Question 1

Is there a generic for Copanlisib dihydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Copanlisib dihydrochloride?

Accepted Answer

ALIQOPA (NDA 209936, BAYER HEALTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Copanlisib dihydrochloride?

Accepted Answer

The Orange Book lists 3 patents against Copanlisib dihydrochloride 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

What dosage forms of Copanlisib dihydrochloride are approved?

Accepted Answer

Copanlisib dihydrochloride is approved in the following dosage form: powder.

Patent	Expires	In	Type
RE46856	Oct 22, 2029	in 3 yr 5 mo	SubstanceProductU-2124
9636344	Mar 29, 2032	in 5 yr 10 mo	U-2124
10383876	Mar 29, 2032	in 5 yr 10 mo	SubstanceProduct

Copanlisib dihydrochloride

Brand (NDA) products · powder

Listed patents (3)

Copanlisib dihydrochloride — frequently asked questions

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