CABOTEGRAVIR SODIUM - Generic Drug Details

What are the generic drug sources for cabotegravir sodium and what is the scope of patent protection?

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

Cabotegravir sodium has one hundred and twenty-five patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for CABOTEGRAVIR SODIUM

International Patents:	125
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	1
Patent Applications:	7
What excipients (inactive ingredients) are in CABOTEGRAVIR SODIUM?	CABOTEGRAVIR SODIUM excipients list
DailyMed Link:	CABOTEGRAVIR SODIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CABOTEGRAVIR SODIUM

Constraining patent/regulatory exclusivity:

8,410,103

Dosage:

TABLET;ORAL

^*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 SODIUM

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

Sponsor	Phase
ViiV Healthcare	Phase 1

See all CABOTEGRAVIR SODIUM clinical trials

Pharmacology for CABOTEGRAVIR SODIUM

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CABOTEGRAVIR SODIUM

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

US Patents and Regulatory Information for CABOTEGRAVIR SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes	8,410,103		Y	Y
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes	10,927,129		Y	Y

International Patents for CABOTEGRAVIR SODIUM

Country	Patent Number	Title	Estimated Expiration
Israel	225207	נגזרת של קרבאמוילפירידון רב-טבעתי, הרכב רוקחי המכיל אותה, השימוש בה ותהליך להכנתה (Polycyclic carbamoylpyridone derivative, pharmaceutical composition comprising the same, use and process for preparation thereof)
World Intellectual Property Organization (WIPO)	2006088173
Norway	20161315	Polysyklisk karbamoylpyridonderivat som har integrase inhibitorisk aktivitet
Canada	2606282	DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASEINHIBITORY ACTIVITY)

Supplementary Protection Certificates for CABOTEGRAVIR SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 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
2465580	LUC00210	Luxembourg		PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
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

CABOTEGRAVIR SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cabotegravir Sodium

Introduction

Cabotegravir sodium, known by its brand name Vocabria, is an HIV-1 integrase inhibitor developed by ViiV Healthcare, a global specialist HIV company majority-owned by GSK, with Pfizer and Shionogi as shareholders. This article delves into the market dynamics and financial trajectory of cabotegravir sodium, highlighting its development, market reception, and future projections.

Development and Approval

Cabotegravir sodium was granted FDA approval on January 21, 2021, in combination with the non-nucleoside reverse transcriptase inhibitor rilpivirine for the treatment of HIV-1 infection in virologically suppressed individuals. Initially approved for monthly intramuscular injections, it was later approved for dosing every two months without the need for an oral lead-in period, effective from February 1, 2022[5].

Market Reception and Patient Preferences

The CARISEL study, conducted by ViiV Healthcare, revealed significant patient preference for long-acting cabotegravir and rilpivirine over daily oral therapy. A staggering 99% of participants preferred the long-acting injectable treatment, and 81% agreed that it alleviated the burden of daily treatment[1].

Clinical and Economic Benefits

The long-acting nature of cabotegravir and rilpivirine has several clinical and economic benefits. It reduces the frequency of dosing, which can improve adherence and reduce the psychological burden associated with daily medication. This formulation also supports the potential for administration outside the clinic environment, enhancing patient convenience and reducing healthcare system costs[1].

Financial Performance and Projections

The HIV market, currently valued at around $28 billion, is expected to grow with an average annual rate of about 5%. ViiV Healthcare aims to achieve annual sales of £2 billion for long-acting (LA) formulations, including cabotegravir and rilpivirine, by leveraging their innovative products to meet unmet needs in the HIV community[3].

Current Sales Trends

Cabotegravir, as part of ViiV Healthcare's portfolio, has contributed significantly to the company's revenue. Products like Cabenuva (cabotegravir and rilpivirine) and Apretude (cabotegravir for PrEP) have shown strong sales growth. For instance, Cabenuva and Apretude have been key drivers in ViiV's sales, with Cabenuva being one of the leading LA formulations in the market[3].

Future Projections

ViiV Healthcare is working on an ultra long-acting formulation of cabotegravir (CAB-ULA), which could extend the dosing interval to at least four months. This development is expected to further enhance market share and revenue, as it addresses the HIV community's desire for longer-acting medicines. The company's medium-to-long-term strategy includes continuous new product launches and the expansion of LA formulations, which are projected to drive significant revenue growth beyond 2030[2][3].

Competitive Landscape

The HIV market is highly competitive, with several major players including Gilead Sciences, Johnson & Johnson, and Merck. However, ViiV Healthcare has managed to secure a significant share of voice in major markets, with over 50% share in countries like the US, France, Italy, Spain, and the UK. The company's focus on top-tier countries and its efficient allocation of sales resources have contributed to its competitive edge[3].

Royalty Income and Partnerships

ViiV Healthcare's partnership with Shionogi involves the licensing of compounds like cabotegravir, which generates significant royalty income. Shionogi, as a 10% shareholder of ViiV, also receives dividends, contributing to its financial stability and growth. The royalty income from these compounds is expected to continue supporting Shionogi's financial performance as the market for LA formulations expands[3].

Innovative Formulations and Pipeline

ViiV Healthcare is continuously innovating, with ongoing phase 1 trials for new formulations like CAB-ULA and combinations with other mechanisms of action, such as broadly neutralizing antibodies. These developments aim to provide even longer dosing intervals, potentially up to six months, and to address future unmet needs in the HIV area[2][3].

Market Projections and Growth Drivers

The market for LA formulations is projected to grow significantly, driven by the strong launch of products like Cabenuva and Apretude. ViiV Healthcare's strategy to expand these formulations and create new solutions is expected to counter the patent cliff for existing drugs and ensure sustained revenue growth. The company aims to maintain its leadership in the HIV market through innovative products and strategic partnerships[3].

Key Takeaways

• Patient Preference: There is a strong preference for long-acting cabotegravir and rilpivirine over daily oral therapy.
• Clinical and Economic Benefits: Long-acting formulations improve adherence and reduce healthcare costs.
• Financial Performance: Cabotegravir and rilpivirine contribute significantly to ViiV Healthcare's revenue.
• Future Projections: Ultra long-acting formulations and continuous innovation are expected to drive revenue growth beyond 2030.
• Competitive Edge: ViiV Healthcare maintains a strong market position through efficient sales strategies and partnerships.

FAQs

What is cabotegravir sodium used for?

Cabotegravir sodium, in combination with rilpivirine, is used for the treatment of HIV-1 infection in virologically suppressed individuals.

How often is cabotegravir sodium administered?

Initially approved for monthly intramuscular injections, cabotegravir sodium is now approved for dosing every two months. An ultra long-acting formulation (CAB-ULA) is in development, which could extend the dosing interval to at least four months.

What are the benefits of long-acting cabotegravir and rilpivirine?

The long-acting nature of these drugs improves adherence, reduces the psychological burden of daily medication, and supports potential administration outside the clinic environment.

How does ViiV Healthcare's financial performance look with cabotegravir?

Cabotegravir, as part of ViiV Healthcare's portfolio, has contributed significantly to the company's revenue. The company aims to achieve annual sales of £2 billion for LA formulations.

What are the future projections for the HIV market and cabotegravir?

The HIV market is expected to grow, driven by the expansion of LA formulations. ViiV Healthcare's innovative products and strategic partnerships are projected to ensure sustained revenue growth beyond 2030.

Sources

1. ViiV Healthcare: "ViiV Healthcare presents positive data showing Vocabria and Rekambys preference and effectiveness in real-world setting" - October 24, 2022.
2. ViiV Healthcare: "ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses" - March 4, 2024.
3. Shionogi Inc.: "HIV Business Meeting" - March 30, 2023.
4. FDA: "212887Orig1s000, 212888Orig1s000ChemR.pdf" - November 30, 2020.
5. DrugBank Online: "Cabotegravir sodium" - Accessed December 16, 2024.