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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207997

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NDA 207997 describes RYDAPT, which is a drug marketed by Novartis Pharms Corp 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 RYDAPT profile page.

The generic ingredient in RYDAPT is midostaurin. One supplier is listed for this compound. Additional details are available on the midostaurin profile page.
Summary for 207997
Tradename:RYDAPT
Applicant:Novartis Pharms Corp
Ingredient:midostaurin
Patents:3
Generic Entry Opportunity Date for 207997
Generic Entry Date for 207997*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)
Dosage:
CAPSULE;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: 207997
Suppliers and Packaging for NDA: 207997
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RYDAPT midostaurin CAPSULE;ORAL 207997 NDA Novartis Pharmaceuticals Corporation 0078-0698 0078-0698-19 4 CARTON in 1 CARTON (0078-0698-19) > 14 BLISTER PACK in 1 CARTON (0078-0698-51) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)
RYDAPT midostaurin CAPSULE;ORAL 207997 NDA Novartis Pharmaceuticals Corporation 0078-0698 0078-0698-99 2 CARTON in 1 CARTON (0078-0698-99) > 14 BLISTER PACK in 1 CARTON (0078-0698-51) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Apr 28, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 28, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 28, 2024
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)
Regulatory Exclusivity Expiration:Apr 28, 2024
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 MUTATION-POSITIVE AS DETECTED BY AN FDA APPROVED TEST, IN COMBINATION WITH STANDARD CYTARABINE AND DAUNORUBICIN INDUCTION AND CYTARABINE CONSOLIDATION

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