Details for New Drug Application (NDA): 208772
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The generic ingredient in ALUNBRIG is brigatinib. One supplier is listed for this compound. Additional details are available on the brigatinib profile page.
Summary for 208772
Tradename: | ALUNBRIG |
Applicant: | Takeda Pharms Usa |
Ingredient: | brigatinib |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208772
Generic Entry Date for 208772*:
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: 208772
Mechanism of Action | Cytochrome P450 3A Inducers Tyrosine Kinase Inhibitors |
Suppliers and Packaging for NDA: 208772
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALUNBRIG | brigatinib | TABLET;ORAL | 208772 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-090 | 63020-090-07 | 7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07) |
ALUNBRIG | brigatinib | TABLET;ORAL | 208772 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-090 | 63020-090-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63020-090-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Apr 28, 2017 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 22, 2027 | ||||||||
Regulatory Exclusivity Use: | FOR THE TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA-APPROVED TEST, NOT INCLUDING PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB | ||||||||
Regulatory Exclusivity Expiration: | Apr 28, 2024 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 10, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) |
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