FDA Orange Book
Is there a generic for Trulance?
Trulance contains plecanatide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Trulance (plecanatide). The Orange Book shows its last listed patent expires June 5, 2034.
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Trulance products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 3MG | Marketed (Rx) | None | 0 | None |
NDA 208745, held by SALIX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Trulance patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7041786 | January 30, 2028 | Drug substance | None | 208745 |
| 9919024 | September 15, 2031 | Method of use | U-2230 | 208745 |
| 9610321 | September 15, 2031 | Method of use | U-1999 | 208745 |
| 9610321 | September 15, 2031 | Method of use | U-2230 | 208745 |
| 9919024 | September 15, 2031 | Method of use | U-1999 | 208745 |
| 9925231 | September 15, 2031 | Drug product | None | 208745 |
| 11319346 | March 1, 2032 | Drug product | None | 208745 |
| 9616097 | August 20, 2032 | Drug product | None | 208745 |
| 12146003 | June 5, 2034 | Drug product | None | 208745 |
| 10011637 | June 5, 2034 | Drug substance | None | 208745 |
| 11142549 | June 5, 2034 | Drug product | None | 208745 |
| 11834521 | June 5, 2034 | Drug product | None | 208745 |
Trulance NDC codes
Questions
Is there a generic for Trulance?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Trulance (plecanatide). The Orange Book shows its last listed patent expires June 5, 2034.
What is the generic name for Trulance?
The active ingredient in Trulance is plecanatide, per the FDA Orange Book.
When does the Trulance patent expire?
The last patent listed for Trulance in the Orange Book expires June 5, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.