ALIQOPA Drug Patent Profile

Which patents cover Aliqopa, and when can generic versions of Aliqopa launch?

Aliqopa is a drug marketed by Bayer Healthcare and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and fifty-four patent family members in fifty countries.

The generic ingredient in ALIQOPA is copanlisib dihydrochloride. One supplier is listed for this compound. Additional details are available on the copanlisib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Aliqopa

Aliqopa was eligible for patent challenges on September 14, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 29, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ALIQOPA

International Patents:	154
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	16
Patent Applications:	717
Drug Prices:	Drug price information for ALIQOPA
What excipients (inactive ingredients) are in ALIQOPA?	ALIQOPA excipients list
DailyMed Link:	ALIQOPA at DailyMed

See drug prices for ALIQOPA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALIQOPA

NDA:

209936

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ALIQOPA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
NRG Oncology	Phase 2
City of Hope Medical Center	Phase 1/Phase 2
Dana-Farber Cancer Institute	Phase 1/Phase 2

See all ALIQOPA clinical trials

Pharmacology for ALIQOPA

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ALIQOPA

L01EM	Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ALIQOPA

ALIQOPA is protected by four US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ALIQOPA

FDA Regulatory Exclusivity protecting ALIQOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No			Y	Y
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No			Y	Y
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No			Y	Y
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017		DISCN	Yes	No

International Patents for ALIQOPA

When does loss-of-exclusivity occur for ALIQOPA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ALIQOPA around the world.

Country	Patent Number	Title	Estimated Expiration
Serbia	53811	SUPSTITUISANE SOLI 2,3-DIHIDROIMIDAZO[1,2-C]HINAZOLINA (SUBSTITUTED 2,3-DIHYDROIMIDAZO[1,2-C]QUINAZOLINE SALTS)
European Patent Office	2694508	SELS DE 2,3-DIHYDROIMIDAZO[1,2-C]QUINAZOLINE SUBSTITUÉS (SUBSTITUTED 2,3-DIHYDROIMIDAZO[1,2-C]QUINAZOLINE SALTS)
Eurasian Patent Organization	023646	ЗАМЕЩЁННЫЕ СОЛИ 2,3-ДИГИДРОИМИДАЗО[1,2-C]ХИНАЗОЛИНА (SUBSTITUTED 2,3-DIHYDROIMIDAZO[1,2-c]QUINAZOLINE SALTS)
Taiwan	I406662
Cuba	20130133	SALES DE 2,3- DIHIDROIMIDAZO[1,2- C] QUINAZOLINAS SUSTITUDA