gemcitabine hydrochloride · Janssen Biotech · NDA 219683
Inlexzo
Earliest generic entry, as listed
7 Nov 2038
Blocked by patent: US 12636300. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12636300 | use U-4552 · sets the listed date | 7 Nov 2038 |
| US 10729823 | drug product | 19 Aug 2034 |
| US 12447241 | drug product | 19 Aug 2034 |
| US 8679094 | drug product | 15 Apr 2032 |
| US 12576253 | drug product | 17 Dec 2030 |
| US 12403086 | drug product | 28 Jun 2030 |
Exclusivities · 1 unexpired
| NP | new product | 9 Sep 2028 |
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 |
|---|---|---|---|
| 219683 · 001 · RLD | system, intravesical | EQ 225MG BASE | 7 Nov 2038 |