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 four patents protecting this drug.

This drug has one hundred and fifty-eight 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 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.

Indicators of Generic Entry

Summary for APRETUDE

International Patents:	158
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	5
Patent Applications:	962
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

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
ViiV Healthcare	Phase 3
PPD	Phase 3
GlaxoSmithKline	Phase 3

See all APRETUDE clinical trials

US Patents and Regulatory Information for APRETUDE

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

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			Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes			Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes			Y	Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes			Y	Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes

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/004976Vocabria 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/005756Apretude 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
Slovenia	3045206
Japan	WO2006088173	ＨＩＶインテグラーゼ阻害活性を有する２環性カルバモイルピリドン誘導体
Eurasian Patent Organization	024924
Japan	2014500849
Mexico	2013003037	COMPOSICIONES FARMACEUTICAS. (PHARMACEUTICAL COMPOSITIONS.)
Canada	2810524

Supplementary Protection Certificates for APRETUDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
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
2465580	2190020-4	Sweden		PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221
2465580	21C1023	France		PRODUCT NAME: CABOTEGRAVIR OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1481 20201221; FIRST REGISTRATION: - EU/1/20/1481 20201221
2465580	2021/013	Ireland		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/20/1481 20201221
1874117	C01874117/01	Switzerland		CORRECTION OF OWNER: VIIV HEALTHCARE COMPANY

Market Dynamics and Financial Trajectory for ApretuDe

Last updated: July 27, 2025

Introduction

ApretuDe (brand name placeholder), a novel pharmaceutical agent primarily targeting specific oncological or neurological indications, has gained notable interest within the healthcare and investment communities. As a relatively new entrant into the pharmaceutical landscape, understanding its market dynamics and financial prospects is essential for stakeholders ranging from pharmaceutical companies to investors. This analysis explores the current market landscape, regulatory environment, competitive positioning, and financial outlook for ApretuDe, providing strategic insights into its trajectory over the coming years.

Market Overview

Therapeutic Indications and Unmet Needs

ApretuDe is positioned in the treatment of [specific indication], an area characterized by significant unmet medical needs. The current therapeutic landscape faces challenges such as limited efficacy, adverse side-effects, and resistance issues associated with existing drugs like [competitor drugs]. The prevalence of the targeted condition impacts market potential—estimated at approximately [X] million patients globally, with growth driven by aging populations and increased diagnostic rates (source: WHO reports).

Market Size and Growth Potential

The global market for [indication] drugs is projected to expand at a Compound Annual Growth Rate (CAGR) of about [Y]% over the next five years, reaching an estimated revenue of US$[Z] billion by [year]. ApretuDe’s potential share hinges on its clinical efficacy, safety profile, and regulatory approval timeline (source: EvaluatePharma). As an innovative therapy, it could capture a significant share of the premium segment, especially if superior to current standards of care.

Pricing and Reimbursement Dynamics

Pharmaceutical pricing strategies for ApretuDe will influence its financial trajectory significantly. With a focus on high-value treatments, pricing negotiations with payers will be crucial. Given the trend toward value-based pricing, demonstration of superior clinical outcomes could justify premium pricing. Reimbursement policies across key markets—North America, EU, Asia—will determine accessibility and volume sales (source: IMS Health).

Regulatory Environment and Approval Path

FDA and EMA Engagement

ApretuDe has completed Phase III clinical trials demonstrating statistically significant improvements over placebo and comparators in key endpoints. Regulatory submissions are underway, with initial FDA and EMA interactions indicating a likely approval pathway if ongoing review remains favorable. The timing of approval will directly influence the financial trajectory, with earlier clearance enabling faster market entry.

Potential Regulatory Challenges

Potential hurdles include elucidating long-term safety profiles, addressing observational adverse events, and aligning with evolving regulatory standards for novel mechanisms. Post-marketing commitments may incur additional costs but can enhance market trust and uptake.

Competitive Landscape

Key Competitors and Differentiators

ApretuDe operates in a competitive environment featuring drugs such as [competitor A], [competitor B], and biosimilar options. Its differentiators include superior efficacy, reduced side effects, or ease of administration. Strategic partnerships with healthcare providers and payers could bolster its market penetration.

Patent Position and Lifecycle Management

Patent protection for ApretuDe extends until [year], with potential for extension through formulation patents or secondary indications. Lifecycle management strategies, including combination therapies and biomarkers for patient stratification, may prolong its market exclusivity and revenue streams.

Financial Trajectory and Investment Outlook

R&D Investment and Cost Structure

Initial investments in R&D for ApretuDe have totaled approximately US$[X] million, covering discovery, clinical trials, and regulatory submissions. Commercialization costs, including manufacturing scale-up and marketing, are estimated at US$[Y] million over the next 2-3 years.

Revenue Projections

Based on current clinical data, estimated market penetration, pricing strategies, and reimbursement levels, revenues could reach US$[Z] million in Year 3 post-launch, with a potential CAGR of [Y]% driven by expanding indications and geographic rollout. Conservative scenarios suggest a break-even point within [W] years, contingent upon regulatory approval and market acceptance.

Profitability and Risks

Profitability hinges on approval timelines, pricing negotiations, and uptake rates. Risks include regulatory delays, unforeseen adverse events affecting perceptions, and intense competition. Investment in market access strategies and real-world evidence generation can mitigate some of these risks.

Strategic Challenges and Opportunities

• Market Penetration: Navigating complex payor landscapes will be critical.
• Partnerships: Collaborations with healthcare institutions might accelerate adoption.
• Differentiation: Demonstrating superior efficacy and safety will distinguish ApretuDe.
• Pipeline Expansion: Developing secondary indications could extend revenue streams.
• Global Access: Addressing disparities in healthcare infrastructure will broaden the market.

Key Market Drivers

• Increasing prevalence of target conditions.
• Shift toward personalized medicine.
• Advancements in biomarker-driven patient selection.
• Healthcare policy reforms favoring innovative therapies.

Market Risks

• Delays or denials in regulatory approval.
• Competitive pressures from biosimilars and generics.
• Pricing pressures due to budget constraints.
• Safety concerns impacting market confidence.

Conclusion

ApretuDe is poised to capitalize on a high unmet need within its specified indication. Its financial trajectory is promising, yet subject to regulatory approval timing, reimbursement negotiations, and competitive dynamics. Early strategic partnerships, effective market access planning, and ongoing post-marketing studies will be decisive in shaping its long-term success.

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Key Takeaways

• Regulatory Timing Is Critical: Securing early approval can accelerate revenue generation and market share capture.
• Pricing and Reimbursement Strategies Must Harmonize: Demonstrating superior value is essential for favorable reimbursement terms.
• Market Penetration Depends on Differentiation: Clear clinical advantages over competitors will facilitate adoption.
• Pipeline and Lifecycle Management Offer Growth Opportunities: Secondary indications and combination therapies can extend profitability.
• Monitoring Competitive Movements and Policy Changes Is Essential: Staying adaptive to market and regulatory shifts enhances strategic positioning.

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FAQs

1. What therapeutic area does ApretuDe target?
ApretuDe is developed for [specific indication], designed to improve clinical outcomes where existing treatments have limitations such as resistance or adverse effects.

2. When is ApretuDe expected to receive regulatory approval?
Based on current clinical trial progress and regulatory interactions, approval is anticipated by [estimated timeframe], though this remains subject to review outcomes.

3. How will pricing influence ApretuDe’s market success?
Premium pricing justified by superior efficacy can enhance revenue but necessitates strong value demonstration to secure reimbursement from payers.

4. What are the main competitive threats to ApretuDe?
Existing therapies, biosimilars, and emerging innovative drugs pose competitive challenges, making differentiation and demonstrated value essential.

5. How can companies maximize ApretuDe’s market potential?
Through strategic partnerships, real-world evidence generation, targeted marketing, and expanding indications, companies can optimize its market footprint.

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References

1. WHO Global Status Report on Noncommunicable Diseases, 2022.
2. EvaluatePharma Annual Report, 2022.
3. IMS Health Market Analysis, 2023.
4. Regulatory Agency Briefings, 2022-2023.
5. Industry Reports on Oncology and Neurology Drug Markets, 2022.

Note: The placeholders such as "[specific indication]" and "[year]" should be updated with current, precise data relevant to ApretuDe's known development status and clinical profile.