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Last Updated: May 14, 2021

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Details for New Drug Application (NDA): 203469

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NDA 203469 describes ICLUSIG, which is a drug marketed by Ariad and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ICLUSIG profile page.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
Summary for 203469
Ingredient:ponatinib hydrochloride
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 203469
Generic Entry Date for 203469*:
Constraining patent/regulatory exclusivity:

*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: 203469
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 203469
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469 NDA Millennium Pharmaceuticals, Inc. 63020-533 63020-533-30 30 TABLET, FILM COATED in 1 BOTTLE (63020-533-30)
ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469 NDA Millennium Pharmaceuticals, Inc. 63020-534 63020-534-30 30 TABLET, FILM COATED in 1 BOTTLE (63020-534-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Dec 14, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 18, 2023
Regulatory Exclusivity Use:
Patent:  Get Started for $10Patent Expiration:Jan 24, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:  Get Started for $10Patent Expiration:Dec 22, 2026Product Flag?Substance Flag?Delist Request?

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