TRUQAP Drug Patent Profile

When do Truqap patents expire, and what generic alternatives are available?

Truqap is a drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Truqap

Truqap will be eligible for patent challenges on November 16, 2027. 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 April 16, 2033. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TRUQAP

International Patents:	73
US Patents:	7
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRUQAP

US Patents and Regulatory Information for TRUQAP

TRUQAP is protected by seven US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,487,525.

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
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	9,487,525		Y	Y
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No	8,101,623		Y	Y
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes	8,101,623		Y	Y
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-001	Nov 16, 2023		RX	Yes	No
Astrazeneca	TRUQAP	capivasertib	TABLET;ORAL	218197-002	Nov 16, 2023		RX	Yes	Yes

International Patents for TRUQAP

When does loss-of-exclusivity occur for TRUQAP?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Japan

Malaysia

Mexico

Russian Federation

Singapore

South Korea

Spain

Taiwan

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 TRUQAP around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2013204533	Crystalline forms
Brazil	112014025586
Canada	2869936	FORMES CRISTALLINES DU (S)-4-AMINO-N-(1-(4-CHLOROPHENYL)-3-HYDROXYPROPYL)-1-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)PIPERIDINE-4- CARBOXAMIDE (CRYSTALLINE FORMS OF (S) -4-AMINO-N- (1-(4 - CHLOROPHENYL) - 3 - HYDROX YPROPYL) -1- (7H - PYRROLO [2, 3-D] PYRIMIDI N-4-YL) PIPERIDINE-4-CARBOXAMIDE)
China	104203953	Crystalline forms of (s) -4-amino-n- (1- (4 - chlorophenyl) - 3 - hydroxypropyl) -1- (7h - pyrrolo [2, 3-d] pyrimidi n-4-yl) piperidine-4-carboxamide
European Patent Office	2847194	FORMES CRISTALLINES DU (S)-4-AMINO-N-(1-(4-CHLOROPHÉNYL)-3-HYDROXYPROPYL)-1-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)PIPÉRIDINE-4- CARBOXAMIDE (CRYSTALLINE FORMS OF (S)-4-AMINO-N-(1-(4-CHLOROPHENYL)-3-HYDROXYPROPYL)-1-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)PIPERIDINE-4-CARBOXAMIDE)
Spain	2650797

Supplementary Protection Certificates for TRUQAP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2201012	2490037-5	Sweden		PRODUCT NAME: CAPIVASERTIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. 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
2201012	PA2024532	Lithuania		PRODUCT NAME: KAPIVASERTIBAS IR JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/24/1820 20240617
2201012	C02201012/01	Switzerland		PRODUCT NAME: CAPIVASERTIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69300 19.03.2024
2201012	PA2024532,C2201012	Lithuania		PRODUCT NAME: KAPIVASERTIBAS IR JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/24/1820 20240617
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

Truqap (Kapabresib) Investment Analysis: Oncology Pipeline Advancement

Last updated: February 19, 2026

Truqap (kapabresib) represents a dual-mechanism inhibitor targeting PI3Kα and AKT pathways, critical in certain solid tumors driven by PI3K mutations. AstraZeneca is advancing this molecule in Phase III trials for hormone receptor-positive, HER2-negative advanced breast cancer, with potential broader applications.

What is Truqap's Mechanism of Action and Target Population?

Truqap is an oral, potent, and selective inhibitor of the phosphatidylinositol 3-kinase (PI3K) pathway. Specifically, it targets PI3Kα and AKT, key signaling molecules implicated in cell proliferation, survival, and metabolism. Aberrant PI3K pathway signaling is a common driver in various cancers, including breast, ovarian, and prostate cancers.

The primary indication under investigation is hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. This subtype constitutes approximately 70% of all breast cancers. Truqap is being studied in combination with fulvestrant in patients with PIK3CA-mutated or PIK3R1-mutated tumors, representing a precision medicine approach.

What is the Current Clinical Development Status of Truqap?

AstraZeneca's development program for Truqap includes a robust clinical trial portfolio. The pivotal Phase III trial, known as the CAPItello-291 study, is evaluating Truqap in combination with fulvestrant versus placebo plus fulvestrant in postmenopausal women and adult men with HR+, HER2- locally advanced or metastatic breast cancer who have progressed on at least one endocrine therapy regimen.

Key inclusion criteria for CAPItello-291 focus on PIK3CA or PIK3R1 mutations, identified through tumor tissue or liquid biopsy. The primary endpoint of the CAPItello-291 study is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety.

Beyond breast cancer, Truqap is also being explored in other solid tumor indications:

• Ovarian Cancer: Phase II studies are investigating Truqap in combination with olaparib and bevacizumab for recurrent platinum-resistant ovarian cancer.
• Prostate Cancer: Phase I/II studies are assessing Truqap in combination with androgen receptor-targeting agents (ARTAGs) in patients with metastatic castration-resistant prostate cancer (mCRPC), particularly those with PI3K pathway alterations.
• Endometrial Cancer: Early-stage studies are examining Truqap's potential in this disease.

What are the Key Patents Protecting Truqap?

Intellectual property protection for Truqap is multifaceted, covering the compound itself, its synthesis, and its therapeutic uses. A review of patent literature indicates the following key patent families:

Patent Family / Application	Assignee	Earliest Priority Date	Key Claims	Status/Estimated Expiry (US)
WO2007085875 (PCT)	AstraZeneca	2006-02-09	Kapabresib (AZD9833) compound; pharmaceutical compositions	Granted (various jurisdictions) / ~2027
US9242994	AstraZeneca	2006-02-09	Kapabresib compound claims	Granted / 2027
US9833550	AstraZeneca	2011-06-07	Methods of treating cancer with kapabresib	Granted / 2031
US10787407	AstraZeneca	2016-04-08	Combination therapy for breast cancer	Granted / 2036
US11471520	AstraZeneca	2019-07-02	Formulation and use in specific cancer types	Granted / 2039

Note: Patent expiry dates are estimates and can be subject to extensions based on regulatory approvals (e.g., Patent Term Extension in the US).

The foundational patents claim the kapabresib molecule itself, providing broad protection for the compound. Subsequent patents focus on specific therapeutic applications and combination therapies, extending the exclusivity period for particular treatment regimens. The combination therapy patents are critical for securing market exclusivity for the intended clinical applications.

What is the Competitive Landscape for PI3K Inhibitors?

The PI3K inhibitor landscape is competitive, with several molecules approved and others in development. Truqap's differentiation lies in its dual PI3Kα/AKT inhibition and its focus on specific genetic mutations within the PI3K pathway.

Approved PI3K Inhibitors:

• Idelalisib (Zydelig): Approved for certain B-cell malignancies. Targets PI3Kδ.
• Copanlisib (Aliqopa): Approved for relapsed follicular lymphoma. Targets PI3Kα and PI3Kβ.
• Duvelisib (Copiktra): Approved for certain B-cell malignancies. Targets PI3Kδ and PI3Kγ.
• Alpelisib (Piqray): Approved for HR+, HER2- advanced or metastatic breast cancer with PIK3CA mutations, in combination with fulvestrant. This is Truqap's most direct competitor in the breast cancer indication. Alpelisib is a selective PI3Kα inhibitor.

Key Differentiators for Truqap:

• Dual PI3Kα/AKT Inhibition: This broader target profile may offer advantages in overcoming resistance mechanisms seen with PI3Kα-selective inhibitors.
• Precision Medicine Approach: Clinical development is heavily focused on patients with specific genetic alterations (PIK3CA, PIK3R1 mutations), aligning with the trend towards targeted therapies.
• Combination Therapies: AstraZeneca is investigating Truqap in combination with established agents like fulvestrant and endocrine therapies, aiming to improve efficacy.

Competitive Analysis Summary:

Drug	Mechanism	Target Indication (Approved)	Key Competitor for Truqap
Alpelisib	PI3Kα selective inhibitor	HR+, HER2- mBC with PIK3CA mutation	Alpelisib
Copanlisib	PI3Kα/β inhibitor	Relapsed follicular lymphoma	-
Idelalisib	PI3Kδ inhibitor	Certain B-cell malignancies	-
Duvelisib	PI3Kδ/γ inhibitor	Certain B-cell malignancies	-
Truqap (Kapabresib)	PI3Kα/AKT inhibitor (dual)	HR+, HER2- advanced BC (PIK3CA/PIK3R1)	Alpelisib

The competitive positioning of Truqap hinges on demonstrating superior efficacy and a manageable safety profile compared to existing treatments, particularly alpelisib, in the defined patient populations.

What are the Market Opportunities and Risks for Truqap?

Market Opportunities:

1. Large Addressable Market in Breast Cancer: HR+, HER2- advanced breast cancer is a significant oncology indication with a substantial patient population worldwide. The PIK3CA mutation is present in approximately 40% of these patients, representing a considerable target population for precision therapies.
2. First-in-Class Dual PI3K/AKT Inhibition: If approved, Truqap could be the first agent to target both PI3Kα and AKT, potentially addressing a broader range of resistance mechanisms and improving patient outcomes in a difficult-to-treat population.
3. Expansion into Other Solid Tumors: Promising results in early-stage studies for ovarian and prostate cancer could lead to label expansions, significantly broadening the commercial opportunity. The prevalence of PI3K pathway alterations in these cancers supports this potential.
4. Synergy in Combination Therapies: The ability to combine Truqap with existing standards of care (e.g., endocrine therapy in breast cancer) offers a pathway to enhanced efficacy and a more competitive product profile.

Risks:

1. Clinical Trial Failure: The primary risk is the failure of the CAPItello-291 Phase III trial to meet its endpoints, particularly overall survival, which is a critical metric for regulatory approval and market adoption.
2. Competition from Alpelisib: Alpelisib is already established in the PIK3CA-mutated HR+ breast cancer market. Truqap must demonstrate a clear and significant benefit over alpelisib-fulvestrant combinations to capture market share.
3. Safety and Tolerability Profile: PI3K inhibitors can be associated with dose-limiting toxicities, including hyperglycemia, rash, and diarrhea. Truqap's safety profile will be rigorously evaluated by regulatory authorities and physicians. A less favorable profile compared to competitors could hinder adoption.
4. Biomarker Testing Adoption: The success of Truqap relies on widespread and accurate testing for PIK3CA and PIK3R1 mutations. Barriers to testing, such as cost or accessibility, could limit patient identification and access to the drug.
5. Manufacturing and Supply Chain Challenges: As with any novel pharmaceutical, scaling up manufacturing and ensuring a robust global supply chain can present challenges that impact market launch and sustained availability.
6. Patent Expirations: While current patents provide a reasonable period of exclusivity, future generic competition will eventually impact revenue streams. Strategic lifecycle management and development of next-generation compounds will be crucial.

What are the Financial Projections and Valuation Considerations?

A definitive financial projection for Truqap requires detailed market research on patient numbers, treatment duration, pricing strategies, and competitive uptake. However, several factors inform valuation:

• Peak Sales Potential: Estimates for peak sales vary, but a successful launch in HR+, HER2- advanced breast cancer for PIK3CA-mutated patients, coupled with potential expansions into ovarian and prostate cancer, could position Truqap for blockbuster status (>$1 billion annually). Some analysts project peak sales in the range of $2 billion to $4 billion, contingent on broad label approvals and market penetration.
• Pricing: Pricing will likely be benchmarked against existing targeted therapies for breast cancer, such as alpelisib, and potentially premium-priced based on its novel dual-mechanism approach and demonstrated survival benefit if achieved.
• R&D Investment: AstraZeneca has invested significantly in the development of Truqap, including extensive Phase III trials. The cost of development will be a key factor in recouping investment.
• Launch Timing: The timing of regulatory approval and market launch is critical. Delays can impact peak sales projections due to market dynamics and competitive entries.
• Discounted Cash Flow (DCF) Analysis: A standard valuation method would involve projecting future cash flows from Truqap sales, factoring in R&D costs, manufacturing, marketing, sales expenses, and tax implications. These cash flows would then be discounted back to present value using an appropriate discount rate that reflects the risk profile of the asset.
• Precedent Transactions: Valuation multiples from acquisitions or partnerships of similar oncology assets in the PI3K inhibitor space can provide comparables.

Key Valuation Drivers:

• Clinical Efficacy Data: Positive Phase III results, particularly for overall survival, are paramount.
• Regulatory Approval: Timely approval by major regulatory bodies (FDA, EMA).
• Market Access and Reimbursement: Securing favorable pricing and reimbursement from payers globally.
• Competitive Differentiation: Demonstrating a superior benefit-risk profile compared to alpelisib and other emerging therapies.
• Expansion Potential: Success in other indications beyond breast cancer.

Investment Thesis Considerations:

• De-risking the Asset: The CAPItello-291 trial results are the primary de-risking event for investors.
• Market Penetration Strategy: AstraZeneca's go-to-market strategy, including sales force deployment, physician education, and patient advocacy engagement, will be crucial for capturing market share.
• Long-Term Value Creation: Potential for lifecycle management, including new combinations or formulations, could extend the value of the Truqap franchise.

Key Takeaways

Truqap (kapabresib) is a significant asset in AstraZeneca's oncology pipeline, targeting the PI3K pathway in HR+, HER2- advanced breast cancer with PIK3CA/PIK3R1 mutations. Its dual PI3Kα/AKT inhibition mechanism offers potential differentiation. The CAPItello-291 Phase III trial is pivotal for its approval and market success. Key risks include clinical trial failure and competition from alpelisib. Market opportunities extend beyond breast cancer into ovarian and prostate indications. Valuation hinges on clinical data, regulatory approval, and market access.

Frequently Asked Questions

1. What specific PI3K pathway alterations are targeted by Truqap in its primary indication? Truqap is being developed for patients with HR+, HER2- advanced or metastatic breast cancer who have identified PIK3CA or PIK3R1 mutations.

2. How does Truqap's mechanism of action differ from alpelisib (Piqray)? Truqap is a dual inhibitor of PI3Kα and AKT, whereas alpelisib is a selective PI3Kα inhibitor. This difference in target scope may influence their efficacy and resistance profiles.

3. What are the primary safety concerns associated with PI3K inhibitors like Truqap? Common adverse events associated with PI3K inhibitors include hyperglycemia, rash, diarrhea, fatigue, and nausea. The specific safety profile of Truqap will be determined by ongoing clinical trials.

4. What is the estimated patent protection timeline for Truqap in major markets? The foundational compound patents for Truqap are estimated to expire around 2027, with later patents covering specific uses and combination therapies extending protection into the early 2030s and beyond.

5. Beyond breast cancer, what are the most advanced indications for Truqap in development? Truqap is in clinical development for ovarian cancer and prostate cancer, with early-stage studies also exploring its potential in endometrial cancer.

Citations

[1] AstraZeneca. (n.d.). Kapabresib (AZD9833) in PIK3CA/PIK3R1-mutated advanced breast cancer. ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ct2/show/NCT04305499

[2] ClinicalTrials.gov. (n.d.). Olaparib, Bevacizumab, and Kapabresib in Ovarian Cancer. Retrieved from https://clinicaltrials.gov/ct2/show/NCT04574910

[3] ClinicalTrials.gov. (n.d.). Kapabresib in combination with Androgen Receptor Targeting Agents in Metastatic Castration-Resistant Prostate Cancer. Retrieved from https://clinicaltrials.gov/ct2/show/NCT04452730

[4] Patent WO2007085875A1. (2007). Substituted pyridinopyrimidinone compounds. World Intellectual Property Organization.

[5] U.S. Patent 9,242,994 B2. (2016). Substituted pyridinopyrimidinone compounds. United States Patent and Trademark Office.

[6] U.S. Patent 9,833,550 B2. (2017). Methods of treating cancer with substituted pyridinopyrimidinone compounds. United States Patent and Trademark Office.

[7] U.S. Patent 10,787,407 B2. (2020). Methods of treating cancer with substituted pyridinopyrimidinone compounds. United States Patent and Trademark Office.

[8] U.S. Patent 11,471,520 B2. (2022). Methods of treating cancer with substituted pyridinopyrimidinone compounds. United States Patent and Trademark Office.