Omlonti Generic: When Will Generic Omidenepag Isopropyl 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
Omlonti Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2035 About 8.5 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? July 2039 13 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 omidenepag isopropyl is expected to be available in January 2035, about 8.5 years away. None is for sale yet.
Why January 2035?
It is when Omlonti’s patents 9,415,038, 10,179,127, 10,702,511, 11,197,849 and 4 more end. They cover the product’s formulation and a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Omlonti’s last patent runs to July 2039, how can a generic come sooner?
The 3 patents that run past the expected month, to July 2039 (10,774,072, 12,290,511 and 11,666,563), cover the active ingredient and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier 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 Omlonti 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.
Omlonti by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2022 September 2022 FDA Orange Book
- Patents listed 13 last runs to July 2039 A generic is expected sooner, in January 2035. See why FDA Orange Book
Omlonti’s Road to a Generic
Omlonti has had the market to itself since the FDA approved it in September 2022 (Ocuvex Therapeutics Inc). Its FDA protection (new chemical entity) runs to September 2027. Its 13 listed patents run to July 2039.
The first generic of Omlonti is expected in January 2035.
Why that month: patents 9,415,038, 10,179,127, 10,702,511, 11,197,849 and 4 more, on the product’s formulation and a way of using it, end then. That is about 4.5 years before the last listed patent runs out, in July 2039.
Why a Generic Can Come Before July 2039
The last listed patent runs to July 2039; a court ruling or a settlement can bring a generic sooner. 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.
Omlonti Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Omlonti’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: patents 9,415,038, 10,179,127, 10,702,511, 11,197,849 and 4 more, which end in January 2035, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,648,097 | The active ingredient; the product’s formulation | October 2029 | Active |
| 8,685,986 | The product’s formulation | October 2029 | Active |
| 9,415,038 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3454) | January 2035 | Active |
| 10,179,127 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3454) | January 2035 | Active |
| 10,702,511 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3454) | January 2035 | Active |
| 10,765,750 | The product’s formulation | January 2035 | Active |
| 11,197,849 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3454) | January 2035 | Active |
| 11,793,798 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3454) | January 2035 | Active |
| 12,295,946 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3454) | January 2035 | Active |
| RE48183 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3454) | January 2035 | Active |
| 10,774,072 | The active ingredient | June 2035 | Active |
| 12,290,511 Sets the expected month of generic availability | A way of using it (U-3454) | December 2038 | Active |
| 11,666,563 | A way of using it (U-3454) | July 2039 | 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. | September 2027 | Active |
Source: FDA Orange Book, application 215092. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Omidenepag Isopropyl
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 Omlonti yet.
Approved by the FDA
Not yet. The FDA has not approved a generic omidenepag isopropyl. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic omidenepag isopropyl 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).
Omlonti 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 Omlonti, 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.
Omlonti Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.002% | Solution | Ophthalmic | September 2022 | Prescription reference product |
Source: FDA Orange Book, Ocuvex Therapeutics Inc. Listed for sale today by Santen Incorporated and Ocuvex Therapeutics, Inc. (FDA NDC Directory).
Omlonti NDC Codes and Packages
Each Omlonti 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 |
|---|---|---|---|
| 65086-0002-01 | 0.02 mg/mL solution/ drops | bottle of 2.5 mL | Santen Incorporated |
| 65086-0002-05 | 0.02 mg/mL solution/ drops | bottle of 2.5 mL | Santen Incorporated |
| 84826-0002-01 | OMIDENEPAG ISOPROPYL .02 mg/mL solution/ drops | bottle of 2.5 mL | Ocuvex Therapeutics, Inc. |
| 84826-0002-03 | OMIDENEPAG ISOPROPYL .02 mg/mL solution/ drops | carton of 3 bottles of 2.5 mL | Ocuvex Therapeutics, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Omlonti’s own FDA approval (NDA 215092) are listed, never a generic. Some codes belong to companies that repackage Omlonti: it is the same medicine in a different package.
What a Generic Omlonti Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Omlonti 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 Omlonti”. 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 Omlonti
Is there a generic for Omlonti right now?
No. As of October 9, 2026 no generic omidenepag isopropyl is listed for sale in the FDA NDC Directory.
When will Omlonti go generic?
January 2035 is the expected month, and that is probable but not certain. It is when Omlonti’s patents 9,415,038, 10,179,127, 10,702,511, 11,197,849 and 4 more end. They cover the product’s formulation and a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to July 2039; a court ruling or a settlement can bring a generic sooner.
Will generic omidenepag isopropyl be the same as Omlonti?
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 Omlonti?
Not yet. The FDA Orange Book lists no approved generic version of Omlonti.
When does the Omlonti patent expire?
The FDA Orange Book lists 13 patents for Omlonti; the last runs to July 2039. The one behind the expected month is patents 9,415,038, 10,179,127, 10,702,511, 11,197,849 and 4 more, which end in January 2035. 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 (January 2035) weighs all of that.
Changes to This Projection
- First generic expected January 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
- GilotrifAfatinib Dimaleate2027 to 2028
- LynparzaOlaparib2029 to 2030
- TruseltiqInfigratinib PhosphateOctober 2033
- CequaCyclosporineFebruary 2037
- QfitliaFitusiran SodiumMarch 2038
- ZilbrysqZilucoplan sodiumOctober 2039
About Omlonti
- Generic name omidenepag isopropyl
- How it is taken In the eye
- Company Ocuvex Therapeutics Inc
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Omlonti
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, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.