Details for New Drug Application (NDA): 212099
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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
Tradename: | NUBEQA |
Applicant: | Bayer Healthcare |
Ingredient: | darolutamide |
Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212099
Generic Entry Date for 212099*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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 |
NUBEQA | darolutamide | TABLET;ORAL | 212099 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-395 | 50419-395-72 | 1 BOTTLE in 1 CARTON (50419-395-72) / 120 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Jul 30, 2019 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jul 30, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Regulatory Exclusivity Expiration: | Aug 5, 2025 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH METASTATIC HORMONEāSENSITIVE PROSTATE CANCER (MHSPC) IN COMBINATION WITH DOCETAXEL | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Jan 28, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? |
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