FDA Orange Book · active-ingredient family
Glasdegib maleate
Glasdegib maleate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DAURISMO · NDA 210656
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAURISMORLD×2 | PFIZER | NDA 210656 | — | Nov 21, 2018 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8431597 | Jun 29, 2028 | in 2 yr 1 mo | Product |
| 8148401 | Nov 21, 2032 | in 6 yr 6 mo | SubstanceProduct |
| 11168066 | Apr 13, 2036 | in 10 yr | U-3254 |
| 11891372 | Apr 13, 2036 | in 10 yr | U-3254 |
| 10414748 | Apr 13, 2036 | in 10 yr | SubstanceProduct |
Glasdegib maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
