Iheezo Generic: When Will Generic Chloroprocaine Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Iheezo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2039 About 12.5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? May 2039 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic chloroprocaine is expected to be available in May 2039, about 12.5 years away. None is for sale yet.
Why May 2039?
It is when Iheezo’s patent 11,969,403 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Iheezo as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Iheezo by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- $113M a yearBig seller
- FDA approved 2022 September 2022 FDA Orange Book
- Patents listed 2 last runs to May 2039 FDA Orange Book
- Medicaid prescriptions 3,549 in the last four reported quarters, $1.8M CMS Medicaid drug utilization, to Q1 2026
Iheezo’s Road to a Generic
Iheezo has had the market to itself since the FDA approved it in September 2022 (Harrow Eye LLC). Its 2 listed patents run to May 2039.
The first generic of Iheezo is expected in May 2039.
Why that month: patent 11,969,403, on the product’s formulation, ends then.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Iheezo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Iheezo’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 11,969,403, which ends in May 2039, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,792,271 | The product’s formulation; a way of using it (U-3457) | September 2038 | Active |
| 11,969,403 Sets the expected month of generic availability | The product’s formulation | May 2039 | Active |
Source: FDA Orange Book, application 216227. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Chloroprocaine
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Iheezo yet.
Approved by the FDA
Not yet. The FDA has not approved a generic chloroprocaine. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic chloroprocaine for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Iheezo Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Iheezo, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Iheezo
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicaid Prescriptions by Quarter
3,549 prescriptions in the four quarters to Q1 2026, $1.8M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 962 | $457,033 |
| Q4 2025 | 892 | $481,503 |
| Q3 2025 | 1,053 | $521,090 |
| Q2 2025 | 642 | $323,849 |
| Q1 2025 | 430 | $177,246 |
Source: CMS Medicaid State Drug Utilization Data, over Iheezo’s own package codes.
Iheezo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 3% | Gel | Ophthalmic | September 2022 | Prescription reference product |
Source: FDA Orange Book, Harrow Eye LLC. Listed for sale today by Harrow Eye, LLC (FDA NDC Directory).
Iheezo NDC Codes and Packages
Each Iheezo package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 82667-0300-00 | CHLOROPROCAINE HYDROCHLORIDE 24 mg/800mg gel | vial of 800 mg | Harrow Eye, LLC |
| 82667-0300-00 | CHLOROPROCAINE HYDROCHLORIDE 24 mg/800mg gel | vial of 800 mg | Harrow Eye, LLC |
| 82667-0300-01 | CHLOROPROCAINE HYDROCHLORIDE 24 mg/800mg gel | vial of 800 mg | Harrow Eye, LLC |
| 82667-0300-01 | CHLOROPROCAINE HYDROCHLORIDE 24 mg/800mg gel | vial of 800 mg | Harrow Eye, LLC |
| 82667-0300-05 | CHLOROPROCAINE HYDROCHLORIDE 24 mg/800mg gel | carton of 5 pouches of 1 vial of 800 mg | Harrow Eye, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Iheezo’s own FDA approval (NDA 216227) are listed, never a generic. Some codes belong to companies that repackage Iheezo: it is the same medicine in a different package.
What a Generic Iheezo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Iheezo as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Iheezo”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Iheezo
Is there a generic for Iheezo right now?
No. As of October 9, 2026 no generic chloroprocaine is listed for sale in the FDA NDC Directory.
When will Iheezo go generic?
May 2039 is the expected month, and that is toss-up but not certain. It is when Iheezo’s patent 11,969,403 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic chloroprocaine be the same as Iheezo?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Iheezo?
Not yet. The FDA Orange Book lists no approved generic version of Iheezo.
When does the Iheezo patent expire?
The FDA Orange Book lists 2 patents for Iheezo; the last runs to May 2039. The one behind the expected month is patent 11,969,403, which ends in May 2039. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (May 2039) weighs all of that.
Changes to This Projection
- First generic expected May 2039 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- KyleenaLevonorgestrelSeptember 2029
- TafinlarDabrafenib MesylateJuly 2030
- BelrapzoBendamustine HydrochlorideJanuary 2031
- ParsabivEtelcalcetide2033 to 2034
- EvrysdiRisdiplam2036 to 2037
- XhanceFluticasone PropionateFebruary 2036
About Iheezo
- Generic name chloroprocaine
- How it is taken In the eye
- Company Harrow Eye LLC
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Iheezo
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.