Question 1

Is there a generic for Lazertinib mesylate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Lazertinib mesylate?

Accepted Answer

LAZCLUZE (NDA 219008, JANSSEN BIOTECH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Lazertinib mesylate?

Accepted Answer

The Orange Book lists 8 patents against Lazertinib mesylate 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 Lazertinib mesylate have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

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

Patent	Expires	In	Type
9593098	Oct 13, 2035	in 9 yr 5 mo	SubstanceProductU-3985
11981659	Apr 18, 2038	in 12 yr	U-3985
11453656	Apr 18, 2038	in 12 yr	SubstanceProduct
12318390	Apr 18, 2038	in 12 yr	Product
12599606	May 14, 2040	in 14 yr 1 mo	U-4512
11879013	May 21, 2040	in 14 yr 2 mo	U-3985
12138351	Apr 13, 2041	in 15 yr	Product
11850248	Aug 01, 2041	in 15 yr 4 mo	U-3985

Lazertinib mesylate

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (8)

Lazertinib mesylate — frequently asked questions

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