Lumify Generic: When Will Generic Brimonidine 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
Lumify Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? June 2027 About 9 months away Why then?
- Has the FDA approved a generic? May 2003 13 companies approved
- When does the last patent end? July 2030 5 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 14 companies list one
It already is. A generic brimonidine tartrate is listed for sale by 14 companies, so ask your pharmacy whether it can fill your prescription with one.
Why June 2027?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it very likely: few things could still move it, but a court ruling or a new deal can.
If Lumify’s last patent runs to July 2030, how can a generic come sooner?
The 5 patents that run past the expected month, to July 2030 (11,596,600, 11,833,245, 12,514,857, 8,293,742 and 1 more), cover a way of using it. 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. Generic companies have been challenging Lumify’s patents with the FDA since July 2021. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Lumify, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Lumify 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
- Very likely Few things could still move it, but a court ruling or a new deal can.
- Price competition
- Strong 5 companies have filed, 1 first in line
- Brand sales
- $43M a yearSmaller seller
- FDA approved 2017 December 2017 FDA Orange Book
- Patents listed 5 last runs to July 2030 FDA Orange Book
- Generics FDA-approved 13 companies, the first approved May 2003 FDA Orange Book
Lumify’s Road to a Generic
Lumify has had the market to itself since the FDA approved it in December 2017 (Bausch And Lomb Inc). Its 5 listed patents run to July 2030. Generic companies have challenged its patents with the FDA since July 2021.
The first generic of Lumify is expected in June 2027.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is about 3 years before the last listed patent runs out, in July 2030.
Why a Generic Can Come Before July 2030
The last listed patent runs to July 2030, but it covers a way of using it, 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.
Lumify Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Lumify’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 |
|---|---|---|---|
| 11,596,600 | A way of using it (U-2222) | July 2029 | Active |
| 11,833,245 | A way of using it (U-2222) | July 2029 | Active |
| 12,514,857 | A way of using it (U-2222) | July 2029 | Active |
| 8,293,742 | A way of using it (U-2222) | July 2030 | Active |
| 9,259,425 | A way of using it (U-2222) | July 2030 | Active |
Source: FDA Orange Book, application 208144. Patent numbers open the patent on Google Patents.
Patent Challenges to Lumify
The first patent challenge to Lumify reached the FDA in July 2021, from one company on that first day. The FDA approved a first challenger’s generic in February 2024, 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 Lumify’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, 0.025% | July 2021 | 1 company | First challenger eligible decided March 2024 | February 2024 | Not yet | July 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
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
At least 13 companies have applied to the FDA to make generic brimonidine tartrate.
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 Lumify’s patents with the FDA since July 2021: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 13 companies, the first in May 2003. 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
Yes. A generic brimonidine tartrate is listed for sale by 14 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Akorn, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Apotex Corp., Bausch & Lomb Incorporated and 8 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Bausch And Lomb Inc | May 2003 | 0.2% | AT |
| Sandoz Inc | September 2003 | 0.1%, 0.2% | AB, AT |
| Rising Pharma Holdings Inc | March 2006 | 0.2% | AT |
| Regcon Holdings LLC | November 2014 | 0.2% | AT |
| Somerset Therapeutics LLC | March 2019 | 0.1%, 0.2% | AB, AT |
| Apotex Inc | January 2022 | 0.1%, 0.15% | AB, AT |
| Alembic Pharmaceuticals Ltd | March 2023 | 0.1%, 0.15% | AB, AT |
| Micro Labs Ltd | November 2023 | 0.1%, 0.2% | AB, AT |
| Dr Reddys Laboratories SA | February 2024 | 0.025% | – |
| Upsher Smith Laboratories LLC | June 2024 | 0.1%, 0.15% | AB, AT |
| Lupin Ltd | August 2024 | 0.1% | AB |
| Gland Pharma Ltd | March 2026 | 0.1% | AB |
| Mankind Pharma Ltd | April 2026 | 0.1% | AB |
| Teva Parenteral Medicines Inc discontinued | September 2004 | 0.2% | – |
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).
Lumify 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 Lumify, 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.
Lumify Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.025% | Solution/drops | Ophthalmic | December 2017 | Over the counter reference product |
Source: FDA Orange Book, Bausch And Lomb Inc.
What a Generic Lumify Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Lumify
Is there a generic for Lumify right now?
Yes. The FDA NDC Directory lists a generic brimonidine tartrate from 14 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Lumify go generic?
It already has. The FDA NDC Directory lists a generic brimonidine tartrate from 14 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic brimonidine tartrate be the same as Lumify?
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. At least 13 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Lumify?
Yes. The FDA Orange Book lists approved generic versions from 13 companies, the first approved in May 2003: Bausch And Lomb Inc, Sandoz Inc, Rising Pharma Holdings Inc, Regcon Holdings LLC and 9 more. 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 Lumify patent expire?
The FDA Orange Book lists 5 patents for Lumify; the last runs to July 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 month on this page (June 2027) weighs all of that.
Has anyone challenged the Lumify patents?
Yes. The first patent challenge to Lumify reached the FDA in July 2021, from one company on that first day. The FDA approved a first challenger’s generic in February 2024, 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.
Changes to This Projection
- First generic expected June 2027 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
- SlyndDrospirenoneJanuary to June 2031
- ApretudeCabotegravirSeptember 2031
- IzervayAvacincaptad Pegol Sodium2033 to 2035
- VoranigoVorasidenibJuly 2038
- EdluarZolpidem TartrateTBD no date yet
- OlpruvaSodium PhenylbutyrateTBD no date yet
About Lumify
- Generic name brimonidine tartrate
- How it is taken In the eye
- Company Bausch And Lomb Inc
- Patent challenges Since July 2021 (FDA)
- More drugs Brand-name drugs starting with L
- Have a question? A pharmacist answers, free. Ask about Lumify
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.