plecanatide · Salix · NDA 208745
Trulance
Earliest generic entry, as listed
5 Jun 2034
Blocked by patent: US 10011637, US 11142549, US 11834521, US 12146003.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10011637 | substance | 5 Jun 2034 |
| US 11142549 | product | 5 Jun 2034 |
| US 11834521 | product | 5 Jun 2034 |
| US 12146003 | product | 5 Jun 2034 |
| US 9616097 | product | 20 Aug 2032 |
| US 11319346 | product | 1 Mar 2032 |
| US 9610321 | use U-1999 | 15 Sep 2031 |
| US 9610321 | use U-2230 | 15 Sep 2031 |
| US 9919024 | use U-2230 | 15 Sep 2031 |
| US 9919024 | use U-1999 | 15 Sep 2031 |
| US 9925231 | product | 15 Sep 2031 |
| US 7041786 | substance | 30 Jan 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 |
|---|---|---|---|
| 208745 · 001 · RLD | tablet, oral | 3MG | 5 Jun 2034 |