Cabotegravir; rilpivirine - Generic Drug Details

What are the generic drug sources for cabotegravir; rilpivirine and what is the scope of freedom to operate?

Cabotegravir; rilpivirine is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabotegravir; rilpivirine has three hundred and ninety-two patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for cabotegravir; rilpivirine

International Patents:	392
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	22
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cabotegravir; rilpivirine
DailyMed Link:	cabotegravir; rilpivirine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cabotegravir; rilpivirine

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 cabotegravir; rilpivirine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Gilead Sciences	Phase 4
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2

See all cabotegravir; rilpivirine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for cabotegravir; rilpivirine

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for cabotegravir; rilpivirine

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	212888-002	Jan 21, 2021		RX	Yes	Yes			Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes			Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes

Expired US Patents for cabotegravir; rilpivirine

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
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021

International Patents for cabotegravir; rilpivirine

Country	Patent Number	Title	Estimated Expiration
Mexico	2008005137	DERIVADO DE CARBAMOILPIRIDONA POLICICLICA QUE TIENE ACTIVIDAD INHIBIDORA EN VIH INTEGRASA. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE.)
Serbia	57111	TMC278 VODENA SUSPENZIJA (AQUEOUS SUSPENSIONS OF TMC278)
Japan	5820045
World Intellectual Property Organization (WIPO)	2005021001
Norway	340111
Hungary	S1500051

Supplementary Protection Certificates for cabotegravir; rilpivirine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
2465580	C202130021	Spain		PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217
1874117	C300676	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
3808743	122022000051	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE EIN PHARMAZEUTISCH AKZEPTABLES ADDITIONSSALZ VON RILPIVIRIN, EINSCHLIESSLICH DES SALZSAEURESALZES VON RILPIVIRIN, UND EMTRICITABIN.; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	2015/052	Ireland		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1632232	132016000129226	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA CLORIDRATO O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, EMTRICITABINA E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623

Market Dynamics and Financial Trajectory for Cabotegravir and Rilpivirine

Introduction to Cabotegravir and Rilpivirine

Cabotegravir and rilpivirine, administered as a long-acting injectable regimen, represent a significant advancement in the treatment of HIV-1 infection. This combination, often referred to as CAB+RPV, has been developed by ViiV Healthcare in collaboration with Janssen Sciences Ireland Unlimited Company, a part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Regulatory Approvals and Market Expansion

The CAB+RPV regimen has received several key regulatory approvals. In December 2020, it was granted marketing authorization by Health Canada under the brand name Cabenuva for the treatment of HIV-1 infection in adults who are virologically stable and suppressed. Similar approvals have been obtained in the USA and Australia[1].

Clinical Efficacy and Patient Benefits

Studies such as FLAIR and ATLAS have demonstrated the efficacy of CAB+RPV. These studies showed that the regimen achieved non-inferior virologic efficacy compared to daily oral antiretroviral therapies (ARTs). Additionally, CAB+RPV has been associated with improved health-related quality of life and better adherence rates due to its less frequent dosing schedule, which can be administered every month or every two months[2][5].

Cost-Effectiveness and Economic Impact

The cost-effectiveness of CAB+RPV has been a subject of extensive study. A study from the Spanish National Healthcare System perspective found that CAB+RPV administered every two months was cost-effective compared to daily oral single-tablet regimens, with a cost-effectiveness ratio below the Spanish willingness-to-pay threshold of €30,000[2].

Another study published in The Lancet modeled the effects of CAB+RPV and found that its introduction could lead to increased viral load suppression and decreased AIDS-related mortality, particularly in individuals with suboptimal adherence to oral ART. However, the cost-effectiveness varied depending on the population and the cost per year of the regimen, which was estimated at $120 per patient per year for illustrative purposes[4].

Market Growth and Sales Projections

ViiV Healthcare's long-acting portfolio, driven by cabotegravir and rilpivirine, is expected to be a significant growth driver. The company forecasts a sales compound annual growth rate (CAGR) of 6% to 8% from 2021 to 2026, with the long-acting portfolio anticipated to deliver over £2 billion in sales by 2026, representing one-third of overall HIV sales[3].

Competitive Landscape and Market Leadership

ViiV Healthcare is leading the market in long-acting antiretroviral therapies. The company's innovative pipeline, including ultra-long-acting (ULA) regimens for both treatment and prevention, is expected to drive continued growth. By 2027, it is estimated that approximately 40% of ViiV's revenue will come from long-acting therapies, with cabotegravir replacing dolutegravir as the foundational medicine[3].

Patent Protection and Exclusivity

The long-acting portfolio of ViiV Healthcare, including cabotegravir and rilpivirine, is protected by patents until 2031, with potential for future protection beyond this date. This extended period of exclusivity is crucial for maintaining market leadership and revenue stability as older products face loss of exclusivity (LOE)[3].

Patient Demand and Preferences

Patient demand for long-acting therapies is strong, driven by the convenience and improved adherence associated with less frequent dosing. A significant portion of patients prefer long-acting injectable regimens over daily oral therapies, which is expected to further drive the growth of CAB+RPV and similar products[3].

Future Developments and Roadmap

ViiV Healthcare is committed to extending the dosing intervals for long-acting regimens. The company aims to increase the dosing interval to every four months by the mid-2020s and to every six months by the end of the decade. This roadmap is expected to enhance patient convenience and further solidify the market position of CAB+RPV[3].

Financial Outlook and Impact of Regulatory Changes

The financial outlook for ViiV Healthcare's long-acting portfolio, including CAB+RPV, is positive but subject to various regulatory and market factors. The US Inflation Reduction Act is expected to have an estimated annual impact of around £200 million from 2025, which could affect the CAGR. However, strong commercial execution and innovative pipeline developments are expected to mitigate these impacts and drive continued growth[3].

Key Takeaways

• Regulatory Approvals: CAB+RPV has received key regulatory approvals in several countries.
• Clinical Efficacy: The regimen has demonstrated non-inferior virologic efficacy and improved health-related quality of life.
• Cost-Effectiveness: CAB+RPV is cost-effective in certain scenarios, particularly for individuals with suboptimal adherence to oral ART.
• Market Growth: ViiV Healthcare forecasts significant growth driven by its long-acting portfolio.
• Competitive Leadership: ViiV Healthcare leads the market in long-acting antiretroviral therapies.
• Patient Demand: Strong patient preference for long-acting injectable regimens.
• Future Developments: Plans to extend dosing intervals to enhance patient convenience.

FAQs

Q: What is the current dosing schedule for CAB+RPV? A: CAB+RPV can be administered every month or every two months.

Q: How does CAB+RPV compare to daily oral ARTs in terms of efficacy? A: CAB+RPV has been shown to achieve non-inferior virologic efficacy compared to daily oral ARTs.

Q: What are the cost-effectiveness implications of CAB+RPV? A: CAB+RPV is cost-effective in scenarios where it improves adherence, particularly in individuals with suboptimal adherence to oral ART.

Q: What is the projected market growth for ViiV Healthcare's long-acting portfolio? A: ViiV Healthcare forecasts a sales CAGR of 6% to 8% from 2021 to 2026, driven by its long-acting portfolio.

Q: How does the patent protection impact the financial trajectory of CAB+RPV? A: The extended patent protection until 2031 and potential future protection beyond this date are crucial for maintaining market leadership and revenue stability.

Sources

1. ViiV Healthcare. "ViiV Healthcare announces the Marketing Authorisation of the first long-acting injectable regimen for the treatment of HIV." December 21, 2020.
2. PubMed. "Cabotegravir and Rilpivirine Long-Acting Antiretroviral Therapy Administered Every 2 Months: A Cost-Effectiveness Analysis from the Spanish National Healthcare System Perspective." July 14, 2023.
3. GSK. "ViiV Healthcare Meet the Management - GSK." September 28, 2023.
4. The Lancet. "The potential role of long-acting injectable cabotegravir–rilpivirine in the treatment of HIV: a modelling study." March 23, 2021.
5. GSK. "ViiV Healthcare announces positive data demonstrating long-acting cabotegravir and rilpivirine dosed every two months achieves non-inferior virologic efficacy versus daily oral BIC/FTC/TAF." February 23, 2023.