Capivasertib - Generic Drug Details

What are the generic drug 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 ninety-three patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for capivasertib

International Patents:	93
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	31
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for capivasertib
What excipients (inactive ingredients) are in capivasertib?	capivasertib excipients list
DailyMed Link:	capivasertib at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Recent Clinical Trials for capivasertib

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

Sponsor	Phase
Princess Maxima Center for Pediatric Oncology	PHASE1
AbbVie	PHASE1
Relay Therapeutics, Inc.	PHASE3

See all capivasertib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for capivasertib

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	8,809,336
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes	10,654,855
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	11,760,760
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes	9,006,430		Y
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes	8,101,623		Y	Y

Expired US Patents for capivasertib

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

International Patents for capivasertib

Country	Patent Number	Title	Estimated Expiration
Ukraine	100390
Israel	204721
European Patent Office	2201012	DÉRIVÉS PYRROLO [2,3-D] PYRIMIDINE COMME INHIBITEURS DE LA PROTÉINE KINASE B (PYRROLO[2,3-D]PYRIMIDIN DERIVATIVES AS PROTEIN KINASE B INHIBITORS)
Cuba	20100062	DERIVADOS DE PIRROLO [2,3-D] PIRIMIDINA COMO INHIBIDORES DE PROTEÍNAS QUINASAS B
Saudi Arabia	08290625

Supplementary Protection Certificates for capivasertib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2201012	CA 2024 00047	Denmark		PRODUCT NAME: CAPIVASERTIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1820 20240618
2201012	C202430046	Spain		PRODUCT NAME: CAPIVASERTIB, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/24/1820; DATE OF AUTHORISATION: 20240617; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1820; DATE OF FIRST AUTHORISATION IN EEA: 20240617
2201012	C02201012/01	Switzerland		PRODUCT NAME: CAPIVASERTIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69300 19.03.2024
2201012	24C1046	France		PRODUCT NAME: CAPIVASERTIB, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/24/1820 20240618
2201012	38/2024	Austria		PRODUCT NAME: CAPIVASERTIB, WAHLWEISE IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/24/1820 (MITTEILUNG) 20240618

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Capivasertib

Last updated: July 29, 2025

Introduction

Capivasertib (AZD5363) is an investigational oral AKT kinase inhibitor developed by AstraZeneca, targeting the PI3K/AKT/mTOR signaling pathway—a critical regulator of cell survival, proliferation, and metabolism. Its therapeutic potential spans several oncology indications, notably breast cancer, prostate cancer, and endometrial carcinoma. This article examines the evolving market landscape, competitive positioning, commercialization prospects, and financial trajectory of capivasertib, emphasizing factors influencing its commercial success within the complex oncology drug arena.

Overview of Capivasertib and Clinical Development Status

Capivasertib functions as a selective pan-AKT inhibitor, aiming to disrupt aberrant signaling common in tumors with PI3K pathway mutations. AstraZeneca initiated pivotal phase III trials, notably the FAKTION study in hormone receptor-positive, HER2-negative breast cancer, with promising preliminary results indicating improved progression-free survival (PFS) [1]. The drug's development pipeline includes investigations in prostate, endometrial, and other solid tumors, with regulatory filings contingent upon clinical efficacy and safety data.

While capivasertib remains investigational, its current clinical development status significantly influences market dynamics. A successful regulatory approval could position the drug as a key component in combination therapies targeting resistant and high-risk patient populations.

Market Dynamics Shaping Capivasertib’s Trajectory

1. Unmet Medical Need and Tumor Biology

The PI3K/AKT pathway is frequently dysregulated across multiple cancer types, particularly in hormone receptor-positive breast cancer, where resistance to endocrine therapy often involves PI3K pathway activation [2]. Capivasertib’s targeted inhibition could fill critical gaps in treatment for patients with limited options, thereby underpinning its market potential.

2. Competitive Landscape

The AKT inhibitor space features several competitors, including:

• Ipatasertib (RAY114) by Radius Health/Pfizer.
• Miransertib (ARQ 092) by Arkus Biosciences.
• Capivasertib’s most direct competitors are peer drugs with similar mechanisms, some of which have advanced further in clinical development.

Moreover, broader PI3K pathway inhibitors, such as alpelisib (by Novartis), have gained regulatory approval in specific indications, notably PIK3CA-mutated breast cancer [3]. Capivasertib’s differentiator may be its safety profile, efficacy in specific genetic contexts, and combination potential.

3. Regulatory and Reimbursement Environment

Positive phase III data could facilitate regulatory approval in primary indications, catalyzing early market entry. Reimbursement strategies hinge on demonstrating added value over existing standards of care, which remains a critical determinant of revenue potential. Payers' acceptance will depend on clinical benefit, cost-effectiveness, and positioning within therapeutic algorithms.

4. Partnering and Licensing Agreements

AstraZeneca’s strategic collaborations with academic institutions and oncology networks could accelerate development and commercialization. Additionally, licensing deals and co-marketing arrangements, especially in emerging markets, can diversify revenue streams and mitigate development risks.

5. Pricing and Market Penetration

Authorized drugs in oncology often command premium prices due to high unmet needs. The ultimate pricing strategy for capivasertib will depend on competitive positioning, clinical efficacy, safety profile, and the overall value proposition presented to payers.

Financial Trajectory and Commercial Outlook

1. Revenue Projections for Capivasertib

Given the drug’s current phase of development, direct revenue generation is likely several years away. However, if regulatory approval occurs in the next 2-3 years post-approval, AstraZeneca could anticipate peak sales reaching several hundred million dollars annually within its primary indications.

The Breast Cancer market alone represents a multibillion-dollar sector, with the global breast cancer therapeutics market projected to surpass $20 billion by 2027 [4]. Capivasertib’s success will depend on its ability to capture a significant share in hormone receptor-positive, endocrine-resistant breast cancers where it has demonstrated clinical promise.

2. Cost of Development and Investment Outlook

AstraZeneca’s ongoing phase III trials entail substantial R&D investments, estimated at hundreds of millions of dollars per program [5]. The costs encompass patient recruitment, clinical monitoring, regulatory filings, and post-marketing surveillance.

3. Risk Factors Influencing Financial Outcomes

• Clinical efficacy and safety profile: Positive outcomes bolster likelihood of approval and commercial adoption.
• Regulatory approvals: Conditional on successful trial results; delays or failures diminish financial prospects.
• Market penetration and uptake: Competitive dynamics, payer acceptance, and clinician preference influence sales.
• Pricing policies: High pricing might face reimbursement hurdles; value demonstrations are essential.

4. Strategic Expansion and Growth Opportunities

Beyond primary indications, capivasertib could expand into combination regimens, leveraging broad biomarker-driven applications. Additionally, exploring other cancer types with relevant genetic alterations (e.g., endometrial or prostate cancer) can diversify revenue streams. Advances in companion diagnostics will play a pivotal role, guiding personalized therapy and expanding market access.

Key Market Trends Impacting Capivasertib

• Precision Oncology Growth: Emphasis on biomarker-driven therapies enhances the potential market for targeted agents like capivasertib.
• Multipathway Inhibition: Combining AKT inhibitors with other agents (e.g., CDK4/6 inhibitors, hormonal therapies) aligns with current oncology treatment trends, potentially amplifying efficacy and expanding indications.
• Regulatory Shifts: Accelerated approval pathways and breakthrough designations could expedite market entry upon positive trial outcomes.
• Pricing and Payer Dynamics: Continuous pressure on drug pricing necessitates demonstrable value propositions for favorable reimbursement.

Conclusion

Capivasertib stands at a pivotal nexus of clinical innovation and commercial promise within the oncology pharmaceutical landscape. While its ultimate market success depends on favorable clinical trial outcomes and regulatory approvals, strategic positioning—focusing on unmet needs, competitive differentiation, and biomarker strategies—can significantly bolster its financial trajectory. Early investments in companion diagnostics and combination therapy frameworks will be crucial for maximizing its market penetration and revenue potential.

Key Takeaways

• Development Stage: Capivasertib remains investigational, with promising clinical data driving anticipation of regulatory approval within the next few years.
• Market Potential: Primarily focused on hormone receptor-positive breast cancer, with opportunities in prostate and endometrial cancers.
• Competitive Edge: Differentiation hinges on efficacy, safety, biomarker-guided patient selection, and combination therapy strategies.
• Financial Prospects: Peak sales could reach hundreds of millions annually, contingent on clinical success and payer reimbursement.
• Strategic Focus: Investment in companion diagnostics and expansion into additional indications can enhance market penetration and revenue growth.

FAQs

1. What is the primary mechanism of action of capivasertib?
Capivasertib selectively inhibits AKT kinase, disrupting the PI3K/AKT/mTOR signaling pathway often deregulated in various cancers, thereby hindering tumor growth and survival.

2. In which cancer types is capivasertib currently under clinical investigation?
It is primarily studied in breast cancer, prostate cancer, and endometrial carcinoma, with ongoing phase III trials particularly focused on hormone receptor-positive breast cancer.

3. How does capivasertib compare to its competitors?
While direct head-to-head comparisons are limited, capivasertib aims to distinguish itself through better safety profiles, enhanced efficacy in biomarker-selected populations, and combination therapy potential.

4. What are the main factors influencing capivasertib’s commercial success?
Regulatory approval outcomes, demonstration of superior efficacy and safety, payer reimbursement strategies, competitive positioning, and adoption in clinical practice are pivotal.

5. When might capivasertib reach the market and generate revenues?
Pending positive trial results and regulatory approval, initial commercialization could occur within 2-3 years, with peak revenues achievable within 5-7 years post-launch.

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References:

[1] AstraZeneca. “Forthcoming data on Capivasertib in breast cancer.” (2022).

[2] Miller, T. et al. “PI3K/AKT/mTOR pathway alterations in breast cancer.” Nature Reviews Clinical Oncology, 2021.

[3] Novartis. “Alpelisib (Piqray): Approved uses and market insights.” (2020).

[4] Grand View Research. “Breast Cancer Therapeutics Market Size, Share & Trends.” (2021).

[5] AstraZeneca. “R&D Investment and Portfolio Strategy.” (2022).