Prescription medicine
Latanoprost Brand names: Xalatan, Iyuzeh, Xelpros
Latanoprost (Xalatan) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $1.58 per mL (Latanoprost 0.005% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the latanoprost FDA label on DailyMed (effective December 18, 2025, Sun Pharmaceutical Industries, Inc.); the NDA 20597 record on Drugs@FDA; every latanoprost label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageXELPROS (latanoprost ophthalmic emulsion) 0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Forms and strengths
- 0.05 mg/ml
Solution/ drops; solution.
On the market
- Earliest approval on file
- June 5, 1996 Xalatan, Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first March 22, 2011; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 14 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- July 8, 2031 Iyuzeh solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.58 per mL Latanoprost 0.005% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest April 22, 2024
- FAERS reports
- 50,627 through July 30, 2026
What is latanoprost used for?
From the label: indications and usageXELPROS (latanoprost ophthalmic emulsion) 0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. XELPROS is a prostaglandin F 2α analog indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension.
Conditions named in the indications of latanoprost's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Prostaglandin Analog.
Source: FDA drug label (XELPROS), Sun Pharmaceutical Industries, Inc., effective December 18, 2025 (SPL set 34ad5cf6-4df0-4104-bddd-4c7631133ded), via openFDA; the full label on DailyMed
Is there a generic for latanoprost (Xalatan)?
The FDA approved the first generic latanoprost on March 22, 2011. 12 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists latanoprost from 14 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Xalatan solution/drops; a patent listed only for Iyuzeh solution/drops runs to July 8, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2011 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for latanoprost (Xalatan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.58 per mL (Latanoprost 0.005% eye drops), down 13% from $1.80 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Latanoprost 0.005% eye drops (generic)
- Iyuzeh 0.005% eye drop (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Latanoprost 0.005% eye drops | Generic | $1.58 per mL | n/a | -13% |
| Iyuzeh 0.005% eye drop | Brand | $10.12 per unit | n/a | no change |
| Xalatan 0.005% eye drops | Brand | $108.34 per mL | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has latanoprost been recalled?
The FDA's Enforcement Report lists 3 recalls naming latanoprost since 2013: 0 Class I (the most serious), 2 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 22, 2024 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Release Testing: Out of specification for particulate matter test. |
| March 17, 2017 | Class II | Akorn, Inc. | Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. |
| June 25, 2013 | Class II | Apotex Inc | Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the latanoprost label say about other medicines?
The latanoprost label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Benzalkonium | contraindications | CONTRAINDICATIONS Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. |
Source: FDA drug label (XELPROS), Sun Pharmaceutical Industries, Inc., effective December 18, 2025 (SPL set 34ad5cf6-4df0-4104-bddd-4c7631133ded), via openFDA; the full label on DailyMed
What do FAERS reports show for latanoprost?
The FDA Adverse Event Reporting System holds 50,627 reports that list latanoprost among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,181 are coded as a death and 10,454 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. Reports rose sharply in 2020 (9,002, against a median of 2,701 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as latanoprost?
16 other medicines are given the same way (ophthalmic) and in the same FDA class as latanoprost 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 |
|---|---|---|---|---|
| Bimatoprost | Glaucoma | 13 labelers | $6.97 per mL 0.03% eye drops | No current entry |
| Travoprost | Glaucoma | 11 labelers | $9.07 per mL 0.004% eye drop | A presentation being discontinued |
| Tafluprost | Glaucoma | 3 labelers | $2.45 per unit 0.0015% eye drop | No current entry |
| 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 |
| 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 |
| Dorzolamide | Glaucoma | 14 labelers | $0.835 per mL 2% eye drops | No current entry |
Every medicine labeled for the same conditions as latanoprost
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does latanoprost compare with medicines for the same use?
6 side-by-side pages set latanoprost beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to latanoprost
- 16 medicines for the same use
- Other prostaglandin analogs
- the pharmacologic class, with prices and generics
- Latanoprost side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other