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Serving leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
Argus Health

Generated: December 15, 2017

DrugPatentWatch Database Preview

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 two suppliers. There are three patents protecting this drug. Additional details are available on the ICLUSIG profile page.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. Two suppliers are listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.

Summary for 203469

Formulation / Manufacturing:see details

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 Millenium Pharmaceuticals Inc. 63020-533 63020-533-30 30 TABLET, FILM COATED in 1 BOTTLE (63020-533-30)
ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469 NDA Millenium Pharmaceuticals Inc. 63020-534 63020-534-30 30 TABLET, FILM COATED in 1 BOTTLE (63020-534-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Dec 14, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 14, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 14, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Dec 22, 2026Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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