Question 1

Is there a generic for Rilzabrutinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Rilzabrutinib?

Accepted Answer

WAYRILZ (NDA 219685, GENZYME CORP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Rilzabrutinib?

Accepted Answer

The Orange Book lists 6 patents against Rilzabrutinib 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 Rilzabrutinib have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Rilzabrutinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9580427	Mar 01, 2033	in 6 yr 10 mo	SubstanceProduct
9994576	Sep 06, 2033	in 7 yr 4 mo	SubstanceProductU-4268
9266895	Sep 06, 2033	in 7 yr 4 mo	SubstanceProductU-4268
8940744	Sep 06, 2033	in 7 yr 4 mo	SubstanceProductU-4270
12178818	Oct 13, 2040	in 14 yr 6 mo	U-4267
11708370	Feb 20, 2041	in 14 yr 11 mo	Substance

Rilzabrutinib

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (6)

Rilzabrutinib — frequently asked questions

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