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 nine 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.
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: | 9 |
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: | Jun 3, 2028 | ||||||||
| Regulatory Exclusivity Use: | DAROLUTAMIDE AS A SINGLE AGENT FOR TREATMENT OF ADULT PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) | ||||||||
| Regulatory Exclusivity Expiration: | Aug 5, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH METASTATIC HORMONE‐SENSITIVE PROSTATE CANCER (MHSPC) IN COMBINATION WITH DOCETAXEL | ||||||||
| Patent: | 10,010,530 | Patent Expiration: | Jan 28, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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