Details for New Drug Application (NDA): 208434
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NDA 208434 describes ALECENSA, which is a drug marketed by Hoffmann-la Roche and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the ALECENSA profile page.
The generic ingredient in ALECENSA is alectinib hydrochloride. One supplier is listed for this compound. Additional details are available on the alectinib hydrochloride profile page.
The generic ingredient in ALECENSA is alectinib hydrochloride. One supplier is listed for this compound. Additional details are available on the alectinib hydrochloride profile page.
Summary for 208434
| Tradename: | ALECENSA |
| Applicant: | Hoffmann-la Roche |
| Ingredient: | alectinib hydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208434
Generic Entry Date for 208434*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 208434
| Mechanism of Action | Kinase Inhibitors |
Suppliers and Packaging for NDA: 208434
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434 | NDA | Genentech, Inc. | 50242-130 | 50242-130-01 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC |
| ALECENSA | alectinib hydrochloride | CAPSULE;ORAL | 208434 | NDA | Genentech, Inc. | 50242-130 | 50242-130-86 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Dec 11, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 18, 2031 | ||||||||
| Regulatory Exclusivity Use: | ADJUVANT TREATMENT IN ADULT PATIENTS FOLLOWING TUMOR RESECTION OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) (TUMORS GREATER THAN OR EQUAL TO 4 CM OR NODE POSITIVE), AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Apr 18, 2027 | ||||||||
| Regulatory Exclusivity Use: | FOR ADJUVANT TREATMENT IN ADULT PATIENTS FOLLOWING TUMOR RESECTION OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) (TUMORS >/= 4 CM OR NODE POSITIVE), AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Nov 6, 2024 | ||||||||
| Regulatory Exclusivity Use: | FOR TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE, METASTATIC NON-SMALL-CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST, EXCLUDING PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB | ||||||||
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