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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 208772


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NDA 208772 describes ALUNBRIG, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ALUNBRIG profile page.

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
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:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 28, 2017TE: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 UpPatent Expiration:Nov 10, 2035Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)

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