Orange Book product · Brand (NDA)
GATTEX KIT
TEDUGLUTIDE
At a glance
Dec 21, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 2012
13 yr 8 mo ago
Patent 7847061 expires
Listed method-of-use patent (U-1320) expiration.
Nov 01, 2025
8 mo ago
Patent 9060992 expires
Listed method-of-use patent (U-1320) expiration.
Nov 01, 2025
8 mo ago
Patent 7847061*PED expires
Listed listed patent expiration.
May 01, 2026
2 mo ago
Patent 9060992*PED expires
Listed listed patent expiration.
May 01, 2026
2 mo ago
Exclusivity ends · ODE-240
Orphan-drug exclusivity (7 years)
May 16, 2026
1 mo ago
Today
Pharmaceutical detail
Active ingredient
TEDUGLUTIDE
Strength
5MG/VIAL
Dosage form
POWDER
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 203441
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.
Marketing exclusivity (1)
- ODE-240Orphan-drug exclusivity (7 years)
May 16, 2026
1 mo ago
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7847061 | Nov 01, 2025 | 8 mo ago | U-1320Delisted |
| 9060992 | Nov 01, 2025 | 8 mo ago | U-1320Delisted |
| 7847061*PED | May 01, 2026 | 2 mo ago | |
| 9060992*PED | May 01, 2026 | 2 mo ago |
