Home / Generic availability / Teduglutide
When will generic Teduglutide be available?
Every patent and exclusivity the FDA listed for teduglutide has now expired, so nothing on the FDA's list blocks a generic version of teduglutide in the United States.
Patents listed with the FDA
2 unexpired or current listing(s), plus 2 delisted. A delisted patent no longer blocks a generic.
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 7847061 delisted | 2025-11-01 | method of use | GATTEX KIT |
| 9060992 delisted | 2025-11-01 | method of use | GATTEX KIT |
| 7847061*PED | 2026-05-01 | method of use | GATTEX KIT |
| 9060992*PED | 2026-05-01 | method of use | GATTEX KIT |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| ODE-240 | 2026-05-16 | Orphan drug exclusivity (7 years) | GATTEX KIT |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| GATTEX KIT | Brand (NDA) | TAKEDA PHARMACEUTICALS USA INC | 2012-12-21 | reference listed drug, reference standard |
What a generic Teduglutide would have to match
Forms and strengths
For Injection: 5 mg teduglutide as a white lyophilized powder for reconstitution in a single-dose vial supplied with 0.5 mL Sterile Water for Injection in a single-dose prefilled syringe. For injection: 5 mg teduglutide in a single-dose vial supplied with 0.5 mL Sterile Water for Injection in a single-dose prefilled syringe. ( 3 )
How it is supplied
GATTEX (teduglutide) for injection is supplied as 5 mg of teduglutide as a white, lyophilized powder for reconstitution in a sterile, single-dose glass vial with 0.5 mL Sterile Water for Injection in a single-dose prefilled syringe. The product to be dispensed is either a one-vial kit or a 30-vial kit. One-vial kits are pre-assembled and ready to be used: GATTEX 5 mg One-vial Kit (NDC 68875-0103-1): One single-dose vial of 5 mg teduglutide (NDC 68875-0101-1) One disposable prefilled syringe containing 0.5 mL Sterile Water for Injection USP for reconstitution, with a separate needle (23G × 1½ in) to attach to the syringe One sterile disposable 1 mL syringe with needle (27G × 1/2 in) for...
Storage
Storage and Handling of One-Vial Kit Prior to Dispensing: Store GATTEX 5 mg Strength one-vial kits refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use beyond the expiration date on the label. After Dispensing by the Pharmacist: Store GATTEX 5 mg Strength one-vial kits at room temperature up to 25°C (77°F). Do not freeze. Dispense with a 90-day "use by" dating. GATTEX is also supplied in 30-vial cartons to be assembled by the dispensing pharmacist into a 30-vial kit by...
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2025-09-05.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Teriparatideno patent or exclusivity listed
- Ziconotideno patent or exclusivity listed
- Romidepsinprotection runs to December 2026
- Pasireotideprotection runs to December 2026
- Leuprolideprotection runs to January 2027
Frequently asked questions
When will generic Teduglutide be available?
Every patent and exclusivity the FDA listed for teduglutide has now expired, so nothing on the FDA's list blocks a generic version of teduglutide in the United States.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
Related data
- Teduglutide clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book