Orange Book product · Brand (NDA)
NERLYNX
NERATINIB MALEATE
At a glance
Jul 17, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 17, 2017
9 yr 1 mo ago
Today
Patent 10035788 expires
Listed method-of-use patent (U-2043) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 10035788 expires
Listed method-of-use patent (U-3047) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 10035788 expires
Listed method-of-use patent (U-3097) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 9139558 expires
Listed method-of-use patent (U-3097) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 9139558 expires
Listed method-of-use patent (U-3047) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 9139558 expires
Listed method-of-use patent (U-2043) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 9630946 expires
Listed method-of-use patent (U-2043) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 9630946 expires
Listed method-of-use patent (U-3047) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 9630946 expires
Listed method-of-use patent (U-3097) expiration.
Oct 15, 2028
in 2 yr 4 mo
Patent 9265784 expires
Listed method-of-use patent (U-3047) expiration.
Aug 04, 2029
in 3 yr 2 mo
Patent 9211291 expires
Listed method-of-use patent (U-2043) expiration.
Mar 24, 2030
in 3 yr 10 mo
Patent 9211291 expires
Listed method-of-use patent (U-3097) expiration.
Mar 24, 2030
in 3 yr 10 mo
Patent 8790708 expires
Listed drug product patent expiration.
Nov 05, 2030
in 4 yr 5 mo
Patent 8790708 expires
Listed drug product patent expiration.
Nov 05, 2030
in 4 yr 5 mo
Patent 8790708 expires
Listed drug product patent expiration.
Nov 05, 2030
in 4 yr 5 mo
Patent 8518446 expires
Listed drug product patent expiration.
Nov 20, 2030
in 4 yr 6 mo
Patent 8518446 expires
Listed drug product patent expiration.
Nov 20, 2030
in 4 yr 6 mo
Patent 8518446 expires
Listed drug product patent expiration.
Nov 20, 2030
in 4 yr 6 mo
Patent 7399865 expires
Listed drug substance patent expiration.
Dec 29, 2030
in 4 yr 7 mo
Patent 8669273 expires
Listed method-of-use patent (U-3047) expiration.
Jul 18, 2031
in 5 yr 2 mo
Pharmaceutical detail
Active ingredient
NERATINIB MALEATE
Strength
EQ 40MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208051
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10035788 | Oct 15, 2028 | in 2 yr 4 mo | U-2043 |
| 10035788 | Oct 15, 2028 | in 2 yr 4 mo | U-3047 |
| 10035788 | Oct 15, 2028 | in 2 yr 4 mo | U-3097 |
| 9139558 | Oct 15, 2028 | in 2 yr 4 mo | U-3097 |
| 9139558 | Oct 15, 2028 | in 2 yr 4 mo | U-3047 |
| 9139558 | Oct 15, 2028 | in 2 yr 4 mo | U-2043 |
| 9630946 | Oct 15, 2028 | in 2 yr 4 mo | U-2043 |
| 9630946 | Oct 15, 2028 | in 2 yr 4 mo | U-3047 |
| 9630946 | 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 |
| 9211291 | Mar 24, 2030 | in 3 yr 10 mo | U-3097 |
| 8790708 | Nov 05, 2030 | in 4 yr 5 mo | ProductU-2043 |
| 8790708 | Nov 05, 2030 | in 4 yr 5 mo | ProductU-3097 |
| 8790708 | Nov 05, 2030 | in 4 yr 5 mo | ProductU-3047 |
| 8518446 | Nov 20, 2030 | in 4 yr 6 mo | ProductU-2043 |
| 8518446 | Nov 20, 2030 | in 4 yr 6 mo | ProductU-3097 |
| 8518446 | Nov 20, 2030 | in 4 yr 6 mo | ProductU-3047 |
| 7399865 | Dec 29, 2030 | in 4 yr 7 mo | SubstanceProduct |
| 8669273 | Jul 18, 2031 | in 5 yr 2 mo | U-3047 |
