Question 1

Is there a generic for Fedratinib hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Fedratinib hydrochloride?

Accepted Answer

INREBIC (NDA 212327, BRISTOL-MYERS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Fedratinib hydrochloride?

Accepted Answer

The Orange Book lists 5 patents against Fedratinib hydrochloride products, with the earliest listed expiry in 2026. 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 Fedratinib hydrochloride have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Fedratinib hydrochloride is approved in the following dosage form: capsule.

Patent	Expires	In	Type
7825246	Dec 16, 2026	in 6 mo	Substance
8138199	Jun 30, 2028	in 2 yr 1 mo	U-2607
7528143	Nov 16, 2031	in 5 yr 6 mo	SubstanceProduct
10391094	Jun 04, 2032	in 6 yr 1 mo	ProductU-2607
11400092	Sep 24, 2039	in 13 yr 6 mo	U-3409

Fedratinib hydrochloride

Brand (NDA) products · capsule

Marketing exclusivity (1)

Listed patents (5)

Fedratinib hydrochloride — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.