Question 1

Is there a generic for Teduglutide?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Teduglutide. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Teduglutide?

Accepted Answer

GATTEX KIT (NDA 203441, TAKEDA PHARMS USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Teduglutide?

Accepted Answer

The Orange Book lists 4 patents against Teduglutide products, with the earliest listed expiry in 2025. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Teduglutide have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Teduglutide. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Teduglutide are approved?

Accepted Answer

Teduglutide is approved in the following dosage form: powder.

Patent	Expires	In	Type
9060992	Nov 01, 2025	8 mo ago	U-1320Delisted
7847061	Nov 01, 2025	8 mo ago	U-1320Delisted
7847061*PED	May 01, 2026	2 mo ago
9060992*PED	May 01, 2026	2 mo ago

Teduglutide

Brand (NDA) products · powder

Marketing exclusivity (1)

Listed patents (4)

Teduglutide — frequently asked questions

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