Details for New Drug Application (NDA): 203469
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NDA 203469 describes ICLUSIG, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are five 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.
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: | Takeda Pharms Usa |
| Ingredient: | ponatinib hydrochloride |
| Patents: | 5 |
| 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 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 | Takeda Pharmaceuticals America, Inc. | 63020-533 | 63020-533-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63020-533-30) |
| ICLUSIG | ponatinib hydrochloride | TABLET;ORAL | 203469 | NDA | Takeda Pharmaceuticals America, 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 18, 2023 | ||||||||
| Regulatory Exclusivity Use: | CHRONIC PHASE (CP) CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO AT LEAST TWO PRIOR KINASE INHIBITORS | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Dec 12, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Dec 12, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN | ||||||||
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