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Last Updated: October 5, 2024

COPANLISIB DIHYDROCHLORIDE - Generic Drug Details


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What are the generic sources for copanlisib dihydrochloride and what is the scope of freedom to operate?

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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COPANLISIB DIHYDROCHLORIDE
Generic Entry Date for COPANLISIB DIHYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
VA Office of Research and DevelopmentPhase 1/Phase 2
M.D. Anderson Cancer CenterPhase 2
Chinese PLA General HospitalPhase 2

See all COPANLISIB DIHYDROCHLORIDE clinical trials

Pharmacology for COPANLISIB DIHYDROCHLORIDE
Drug ClassKinase Inhibitor
Mechanism of ActionKinase Inhibitors

US Patents and Regulatory Information for COPANLISIB DIHYDROCHLORIDE

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 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for COPANLISIB DIHYDROCHLORIDE

Country Patent Number Title Estimated Expiration
South Africa 201307105 SUBSTITUTED 2,3-DIHYDROIMIDAZO[1,2-C]QUINAZOLINE SALTS ⤷  Sign Up
Cuba 20090103 DERIVADOS DE 2,3-DIHIDROIMIDAZOL[1,2-C]QUINAZOLINA SUSTITUIDOS DE UTILIDAD EN EL TRATAMIENTO DE TRASTORNOS HIPERPROLIFERATIVOS Y ENFERMEDADES ASOCIADAS CON LA ANGIOGÉNESIS ⤷  Sign Up
Morocco 35014 SELS DE 2,3-DIHYDROIMIDAZO [1,2-C]QUINAZOLINE SUBSTITUÉS ⤷  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.