Question 1

Is there a generic for Belumosudil mesylate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Belumosudil mesylate?

Accepted Answer

REZUROCK (NDA 214783, KADMON PHARMS LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Belumosudil mesylate?

Accepted Answer

The Orange Book lists 5 patents against Belumosudil mesylate products, with the earliest listed expiry in 2033. 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 Belumosudil mesylate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Belumosudil mesylate. 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 Belumosudil mesylate are approved?

Accepted Answer

Belumosudil mesylate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
10183931	Oct 07, 2033	in 7 yr 5 mo	U-4260
10696660	Oct 07, 2033	in 7 yr 5 mo	U-4260
8357693	Jun 20, 2034	in 8 yr 1 mo	SubstanceProductU-4259
11311541	Apr 09, 2035	in 8 yr 11 mo	U-3369
12097202	Jul 14, 2042	in 16 yr 4 mo	U-4014

Belumosudil mesylate

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (5)

Belumosudil mesylate — frequently asked questions

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