Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Colorcon
Express Scripts
McKinsey
Boehringer Ingelheim

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209936


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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
Generic Entry Opportunity Date for 209936
Generic Entry Date for 209936*:
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.

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:  Start TrialPatent Expiration:Mar 29, 2032Product Flag?YSubstance Flag?YDelist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Merck
Harvard Business School
McKinsey
Express Scripts
AstraZeneca

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.