small molecule

GATTEX KIT

TEDUGLUTIDE

Loss of exclusivityMay 2026FDA regulatory exclusivity expiry

CompanyTAKEDA PHARMACEUTICALS USA INC

Drug detail

Brand name	GATTEX KIT
Active ingredient	TEDUGLUTIDE
Strength	5MG/VIAL
Dosage form	POWDER
Route	SUBCUTANEOUS
Modality	Small molecule
FDA approval	December 2012
Marketing status	RX

Listed patents

Patent	Expires	Type
7847061*PED	May 2026	—
9060992*PED	May 2026	—
9060992	November 2025	use U-1320
7847061	November 2025	use U-1320

Regulatory exclusivity

Code	Expires
ODE-240	May 2026

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

Drug detail

Listed patents

Regulatory exclusivity

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