Prescription medicine
Dorzolamide and timolol Brand names: Cosopt
Dorzolamide and timolol (Cosopt) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.893 per mL (Dorzolamide-timolol eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the dorzolamide and timolol FDA label on DailyMed (effective May 13, 2026, Thea Pharma Inc.); the NDA 20869 record on Drugs@FDA; every dorzolamide and timolol label on DailyMed.
Highlights of the record
FDA label of May 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCOSOPT® PF is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time).
Forms and strengths
- 20 mg/ml / 5 mg/ml
- 22.3 mg/ml / 6.8 mg/ml
Solution/ drops; solution.
On the market
- Earliest approval on file
- April 7, 1998 Cosopt, Thea Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first October 28, 2008; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 14 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.893 per mL Dorzolamide-timolol eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest July 22, 2026
- FAERS reports
- 8,525 through July 30, 2026
What is dorzolamide and timolol used for?
From the label: indications and usageCOSOPT® PF is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT® administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14.1) ]. […]
Conditions named in the indications of dorzolamide and timolol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Carbonic Anhydrase Inhibitor and beta-Adrenergic Blocker.
Source: FDA drug label (COSOPT PF), Thea Pharma Inc., effective May 13, 2026 (SPL set 535fc801-8c3f-4974-a120-3eff1d5a5062), via openFDA; the full label on DailyMed
Is there a generic for dorzolamide and timolol (Cosopt)?
The FDA approved the first generic dorzolamide and timolol on October 28, 2008. 20 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dorzolamide and timolol from 14 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2008 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dorzolamide and timolol (Cosopt)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.893 per mL (Dorzolamide-timolol eye drops), down 13% from $1.02 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.
- Dorzolamide-timolol eye drops (generic)
- Cosopt pf eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dorzolamide-timolol 2-0.5%(pf) | Generic | $1.09 per unit | n/a | +0.7% |
| Dorzolamide-timolol eye drops | Generic | $0.893 per mL | n/a | -13% |
| Cosopt eye drops | Brand | $23.16 per mL | n/a | -0.4% |
| Cosopt pf eye drops | Brand | $3.30 per unit | n/a | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dorzolamide and timolol been recalled?
The FDA's Enforcement Report lists 1 recall naming dorzolamide and timolol since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 22, 2026 | Class II | MICRO LABS USA INC | Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dorzolamide and timolol label say about other medicines?
The dorzolamide and timolol label names 3 other medicines 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 |
|---|---|---|
| Clonidine | drug interactions | Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. |
| Epinephrine | warnings and precautions | Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions. |
| Quinidine | drug interactions | Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine, SSRIs) and timolol. |
Source: FDA drug label (COSOPT PF), Thea Pharma Inc., effective May 13, 2026 (SPL set 535fc801-8c3f-4974-a120-3eff1d5a5062), via openFDA; the full label on DailyMed
What do FAERS reports show for dorzolamide and timolol?
The FDA Adverse Event Reporting System holds 8,525 reports that list dorzolamide and timolol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 661 are coded as a death and 1,761 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 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 dorzolamide and timolol?
15 other medicines are given the same way (ophthalmic) and in the same FDA class as dorzolamide and timolol 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 |
|---|---|---|---|---|
| Brinzolamide | Glaucoma | 4 labelers | $9.00 per mL 1% eye drops | No current entry |
| Betaxolol | Glaucoma | none listed | $8.97 per mL 0.5% eye drop | No current entry |
| Brimonidine and brinzolamide | Glaucoma | none listed | $26.04 per mL 1%-0.2% eye drop | No current entry |
| Carteolol | Glaucoma | 1 labeler | $1.63 per mL 1% eye drops | No current entry |
| Levobunolol | Glaucoma | 1 labeler | $2.82 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 |
| Latanoprost | Glaucoma | 14 labelers | $1.58 per mL 0.005% eye drops | No current entry |
Every medicine labeled for the same conditions as dorzolamide and timolol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dorzolamide and timolol
- 15 medicines for the same use
- Other carbonic anhydrase inhibitors
- the pharmacologic class, with prices and generics
- Dorzolamide and timolol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other