Orange Book product · Brand (NDA)
COBENFY
TROSPIUM CHLORIDE; XANOMELINE TARTRATE
At a glance
Sep 26, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 26, 2024
1 yr 9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 26, 2029
in 3 yr 4 mo
Patent 10238643 expires
Listed drug product patent expiration.
Jul 21, 2030
in 4 yr 2 mo
Patent 10265311 expires
Listed method-of-use patent (U-3513) expiration.
Jul 21, 2030
in 4 yr 2 mo
Patent 10369143 expires
Listed method-of-use patent (U-3513) expiration.
Jul 21, 2030
in 4 yr 2 mo
Patent 10369144 expires
Listed drug product patent expiration.
Jul 21, 2030
in 4 yr 2 mo
Patent 10695339 expires
Listed method-of-use patent (U-3513) expiration.
Jul 21, 2030
in 4 yr 2 mo
Patent 10925832 expires
Listed drug product patent expiration.
Sep 27, 2039
in 13 yr 6 mo
Patent 10933020 expires
Listed drug product patent expiration.
Sep 27, 2039
in 13 yr 6 mo
Patent 11452692 expires
Listed method-of-use patent (U-3513) expiration.
Sep 27, 2039
in 13 yr 6 mo
Patent 11471413 expires
Listed method-of-use patent (U-3513) expiration.
Sep 27, 2039
in 13 yr 6 mo
Patent 11890378 expires
Listed drug product patent expiration.
Sep 27, 2039
in 13 yr 6 mo
Patent 12558317 expires
Listed drug product patent expiration.
Oct 29, 2039
in 13 yr 7 mo
Pharmaceutical detail
Active ingredient
TROSPIUM CHLORIDE; XANOMELINE TARTRATE
Strength
30MG;EQ 125MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 216158
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Sep 26, 2029
in 3 yr 4 mo
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10238643 | Jul 21, 2030 | in 4 yr 2 mo | Product |
| 10265311 | Jul 21, 2030 | in 4 yr 2 mo | U-3513 |
| 10369143 | Jul 21, 2030 | in 4 yr 2 mo | U-3513 |
| 10369144 | Jul 21, 2030 | in 4 yr 2 mo | ProductU-3513 |
| 10695339 | Jul 21, 2030 | in 4 yr 2 mo | U-3513 |
| 10925832 | Sep 27, 2039 | in 13 yr 6 mo | Product |
| 10933020 | Sep 27, 2039 | in 13 yr 6 mo | ProductU-3513 |
| 11452692 | Sep 27, 2039 | in 13 yr 6 mo | U-3513 |
| 11471413 | Sep 27, 2039 | in 13 yr 6 mo | U-3513 |
| 11890378 | Sep 27, 2039 | in 13 yr 6 mo | ProductU-3513 |
| 12558317 | Oct 29, 2039 | in 13 yr 7 mo | Product |

