FDA Orange Book · active-ingredient family
Neratinib maleate
Neratinib maleate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:NERLYNX · NDA 208051
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NERLYNXRLD | PUMA BIOTECH | NDA 208051 | — | Jul 17, 2017 |
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10035788 | Oct 15, 2028 | in 2 yr 4 mo | U-2043 |
| 9630946 | Oct 15, 2028 | in 2 yr 4 mo | U-2043 |
| 9139558 | Oct 15, 2028 | in 2 yr 4 mo | U-3097 |
| 9265784 | Aug 04, 2029 | in 3 yr 2 mo | U-3047 |
| 9211291 | Mar 24, 2030 | in 3 yr 10 mo | U-2043 |
| 8790708 | Nov 05, 2030 | in 4 yr 5 mo | ProductU-2043 |
| 8518446 | Nov 20, 2030 | in 4 yr 6 mo | ProductU-2043 |
| 7399865 | Dec 29, 2030 | in 4 yr 7 mo | SubstanceProduct |
| 8669273 | Jul 18, 2031 | in 5 yr 2 mo | U-3047 |
Neratinib maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
