Viewing data from:

ALIQOPA

NDA

COPANLISIB DIHYDROCHLORIDE | N209936 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

Today

RE46856

Oct. 22, 2029

9636344

Mar. 29, 2032

10383876

Mar. 29, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Aliqopa (2023)

Total Spending

$363K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$5496.50

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Sep 8, 2023	SUPPL -12	View Letter (PDF)
Mar 31, 2023	SUPPL -11	View Letter (PDF)
Feb 24, 2022	SUPPL -10	View Letter (PDF)
Feb 13, 2020	SUPPL -4	View Letter (PDF)
Oct 29, 2019	SUPPL -3	View Letter (PDF)
Jun 4, 2019	SUPPL -2	View Letter (PDF)
Sep 14, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG/VIAL

RLD

3 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Sep 14, 2017

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE46856	Oct 22, 2029	—	Yes	Yes		—
9636344	Mar 29, 2032	—	—	—		—
10383876	Mar 29, 2032	—	Yes	Yes	—	—