FDA Orange Book · active-ingredient family
Plecanatide
Plecanatide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TRULANCE · NDA 208745
1
Brand (NDA)
0
Generics (ANDA)
10
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRULANCERLD | SALIX | NDA 208745 | — | Jan 19, 2017 |
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7041786 | Jan 30, 2028 | in 1 yr 8 mo | Substance |
| 9919024 | Sep 15, 2031 | in 5 yr 4 mo | U-2230 |
| 9610321 | 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 |
| 12146003 | Jun 05, 2034 | in 8 yr 1 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 |
Plecanatide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
