Orange Book product · Brand (NDA)

ALIQOPA

COPANLISIB DIHYDROCHLORIDE

Brand (NDA)NDA 209936DISCN BAYER HEALTHCARE

Sep 14, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 14, 2017
8 yr 11 mo ago
Today
Patent RE46856 expires
Listed drug substance patent expiration.
Oct 22, 2029
in 3 yr 5 mo
Patent 10383876 expires
Listed drug substance patent expiration.
Mar 29, 2032
in 5 yr 10 mo
Patent 9636344 expires
Listed method-of-use patent (U-2124) expiration.
Mar 29, 2032
in 5 yr 10 mo

Active ingredient

COPANLISIB DIHYDROCHLORIDE

Strength

60MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 209936

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE46856	Oct 22, 2029	in 3 yr 5 mo	SubstanceProductU-2124
10383876	Mar 29, 2032	in 5 yr 10 mo	SubstanceProduct
9636344	Mar 29, 2032	in 5 yr 10 mo	U-2124