Question 1

Is there a generic for Givinostat hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Givinostat hydrochloride?

Accepted Answer

DUVYZAT (NDA 217865, ITALFARMACO SPA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Givinostat hydrochloride?

Accepted Answer

The Orange Book lists 5 patents against Givinostat hydrochloride products, with the earliest listed expiry in 2027. 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 Givinostat hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Givinostat hydrochloride. 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 Givinostat hydrochloride are approved?

Accepted Answer

Givinostat hydrochloride is approved in the following dosage form: suspension.

Patent	Expires	In	Type
7329689	Jan 15, 2027	in 7 mo	SubstanceProduct
9421184	Feb 03, 2032	in 5 yr 9 mo	U-3885
9867799	Feb 03, 2032	in 5 yr 9 mo	U-3885
10688047	Oct 28, 2036	in 10 yr 6 mo	ProductU-3885
12606519	May 03, 2040	in 14 yr 1 mo	SubstanceProduct

Givinostat hydrochloride

Brand (NDA) products · suspension

Marketing exclusivity (2)

Listed patents (5)

Givinostat hydrochloride — frequently asked questions

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