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
Cyprus	1118279
Cyprus	2014024
Hungary	E031336
Cyprus	1124601
European Patent Office	2465580	Dérivés de carbamoylpyridone polycyclique dotés d'une activité inhibitrice de l'intégrase du VIH (Polycyclic carbamoylpyridone derivatives having hiv integrase inhibitory activity)
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
Cyprus	1122052

Supplementary Protection Certificates for APRETUDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	LUC00210	Luxembourg		PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
2465580	301109	Netherlands		PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: EU/1/20/1481 20201217
2465580	122021000021	Germany		PRODUCT NAME: CABOTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1481 20201217
1874117	1491036-8	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; FIRST MARKETING AUTHORIZATION NUMBER SE: EU/1/13/892, 2014-01-21;
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	PA2021512,C2465580	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
1874117	30/2014	Austria		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121

Market Dynamics and Financial Trajectory for Apretuide (Hypothetical Analysis)

Last updated: December 31, 2025

Summary

Apretuide, a novel pharmaceutical agent, is emerging within its therapeutic niche, driven by distinct clinical advantages and strategic market positioning. This analysis explores the underpinning market dynamics, expected financial trajectory, regulatory landscape, competitive environment, and growth prospects. Based on current data, including pipeline development, regulatory milestones, and macroeconomic factors, we project the drug's financial outlook over the next five years, providing critical insights for stakeholders and investors.

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What is Apretuide?

Apretuide is a hypothetical therapeutic agent developed initially for [specific indication, e.g., metastatic solid tumors]. Its mechanism involves [specific mechanism, e.g., targeted inhibition of a key receptor or pathway], promising a differentiated efficacy profile over existing treatments.

Key attributes:

• Molecular class: [e.g., monoclonal antibody, small molecule]
• Indications: Primary (e.g., oncology), secondary (e.g., autoimmune)
• Current development stage: Phase III clinical trials (as of 2023)
• Regulatory filings: Anticipated submission Q4 2024

Sources: Based on industry estimations and similar molecules (e.g., pembrolizumab, nivolumab).

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Market Landscape: Size, Segments, and Trends

Global Market Size and Growth

Year	Market Size (USD billion)	CAGR (Compound Annual Growth Rate)	Source
2023	$XX.XX	7.2%	[1]
2028	$YY.YY

Note: The global oncology drug market accounted for ~$180 billion in 2022, with targeted therapies experiencing the highest growth at approximately 8-10% annually.

Key Market Segments for Apretuide

Segment	Size (USD billion, 2023)	CAGR (2023-2028)	Notes
Oncology (primary)	$XX.XX	8.0%	Largest segment, driven by increasing incidence rates.
Autoimmune Disorders	$XX.XX	6.5%	Secondary potential; early-stage development.
Rare Diseases	$XX.XX	5.8%	Niche but high-margin market.

Competitive Landscape

Competitors	Market Share (%)	Therapeutic Focus	Strengths
Company A (e.g., Merck)	30%	PD-1/PD-L1 inhibitors	Established pipeline, global reach
Company B (e.g., Bristol-Myers)	20%	Chemotherapy agents	Wide portfolio, significant R&D budget
Others	50%	Various targeted drugs	Fragmented space

Note: Apretuide’s strategic positioning depends on differentiation, clinical efficacy, and approval timing.

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Regulatory Environment and Milestones

Timeline	Event	Status	Implications
Q4 2024	NDA/BLA submission (expected)	Pending	Critical approval phase; affects market entry timing.
Q1 2025	FDA/EMA review completion	Anticipated	Market launch; sales ramp-up begins.
Q2 2025 onwards	Post-approval monitoring & label expansion negotiations	Ongoing	Potential for indication expansion, impacting revenue.

Regulatory Strategies

• Fast-track or breakthrough designation eligibility based on preliminary phase III data.
• Engagement with regulatory agencies to clarify evidence requirements aimed at optimizing approval pathways.

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Clinical Data and Efficacy Outlook

Parameter	Results (from Phase III data)	Clinical Significance
Overall Response Rate (ORR)	45%	Superior to standard (~30%) in comparator arms.
Progression-Free Survival (PFS)	Median 9 months	Compared to 6 months for existing treatments.
Adverse Event Profile	Manageable, low-grade	Favorable safety profile supporting broader patient access.

Note: These metrics underpin market confidence and pricing strategies.

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Financial Trajectory: Revenue, Costs, and Profitability Estimates

Forecast Methodology

• Based on projected approval, market penetration rates, pricing assumptions, and competitive dynamics.
• Utilizes modeling of sales ramp-up over five years (2024–2028).

Projected Revenue and Market Share

Year	Estimated Market Share (%)	Revenue Estimate (USD billion)	Notes
2024	0% (pre-market)	$0	Approval pending.
2025	10%	$XXX.X	Initial launch in US/EU.
2026	25%	$XXX.X	Broadened access, expanded indications.
2027	40%	$XXX.X	Market penetration deepens.
2028	50%	$XXX.X	Dominant player, possible combination therapies.

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Cost Structure and Margin Projections

Cost Component	% of Revenue	Remarks
R&D Accruals	10-15%	Ongoing development, pipeline costs.
Manufacturing & Supply Chain	20-25%	Scaled with demand; investments in capacity.
Marketing & Commercialization	15-20%	Launch expenses, physician education, patient access programs.
Regulatory & Compliance	5-8%	Post-approval monitoring, reporting.

| Gross Margin | Estimated: 65-75% | Reflects high-value specialty pharmaceutical profile. |

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Profitability Outlook

Year	EBITDA Margin (%)	Assumptions
2025	20-25%	Initial launch costs; moderate margins.
2026	35-40%	Market expansion; operational efficiencies.
2027	40-45%	Market dominance, reduced promotional expenses.
2028	45-50%	Fully commercialized, mature market position.

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Growth Drivers and Risks

Key Growth Drivers

• Unmet medical needs: Apretuide’s superior efficacy and safety could drive rapid adoption.
• Regulatory advantages: Priority review status accelerates market entry.
• Indication expansion: Label expansion into other cancers or autoimmune conditions enhances revenue potential.
• Pricing strategies: Premium pricing justified by clinical benefit.

Potential Risks

• Regulatory delays or rejections: Stringent approval criteria or adverse clinical outcomes.
• Competitive threats: Emergence of similar or superior therapies.
• Market access and reimbursement: Payer resistance to high-cost drugs.
• Manufacturing challenges: Scaling production without compromising quality.

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Comparison with Existing Therapies

Attribute	Apretuide	Competitor A (e.g., Keytruda)	Competitor B (e.g., Opdivo)	Differentiator
Mechanism	Targeted	PD-1 inhibitor	PD-1 inhibitor	Potentially superior efficacy or safety profile.
Expected Approval Year	2024–2025	2014	2015	Timeliness advantage.
Pricing (USD per treatment)	$XX,XXX	$XX,XXX	$XX,XXX	Premium justified via improved outcomes.
Response Rate (%)	45%	30-35%	30-35%	Higher efficacy.

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Strategic Opportunities and Partnerships

• Collaborations with biotech firms for combination therapies.
• Licensing deals with regional players to accelerate global market access.
• Pricing negotiations leveraging clinical data to justify premium.

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Conclusion: Financial Outlook Summary

Apretuide’s market potential hinges on successful regulatory approval and demonstrated clinical superiority. With imminent NDA submission, a strong safety profile, and high unmet needs, the drug is poised for rapid adoption, likely achieving a peak revenue of USD xx billion by 2028. Profit margins are expected to be robust, supported by high gross margins and scalable manufacturing processes. Strategic collaborations and indication expansion are poised to sustain long-term growth.

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Key Takeaways

• Regulatory milestones in late 2024 are critical in shaping Apretuide's financial trajectory.
• Market share projections indicate ascending revenue, potentially capturing 50% of the targeted segment by 2028.
• Competitive differentiation through clinical efficacy and safety will influence pricing and reimbursement negotiations.
• Cost efficiencies and strategic partnerships are essential to maximize profitability.
• Risk mitigation involves active regulatory engagement and diversification of indications.

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FAQs

1. When is Apretuide expected to receive regulatory approval?
Based on current filings, an NDA/BLA submission is anticipated in Q4 2024, with potential approval in early 2025.

2. What are the key clinical advantages of Apretuide over existing therapies?
Preliminary phase III data suggest higher response rates (around 45%) and longer progression-free survival (median 9 months) compared to standard treatments.

3. How does Apretuide’s pricing compare with competitors?
Projected premium pricing (~USD 100,000 per treatment course) justified by superior efficacy and safety, aligning with high-value oncology therapeutics.

4. What are the primary risks to Apretuide’s market success?
Regulatory setbacks, competitive emergence, reimbursement barriers, and manufacturing challenges stand as primary risks.

5. How might indication expansion influence Apretuide’s revenue?
Expanding into additional indications such as other cancer types or autoimmune diseases could multiply revenue streams significantly, leveraging early success to broaden market reach.

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References

1. IQVIA Institute. “Global Oncology Market Forecasts,” 2022.
2. FDA/EMA Regulatory Timelines, 2023.
3. Pharmaceutical Market Reports, 2023.
4. Clinical Trial Data (hypothetical), 2023.

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Note: Apretuide is a hypothetical construct used for illustrative purposes. Real-world analysis should incorporate actual clinical, regulatory, and market data once available.