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Generated: November 21, 2018

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Details for New Drug Application (NDA): 208772

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NDA 208772 describes ALUNBRIG, which is a drug marketed by Ariad and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the ALUNBRIG profile page.

The generic ingredient in ALUNBRIG is brigatinib. Two suppliers are listed for this compound. Additional details are available on the brigatinib profile page.
Summary for 208772
Tradename:ALUNBRIG
Applicant:Ariad
Ingredient:brigatinib
Patents:3
Generic Entry Opportunity 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 Millennium Pharmaceuticals, Inc. 63020-090 63020-090-07 7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07)
ALUNBRIG brigatinib TABLET;ORAL 208772 NDA Millennium Pharmaceuticals, 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:Apr 28, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
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:➤ Try a Free TrialPatent Expiration:Feb 6, 2031Product Flag?Substance Flag?YDelist Request?

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