FDA Orange Book · active-ingredient family
Midostaurin
Midostaurin is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RYDAPT · NDA 207997
1
Brand (NDA)
3
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RYDAPTRLD | NOVARTIS | NDA 207997 | AB | Apr 28, 2017 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MIDOSTAURIN | DR REDDYS | ANDA 215921 | AB | Jun 28, 2024 | |
| MIDOSTAURIN | LUPIN | ANDA 216015 | AB | May 10, 2024 | |
| MIDOSTAURIN | TEVA PHARMS | ANDA 216076 | — | Apr 29, 2024 |
Listed patents (2)
| 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 |
Midostaurin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
