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APRETUDE Drug Patent Profile

Which patents cover Apretude, and when can generic versions of Apretude launch?

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

This drug has one hundred and fifty-seven patent family members in thirty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Apretude

Apretude 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 September 15, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for APRETUDE

International Patents:	157
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	4
Patent Applications:	322
Drug Prices:	Drug price information for APRETUDE
What excipients (inactive ingredients) are in APRETUDE?	APRETUDE excipients list
DailyMed Link:	APRETUDE at DailyMed

See drug prices for APRETUDE

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

Constraining patent/regulatory exclusivity:

11,224,597

NDA:

215499

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 APRETUDE

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

Sponsor	Phase
GlaxoSmithKline	Phase 3
ViiV Healthcare	Phase 3
PPD	Phase 3

See all APRETUDE clinical trials

US Patents and Regulatory Information for APRETUDE

APRETUDE is protected by three US patents and one FDA Regulatory Exclusivity.

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	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes	10,927,129		Y	Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes	8,410,103		Y	Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes	11,224,597		Y

EU/EMA Drug Approvals for APRETUDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ViiV Healthcare B.V.	Vocabria	cabotegravir	EMEA/H/C/004976 Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA	Authorised	no	no	no	2020-12-17
ViiV Healthcare B.V.	Apretude	cabotegravir	EMEA/H/C/005756 Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1).	Authorised	no	no	no	2023-09-15

International Patents for APRETUDE

When does loss-of-exclusivity occur for APRETUDE?

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 APRETUDE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5131689
South Korea	20080064182	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE
Brazil	PI0610030	composto, processo para a preparação de um composto, método de tratamento de uma infecção por hiv em um humano, uso de um composto, e, composição farmacêutica
Israel	225028	תכשיר רוקחי פרנטרלי לשימוש בטיפול בזיהום על ידי hiv באדם (Parenteral pharmaceutical composition for use in the treatment of an hiv infection in a human)
Slovenia	3045206
Morocco	29460	DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH
China	101212903	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity

Supplementary Protection Certificates for APRETUDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	14C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117	300676	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
2465580	122021000021	Germany		PRODUCT NAME: CABOTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1481 20201217
2465580	CR 2021 00010	Denmark		PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221
1874117	122014000066	Germany		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
2465580	C 2021 017	Romania		PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF NATIONAL AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217
2465580	PA2021512,C2465580	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217

APRETUDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Apretude

Introduction to Apretude

Apretude, also known as cabotegravir, is a groundbreaking long-acting injectable drug developed by ViiV Healthcare, a subsidiary of GlaxoSmithKline (GSK), for the prevention of HIV infection. This drug has revolutionized the HIV pre-exposure prophylaxis (PrEP) market by offering an alternative to daily oral medications.

Market Position and Competition

Apretude has entered a market dominated by Gilead Sciences’ oral PrEP drugs, such as Truvada and its generic versions. However, Apretude's unique selling point is its long-acting injectable formulation, which is administered every eight weeks. This has shown significant efficacy in reducing the risk of HIV infection, with a 69% reduction in men and transgender women and an 89% reduction in women compared to Truvada[2].

Sales Performance and Growth Projections

Since its FDA approval in December 2021, Apretude has demonstrated robust sales growth. In the second quarter of 2022, Apretude generated £8 million in sales, while its counterpart, Cabenuva, a long-acting treatment for HIV, registered £72 million in sales[2].

GSK has revised its medium-term growth forecast for its HIV drug business, driven largely by the success of Apretude. The company now projects annual sales growth rates of 6% to 8% from 2021 to 2026, aiming for sales between £6 billion and £7 billion by 2026[4].

Market Share and Expansion

ViiV Healthcare holds a significant market share in the HIV treatment and prevention market. In the US, ViiV has about 25.5% of the market share, with Apretude and Cabenuva contributing substantially to this figure. The overall HIV market is valued at USD 28 billion, with a growing number of infected individuals each year[1].

Apretude is expected to play a crucial role in expanding ViiV’s market share, particularly as it gains broader reimbursement in the United States and Europe. The drug’s acceptance is driven by its convenience and efficacy, addressing the challenges of adherence associated with daily oral PrEP medications[4].

Global Access and Licensing

To enhance global access to Apretude, GSK has signed a licensing deal with the Medicines Patent Pool (MPP), allowing selected generics manufacturers to produce and supply the drug in 90 poorer countries. This initiative aims to make the drug more accessible in regions with the highest burden of HIV, such as sub-Saharan Africa[2].

Financial Outlook and Revenue Projections

The financial trajectory for Apretude is promising. ViiV Healthcare anticipates that its long-acting portfolio, including Apretude, will deliver over £2 billion in sales by 2026, representing about one-third of the company’s overall HIV sales during this period[3].

Apretude’s list price is approximately $3,700 per vial, or $22,200 per year. However, generics manufacturers could potentially produce the drug at a significantly lower cost, around $2.60 per vial, according to research by the Clinton Health Access Initiative[2].

Future Developments and Dosing Intervals

GSK is committed to further enhancing the convenience of Apretude. The company plans to extend the dosing interval to every four months by 2026 and aims to achieve a six-month dosing interval by the end of the decade. Additionally, there are plans to develop self-administered formulations, which could significantly improve patient compliance and convenience[1][3].

Patent Expiry and Long-Term Prospects

While the core patent for dolutegravir, ViiV’s top-selling anti-HIV drug, is set to expire in 2028, the patents for Apretude and other long-acting formulations are expected to remain valid until 2031 or beyond. This extended period of exclusivity is crucial for maintaining ViiV’s market leadership and ensuring continued revenue growth[3].

Challenges and Implementation

Despite its potential, Apretude faces several challenges, including logistical issues in low-income regions where healthcare infrastructure may not be as robust. Doctors prescribing HIV medications are also in the process of adapting to the administration of injectable drugs, which requires additional training and infrastructure setup[2].

Key Trends Shaping the Market

The HIV treatment and prevention market is influenced by several key trends, including the persistence of stigma and inequity, low PrEP utilization rates, and increasing payer pressure. However, the strong demand for long-acting injectables and the focus on access and equity are driving market dynamism[3].

Community Engagement and Access

ViiV Healthcare and its partners are actively engaged in ensuring equitable access to Apretude. Collaborations with organizations like the Bill & Melinda Gates Foundation, the Children’s Investment Fund Foundation, and Unitaid are facilitating pricing discussions for government purchases and implementing studies to optimize drug delivery in different settings[2].

Conclusion

Apretude has emerged as a game-changer in the HIV PrEP market, offering a convenient and highly effective alternative to daily oral medications. With strong sales growth, expanded global access initiatives, and a robust financial outlook, Apretude is poised to continue driving ViiV Healthcare’s leadership in the HIV treatment and prevention market.

Key Takeaways

• Apretude is a long-acting injectable PrEP drug that has shown significant efficacy in reducing HIV infection risk.
• The drug has gained strong market acceptance, contributing to ViiV Healthcare’s revised growth forecasts.
• Global access initiatives, including a licensing deal with the Medicines Patent Pool, aim to make Apretude available in poorer countries.
• Future developments include extended dosing intervals and self-administered formulations.
• Patent exclusivity for Apretude is expected to last until 2031 or beyond.

Frequently Asked Questions

What is Apretude and how does it work?

Apretude, or cabotegravir, is a long-acting injectable drug used for HIV pre-exposure prophylaxis (PrEP). It is administered every eight weeks and has shown to significantly reduce the risk of HIV infection compared to daily oral PrEP medications.

How effective is Apretude in preventing HIV?

Apretude has been shown to reduce the risk of HIV infection by 69% in men and transgender women and by 89% in women compared to Truvada[2].

What are the challenges in implementing Apretude in low-income regions?

Implementing Apretude in low-income regions faces logistical challenges, including the need for healthcare infrastructure to administer the injections and the higher cost compared to generic oral PrEP medications[2].

How does Apretude’s pricing compare to other PrEP options?

Apretude’s list price is approximately $3,700 per vial, or $22,200 per year. However, generics manufacturers could produce it at a lower cost, around $2.60 per vial[2].

What are the future plans for Apretude’s dosing intervals?

GSK plans to extend the dosing interval for Apretude to every four months by 2026 and aims to achieve a six-month dosing interval by the end of the decade[1][3].

Cited Sources:

1. SHIONOGI & CO., LTD. - SHIONOGI & CO., LTD. Investor Presentation.
2. FiercePharma - GSK feeds HIV PrEP drug to Medicines Patent Pool amid US launch.
3. GSK - ViiV Healthcare Meet the Management.
4. GENE ONLINE - GSK Boosts HIV Drug Business Forecasts as Apretude Sales Surge.