Orange Book product · Brand (NDA)
TRULANCE
PLECANATIDE
At a glance
Jan 19, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 19, 2017
9 yr 7 mo ago
Today
Patent 7041786 expires
Listed drug substance patent expiration.
Jan 30, 2028
in 1 yr 8 mo
Patent 9610321 expires
Listed method-of-use patent (U-1999) expiration.
Sep 15, 2031
in 5 yr 4 mo
Patent 9610321 expires
Listed method-of-use patent (U-2230) expiration.
Sep 15, 2031
in 5 yr 4 mo
Patent 9919024 expires
Listed method-of-use patent (U-2230) expiration.
Sep 15, 2031
in 5 yr 4 mo
Patent 9919024 expires
Listed method-of-use patent (U-1999) expiration.
Sep 15, 2031
in 5 yr 4 mo
Patent 9925231 expires
Listed drug product patent expiration.
Sep 15, 2031
in 5 yr 4 mo
Patent 11319346 expires
Listed drug product patent expiration.
Mar 01, 2032
in 5 yr 9 mo
Patent 9616097 expires
Listed drug product patent expiration.
Aug 20, 2032
in 6 yr 3 mo
Patent 10011637 expires
Listed drug substance patent expiration.
Jun 05, 2034
in 8 yr 1 mo
Patent 11142549 expires
Listed drug product patent expiration.
Jun 05, 2034
in 8 yr 1 mo
Patent 11834521 expires
Listed drug product patent expiration.
Jun 05, 2034
in 8 yr 1 mo
Patent 12146003 expires
Listed drug product patent expiration.
Jun 05, 2034
in 8 yr 1 mo
Pharmaceutical detail
Active ingredient
PLECANATIDE
Strength
3MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208745
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7041786 | Jan 30, 2028 | in 1 yr 8 mo | Substance |
| 9610321 | Sep 15, 2031 | in 5 yr 4 mo | U-1999 |
| 9610321 | Sep 15, 2031 | in 5 yr 4 mo | U-2230 |
| 9919024 | Sep 15, 2031 | in 5 yr 4 mo | U-2230 |
| 9919024 | Sep 15, 2031 | in 5 yr 4 mo | U-1999 |
| 9925231 | Sep 15, 2031 | in 5 yr 4 mo | Product |
| 11319346 | Mar 01, 2032 | in 5 yr 9 mo | Product |
| 9616097 | Aug 20, 2032 | in 6 yr 3 mo | Product |
| 10011637 | Jun 05, 2034 | in 8 yr 1 mo | Substance |
| 11142549 | Jun 05, 2034 | in 8 yr 1 mo | Product |
| 11834521 | Jun 05, 2034 | in 8 yr 1 mo | Product |
| 12146003 | Jun 05, 2034 | in 8 yr 1 mo | Product |

