Copanlisib dihydrochloride - Generic Drug Details

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What are the generic sources for copanlisib dihydrochloride and what is the scope of patent protection?

Copanlisib dihydrochloride is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Copanlisib dihydrochloride has one hundred and fifty-four patent family members in fifty countries.

One supplier is listed for this compound.

Summary for copanlisib dihydrochloride

International Patents:	154
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	68
Patent Applications:	294
DailyMed Link:	copanlisib dihydrochloride at DailyMed

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

Generic Entry Date for copanlisib dihydrochloride^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 copanlisib dihydrochloride

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

Sponsor	Phase
VA Office of Research and Development	Phase 1/Phase 2
M.D. Anderson Cancer Center	Phase 2
Chinese PLA General Hospital	Phase 2

See all copanlisib dihydrochloride clinical trials

Pharmacology for copanlisib dihydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for copanlisib dihydrochloride

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

US Patents and Regulatory Information for copanlisib dihydrochloride

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Glossary

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

Expired US Patents for copanlisib dihydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare	ALIQOPA	copanlisib dihydrochloride	POWDER;INTRAVENOUS	209936-001	Sep 14, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for copanlisib dihydrochloride

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Country	Patent Number	Title	Estimated Expiration
Hungary	E028773		⤷ Sign Up
Taiwan	201637656	Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts	⤷ Sign Up
New Zealand	539062	Fused azole-pyrimidine derivatives exhibiting enhanced potency for phosphotidylinositol-3-kinase (P13K) inhibition	⤷ Sign Up
Japan	4790266		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.