Question 1

Is there a generic for Acalabrutinib maleate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Acalabrutinib maleate?

Accepted Answer

CALQUENCE (NDA 216387, ASTRAZENECA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Acalabrutinib maleate?

Accepted Answer

The Orange Book lists 8 patents against Acalabrutinib maleate products, with the earliest listed expiry in 2026. 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 Acalabrutinib maleate have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Acalabrutinib maleate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7459554	Nov 24, 2026	in 5 mo	Substance
9758524	Jul 11, 2032	in 6 yr 2 mo	U-4108
10239883	Jul 11, 2032	in 6 yr 2 mo	U-2666
9290504	Jul 11, 2032	in 6 yr 2 mo	SubstanceProduct
10272083	Jan 21, 2035	in 8 yr 9 mo	U-4109
11771696	Jan 21, 2035	in 8 yr 9 mo	U-3710
11166951	Aug 11, 2035	in 9 yr 3 mo	U-4426
11059829	Jul 01, 2036	in 10 yr 2 mo	SubstanceProductU-4108

Acalabrutinib maleate

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (8)

Acalabrutinib maleate — frequently asked questions

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