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Last Updated: November 26, 2022

Copanlisib dihydrochloride - Generic Drug Details


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What are the generic drug 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-three patent family members in fifty countries.

One supplier is listed for this compound.

Summary for copanlisib dihydrochloride
Recent Clinical Trials for copanlisib dihydrochloride

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

SponsorPhase
M.D. Anderson Cancer CenterPhase 2
Chinese PLA General HospitalPhase 2
City of Hope Medical CenterPhase 1/Phase 2

See all copanlisib dihydrochloride clinical trials

Pharmacology for copanlisib dihydrochloride
Drug ClassKinase Inhibitor
Mechanism of Action Kinase 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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Healthcare ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936-001 Sep 14, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Healthcare ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936-001 Sep 14, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Healthcare ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936-001 Sep 14, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Healthcare ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936-001 Sep 14, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Peru 20050089 DERIVADOS DE AZO [1,2-C] QUINAZOLINA CONDENSADOS See Plans and Pricing
Slovenia 2096919 See Plans and Pricing
Ukraine 111604 ЗАМІЩЕНІ 2,3-ДИГІДРОІМІДАЗО[1,2-c]ХІНАЗОЛІНОВІ СОЛІ See Plans and Pricing
Uruguay 33985 SALES DE 2,3-DIHIDROIMIDAZO [1,2-C] QUINAZOLINA SUSTITUIDA See Plans and Pricing
Honduras 2009001131 DERIVADOS DE 2,3-DIHIDROIMIDAZOL [1,2-C] QUINAZOLINAS SUSTITUIDAS DE UTILIDAD EN EL TRATAMIENTO DE TRASTORNOS HIPERPROLIFERATIVOS Y ENFERMEDADES ASOCIADAS CON LA ANGIOGENESIS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
AstraZeneca
Express Scripts
Medtronic
Moodys

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