Viewing data from:

INQOVI

NDA

CEDAZURIDINE; DECITABINE | N212576 | TAIHO ONCOLOGY INC

1 strength7 unique patents2 unique exclusivities

Patent Timeline

7 unique patents, 2 exclusivities by expiration date

Active (7)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Feb. 12, 2034

Oct. 16, 2028

Oct. 16, 2028

Feb. 24, 2041

Oct. 7, 2040

Feb. 24, 2041

Dec. 10, 2042

ODE-316

Jul. 7, 2027

I-990

May. 13, 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

40 trials from ClinicalTrials.gov — 21 recruiting, 12 active, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma NCT05089370	Phase 1/2	Active	University of Colorado, Denver	8	2022-06-20 → 2026-10
ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase NCT05007873	Phase 2	Active	M.D. Anderson Cancer Center	39	2021-10-21 → 2028-10-30
Venetoclax in Combination With Decitabine and Cedazuridine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia NCT04975919	Phase 2	Active	M.D. Anderson Cancer Center	20	2021-09-29 → 2027-05-31
Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia NCT04746235	Phase 2	Active	M.D. Anderson Cancer Center	85	2021-02-22 → 2028-10-31
Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients NCT04817241	Phase 1/2	Active	National Cancer Institute (NCI)	5	2022-02-10 → 2026-11-05
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)NCT04657081	Phase 1/2	Active	Taiho Oncology, Inc.	101	2021-02-09 → 2028-12-31
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN NCT03613532	Phase 1	Active	Jacqueline Garcia, MD	102	2018-10-24 → 2030-03-05
Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia NCT05396859	Phase 1	Active	OHSU Knight Cancer Institute	13	2022-10-28 → 2027-02-01
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes NCT06091267	Phase 1/2	Active	Otsuka Beijing Research Institute	72	2023-10-16 → 2027-06-30
Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia NCT04655755	Phase 1/2	Active	M.D. Anderson Cancer Center	52	2021-01-19 → 2028-07-20

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$5795.01

Highest Price

$5795.01

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64842-0727-09INQOVI TAB	$5795.01	FSS	Taiho Oncology, Inc.	03/31/2027

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

Medicare Part D Spending

CMS annual spending data for Inqovi (2024)

Total Spending

$94.5M

Total Claims

12,036

Beneficiaries

2,928

Avg Cost/Unit

$1616.93

Spending Trend

$9.1M(2020)→$53.2M(2021)→$69.6M(2022)→$77.3M(2023)→$94.5M(2024)

YoY Change:-6.0%

5yr CAGR:+1.5%

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 15, 2026	SUPPL -8	View Letter (PDF)
Mar 25, 2022	SUPPL -3	View Letter (PDF)
Jul 8, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG;35MG

RLD

7 patents2 exclusivities▴

TABLET;ORAL | Approved: Jul 7, 2020

Patents (7) · 9 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8268800	Feb 12, 2034	—	Yes	—		—
8618075	Oct 16, 2028	—	—	—		—
9567363	Oct 16, 2028	—	Yes	—	—	—
11963971	Feb 24, 2041	—	—	Yes	—	—
12195496	Oct 7, 2040	—	—	Yes	—	—
12239653	Feb 24, 2041	—	—	—		—
12697347	Dec 10, 2042	—	—	—		—

Exclusivities (2)

Code	Date	Status
I-990	May 13, 2029	Active
ODE-316	Jul 7, 2027	< 1 year