Inveltys Generic: When Will Generic Loteprednol Etabonate 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
Inveltys Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2033 About 6.5 years away Why then?
- Has the FDA approved a generic? April 2019 5 companies approved
- When does the last patent end? May 2033 13 patents listed with the FDA
- Can you buy a generic today? Yes 12 companies list one
It already is. A generic loteprednol etabonate is listed for sale by 12 companies, so ask your pharmacy whether it can fill your prescription with one.
Why May 2033?
It is when Inveltys’s patents 9,056,057, 9,393,213, 9,532,955, 9,737,491 and 9 more end. They cover the product’s formulation and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Inveltys, 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.
Inveltys 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 2018 August 2018 FDA Orange Book
- Patents listed 13 last runs to May 2033 FDA Orange Book
- Generics FDA-approved 5 companies, the first approved April 2019 FDA Orange Book
- Pharmacies pay $103.11 per mL, up 0.4% in a year NADAC, October 2026
- Medicare Part D spent $1.1M in 2025, for 1,379 people CMS Part D Spending by Drug
- Medicaid prescriptions 99 in the last four reported quarters, $30.1K CMS Medicaid drug utilization, to Q1 2026
Inveltys’s Road to a Generic
Inveltys has had the market to itself since the FDA approved it in August 2018 (Alcon Laboratories Inc). Its 13 listed patents run to May 2033.
The first generic of Inveltys is expected in May 2033.
Why that month: patents 9,056,057, 9,393,213, 9,532,955, 9,737,491 and 9 more, on the product’s formulation and a way of using it, end then.
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.
Inveltys Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Inveltys’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 9,056,057, 9,393,213, 9,532,955, 9,737,491 and 9 more, which end in May 2033, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,056,057 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-2491) | May 2033 | Active |
| 9,393,213 Sets the expected month of generic availability | The product’s formulation | May 2033 | Active |
| 9,532,955 Sets the expected month of generic availability | A way of using it (U-2491) | May 2033 | Active |
| 9,737,491 Sets the expected month of generic availability | A way of using it (U-2492) | May 2033 | Active |
| 9,827,191 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-2493) | May 2033 | Active |
| 10,058,511 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-2492) | May 2033 | Active |
| 10,646,437 Sets the expected month of generic availability | The product’s formulation | May 2033 | Active |
| 10,688,045 Sets the expected month of generic availability | The product’s formulation | May 2033 | Active |
| 10,864,219 Sets the expected month of generic availability | A way of using it (U-3011) | May 2033 | Active |
| 11,219,597 Sets the expected month of generic availability | A way of using it (U-3278, U-3279) | May 2033 | Active |
| 11,642,317 Sets the expected month of generic availability | The product’s formulation | May 2033 | Active |
| 11,872,318 Sets the expected month of generic availability | The product’s formulation | May 2033 | Active |
| 12,115,246 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-4025) | May 2033 | Active |
Source: FDA Orange Book, application 210565. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Loteprednol Etabonate
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 application count is on record for Inveltys, but the FDA has already approved 5 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 5 companies, the first in April 2019. 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 loteprednol etabonate is listed for sale by 12 companies. Ask your pharmacy whether it can fill your prescription with it.
Akorn, Amneal Pharmaceuticals NY LLC, ARMAS PHARMACEUTICALS INC., Bausch & Lomb Americas Inc., Bausch & Lomb Incorporated, Lupin Pharmaceuticals, Inc. and 6 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Sentiss AG | April 2019 | 0.2%, 0.5% | AB |
| Sun Pharmaceutical Industries Ltd | February 2021 | 0.5% | AB |
| Lupin Ltd | December 2023 | 0.2%, 0.5%, 0.38% | AB |
| Padagis US LLC | July 2024 | 0.2%, 0.5% | AB |
| Amneal Eu Ltd | December 2024 | 0.2%, 0.5% | AB |
| Hikma Pharmaceuticals USA Inc discontinued | November 2023 | 0.5% | – |
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).
Inveltys Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Inveltys 1% eye drop
$103.11 per mL in October 2026, up 0.4% 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 | $103.11 |
| September 2026 | $103.11 |
| August 2026 | $103.19 |
| July 2026 | $103.22 |
| June 2026 | $103.20 |
| May 2026 | $103.17 |
| April 2026 | $103.17 |
| March 2026 | $103.15 |
| February 2026 | $103.15 |
| January 2026 | $103.21 |
| February 2024 | $102.71 |
| January 2024 | $102.71 |
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 Inveltys today: $103.11 per mL for Inveltys 1% 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 $103.11 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 Inveltys
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 Inveltys, before manufacturer rebates.
- $200.2K
- January to March 2026, the latest CMS has posted
For 384 people, about $371 per prescription fill - $1.1M
- 2025, the whole year
For 1,379 people, about $355 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $200,164 | 384 | $370.67 |
| 2025 | $1,061,491 | 1,379 | $355.01 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Inveltys only, so no generic is counted in it. What CMS says it is used for: This medication is used after eye surgery to help relieve pain and swelling (inflammation). Loteprednol belongs to a class of drugs known as corticosteroids.
Medicaid Prescriptions by Quarter
99 prescriptions in the four quarters to Q1 2026, $30.1K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 25 | $8,040 |
| Q4 2025 | 21 | $6,236 |
| Q3 2025 | 28 | $8,350 |
| Q2 2025 | 25 | $7,452 |
| Q1 2025 | 31 | $9,279 |
Source: CMS Medicaid State Drug Utilization Data, over Inveltys’s own package codes.
Inveltys Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 1% | Suspension/drops | Ophthalmic | August 2018 | Prescription reference product |
Source: FDA Orange Book, Alcon Laboratories Inc. Listed for sale today by Alcon Laboratories, Inc. (FDA NDC Directory).
Inveltys NDC Codes and Packages
Each Inveltys 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 |
|---|---|---|---|
| 00065-9307-04 | LOTEPREDNOL ETABONATE 10 mg/mL suspension | bottle of 2.8 mL | Alcon Laboratories, Inc. |
| 00065-9307-05 | LOTEPREDNOL ETABONATE 10 mg/mL suspension | bottle of 2.8 mL | Alcon Laboratories, Inc. |
| 71571-0121-20 | LOTEPREDNOL ETABONATE 10 mg/mL suspension | bottle of 2.8 mL | Alcon Laboratories, Inc. |
| 71571-0121-20 | LOTEPREDNOL ETABONATE 10 mg/mL suspension | bottle of 2.8 mL | Alcon Laboratories, Inc. |
| 71571-0121-28 | LOTEPREDNOL ETABONATE 10 mg/mL suspension | bottle of 2.8 mL | Alcon Laboratories, Inc. |
| 71571-0121-28 | LOTEPREDNOL ETABONATE 10 mg/mL suspension | bottle of 2.8 mL | Alcon Laboratories, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Inveltys’s own FDA approval (NDA 210565) are listed, never a generic. Some codes belong to companies that repackage Inveltys: it is the same medicine in a different package.
What a Generic Inveltys 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 Inveltys
Is there a generic for Inveltys right now?
Yes. The FDA NDC Directory lists a generic loteprednol etabonate from 12 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Inveltys go generic?
It already has. The FDA NDC Directory lists a generic loteprednol etabonate from 12 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic loteprednol etabonate be the same as Inveltys?
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. The FDA has already approved 5 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Inveltys?
Yes. The FDA Orange Book lists approved generic versions from 5 companies, the first approved in April 2019: Sentiss AG, Sun Pharmaceutical Industries Ltd, Lupin Ltd, Padagis US LLC and 1 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 Inveltys patent expire?
The FDA Orange Book lists 13 patents for Inveltys; the last runs to May 2033. The one behind the expected month is patents 9,056,057, 9,393,213, 9,532,955, 9,737,491 and 9 more, which end in May 2033. 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 (May 2033) weighs all of that.
How much does Inveltys cost now?
Pharmacies paid about $103.11 per mL for Inveltys 1% 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 May 2033 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
- BunavailBuprenorphine Hydrochloride and Naloxone HydrochlorideJuly 2028
- Tobradex STDexamethasone and TobramycinAugust 2028
- Lo Loestrin FeEthinyl Estradiol and Norethindrone AcetateJanuary to March 2029
- PrevymisLetermovirFebruary 2033
- ForzinityElamipretide HydrochlorideFebruary 2039
- YuvezziBrimonidine Tartrate and CarbacholNovember 2042
About Inveltys
- Generic name loteprednol etabonate
- 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.
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Inveltys
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.