small molecule

ICLUSIG

PONATINIB HYDROCHLORIDE

Loss of exclusivityDecember 2033latest FDA-listed patent expiry

CompanyTAKEDA PHARMACEUTICALS USA INC

Drug detail

Brand name	ICLUSIG
Active ingredient	PONATINIB HYDROCHLORIDE
Strength	EQ 45MG BASE
Dosage form	TABLET
Route	ORAL
Modality	Small molecule
FDA approval	December 2012
Marketing status	RX

Listed patents

Patent	Expires	Type
9493470	December 2033	substance, product
11384086	December 2033	substance, product
11192897	December 2033	substance
11192895	December 2033	use U-1948
8114874	January 2027	substance, product
9029533	December 2026	use U-1699

Regulatory exclusivity

Code	Expires
ODE-472	March 2031
I-934	March 2027

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

Drug detail

Listed patents

Regulatory exclusivity

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