FDA Orange Book
Is there a generic for Gattex Kit?
Gattex Kit contains teduglutide. 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 Gattex Kit (teduglutide). The Orange Book shows its last listed patent expires May 1, 2026 and its last listed exclusivity ends May 16, 2026.
Run it in Rivvi
Map Gattex Kit and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Gattex Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, subcutaneous | 5MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 203441, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gattex Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9060992 | November 1, 2025 | Method of use | U-1320 | 203441 |
| 7847061 | November 1, 2025 | Method of use | U-1320 | 203441 |
| 7847061*PED | May 1, 2026 | Method of use | None | 203441 |
| 9060992*PED | May 1, 2026 | Method of use | None | 203441 |
Gattex Kit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-240 | Orphan drug exclusivity | May 16, 2026 | 203441 |
Gattex Kit NDC codes
Questions
Is there a generic for Gattex Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gattex Kit (teduglutide). The Orange Book shows its last listed patent expires May 1, 2026 and its last listed exclusivity ends May 16, 2026.
What is the generic name for Gattex Kit?
The active ingredient in Gattex Kit is teduglutide, per the FDA Orange Book.
When does the Gattex Kit patent expire?
The last patent listed for Gattex Kit in the Orange Book expires May 1, 2026. 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.