Question 1

Is there a generic for Momelotinib dihydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Momelotinib dihydrochloride?

Accepted Answer

OJJAARA (NDA 216873, GLAXOSMITHKLINE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Momelotinib dihydrochloride?

Accepted Answer

The Orange Book lists 5 patents against Momelotinib dihydrochloride products, with the earliest listed expiry in 2035. 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 Momelotinib dihydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Momelotinib dihydrochloride. 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 Momelotinib dihydrochloride are approved?

Accepted Answer

Momelotinib dihydrochloride is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8486941	Jan 03, 2035	in 8 yr 8 mo	SubstanceProductU-1201
9809559	Jun 11, 2035	in 9 yr 1 mo	U-1201
RE48285	Jun 11, 2035	in 9 yr 1 mo	SubstanceProductU-1201
12576089	Aug 21, 2039	in 13 yr 4 mo	U-4441
11963962	Dec 02, 2040	in 14 yr 8 mo	U-3928

Momelotinib dihydrochloride

Brand (NDA) products · tablet

Marketing exclusivity (6)

Listed patents (5)

Momelotinib dihydrochloride — frequently asked questions

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