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 four 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:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209936

Generic Entry Date for 209936^: ⤷ 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.

Pharmacology for NDA: 209936

Mechanism of Action	Kinase 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:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	60MG/VIAL
Approval Date:	Sep 14, 2017	TE:		RLD:	Yes
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 Up	Patent Expiration:	Mar 29, 2032	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	May 13, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 209936

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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

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