small molecule

INLEXZO

GEMCITABINE HYDROCHLORIDE

Loss of exclusivityNovember 2038latest FDA-listed patent expiry

CompanyJanssen Biotech →See this company's full patent-cliff portfolio

Drug detail

Brand name	INLEXZO
Active ingredient	GEMCITABINE HYDROCHLORIDE
Strength	EQ 225MG BASE
Dosage form	SYSTEM
Route	INTRAVESICAL
Modality	Small molecule
FDA approval	September 2025
Marketing status	RX

Listed patents

Patent	Expires	Type
12636300	November 2038	use U-4552
10729823	August 2034	product
12447241	August 2034	product
8679094	April 2032	product
12576253	December 2030	product
12403086	June 2030	product

Regulatory exclusivity

Code	Expires
NP	September 2028

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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