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NDA

ACALABRUTINIB MALEATE | N216387 | ASTRAZENECA UK LTD

1 strength8 unique patents2 unique exclusivities

Patent Timeline

8 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (1)Active (7)TodayExclusivityIPRPTAB Challenge

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Nov. 24, 2026

Jul. 11, 2032

Jul. 11, 2032

Jul. 11, 2032

Jan. 21, 2035IPR

Jul. 1, 2036

Aug. 11, 2035

Jan. 21, 2035

I-960

Jan. 16, 2028

D-200

Feb. 19, 2029

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2023-00478	10272083	IPR	Sandoz Inc.	Institution Denied	2023-02-03	2023-08-07

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Acerta Pharma B.V. et al v. MSN Pharmaceuticals Inc. et al 1:2025cv00043 6 patentsANDA 220055acalabrutinib maleate	D. Del.	2025-01-10	Terminated 2025-12-22	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CIPLA LTDACALABRUTINIB MALEATE

DMF 383252023

MSN LABORATORIES PRIVATE LTDACALABRUTINIB MALEATE

DMF 394682024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 23, 2026	SUPPL -6	View Letter (PDF)
Jan 17, 2025	SUPPL -5	View Letter (PDF)
Jul 2, 2024	SUPPL -4	View Letter (PDF)
Aug 5, 2022	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 100MG BASE

RLD

8 patents2 exclusivities▴

TABLET;ORAL | Approved: Aug 3, 2022

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7459554	Nov 24, 2026	—	Yes	—	—	—
9290504	Jul 11, 2032	—	Yes	Yes	—	—
9758524	Jul 11, 2032	—	—	—		—
10239883	Jul 11, 2032	—	—	—		—
10272083	Jan 21, 2035	—	—	—		—
11059829	Jul 1, 2036	—	Yes	Yes		—
11166951	Aug 11, 2035	—	—	—	U-4426	—
11771696	Jan 21, 2035	—	—	—		—

Exclusivities (2)

Code	Date	Status
D-200	Feb 19, 2029	Active
I-960	Jan 16, 2028	Active