olanzapine; samidorphan l-malate · Alkermes Inc · NDA 213378
Lybalvi
Earliest generic entry, as listed · earliest of 4 marketed strengths
12 Nov 2041
Blocked by patent: US 11707466, US 11951111, US 12390474.
Listed patents · 14 unexpired
21 Orange Book listing rows for 14 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11707466 | drug product · sets the listed date | 12 Nov 2041 |
| US 11951111 | use U-3886, U-3887 | 12 Nov 2041 |
| US 11951111 listing row | use U-3886 · sets the listed date | 12 Nov 2041 |
| US 11951111 listing row | use U-3887 · sets the listed date | 12 Nov 2041 |
| US 12390474 | drug product · sets the listed date | 12 Nov 2041 |
| US 10300054 | drug product, use U-3140, U-3141 | 31 May 2033 |
| US 10300054 listing row | drug product, use U-3140 | 31 May 2033 |
| US 10300054 listing row | drug product, use U-3141 | 31 May 2033 |
| US 8778960 | use U-3136, U-3137 | 13 Feb 2032 |
| US 8778960 listing row | use U-3136 | 13 Feb 2032 |
| US 8778960 listing row | use U-3137 | 13 Feb 2032 |
| US 9119848 | drug substance | 30 Aug 2031 |
| US 10716785 | use U-3136, U-3137 | 23 Aug 2031 |
| US 10716785 listing row | use U-3136 | 23 Aug 2031 |
| US 10716785 listing row | use U-3137 | 23 Aug 2031 |
| US 11185541 | use U-3140 | 23 Aug 2031 |
| US 11241425 | use U-3137 | 23 Aug 2031 |
| US 11351166 | use U-3140, U-3141 | 23 Aug 2031 |
| US 11351166 listing row | use U-3140 | 23 Aug 2031 |
| US 11351166 listing row | use U-3141 | 23 Aug 2031 |
| US 11793805 | use U-3734 | 23 Aug 2031 |
| US 12194035 | use U-3141 | 23 Aug 2031 |
| US 9126977 | drug product, use U-3136, U-3137 | 23 Aug 2031 |
| US 9126977 listing row | drug product, use U-3136 | 23 Aug 2031 |
| US 9126977 listing row | drug product, use U-3137 | 23 Aug 2031 |
| US 9517235 | use U-3138, U-3139 | 23 Aug 2031 |
| US 9517235 listing row | use U-3138 | 23 Aug 2031 |
| US 9517235 listing row | use U-3139 | 23 Aug 2031 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213378 · 001 · RLD | tablet, oral | 5MG;EQ 10MG BASE | 12 Nov 2041 |
| 213378 · 002 · RLD | tablet, oral | 10MG;EQ 10MG BASE | 12 Nov 2041 |
| 213378 · 003 · RLD | tablet, oral | 15MG;EQ 10MG BASE | 12 Nov 2041 |
| 213378 · 004 · RLD | tablet, oral | 20MG;EQ 10MG BASE | 12 Nov 2041 |
Expired or delisted (1)
- NCE · 28 May 2026