Orange Book product · Brand (NDA)

RYDAPT

MIDOSTAURIN

Brand (NDA)NDA 207997TE ABRX NOVARTIS

Apr 28, 2017

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 28, 2017
9 yr 3 mo ago
Today
Patent 7973031 expires
Listed method-of-use patent (U-2007) expiration.
Oct 09, 2028
in 2 yr 4 mo
Patent 8575146 expires
Listed method-of-use patent (U-2008) expiration.
Dec 02, 2030
in 4 yr 6 mo

Active ingredient

MIDOSTAURIN

Strength

25MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 207997

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7973031	Oct 09, 2028	in 2 yr 4 mo	U-2007
8575146	Dec 02, 2030	in 4 yr 6 mo	U-2008