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VOCABRIA Drug Patent Profile

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

Vocabria is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and twenty-five patent family members in thirty-three countries.

The generic ingredient in VOCABRIA is cabotegravir sodium. One supplier is listed for this compound. Additional details are available on the cabotegravir sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Vocabria

Vocabria 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 April 28, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VOCABRIA

International Patents:	125
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Patent Applications:	4
What excipients (inactive ingredients) are in VOCABRIA?	VOCABRIA excipients list
DailyMed Link:	VOCABRIA at DailyMed

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

NDA:

212887

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.

Pharmacology for VOCABRIA

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

US Patents and Regulatory Information for VOCABRIA

VOCABRIA is protected by three US patents and three FDA Regulatory Exclusivities.

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	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes			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			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

International Patents for VOCABRIA

When does loss-of-exclusivity occur for VOCABRIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Morocco

Netherlands

New Zealand

Norway

Philippines

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Viet Nam

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 VOCABRIA around the world.

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)
European Patent Office	3187225	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
Hungary	S1400039

Supplementary Protection Certificates for VOCABRIA

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
1874117	1490036-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
1874117	CR 2014 00032	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121

VOCABRIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vocabria (Cabotegravir)

Introduction to Vocabria (Cabotegravir)

Vocabria, known by its active ingredient cabotegravir, is a crucial component in the treatment and prevention of HIV. Developed by ViiV Healthcare, a subsidiary of GSK, this drug has been making significant waves in the HIV treatment landscape.

Market Context: HIV Treatment and Prevention

The global HIV drugs market is projected to grow from $32.8 billion in 2022 to $51.1 billion by 2032, at a CAGR of 4.5%[4].

• This growth is driven by increasing cases of HIV, government initiatives for awareness and management, and advancements in HIV drugs.

Role of Vocabria in HIV Treatment

Vocabria is part of the long-acting (LA) portfolio of ViiV Healthcare, which includes Cabenuva (cabotegravir + rilpivirine) for treatment and Apretude (cabotegravir) for pre-exposure prophylaxis (PrEP)[1].

Treatment Regimens

• Cabotegravir is used in combination with other drugs, such as rilpivirine, to form Cabenuva, an injectable two-drug regimen for HIV treatment.
• It is also used as Apretude, an injectable PrEP option, administered every two months.

Market Impact

• The LA portfolio, including Vocabria, is expected to drive significant growth for ViiV Healthcare, with sales projected to exceed £2 billion by 2026, representing one-third of overall HIV sales[1].

Financial Trajectory

Sales Projections

• ViiV Healthcare anticipates strong commercial execution to drive a 6% to 8% sales CAGR from 2021 to 2026, with cabotegravir being a key driver of this growth[1].
• The company forecasts total HIV sales, including Vocabria, to reach approximately £7 billion by 2026[1].

Revenue Replacement and Growth

• Cabotegravir's LA portfolio is set to replace dolutegravir (DTG) as the foundational medicine, ensuring revenue continuity beyond the patent expiration of dolutegravir[1].
• The innovative LA pipeline from 2026 to 2031 is expected to power potential revenue renewal and growth beyond the current dolutegravir-based regimens[1].

Competitive Landscape

Key Players

• ViiV Healthcare, along with other major players like Gilead Sciences, Merck, and Johnson & Johnson, dominates the HIV drugs market[4].
• The competitive landscape is driven by strong commercial execution, innovative products, and patient preference for long-acting treatments.

Patient Preference and Demand

• There is a significant demand for long-acting treatments due to their convenience and reduced dosing frequency. For instance, dosing intervals for long-acting regimens are being increased to every four months, with a roadmap to extend this to every six months by the end of the decade[1].

Regulatory and Market Challenges

Payer Pressure and Patent Expirations

• The HIV market faces challenges such as payer pressure, particularly with the impact of the US Inflation Reduction Act, which is estimated to have a one percentage point impact on the CAGR from 2025[1].
• The loss of exclusivity (LOE) for key drugs like dolutegravir necessitates continuous innovation to maintain revenue streams[1].

Innovative Pipeline and R&D

Future Growth Drivers

• ViiV Healthcare's R&D efforts are focused on expanding the LA pipeline, including ultra-long-acting (ULA) options for both treatment and PrEP, and self-administered LA treatments[1].
• These innovations are critical for maintaining market leadership and addressing the ongoing need for effective HIV treatments.

Geographical Market Dynamics

Regional Market Share

• North America currently dominates the HIV drugs market, driven by robust healthcare infrastructure, strong presence of key players, and high healthcare expenditure[4].
• However, emerging markets, particularly in the Asia-Pacific region, are expected to witness significant growth due to high unmet medical demands and increasing public-private investments in healthcare[4].

Patient Access and Stigma

Challenges in HIV Treatment

• Despite advancements, HIV treatment faces challenges such as stigma, inequity, and low PrEP utilization. For example, only 25% of eligible US patients are currently taking PrEP[1].
• Addressing these issues is crucial for maximizing the impact of drugs like Vocabria.

Key Takeaways

• Vocabria (cabotegravir) is a pivotal drug in the HIV treatment and prevention landscape.
• Strong sales projections and a robust LA pipeline position ViiV Healthcare for continued growth.
• Market dynamics are influenced by patient preference for long-acting treatments, regulatory challenges, and ongoing R&D efforts.
• Geographical expansion, particularly in emerging markets, offers significant growth opportunities.

FAQs

What is Vocabria used for?

Vocabria (cabotegravir) is used in combination with other drugs for the treatment of HIV and as a pre-exposure prophylaxis (PrEP) to prevent HIV infection.

How does Vocabria fit into ViiV Healthcare's LA portfolio?

Vocabria is part of ViiV Healthcare's long-acting portfolio, which includes Cabenuva for treatment and Apretude for PrEP, both of which are injectable regimens.

What are the sales projections for ViiV Healthcare's HIV drugs, including Vocabria?

ViiV Healthcare anticipates sales of its HIV drugs, including Vocabria, to reach approximately £7 billion by 2026, with a CAGR of 6% to 8% from 2021 to 2026.

What are the key challenges facing the HIV drugs market?

The HIV drugs market faces challenges such as payer pressure, patent expirations, stigma, inequity, and low PrEP utilization.

How is the geographical market share expected to evolve?

North America currently dominates the market, but the Asia-Pacific region is expected to witness significant growth due to high unmet medical demands and increasing public-private investments in healthcare.

Cited Sources:

1. ViiV Healthcare Meet the Management - GSK - [PDF]
2. 3rd Quarter of Fiscal 2020 Financial Results Conference Call - [PDF]
3. Annual Report 2022 | GSK - [PDF]
4. HIV Drugs Market Size, Share and Growth Analysis | Report, 2032 - Allied Market Research