neratinib maleate · Puma Biotech · NDA 208051
Nerlynx
Earliest generic entry, as listed
18 Jul 2031
Blocked by patent: US 8669273. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
20 Orange Book listing rows for 9 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8669273 | use U-3047 · sets the listed date | 18 Jul 2031 |
| US 7399865 | drug substance, drug product | 29 Dec 2030 |
| US 8518446 | drug product, use U-2043, U-3047, U-3097 | 20 Nov 2030 |
| US 8518446 listing row | drug product, use U-2043 | 20 Nov 2030 |
| US 8518446 listing row | drug product, use U-3047 | 20 Nov 2030 |
| US 8518446 listing row | drug product, use U-3097 | 20 Nov 2030 |
| US 8790708 | drug product, use U-2043, U-3047, U-3097 | 5 Nov 2030 |
| US 8790708 listing row | drug product, use U-2043 | 5 Nov 2030 |
| US 8790708 listing row | drug product, use U-3047 | 5 Nov 2030 |
| US 8790708 listing row | drug product, use U-3097 | 5 Nov 2030 |
| US 9211291 | use U-2043, U-3097 | 24 Mar 2030 |
| US 9211291 listing row | use U-2043 | 24 Mar 2030 |
| US 9211291 listing row | use U-3097 | 24 Mar 2030 |
| US 9265784 | use U-3047 | 4 Aug 2029 |
| US 10035788 | use U-2043, U-3047, U-3097 | 15 Oct 2028 |
| US 10035788 listing row | use U-2043 | 15 Oct 2028 |
| US 10035788 listing row | use U-3047 | 15 Oct 2028 |
| US 10035788 listing row | use U-3097 | 15 Oct 2028 |
| US 9139558 | use U-2043, U-3047, U-3097 | 15 Oct 2028 |
| US 9139558 listing row | use U-2043 | 15 Oct 2028 |
| US 9139558 listing row | use U-3047 | 15 Oct 2028 |
| US 9139558 listing row | use U-3097 | 15 Oct 2028 |
| US 9630946 | use U-2043, U-3047, U-3097 | 15 Oct 2028 |
| US 9630946 listing row | use U-2043 | 15 Oct 2028 |
| US 9630946 listing row | use U-3047 | 15 Oct 2028 |
| US 9630946 listing row | use U-3097 | 15 Oct 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208051 · 001 · RLD | tablet, oral | EQ 40MG BASE | 18 Jul 2031 |