Optical Imaging Agent Drug Class List

Drugs in Drug Class: Optical Imaging Agent

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nxdc	GLEOLAN	aminolevulinic acid hydrochloride	FOR SOLUTION;ORAL	208630-001	Jun 6, 2017		RX	Yes	Yes
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y

Optical Imaging Agents Patent Landscape, Market Dynamics, and Generic/Biosimilar Risk (US and Key EU Markets)

Last updated: July 18, 2026

Optical imaging agents are dominated by (1) near-infrared (NIR) fluorophores, (2) targeted conjugates (antibodies, peptides, small molecules), and (3) formulation and manufacturing know-how that drives regulatory submissions. Patent risk is concentrated in fluorophore-chemistry, conjugation/linker platforms, dosing/administration regimens, and specific imaging uses (tumor imaging, sentinel node mapping, intraoperative guidance). Competitive entry is typically prevented by a patchwork of composition-of-matter, method-of-use, and process patents that may not be fully reflected in Orange Book style listings for imaging drugs.

Scope note: “Optical imaging agent” is not a single FDA-approved active ingredient class; it is a functional category spanning multiple small molecules and biologic conjugates with different IP estates. A complete, accurate landscape by molecule, patent numbers, assignees, and expiration dates cannot be produced without a defined reference list of specific FDA-approved optical imaging agents (and their strengths/dosage forms) to anchor the analysis.