Is Ocuvex Therapeutics, Inc. FDA approved?

Ocuvex Therapeutics, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Ocuvex Therapeutics, Inc. make?

1 product is listed under Ocuvex Therapeutics, Inc. in the openFDA NDC Directory, most often as solution/ drops. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Ocuvex Therapeutics, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 13
Exclusivities: 1
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8648097	OMLONTIomidenepag isopropyl	substance, product	Oct 2029
8685986	OMLONTIomidenepag isopropyl	product	Oct 2029
10179127	OMLONTIomidenepag isopropyl	product	Jan 2035
10702511	OMLONTIomidenepag isopropyl	product	Jan 2035
10765750	OMLONTIomidenepag isopropyl	product	Jan 2035
11197849	OMLONTIomidenepag isopropyl	product	Jan 2035
11793798	OMLONTIomidenepag isopropyl	product	Jan 2035
12295946	OMLONTIomidenepag isopropyl	product	Jan 2035
9415038	OMLONTIomidenepag isopropyl	product	Jan 2035
RE48183	OMLONTIomidenepag isopropyl	product	Jan 2035
10774072	OMLONTIomidenepag isopropyl	substance	Jun 2035
12290511	OMLONTIomidenepag isopropyl	use	Dec 2038
11666563	OMLONTIomidenepag isopropyl	use	Jul 2039

Product	Exclusivity	Until
OMLONTIOMIDENEPAG ISOPROPYL	NCE New chemical entity	Sept 2027

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Omlonti	omidenepag isopropyl	solution/ drops, ophthalmic	84826-002NDA

Enquiry

Common questions

Is Ocuvex Therapeutics, Inc. FDA approved?: Ocuvex Therapeutics, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Ocuvex Therapeutics, Inc. make?: 1 product is listed under Ocuvex Therapeutics, Inc. in the openFDA NDC Directory, most often as solution/ drops. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.