Question 1

Is there a generic for Lorlatinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Lorlatinib?

Accepted Answer

LORBRENA (NDA 210868, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Lorlatinib?

Accepted Answer

The Orange Book lists 4 patents against Lorlatinib 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 Lorlatinib have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Lorlatinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8680111	Mar 05, 2033	in 6 yr 10 mo	SubstanceProduct
10420749	Jul 27, 2036	in 10 yr 3 mo	SubstanceProductU-2633
11020376	Jul 27, 2036	in 10 yr 3 mo	Product
11299500	Oct 04, 2038	in 12 yr 6 mo	Substance

Lorlatinib

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (4)

Lorlatinib — frequently asked questions

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