This growth is expected to be driven by the continuous launch of new products that improve upon prior LA formulations, with Cabenuva being a key product in this strategy[3].

Royalty Income and Patent Cliff

The growth of LA formulations, including Cabenuva, is also seen as a strategy to counter the potential patent cliff in the HIV treatment market. By expanding the market share of LA formulations, ViiV Healthcare and its partners aim to maintain and increase revenue despite the expiration of patents on older treatments[3].

Market Dynamics

Competitive Landscape

The HIV treatment market is highly competitive, but Cabenuva's unique long-acting injectable formulation gives it a significant edge. The product's ability to reduce the burden of daily oral therapy and improve adherence rates makes it an attractive option for both patients and healthcare providers[1][4].

Patient Demand and Access

Strong patient demand and high levels of market access and reimbursement have been key factors in Cabenuva's success. The product's implementation across various healthcare settings, as demonstrated in the CUSTOMIZE trial, has shown that it can be successfully integrated into different care environments[4].

Regulatory and Clinical Support

The positive findings from clinical trials, such as the LATITUDE phase III trial and the CUSTOMIZE trial, have provided strong regulatory and clinical support for Cabenuva. These trials have highlighted the product's efficacy and feasibility, further bolstering its market position[1][4].

Future Outlook

Growth Prospects

ViiV Healthcare expects continued growth in the HIV segment, driven by products like Cabenuva. The company has upgraded its growth outlooks for the coming years, reflecting the strong performance of its long-acting medicines[5].

Innovation and New Launches

The future growth of Cabenuva and other LA formulations will be supported by continuous innovation and new product launches. ViiV Healthcare is planning for at least 12 major launches from 2025, including new vaccines and specialty medicines for infectious diseases, HIV, respiratory, and oncology[5].

Key Takeaways

• Clinical Efficacy: Cabenuva has demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy.
• Sales Growth: Cabenuva sales have shown significant growth, contributing substantially to ViiV Healthcare's HIV portfolio.
• Market Projections: The market for long-acting formulations, including Cabenuva, is projected to grow significantly, aiming for £2 billion in annual sales by the late 2020s.
• Competitive Edge: Cabenuva's long-acting injectable formulation provides a competitive advantage in the HIV treatment market.
• Future Outlook: Continued innovation and new product launches are expected to support the growth of Cabenuva and other LA formulations.

FAQs

Q: What is Cabenuva and how does it work?

A: Cabenuva is a long-acting injectable antiretroviral treatment for HIV, combining cabotegravir and rilpivirine. It is administered every two months and is indicated for the treatment of HIV-1 infection in adults who are virologically suppressed.

Q: How has Cabenuva performed in clinical trials?

A: Cabenuva has demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy, particularly in individuals with adherence challenges to ART.

Q: What is the current market share of Cabenuva in the HIV treatment market?

A: Cabenuva and other long-acting medicines now represent 18% of the total HIV portfolio for ViiV Healthcare, up from 13% in Q2 2023.

Q: What are the future growth prospects for Cabenuva?

A: ViiV Healthcare expects continued growth driven by products like Cabenuva, with plans for at least 12 major launches from 2025, including new vaccines and specialty medicines.

Q: How does Cabenuva address the issue of adherence in HIV treatment?

A: Cabenuva's long-acting injectable formulation reduces the burden of daily oral therapy, improving adherence rates and making it an attractive option for both patients and healthcare providers.

Sources

1. ViiV Healthcare. ViiV Healthcare announces interim data at CROI indicating superior efficacy of long-acting injectable HIV treatment Cabenuva compared to daily oral therapy. Retrieved from https://us.gsk.com/en-us/media/press-releases/viiv-healthcare-announces-interim-data-at-croi-indicating-superior-efficacy-of-long-acting-injectable-hiv-treatment-cabenuva-compared-to-daily-oral-therapy/
2. GSK. Q2 2024 Results Announcement. Retrieved from https://www.gsk.com/media/11412/q2-2024-results-announcement.pdf
3. Shionogi Inc.. HIV Business Meeting. Retrieved from https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2022/E20230330.pdf
4. ViiV Healthcare. ViiV Healthcare study shows new long-acting HIV regimen Cabenuva. Retrieved from https://viivhealthcare.com/en-us/media-center/news/press-releases/2021/july/viiv-healthcare-study-shows-new-long-acting-hiv-regimen-cabenuva/
5. GSK. Q4 2023 Announcement. Retrieved from https://www.gsk.com/media/10928/fy-2023-results-announcement.pdf