Vyzulta Generic: When Will Generic Latanoprostene Bunod 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
Vyzulta Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2028 to 2029 A wide window Why then?
- Has the FDA approved a generic? April 2025 1 company approved Why not on sale?
- When does the last patent end? February 2029 Its only patent listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic latanoprostene bunod is expected to be available between 2028 and 2029. None is for sale yet.
Why 2028 to 2029?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since April 2025, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 4 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $102.29 pharmacies pay per mL for Vyzulta today to about $27.62. See the price estimate
What should I do now?
Keep taking Vyzulta 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.
Vyzulta 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
- Probable More likely than not, but it can still move.
- Price competition
- Strong 4 companies have filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2017 November 2017 FDA Orange Book
- Patents listed 1 last runs to February 2029 FDA Orange Book
- Generics FDA-approved 1 company, approved April 2025 FDA Orange Book
- Pharmacies pay $102.29 per mL, up 4.5% in a year NADAC, October 2026
- Medicare Part D spent $136M in 2025, for 79.7K people CMS Part D Spending by Drug
- Medicaid prescriptions 13.7K in the last four reported quarters, $4.9M CMS Medicaid drug utilization, to Q1 2026
Vyzulta’s Road to a Generic
Vyzulta has had the market to itself since the FDA approved it in November 2017 (Bausch And Lomb Inc). Its one listed patent runs to February 2029. Generic companies have challenged its patents with the FDA since March 2022.
The first generic of Vyzulta is expected between 2028 and 2029.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Vyzulta Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Vyzulta’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 |
|---|---|---|---|
| 8,058,467 | The active ingredient; a way of using it (U-2144) | February 2029 | Active |
Source: FDA Orange Book, application 207795. Patent numbers open the patent on Google Patents.
Patent Challenges to Vyzulta
The first patent challenge to Vyzulta reached the FDA in March 2022, from one company on that first day. The FDA approved a first challenger’s generic in April 2025, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Vyzulta’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 solution, 0.00024 | March 2022 | 1 company | First challenger eligible decided May 2025 | April 2025 | Not yet | February 2029 |
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 Latanoprostene Bunod
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
4 companies have applied to the FDA to make generic latanoprostene bunod.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
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 Vyzulta’s patents with the FDA since March 2022: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in April 2025. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic latanoprostene bunod for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Gland Pharma Ltd | April 2025 | 0.024% | AB |
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).
Vyzulta Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Vyzulta 0.024% ophth solution
$102.29 per mL in October 2026, up 4.5% 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 | $102.29 |
| September 2026 | $102.29 |
| August 2026 | $102.29 |
| July 2026 | $102.30 |
| June 2026 | $102.27 |
| May 2026 | $102.19 |
| April 2026 | $102.46 |
| March 2026 | $102.46 |
| February 2026 | $102.46 |
| January 2026 | $102.46 |
| February 2024 | $97.84 |
| January 2024 | $97.84 |
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 Vyzulta today: $102.29 per mL for Vyzulta 0.024% ophth solution 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). Vyzulta has 4 companies lined up, so our estimate uses the figure for four companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $102.29 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 Vyzulta
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 Vyzulta, before manufacturer rebates.
- $32.6M
- January to March 2026, the latest CMS has posted
For 49,880 people, about $398 per prescription fill - $136M
- 2025, the whole year
For 79,708 people, about $403 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $32,554,945 | 49,880 | $397.96 |
| 2025 | $136,041,201 | 79,708 | $403.00 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Vyzulta only, so no generic is counted in it. What CMS says it is used for: Latanoprostene bunod is used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye can help prevent blindness.
Medicaid Prescriptions by Quarter
13,697 prescriptions in the four quarters to Q1 2026, $4.9M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 3,272 | $1,172,930 |
| Q4 2025 | 3,436 | $1,229,180 |
| Q3 2025 | 3,632 | $1,302,540 |
| Q2 2025 | 3,357 | $1,219,837 |
| Q1 2025 | 3,486 | $1,240,658 |
Source: CMS Medicaid State Drug Utilization Data, over Vyzulta’s own package codes.
Vyzulta Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.024% | Solution/drops | Ophthalmic | November 2017 | Prescription reference product |
Source: FDA Orange Book, Bausch And Lomb Inc. Listed for sale today by Bausch & Lomb Incorporated (FDA NDC Directory).
Vyzulta NDC Codes and Packages
Each Vyzulta 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 |
|---|---|---|---|
| 24208-0504-01 | LATANOPROSTENE BUNOD .24 mg/mL solution/ drops | bottle of 2.5 mL | Bausch & Lomb Incorporated |
| 24208-0504-01 | LATANOPROSTENE BUNOD .24 mg/mL solution/ drops | bottle of 2.5 mL | Bausch & Lomb Incorporated |
| 24208-0504-02 | LATANOPROSTENE BUNOD .24 mg/mL solution/ drops | bottle of 2.5 mL | Bausch & Lomb Incorporated |
| 24208-0504-02 | LATANOPROSTENE BUNOD .24 mg/mL solution/ drops | bottle of 2.5 mL | Bausch & Lomb Incorporated |
| 24208-0504-05 | LATANOPROSTENE BUNOD .24 mg/mL solution/ drops | bottle of 5 mL | Bausch & Lomb Incorporated |
| 24208-0504-05 | LATANOPROSTENE BUNOD .24 mg/mL solution/ drops | bottle of 5 mL | Bausch & Lomb Incorporated |
| 24208-0504-06 | LATANOPROSTENE BUNOD .24 mg/mL solution/ drops | bottle of 5 mL | Bausch & Lomb Incorporated |
| 24208-0504-06 | LATANOPROSTENE BUNOD .24 mg/mL solution/ drops | bottle of 5 mL | Bausch & Lomb Incorporated |
Source: the FDA NDC Directory, current listings only. Only packages sold under Vyzulta’s own FDA approval (NDA 207795) are listed, never a generic. Some codes belong to companies that repackage Vyzulta: it is the same medicine in a different package.
What a Generic Vyzulta Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Vyzulta 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 Vyzulta”. 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 Vyzulta
Is there a generic for Vyzulta right now?
No. As of October 9, 2026 no generic latanoprostene bunod is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Vyzulta go generic?
2028 to 2029 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Will generic latanoprostene bunod be the same as Vyzulta?
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. 4 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $102.29 pharmacies pay per mL for Vyzulta today to about $27.62. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Vyzulta?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in April 2025: Gland Pharma Ltd. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Vyzulta patent expire?
One patent is listed for Vyzulta in the FDA Orange Book; it runs to February 2029. 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 (2028 to 2029) weighs all of that.
Has anyone challenged the Vyzulta patents?
Yes. The first patent challenge to Vyzulta reached the FDA in March 2022, from one company on that first day. The FDA approved a first challenger’s generic in April 2025, and the list records no sale by a first challenger 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 Vyzulta cost now?
Pharmacies paid about $102.29 per mL for Vyzulta 0.024% ophth solution 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 2028 to 2029 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
- ZontivityVorapaxar SulfateDecember 2027
- TwirlaEthinyl Estradiol and LevonorgestrelAugust 2028
- MitosolMitomycinMay 2029
- CometriqCabozantinib S-MalateFebruary 2032
- RapiblykLandiololApril 2034
- HemadyDexamethasoneDecember 2037
About Vyzulta
- Generic name latanoprostene bunod
- How it is taken In the eye
- Company Bausch And Lomb Inc
- Patent challenges Since March 2022 (FDA)
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about Vyzulta
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.