Details for New Drug Application (NDA): 212018
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NDA 212018 describes BALVERSA, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the BALVERSA profile page.
The generic ingredient in BALVERSA is erdafitinib. One supplier is listed for this compound. Additional details are available on the erdafitinib profile page.
The generic ingredient in BALVERSA is erdafitinib. One supplier is listed for this compound. Additional details are available on the erdafitinib profile page.
Summary for 212018
| Tradename: | BALVERSA |
| Applicant: | Janssen Biotech |
| Ingredient: | erdafitinib |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212018
Generic Entry Date for 212018*:
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.
Pharmacology for NDA: 212018
Suppliers and Packaging for NDA: 212018
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BALVERSA | erdafitinib | TABLET;ORAL | 212018 | NDA | Janssen Products LP | 59676-030 | 59676-030-56 | 1 BOTTLE in 1 CARTON (59676-030-56) / 56 TABLET, FILM COATED in 1 BOTTLE |
| BALVERSA | erdafitinib | TABLET;ORAL | 212018 | NDA | Janssen Products LP | 59676-030 | 59676-030-84 | 1 BOTTLE in 1 CARTON (59676-030-84) / 84 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Apr 12, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 12, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 19, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA (MUC)WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY | ||||||||
| Patent: | 10,478,494 | Patent Expiration: | Aug 13, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PRIOR PD-1 OR PD-L1 INHIBITOR THERAPY | ||||||||
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