Viewing data from:

TRUQAP

NDA

CAPIVASERTIB | N218197 | ASTRAZENECA PHARMACEUTICALS LP

2 strengths9 unique patents2 unique exclusivities

Patent Timeline

9 unique patents, 2 exclusivities by expiration date

Active (9)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

Today

Mar. 10, 2030

Apr. 16, 2033

Oct. 10, 2028

Apr. 16, 2033

Oct. 10, 2028

Oct. 10, 2028

Oct. 10, 2028

Oct. 10, 2028

Oct. 10, 2028

NCE

Nov. 16, 2028

I-991

Jun. 12, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

26 trials from ClinicalTrials.gov — 11 recruiting, 11 active, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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 NCT06764186	Phase 3	Active	AstraZeneca	101	2025-01-07 → 2027-12-31
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)NCT02465060	Phase 2	Active	National Cancer Institute (NCI)	6,452	2015-08-17 → 2026-12-31
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)NCT04862663	Phase 3	Active	AstraZeneca	893	2021-05-10 → 2029-08-14
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients NCT06635447	Phase 3	Active	AstraZeneca	293	2024-09-26 → 2027-01-10
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 NCT03660826	Phase 2	Active	National Cancer Institute (NCI)	288	2018-09-27 → 2027-07-01
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer NCT04556773	Phase 1	Active	AstraZeneca	138	2020-12-17 → 2027-06-01
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer NCT03742102	Phase 1/2	Active	AstraZeneca	243	2018-12-21 → 2027-02-26
Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.NCT03616587	Phase 1	Active	AstraZeneca	396	2018-10-11 → 2027-06-24
mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian NCT02208375	Phase 1	Active	M.D. Anderson Cancer Center	159	2014-11-11 → 2028-06-30
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer NCT04305496	Phase 3	Active	AstraZeneca	818	2020-04-16 → 2026-06-22

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$16770.46

Highest Price

$22067.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00310-9500-01TRUQAP 160MG TAB	$16770.46	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-9500-01TRUQAP 160MG TAB	$22067.32	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-9500-02TRUQAP 160MG TAB	$17474.13	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-9500-02TRUQAP 160MG TAB	$21830.04	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-9501-01TRUQAP 200MG TAB	$17288.05	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-9501-01TRUQAP 200MG TAB	$21830.04	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-9501-02TRUQAP 200MG TAB	$17400.73	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-9501-02TRUQAP 200MG TAB	$21830.04	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Truqap (2024)

Total Spending

$184.2M

Total Claims

8,670

Beneficiaries

2,247

Avg Cost/Unit

$349.43

Spending Trend

$1.5M(2023)→$184.2M(2024)

YoY Change:-9.1%

5yr CAGR:-9.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jun 16, 2026	SUPPL -4	View Letter (PDF)
May 29, 2026	SUPPL -5	View Letter (PDF)
Nov 18, 2025	SUPPL -3	View Letter (PDF)
Feb 14, 2025	SUPPL -2	View Letter (PDF)
Sep 24, 2024	SUPPL -1	View Letter (PDF)
Nov 17, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 160MG

RLD

9 patents2 exclusivities▴

TABLET;ORAL | Approved: Nov 16, 2023

Patents (9) · 8 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8101623	Mar 10, 2030	—	Yes	Yes		—
9487525	Apr 16, 2033	—	Yes	Yes	—	—
9492453	Oct 10, 2028	—	—	—		—
10039766	Apr 16, 2033	—	—	—		—
10059714	Oct 10, 2028	—	Yes	Yes	—	—
10654855	Oct 10, 2028	—	—	—		—
11236095	Oct 10, 2028	—	—	—		—
11760760	Oct 10, 2028	—	—	—		—
12252495	Oct 10, 2028	—	—	—		—

Exclusivities (2)

Code	Date	Status
I-991	Jun 12, 2029	Active
NCE	Nov 16, 2028	Active

#002 — 200MG

RLD

9 patents2 exclusivities▾

TABLET;ORAL | Approved: Nov 16, 2023