trospium chloride; xanomeline tartrate · Bristol-Myers · NDA 216158
Cobenfy
Earliest generic entry, as listed · earliest of 3 marketed strengths
29 Oct 2039
Blocked by patent: US 12558317.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12558317 | drug product · sets the listed date | 29 Oct 2039 |
| US 10925832 | drug product | 27 Sep 2039 |
| US 10933020 | drug product, use U-3513 | 27 Sep 2039 |
| US 11452692 | use U-3513 | 27 Sep 2039 |
| US 11471413 | use U-3513 | 27 Sep 2039 |
| US 11890378 | drug product, use U-3513 | 27 Sep 2039 |
| US 10238643 | drug product | 21 Jul 2030 |
| US 10265311 | use U-3513 | 21 Jul 2030 |
| US 10369143 | use U-3513 | 21 Jul 2030 |
| US 10369144 | drug product, use U-3513 | 21 Jul 2030 |
| US 10695339 | use U-3513 | 21 Jul 2030 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 26 Sep 2029 |
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 |
|---|---|---|---|
| 216158 · 001 · RLD | capsule, oral | 20MG;EQ 50MG BASE | 29 Oct 2039 |
| 216158 · 002 · RLD | capsule, oral | 20MG;EQ 100MG BASE | 29 Oct 2039 |
| 216158 · 003 · RLD | capsule, oral | 30MG;EQ 125MG BASE | 29 Oct 2039 |