FDA Orange Book · active-ingredient family
Sonidegib phosphate
Sonidegib phosphate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ODOMZO · NDA 205266
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ODOMZORLD | SUN PHARM | NDA 205266 | — | Jul 24, 2015 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8178563 | Jul 24, 2029 | in 3 yr 2 mo | SubstanceU-1722 |
| 8063043 | Sep 15, 2029 | in 3 yr 3 mo | SubstanceProduct |
| 10266523 | Mar 30, 2036 | in 9 yr 11 mo | SubstanceProduct |
Sonidegib phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
