Details for New Drug Application (NDA): 207997

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NDA 207997 describes RYDAPT, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two 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
Ingredient:	midostaurin
Patents:	2

Pharmacology for NDA: 207997

Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

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:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Apr 28, 2017	TE:	AB	RLD:	Yes
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
Patent:	⤷ Sign Up	Patent Expiration:	Oct 9, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WHO ARE FLT3 MUTATION-POSITIVE, IN COMBINATION WITH STANDARD CYTARABINE AND DAUNORUBICIN INDUCTION AND CYTARABINE CONSOLIDATION CHEMOTHERAPY

Expired US Patents for NDA 207997

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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