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Last Updated: March 28, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212099

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NDA 212099 describes NUBEQA, 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 NUBEQA profile page.

The generic ingredient in NUBEQA is darolutamide. One supplier is listed for this compound. Additional details are available on the darolutamide profile page.
Summary for 212099
Applicant:Bayer Healthcare
Generic Entry Opportunity Date for 212099
Generic Entry Date for 212099*:
Constraining patent/regulatory exclusivity:

*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.

Suppliers and Packaging for NDA: 212099
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUBEQA darolutamide TABLET;ORAL 212099 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-395 50419-395-01 1 BOTTLE in 1 CARTON (50419-395-01) > 120 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jul 30, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 30, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jan 28, 2036Product Flag?Substance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jan 28, 2036Product Flag?Substance Flag?YDelist Request?

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