Question 1

Is there a generic for Pacritinib citrate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Pacritinib citrate?

Accepted Answer

VONJO (NDA 208712, SOBI) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Pacritinib citrate?

Accepted Answer

The Orange Book lists 3 patents against Pacritinib citrate 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 Pacritinib citrate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Pacritinib citrate. 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 Pacritinib citrate are approved?

Accepted Answer

Pacritinib citrate is approved in the following dosage form: capsule.

Patent	Expires	In	Type
9573964	May 05, 2028	in 1 yr 11 mo	U-3332
8153632	Jan 17, 2029	in 2 yr 7 mo	SubstanceProductU-3332
8980873	Mar 25, 2030	in 3 yr 10 mo	SubstanceProductU-3331

Pacritinib citrate

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (3)

Pacritinib citrate — frequently asked questions

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