Viewing data from:

INQOVI

NDA

CEDAZURIDINE; DECITABINE | N212576 | TAIHO ONCOLOGY INC

1 strength6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Aug. 22, 2030

Oct. 16, 2028

Oct. 16, 2028

Feb. 24, 2041

Oct. 7, 2040

Feb. 24, 2041

ODE-316

Jul. 7, 2027

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Inqovi (2023)

Total Spending

$77.3M

Total Claims

9,227

Beneficiaries

2,272

Avg Cost/Unit

$1719.18

Spending Trend

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

YoY Change:+6.2%

5yr CAGR:+4.1%

Source: CMS Medicare Part D Spending by Drug (2023). 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

6 patents1 exclusivity▴

TABLET;ORAL | Approved: Jul 7, 2020

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8268800	Aug 22, 2030	—	Yes	—		—
8618075	Oct 16, 2028	—	—	—		—
9567363	Oct 16, 2028	—	Yes	—	—	—
11963971	Feb 24, 2041	—	—	Yes	—	—
12195496	Oct 7, 2040	—	—	Yes	—	—
12239653	Feb 24, 2041	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-316	Jul 7, 2027	Active