Caplin Steriles (Caplin), a subsidiary of Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops), a generic therapeutic equivalent version of the Reference Listed Drug (RLD), from Alcon Research LLC.

Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% is indicated to dilate the pupil of the eyes. According to IQVIATM (IMS Health), Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% had US sales of approximately $32 million for the 12-month period ending Mar 2024