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Home / Generic availability / Teduglutide

FDA Orange Book · updated 2026-09-23

When will generic Teduglutide be available?

All listed protection expired

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.

None
No protection listed
2
Patents listed
1
Exclusivity records
0
Generics waiting

Patents listed with the FDA

2 unexpired or current listing(s), plus 2 delisted. A delisted patent no longer blocks a generic.

PatentExpiresCoversProduct
7847061 delisted2025-11-01method of useGATTEX KIT
9060992 delisted2025-11-01method of useGATTEX KIT
7847061*PED2026-05-01method of useGATTEX KIT
9060992*PED2026-05-01method of useGATTEX KIT

FDA exclusivity

Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.

CodeExpiresWhat it isProduct
ODE-2402026-05-16Orphan drug exclusivity (7 years)GATTEX KIT

Approved products

ProductTypeApplicantApproved
GATTEX KITBrand (NDA)TAKEDA PHARMACEUTICALS USA INC2012-12-21reference listed drug, reference standard
How to read these dates. They come from the FDA Orange Book, which records the patents a brand has listed and the exclusivity the FDA has granted. The date shown is when the last of those expires. It is an upper bound on protection, not a prediction of when a generic will actually reach pharmacies.

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 2026-09-23. 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.