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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 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. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. Two suppliers are 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 |
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 Action | Protein 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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Dec 14, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 14, 2019 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL) THAT IS RESISTANT OR INTOLERANT TO PRIOR TYROSINE KINASE INHIBITOR THERAPY. | ||||||||
| Patent: | Start Trial | Patent Expiration: | Dec 22, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Dec 22, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR THE TREATMENT OF LEUKEMIAS | ||||||||
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