small molecule

AEMCOLO

RIFAMYCIN SODIUM

Loss of exclusivityNovember 2028FDA regulatory exclusivity expiry

CompanyCOSMO TECHNOLOGIES LTD

Drug detail

Brand name	AEMCOLO
Active ingredient	RIFAMYCIN SODIUM
Strength	EQ 194MG BASE
Dosage form	TABLET, DELAYED RELEASE
Route	ORAL
Modality	Small molecule
FDA approval	November 2018
Marketing status	DISCN

Regulatory exclusivity

Code	Expires
GAIN	November 2028
NCE	November 2023

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