Question 1

Is there a generic for Brigatinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Brigatinib?

Accepted Answer

ALUNBRIG (NDA 208772, TAKEDA PHARMS USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Brigatinib?

Accepted Answer

The Orange Book lists 4 patents against Brigatinib products, with the earliest listed expiry in 2029. 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 Brigatinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Brigatinib. 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 Brigatinib are approved?

Accepted Answer

Brigatinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9273077	May 21, 2029	in 3 yr	U-2837
9012462	Apr 28, 2031	in 4 yr 11 mo	Substance
9611283	Apr 10, 2034	in 7 yr 11 mo	U-2837
10385078	Nov 10, 2035	in 9 yr 6 mo	SubstanceProductU-2837

Brigatinib

Brand (NDA) products · tablet

Marketing exclusivity (3)

Listed patents (4)

Brigatinib — frequently asked questions

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