➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Moodys
Boehringer Ingelheim
Express Scripts
Baxter

Last Updated: May 14, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203469

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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
Tradename:ICLUSIG
Applicant:Ariad
Ingredient:ponatinib hydrochloride
Patents:3
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 203469
Generic Entry Date for 203469*:
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: 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?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
McKesson
Colorcon
Mallinckrodt
Merck
Harvard Business School

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 verification 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.