Prescription medicine

Omidenepag isopropyl Brand names: Omlonti

Omidenepag isopropyl (Omlonti) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the omidenepag isopropyl FDA label on DailyMed (effective April 21, 2025, Ocuvex Therapeutics, Inc.); the NDA 215092 record on Drugs@FDA; every omidenepag isopropyl label on DailyMed.

Highlights of the record

FDA label of April 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Forms and strengths

0.02 mg/ml

Solution/ drops.

On the market

Earliest approval on file: September 22, 2022 Omlonti, Ocuvex Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: July 16, 2039 Omlonti solution; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 61 through July 30, 2026

What is omidenepag isopropyl used for?

From the label: indications and usage
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Conditions named in the indications of omidenepag isopropyl's FDA labels, with every medicine labeled for each:

Glaucoma

FDA pharmacologic class: Prostaglandin E2 Receptor Agonist.

Source: FDA drug label (Omlonti), Ocuvex Therapeutics, Inc., effective April 21, 2025 (SPL set 4258e437-7e92-4b09-baf1-01cb158cfc05), via openFDA; the full label on DailyMed

Is there a generic for omidenepag isopropyl (Omlonti)?

No generic omidenepag isopropyl is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 13 patents for Omlonti solution: the compound patent runs to June 10, 2035, and the last listed entry to July 16, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2022 earliest approval on file
2039 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for omidenepag isopropyl?

The FDA Adverse Event Reporting System holds 61 reports that list omidenepag isopropyl among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 8 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Cataract18
Contraindicated Product Administered8
Cystoid Macular Oedema (named in the label)5
Intercepted Product Prescribing Error (a use or a product term, not a reaction)5
Anaphylactic Reaction4
Glaucoma (a use or a product term, not a reaction)4
Intraocular Pressure Increased4
Macular Oedema (named in the label)4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as omidenepag isopropyl?

17 other medicines are given the same way (ophthalmic) and in the same FDA class as omidenepag isopropyl or labeled mainly for the same use (glaucoma), the same class first. Glaucoma lists all 20 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (ophthalmic)	Pharmacy cost	Shortage
Timolol	Glaucoma	21 labelers	$0.774 per mL 0.5% eye drops	No current entry
Brimonidine	Glaucoma	12 labelers	$9.06 per mL 0.1% drop	No current entry
Bimatoprost	Glaucoma	13 labelers	$6.97 per mL 0.03% eye drops	No current entry
Dorzolamide and timolol	Glaucoma	14 labelers	$0.893 per mL Dorzolamide-timolol eye drops	No current entry
Brimonidine and timolol	Glaucoma	14 labelers	$2.15 per mL 0.2%-0.5%	No current entry
Latanoprost	Glaucoma	14 labelers	$1.58 per mL 0.005% eye drops	No current entry
Travoprost	Glaucoma	11 labelers	$9.07 per mL 0.004% eye drop	A presentation being discontinued
Dorzolamide	Glaucoma	14 labelers	$0.835 per mL 2% eye drops	No current entry

Every medicine labeled for the same conditions as omidenepag isopropyl

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to omidenepag isopropyl: 17 medicines for the same use
Omidenepag isopropyl side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other