Capivasertib Patent Expiration

Capivasertib is used for treating HR-positive, HER2-negative locally advanced or metastatic breast cancer with specific genetic alterations after progression on endocrine therapy in the metastatic setting or recurrence within 12 months of adjuvant therapy. It was first introduced by Astrazeneca Pharmaceuticals Lp in its drug Truqap on Nov 16, 2023.


Capivasertib Patents

Given below is the list of patents protecting Capivasertib, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Truqap US10039766 Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d] pyrimidin-4-y1) piperidine-4-carboxamide Apr 16, 2033 Astrazeneca
Truqap US9487525 Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl) piperidine-4-carboxamide Apr 16, 2033 Astrazeneca
Truqap US8101623 Substituted pyrrolo[2,3-d]pyrimidine as a protein kinase B inhibitor Mar 10, 2030 Astrazeneca
Truqap US10059714 Protein kinase B inhibitors Oct 10, 2028 Astrazeneca
Truqap US10654855 Protein kinase B inhibitors Oct 10, 2028 Astrazeneca
Truqap US11236095 Protein Kinase B Inhibitors Oct 10, 2028 Astrazeneca
Truqap US11760760 Protein kinase B inhibitors Oct 10, 2028 Astrazeneca
Truqap US12252495 Protein kinase B inhibitors Oct 10, 2028 Astrazeneca
Truqap US9492453 Protein Kinase B Inhibitors Oct 10, 2028 Astrazeneca
Truqap US8809336 Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein kinases inhibitors Oct 25, 2025

(Expired)

Astrazeneca
Truqap US9006430 Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein Oct 25, 2025

(Expired)

Astrazeneca



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Capivasertib's patents.

Given below is the list recent legal activities going on the following patents of Capivasertib.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 22 Jan, 2026 US10039766
Payment of Maintenance Fee, 8th Year, Large Entity 22 Jan, 2026 US10059714
transaction for FDA Determination of Regulatory Review Period 20 Jun, 2025 US8101623
transaction for FDA Determination of Regulatory Review Period 20 Jun, 2025 US10059714
transaction for FDA Determination of Regulatory Review Period 02 May, 2025 US8101623
Information Disclosure Statement (IDS) Filed 02 May, 2025 US8101623
transaction for FDA Determination of Regulatory Review Period 02 May, 2025 US10059714
Second letter to regulating agency to determine regulatory review period 16 May, 2024 US10059714
Second letter to regulating agency to determine regulatory review period 16 May, 2024 US8101623
Letter from FDA or Dept of Agriculture re PTE application 08 May, 2024 US8101623


Capivasertib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Capivasertib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors Aminex Therapeutics, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE1
Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing SWOG Cancer Research Network NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss VA Office of Research and Development NA RECRUITING
(Aug 1, 2026)
PHASE2
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment Women's Cancer Study Group GmbH NA RECRUITING
(Aug 1, 2026)
PHASE3
Immunotherapy Plus Capivasertib for Metastatic Bladder Cancer VA Office of Research and Development NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors Gustave Roussy, Cancer Campus, Grand Paris NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain AstraZeneca NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer Relay Therapeutics, Inc. NA RECRUITING
(Jul 1, 2026)
PHASE3
A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants AstraZeneca NA COMPLETED
(Jul 1, 2026)
PHASE1
Rash & Diarrhea Prophylaxis With Capivasertib Maryam Lustberg NA RECRUITING
(Jul 1, 2026)
PHASE2
mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors M.D. Anderson Cancer Center NA RECRUITING
(May 1, 2026)
PHASE1
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer AstraZeneca NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3
Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib Shanxi Province Cancer Hospital NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


Capivasertib Generic API Manufacturers

Given below is the list of companies who have filed for Capivasertib generic, along with the locations of their manufacturing plants worldwide.