baclofen · Strides Pharma Intl · NDA 215422
Lyvispah
Earliest generic entry, as listed · earliest of 3 marketed strengths
29 Sep 2041
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11491125, US 11491125, US 11850225, US 11850225.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11491125 | product, use U-3488 | 29 Sep 2041 |
| US 11491125 | product, use U-3489 | 29 Sep 2041 |
| US 11850225 | product, use U-3488 | 29 Sep 2041 |
| US 11850225 | product, use U-3489 | 29 Sep 2041 |
| US 10792262 | product, use U-3263 | 29 Jul 2039 |
| US 11654124 | product | 29 Jul 2039 |
| US 11931328 | product | 29 Jul 2039 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215422 · 001 · RLD · discontinued | granule, oral | 5MG/PACKET | 29 Sep 2041 |
| 215422 · 002 · RLD · discontinued | granule, oral | 10MG/PACKET | 29 Sep 2041 |
| 215422 · 003 · RLD · discontinued | granule, oral | 20MG/PACKET | 29 Sep 2041 |