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Details for New Drug Application (NDA): 210951
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NDA 210951 describes ERLEADA, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the ERLEADA profile page.
The generic ingredient in ERLEADA is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.
The generic ingredient in ERLEADA is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.
Summary for 210951
| Tradename: | ERLEADA |
| Applicant: | Janssen Biotech |
| Ingredient: | apalutamide |
| Patents: | 7 |
Generic Entry Opportunity Date for 210951
Generic Entry Date for 210951*:
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: 210951
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERLEADA | apalutamide | TABLET;ORAL | 210951 | NDA | Janssen Products, LP | 59676-600 | 59676-600-12 | 120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12) |
| ERLEADA | apalutamide | TABLET;ORAL | 210951 | NDA | Janssen Products, LP | 59676-600 | 59676-600-56 | 2 BLISTER PACK in 1 CARTON (59676-600-56) > 28 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Feb 14, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 14, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 17, 2022 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) | ||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 23, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT IN COMBINATION WITH A GNRH AGONIST OF HIGH RISK NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC) | ||||||||
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