Prescription medicine
Teduglutide Brand names: Gattex
Teduglutide (Gattex) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the teduglutide FDA label on DailyMed (effective September 5, 2025, Takeda Pharmaceuticals America, Inc.); the NDA 203441 record on Drugs@FDA; every teduglutide label on DailyMed.
Highlights of the record
FDA label of September 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageGATTEX ® is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
Forms and strengths
- 5 mg/.5ml
Kit; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- December 21, 2012 Gattex Kit, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 1, 2026 Gattex Kit injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 13,396 through July 30, 2026
What is teduglutide used for?
From the label: indications and usageGATTEX ® is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support. GATTEX ® is a glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
FDA pharmacologic class: GLP-2 Analog.
Source: FDA drug label (Gattex), Takeda Pharmaceuticals America, Inc., effective September 5, 2025 (SPL set 66b69c1e-b25c-44d3-b5ff-1c1de9a516fa), via openFDA; the full label on DailyMed
What does the patient leaflet for teduglutide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about GATTEX?GATTEX may cause serious side effects, including: Making abnormal cells grow faster. GATTEX can make abnormal cells that are already in your body grow faster. There is an increased risk that abnormal cells could become cancer. If you get cancer of the bowel (intestines), liver, gallbladder, or pancreas while using GATTEX, your healthcare provider should stop GATTEX. If you get other types of cancers, you and your healthcare provider should discuss the risks and benefits of using GATTEX. Polyps in the intestines. Polyps are growths on the inside of the intestines. Before you start using GATTEX, your healthcare provider will: For Adult Patients Have your colon and upper intestines checked for polyps within 6 months before starting GATTEX. Have any polyps removed. For Pediatric Patients Check for blood in the stool within 6 months before starting GATTEX. If there is blood found in the stool, have your colon and upper intestines checked for polyps. Have any polyps removed. To keep using GATTEX, your healthcare provider should: For Adult Patients Have your colon and upper intestines checked for new polyps at the end of 1 year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every 5 years. Have any new polyps removed. For Pediatric Patients Check for blood in the stool every year while using GATTEX. If there is blood found in the stool, have your colon and upper intestines checked for polyps. Have your colon checked for new polyps at the end of 1 year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every 5 years. Have any new polyps removed. If cancer is found in a polyp, your healthcare provider should stop GATTEX. […]
From the patient leaflet: How should I store GATTEX?Store GATTEX powder at room temperature up to 77°F (25°C). Do not freeze GATTEX. Use the GATTEX powder by the expiration date on the "Use By" sticker on the kit. Use GATTEX within 3 hours after mixing it. Throw away any unused GATTEX that has been mixed, even if there is medicine left in the vial. Do not store any GATTEX you have mixed. Keep GATTEX and all medicines out of the reach of children.
Source: FDA drug label (Gattex), Takeda Pharmaceuticals America, Inc., effective September 5, 2025 (SPL set 66b69c1e-b25c-44d3-b5ff-1c1de9a516fa), via openFDA; the full label on DailyMed
Is there a generic for teduglutide (Gattex)?
No generic teduglutide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Gattex Kit injection, the last expiring on May 1, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2026 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for teduglutide?
The FDA Adverse Event Reporting System holds 13,396 reports that list teduglutide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,151 are coded as a death and 8,022 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Teduglutide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other