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Generated: November 20, 2018

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Details for New Drug Application (NDA): 209936

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NDA 209936 describes ALIQOPA, which is a drug marketed by Bayer Healthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ALIQOPA profile page.

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.
Summary for 209936
Tradename:ALIQOPA
Applicant:Bayer Healthcare
Ingredient:copanlisib dihydrochloride
Patents:3
Generic Entry Opportunity Date for 209936
Generic Entry Date for 209936*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;IV (INFUSION)

*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.

Pharmacology for NDA: 209936
Mechanism of ActionKinase Inhibitors
Suppliers and Packaging for NDA: 209936
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-385 50419-385-01 1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-01) > 4 mL in 1 VIAL, SINGLE-DOSE
ALIQOPA copanlisib dihydrochloride POWDER;INTRAVENOUS 209936 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-385 50419-385-72 1 VIAL, SINGLE-DOSE in 1 CARTON (50419-385-72) > 4 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength60MG/VIAL
Approval Date:Sep 14, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 14, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 14, 2024
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES
Patent:➤ Sign UpPatent Expiration:May 13, 2024Product Flag?YSubstance Flag?YDelist Request?

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