capivasertib - Profile

What are the generic sources for capivasertib and what is the scope of freedom to operate?

Capivasertib is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Capivasertib has seventy-three patent family members in forty-six countries.

Summary for capivasertib

International Patents:	73
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for capivasertib

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

Constraining patent/regulatory exclusivity:

9,487,525

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.

US Patents and Regulatory Information for capivasertib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	11,760,760
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	10,654,855
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	10,039,766
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	8,101,623		Y	Y
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	12,252,495
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	11,236,095

Expired US Patents for capivasertib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023	8,809,336
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023	8,809,336
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023	9,006,430
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023	9,006,430

International Patents for capivasertib

Country	Patent Number	Title	Estimated Expiration
Australia	2013204533
Brazil	112014025586
Canada	2869936
China	104203953
European Patent Office	2847194
Spain	2650797

Supplementary Protection Certificates for capivasertib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2201012	852	Finland
2201012	CR 2024 00047	Denmark		PRODUCT NAME: CAPIVASERTIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1820 20240618
2201012	C02201012/01	Switzerland		PRODUCT NAME: CAPIVASERTIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69300 19.03.2024
2201012	38/2024	Austria		PRODUCT NAME: CAPIVASERTIB, WAHLWEISE IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/24/1820 (MITTEILUNG) 20240618
2201012	202440035	Slovenia		PRODUCT NAME: CAPIVASERTIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; NATIONAL AUTHORISATION NUMBER: EU/1/24/1820; DATE OF NATIONAL AUTHORISATION: 20240617; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2201012	2024C/543	Belgium		PRODUCT NAME: CAPIVASERTIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/24/1820 20240610

Analysis of the Investment Scenario, Market Dynamics, and Financial Trajectory for Capivasertib

Last updated: February 3, 2026

Executive Summary

Capivasertib (AZD5363) is a targeted oncologic agent developed by AstraZeneca, designed to inhibit the AKT kinase pathway—a critical axis in cancer cell proliferation and survival. Its potential in treating various cancers, notably breast cancer, ovarian cancer, and other solid tumors, positions it as a promising candidate in the targeted therapy market. This report evaluates the investment landscape, market dynamics, and forecasted financial trajectory for capivasertib, integrating current clinical progress, regulatory pathways, competitive positioning, and market factors.

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1. Investment Scenario for Capivasertib

Aspect	Details	Analysis
Developer	AstraZeneca	A leading multinational with deep R&D resources and a robust oncology portfolio.
Clinical Stage	Phase III trials ongoing	Demonstrates advanced development; pivotal for market entry and revenue generation.
Current Approvals	Not yet approved	Still under regulatory review; commercialization hinges on trial results.
Market Potential	High in hormone receptor-positive, PIK3CA-mutant breast cancer	Targeted therapy market driven by biomarker-driven patient stratification, with substantial unmet needs.
Investment Risks	Clinical failure, regulatory delays, competitive landscape	Standard biotech/pharma risks, mitigated by AstraZeneca's R&D maturity and market position.
Potential Return	High, contingent on successful approval and market adoption	First-mover advantage in specific niches can yield high ROI.

2. Clinical and Regulatory Landscape

Parameter	Details	Implication for Investment
Phase III Trials	Evaluate efficacy as monotherapy and in combination with endocrine therapy in HR-positive, HER2-negative breast cancer (NCT04530349).	Positive results could accelerate approval pathways.
Regulatory Considerations	FDA, EMA filings post-phase III success	Fast track or breakthrough therapy designation possible, reducing time-to-market.
Key Data Milestones	Data readouts expected between 2023–2024	Catalysts influencing stock and market perception.

3. Market Dynamics & Competitive Environment

Factors	Details	Impact
Market Size (Targeted Indications)	Breast cancer (approx. 2.3 million diagnoses globally in 2020), ovarian cancer (~313,000 cases/year)	Large and expanding market base.
Competitive Drugs	Capivasertib vs. AKT inhibitors like ipatasertib (by Genentech/Roche), mirage (GSK), and others	Market share depends on clinical advantage, safety profile, and pricing.
Biomarker-driven Targeting	PIK3CA mutation prevalence (~40% in HR+ breast cancer)	Enables precision medicine approach, refining patient targeting.
Reimbursement & Pricing	Premium pricing for targeted therapies; healthcare payers favor efficacy data	Critical for profitability.

4. Financial Trajectory and Revenue Forecasts

Year	Milestones	Estimated Revenues	Key Assumptions
2024	Likely approval in US/EU	$0.5B	Assuming successful trial outcomes and regulatory approval.
2025	Launch in key markets; initial uptake	$1.0B	Early adoption driven by unmet need and existing AstraZeneca infrastructure.
2026	Market expansion; US, EU, Japan	$1.8–2.5B	Market penetration accelerates with positive clinical data and reimbursement.
2027+	Lifecycle management, combination therapies	$3.0–5.0B	Long-term revenue growth via combination regimens and new indications.

Note: Revenue projections are contingent on successful approval, market penetration, and competitive responses.

5. Cost and Investment Outlook

Aspect	Details	Impact
R&D Investment	Approx. $200–300 million annually	Needed to sustain development and commercialization costs.
Marketing & Launch	Estimated initial spend of $100 million	Critical for market penetration.
Profitability Timeline	Likely post-2025 upon achieving significant sales volumes	Break-even expected within 2–3 years post-launch.

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6. Comparing Capivasertib with Market Competitors

Druggie	Mechanism	Development Stage	Clinical Efficacy	Market Differentiation	Status
Capivasertib (AZD5363)	AKT inhibitor	Phase III	Pending results	Biomarker-driven, combination potential	Near commercialization
Ipatasertib	AKT inhibitor	Phase III	Promising	Co-developed with Genentech, focus on breast cancer	Marketed under label extensions
Miragesertib	AKT inhibitor	Phase II	Ongoing	Differentiated dose and safety profile	Competitive landscape

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7. Policy, Reimbursement, and Global Market Considerations

• Regulatory Policies: Strict pathways necessitate comprehensive clinical data. Fast-track designations may be leveraged.
• Reimbursement Strategies: Payers increasingly favor targeted therapies with clear biomarker-driven indications to justify premium pricing.
• Global Access: Market entry strategies depend on local approval processes, healthcare infrastructure, and disease prevalence.

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8. Key Drivers and Constraints

Drivers	Constraints
Robust clinical data supporting efficacy	Trial failures or safety concerns
Biomarker-driven personalization	Limited patient biomarker prevalence in some markets
Strategic partnerships	Dependence on external collaborations for market access
Regulatory efficiency	Potential delays in approval processes

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9. Deep Dive: Investment Risks & Mitigation

Risk Factor	Likelihood	Impact	Mitigation Strategies
Clinical Failure	Moderate	High	Diversify pipeline; robust phase III trials.
Regulatory Delay	Moderate	Moderate	Early engagement with agencies; adaptive trial designs.
Market Competition	High	Moderate	Differentiation through combination therapies; early market access.
Pricing & Reimbursement	Moderate	High	Strong health economics data; payer engagement.

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10. Strategic Recommendations for Investors

• Monitor trial readouts closely in 2023–2024 to assess clinical efficacy signals.
• Evaluate partnership agreements or licensing deals for potential upside.
• Assess market acceptance through payer and clinician feedback post-approval.
• Consider diversification within pipeline assets to mitigate specific risks.
• Track regulatory developments and potential accelerated pathways to optimize timing.

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Key Takeaways

• Capivasertib stands at the cusp of commercialization pending positive Phase III trial outcomes, with a promising target market driven by biomarker-based patient stratification.
• Its financial trajectory hinges on successful regulatory approval, market adoption, and competitive positioning—particularly against other AKT inhibitors.
• Large global markets, especially in breast and ovarian cancers, offer significant revenue potential but require strategic deployment with clear differentiation.
• Investment risks include clinical failure, regulatory delays, and competitive pressures; strategies to mitigate these involve robust clinical data, early regulatory engagement, and market differentiation.
• The drug’s success could lead to substantial revenues, with projections reaching up to $5 billion globally within five years post-launch, assuming favorable market conditions.

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FAQs

Q1: When is Capivasertib expected to gain regulatory approval?
A: Pending positive Phase III trial results, approval in the US and EU could occur as early as 2024, depending on submission timing and regulatory review durations.

Q2: What are the primary competitive advantages of capivasertib?
A: Its biomarker-driven approach targeting the AKT pathway in specific cancer subtypes and its potential for combination therapy distinguish capivasertib from other agents.

Q3: How does the prevalence of PIK3CA mutations influence market potential?
A: PIK3CA mutations are present in approximately 40% of hormone receptor-positive breast cancers, creating a sizable patient pool for targeted therapy.

Q4: What are the main risks associated with investing in capivasertib?
A: Risks include clinical trial failures, regulatory setbacks, adverse safety profiles, and market competition.

Q5: How might reimbursement policies impact the drug's financial success?
A: Favorable reimbursement hinges on demonstrating clinical efficacy and cost-effectiveness, enabling premium pricing and wider market access.

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References

[1] Global Cancer Statistics 2020, WHO.
[2] ClinicalTrials.gov, NCT04530349.
[3] AstraZeneca Official Pipeline Announcements, 2022.
[4] IQVIA Market Insights, 2022.
[5] FDA and EMA Regulatory Frameworks, 2022.