Question 1

Is there a generic for Cedazuridine; decitabine?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Cedazuridine; decitabine. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Cedazuridine; decitabine?

Accepted Answer

INQOVI (NDA 212576, TAIHO ONCOLOGY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Cedazuridine; decitabine?

Accepted Answer

The Orange Book lists 6 patents against Cedazuridine; decitabine products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Cedazuridine; decitabine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Cedazuridine; decitabine. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Cedazuridine; decitabine are approved?

Accepted Answer

Cedazuridine; decitabine is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8618075	Oct 16, 2028	in 2 yr 4 mo	U-2864
9567363	Oct 16, 2028	in 2 yr 4 mo	Substance
8268800	Aug 22, 2030	in 4 yr 3 mo	SubstanceU-2866
12195496	Oct 07, 2040	in 14 yr 6 mo	Product
12239653	Feb 24, 2041	in 14 yr 11 mo	U-2865
11963971	Feb 24, 2041	in 14 yr 11 mo	Product

Cedazuridine; decitabine

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (6)

Cedazuridine; decitabine — frequently asked questions

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