Simbrinza Generic: When Will Generic Brimonidine and Brinzolamide 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
Simbrinza Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2026 Sometime that year Why then?
- Has the FDA approved a generic? Not yet 1 company holds a tentative approval Why not yet?
- When does the last patent end? October 2030 2 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 brimonidine tartrate and brinzolamide is expected to be available sometime in 2026. None is for sale yet.
Why 2026?
One generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
If Simbrinza’s last patent runs to October 2030, how can a generic come sooner?
The 2 patents that run past the expected month, to October 2030 (9,421,265 and 9,044,484), cover 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. Generic companies have been challenging Simbrinza’s patents with the FDA since August 2022. 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. One company already holds a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Perrigo Pharma International Dac (November 2023). See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic, which would take the $26.04 pharmacies pay per mL for Simbrinza today to about $17.97. See the price estimate
What should I do now?
Keep taking Simbrinza 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.
Simbrinza by the Numbers
- Reason
- Not yet clearOne generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $96M a yearSmaller seller
- FDA approved 2013 April 2013 FDA Orange Book
- Patents listed 2 last runs to October 2030 A generic is expected sooner, sometime in 2026. See why FDA Orange Book
- Pharmacies pay $26.04 per mL, up 4.9% in a year NADAC, October 2026
- Medicare Part D spent $76.9M in 2025, for 70.7K people CMS Part D Spending by Drug
- Medicaid prescriptions 20.3K in the last four reported quarters, $4.6M CMS Medicaid drug utilization, to Q1 2026
Simbrinza’s Road to a Generic
Simbrinza has had the market to itself since the FDA approved it in April 2013 (Alcon Laboratories Inc). Its 2 listed patents run to October 2030. Generic companies have challenged its patents with the FDA since August 2022.
The first generic of Simbrinza is expected sometime in 2026.
One generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
Why a Generic Can Come Before October 2030
The last listed patent runs to October 2030, but it covers 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.
Simbrinza Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Simbrinza’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 |
|---|---|---|---|
| 9,421,265 | The product’s formulation | June 2030 | Active |
| 9,044,484 | The product’s formulation | October 2030 | Active |
Source: FDA Orange Book, application 204251. Patent numbers open the patent on Google Patents.
Patent Challenges to Simbrinza
The first patent challenge to Simbrinza reached the FDA in August 2022, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Simbrinza’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Ophthalmic suspension, 1%/0.2% | August 2022 | 1 company | No decision yet | Not yet | Not yet | October 2030 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Brimonidine Tartrate and Brinzolamide
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
One company has applied to the FDA to make generic brimonidine tartrate and brinzolamide.
The FDA has tentatively approved one company’s generic: Perrigo Pharma International Dac (November 2023). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Simbrinza’s patents with the FDA since August 2022: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic brimonidine tartrate and brinzolamide. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic brimonidine tartrate and brinzolamide 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).
Simbrinza Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Simbrinza 1%-0.2% eye drop
$26.04 per mL in October 2026, up 4.9% 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 | $26.04 |
| September 2026 | $26.04 |
| August 2026 | $26.04 |
| July 2026 | $26.05 |
| June 2026 | $26.04 |
| May 2026 | $26.04 |
| April 2026 | $26.07 |
| March 2026 | $26.07 |
| February 2026 | $26.07 |
| January 2026 | $26.07 |
| February 2024 | $24.82 |
| January 2024 | $24.82 |
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 Simbrinza today: $26.04 per mL for Simbrinza 1%-0.2% 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). Simbrinza has one company lined up, so our estimate uses the figure for one company. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $26.04 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 Simbrinza
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 Simbrinza, before manufacturer rebates.
- $17.7M
- January to March 2026, the latest CMS has posted
For 40,438 people, about $277 per prescription fill - $76.9M
- 2025, the whole year
For 70,709 people, about $271 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $17,687,176 | 40,438 | $276.97 |
| 2025 | $76,939,985 | 70,709 | $271.25 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Simbrinza only, so no generic is counted in it. What CMS says it is used for: This product contains two medications used to treat high pressure in the eye due to glaucoma (open-angle glaucoma-type) or a certain other eye disease (ocular hypertension). Lowering high pressure in the eye reduces the risk of vision loss, nerve damage, or blindness.
Medicaid Prescriptions by Quarter
20,269 prescriptions in the four quarters to Q1 2026, $4.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 4,834 | $1,110,860 |
| Q4 2025 | 5,033 | $1,131,710 |
| Q3 2025 | 5,366 | $1,222,047 |
| Q2 2025 | 5,036 | $1,145,760 |
| Q1 2025 | 5,132 | $1,169,224 |
Source: CMS Medicaid State Drug Utilization Data, over Simbrinza’s own package codes.
Simbrinza Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.2%;1% | Suspension/drops | Ophthalmic | April 2013 | Prescription reference product |
Source: FDA Orange Book, Alcon Laboratories Inc. Listed for sale today by Alcon Laboratories, Inc. and Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Simbrinza NDC Codes and Packages
Each Simbrinza 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 |
|---|---|---|---|
| 00078-0904-38 | 2 mg/mL / 10 mg/mL suspension/ drops | bottle of 8 mL | Novartis Pharmaceuticals Corporation |
| 00078-0904-98 | 2 mg/mL / 10 mg/mL suspension/ drops | bottle of 2.5 mL | Novartis Pharmaceuticals Corporation |
| 00065-4147-25 | BRINZOLAMIDE 10 mg/mL / BRIMONIDINE TARTRATE 2 mg/mL suspension/ drops | bottle of 2.5 mL | Alcon Laboratories, Inc. |
| 00065-4147-25 | BRINZOLAMIDE 10 mg/mL / BRIMONIDINE TARTRATE 2 mg/mL suspension/ drops | bottle of 2.5 mL | Alcon Laboratories, Inc. |
| 00065-4147-27 | BRINZOLAMIDE 10 mg/mL / BRIMONIDINE TARTRATE 2 mg/mL suspension/ drops | bottle of 8 mL | Alcon Laboratories, Inc. |
| 00065-4147-27 | BRINZOLAMIDE 10 mg/mL / BRIMONIDINE TARTRATE 2 mg/mL suspension/ drops | bottle of 8 mL | Alcon Laboratories, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Simbrinza’s own FDA approval (NDA 204251) are listed, never a generic. Some codes belong to companies that repackage Simbrinza: it is the same medicine in a different package.
What a Generic Simbrinza Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Simbrinza 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 Simbrinza”. 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 Simbrinza
Is there a generic for Simbrinza right now?
No. As of October 9, 2026 no generic brimonidine tartrate and brinzolamide is listed for sale in the FDA NDC Directory.
When will Simbrinza go generic?
Sometime in 2026 is the expected window, and that is toss-up but not certain. One generic maker has filed an application with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet. The last listed patent runs to October 2030, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic brimonidine tartrate and brinzolamide be the same as Simbrinza?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic, which would take the $26.04 pharmacies pay per mL for Simbrinza today to about $17.97. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Simbrinza?
Not yet. The FDA Orange Book lists no approved generic version of Simbrinza.
When does the Simbrinza patent expire?
The FDA Orange Book lists 2 patents for Simbrinza; the last runs to October 2030. 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 (Sometime in 2026) weighs all of that.
Has anyone challenged the Simbrinza patents?
Yes. The first patent challenge to Simbrinza reached the FDA in August 2022, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Simbrinza cost now?
Pharmacies paid about $26.04 per mL for Simbrinza 1%-0.2% 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 Sometime in 2026 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
- Lumify PFBrimonidine TartrateJuly to December 2027
- TriesenceTriamcinolone AcetonideDecember 2029
- ZenbexusIberdomide Hydrochloride2037 to 2038
- GavretoPralsetinibApril 2039
- Purified CortrophinCorticotropinOctober 2043
- CaldolorIbuprofenTBD no date yet
About Simbrinza
- Generic name brimonidine tartrate and brinzolamide
- How it is taken In the eye
- Company Alcon Laboratories Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since August 2022 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Simbrinza
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, FDA Paragraph IV Patent Certifications list, 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.