Miebo Generic: When Will Generic Perfluorohexyloctane 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
Miebo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2034 to 2035 A wide window 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? June 2037 10 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic perfluorohexyloctane is expected to be available between 2034 and 2035. None is for sale yet.
Why 2034 to 2035?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
If Miebo’s last patent runs to June 2037, how can a generic come sooner?
The 5 patents that run past the expected month, to June 2037 (10,682,315, 11,357,738, 12,128,010, 10,507,132 and 1 more), cover a way of using it and the product’s formulation. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. That is why the expected month comes before the last protection ends. See the road to a generic
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 Miebo 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.
Miebo by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- 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
- $1.1B a yearBlockbuster
- FDA approved 2023 May 2023 FDA Orange Book
- Patents listed 10 last runs to June 2037 A generic is expected sooner, between 2034 and 2035. See why FDA Orange Book
- Pharmacies pay $263.57 per mL, up 6.8% in a year NADAC, October 2026
- Medicare Part D spent $444.8M in 2025, for 134.3K people CMS Part D Spending by Drug
- Medicaid prescriptions 49.8K in the last four reported quarters, $40.1M CMS Medicaid drug utilization, to Q1 2026
Miebo’s Road to a Generic
Miebo has had the market to itself since the FDA approved it in May 2023 (Bausch And Lomb Inc). Its FDA protection (new chemical entity) runs to May 2028. Its 10 listed patents run to June 2037.
The first generic of Miebo is expected between 2034 and 2035.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before June 2037
The last listed patent runs to June 2037, but it covers a way of using it and the product’s formulation, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Miebo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Miebo’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,058,615 | A way of using it (U-1900) | September 2033 | Active |
| 10,369,117 | A way of using it (U-1900) | September 2033 | Active |
| 10,449,164 | A way of using it (U-1900) | September 2033 | Active |
| 12,005,033 | A way of using it (U-4586) | September 2033 | Active |
| 10,576,154 | A way of using it (U-1900) | October 2035 | Active |
| 10,682,315 | A way of using it (U-4586) | September 2036 | Active |
| 11,357,738 | The product’s formulation | September 2036 | Active |
| 12,128,010 | The product’s formulation | September 2036 | Active |
| 10,507,132 | A way of using it (U-1900) | June 2037 | Active |
| RE50060 | A way of using it (U-4586) | June 2037 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | May 2028 | Active |
Source: FDA Orange Book, application 216675. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Perfluorohexyloctane
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 Miebo yet.
Approved by the FDA
Not yet. The FDA has not approved a generic perfluorohexyloctane. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic perfluorohexyloctane 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).
Miebo Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Miebo 100% eye drop
$263.57 per mL in October 2026, up 6.8% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $263.57 |
| September 2026 | $263.57 |
| August 2026 | $263.61 |
| July 2026 | $263.64 |
| June 2026 | $263.63 |
| May 2026 | $263.56 |
| April 2026 | $263.80 |
| March 2026 | $263.80 |
| February 2026 | $263.80 |
| January 2026 | $263.80 |
| February 2024 | $246.70 |
| January 2024 | $246.70 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Miebo today: $263.57 per mL for Miebo 100% eye drop in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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).
Dollar figures apply FDA’s median drops to the $263.57 pharmacies pay per mL today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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 Miebo
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.
Medicare Part D Spending
What Medicare drug plans spent on Miebo, before manufacturer rebates.
- $129.1M
- January to March 2026, the latest CMS has posted
For 76,725 people, about $929 per prescription fill - $444.8M
- 2025, the whole year
For 134,309 people, about $878 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $129,067,961 | 76,725 | $929.13 |
| 2025 | $444,790,898 | 134,309 | $877.56 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Miebo only, so no generic is counted in it. What CMS says it is used for: This medication is used to relieve dry, irritated eyes. Perfluorohexyloctane works by keeping your tears from drying up.
Medicaid Prescriptions by Quarter
49,792 prescriptions in the four quarters to Q1 2026, $40.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 14,424 | $11,794,157 |
| Q4 2025 | 13,528 | $10,743,047 |
| Q3 2025 | 12,262 | $9,854,111 |
| Q2 2025 | 9,578 | $7,684,343 |
| Q1 2025 | 7,505 | $6,053,251 |
Source: CMS Medicaid State Drug Utilization Data, over Miebo’s own package codes.
Miebo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 1.338GM/ML | Solution/drops | Ophthalmic | May 2023 | Prescription reference product |
Source: FDA Orange Book, Bausch And Lomb Inc. Listed for sale today by Bausch & Lomb Incorporated (FDA NDC Directory).
Miebo NDC Codes and Packages
Each Miebo 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 |
|---|---|---|---|
| 24208-0377-01 | PERFLUOROHEXYLOCTANE 1 mg/mg solution | bottle of 3 mg | Bausch & Lomb Incorporated |
| 24208-0377-01 | PERFLUOROHEXYLOCTANE 1 mg/mg solution | bottle of 3 mg | Bausch & Lomb Incorporated |
| 24208-0377-05 | PERFLUOROHEXYLOCTANE 1 mg/mg solution | bottle of 3 mg | Bausch & Lomb Incorporated |
| 24208-0377-05 | PERFLUOROHEXYLOCTANE 1 mg/mg solution | bottle of 3 mg | Bausch & Lomb Incorporated |
| 24208-0377-06 | PERFLUOROHEXYLOCTANE 1 mg/mg solution | bottle of 1.6 mg | Bausch & Lomb Incorporated |
Source: the FDA NDC Directory, current listings only. Only packages sold under Miebo’s own FDA approval (NDA 216675) are listed, never a generic. Some codes belong to companies that repackage Miebo: it is the same medicine in a different package.
What a Generic Miebo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Miebo 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 Miebo”. 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 Miebo
Is there a generic for Miebo right now?
No. As of October 9, 2026 no generic perfluorohexyloctane is listed for sale in the FDA NDC Directory.
When will Miebo go generic?
2034 to 2035 is the expected window, and that is toss-up but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to June 2037, but it covers a way of using it and the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic perfluorohexyloctane be the same as Miebo?
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 Miebo?
Not yet. The FDA Orange Book lists no approved generic version of Miebo.
When does the Miebo patent expire?
The FDA Orange Book lists 10 patents for Miebo; the last runs to June 2037. 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 window on this page (2034 to 2035) weighs all of that.
How much does Miebo cost now?
Pharmacies paid about $263.57 per mL for Miebo 100% eye drop in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected 2034 to 2035 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
- StribildCobicistat, Elvitegravir, Emtricitabine, and Tenofovir Disoproxil Fumarate2029 to 2030
- JubliaEfinaconazole2030 to 2031
- AugtyroRepotrectinibNovember 2037
- WayrilzRilzabrutinibOctober 2040
- EnbumystBumetanideDecember 2040
- OpveeNalmefene HydrochlorideTBD no date yet
About Miebo
- Generic name perfluorohexyloctane
- How it is taken In the eye
- Company Bausch And Lomb Inc
- 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 M
- Have a question? A pharmacist answers, free. Ask about Miebo
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, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.