Question 1

Is there a generic for Icotrokinra hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Icotrokinra hydrochloride?

Accepted Answer

ICOTYDE (NDA 220149, JANSSEN BIOTECH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Icotrokinra hydrochloride?

Accepted Answer

The Orange Book lists 3 patents against Icotrokinra hydrochloride products, with the earliest listed expiry in 2039. 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 Icotrokinra hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Icotrokinra 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 Icotrokinra hydrochloride are approved?

Accepted Answer

Icotrokinra hydrochloride is approved in the following dosage form: tablet.

Patent	Expires	In	Type
12552836	Jul 12, 2039	in 13 yr 3 mo	SubstanceProduct
11845808	Jan 14, 2041	in 14 yr 9 mo	SubstanceU-4447
11939361	Nov 19, 2041	in 15 yr 8 mo	ProductU-4447

Icotrokinra hydrochloride

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (3)

Icotrokinra hydrochloride — frequently asked questions

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