Cequa Generic: When Will Generic Cyclosporine 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
Cequa Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2037 About 10.5 years away Why then?
- Has the FDA approved a generic? February 2022 7 companies approved
- When does the last patent end? February 2037 5 patents listed with the FDA
- Can you buy a generic today? Yes 11 companies list one
It already is. A generic cyclosporine is listed for sale by 11 companies, so ask your pharmacy whether it can fill your prescription with one.
Why February 2037?
It is when Cequa’s patents 10,918,694 and 11,951,153 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 toss-up: still unsettled. Just as likely to slip as to hold.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Cequa, 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.
Cequa by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- $299M a yearBig seller
- FDA approved 2018 August 2018 FDA Orange Book
- Patents listed 5 last runs to February 2037 FDA Orange Book
- Generics FDA-approved 7 companies, the first approved February 2022 FDA Orange Book
- Pharmacies pay $10.38 each, up 10.5% in a year NADAC, October 2026
- Medicare Part D spent $96.6M in 2025, for 37.8K people CMS Part D Spending by Drug
- Medicaid prescriptions 34.2K in the last four reported quarters, $25.3M CMS Medicaid drug utilization, to Q1 2026
Cequa’s Road to a Generic
Cequa has had the market to itself since the FDA approved it in August 2018 (Sun Pharmaceutical Industries Ltd). Its 5 listed patents run to February 2037.
The first generic of Cequa is expected in February 2037.
Why that month: patents 10,918,694 and 11,951,153, 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.
Cequa Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Cequa’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 10,918,694 and 11,951,153, which end in February 2037, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,980,839 | The product’s formulation; a way of using it (U-1483) | August 2033 | Active |
| 9,937,225 | The product’s formulation; a way of using it (U-1483) | August 2033 | Active |
| 10,441,630 | The product’s formulation | August 2033 | Active |
| 10,918,694 Sets the expected month of generic availability | The product’s formulation | February 2037 | Active |
| 11,951,153 Sets the expected month of generic availability | A way of using it (U-1483) | February 2037 | Active |
Source: FDA Orange Book, application 210913. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Cyclosporine
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 Cequa, but the FDA has already approved 7 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 7 companies, the first in February 2022. 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 cyclosporine is listed for sale by 11 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Amneal Pharmaceuticals NY LLC, Apotex Corp, Cipla USA Inc., Devatis Inc., KVK-TECH, INC. and 5 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Mylan Pharmaceuticals Inc | February 2022 | 0.05% | AB |
| Teva Pharmaceuticals USA Inc | December 2023 | 0.05% | AB |
| Deva Holding As | May 2024 | 0.05% | AB |
| Saptalis Pharmaceuticals LLC | July 2024 | 0.05% | AB |
| Amneal Pharmaceuticals LLC | November 2025 | 0.05% | AB |
| Twi Pharmaceuticals Inc | January 2026 | 0.05% | AB |
| Jiangsu Anbison Pharmaceutical Co Ltd | June 2026 | 0.05% | AB |
| Apotex Inc discontinued | January 2023 | 0.05% | – |
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).
Cequa Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Cequa 0.09% solution
$10.38 each in October 2026, up 10.5% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid each |
|---|---|
| October 2026 | $10.38 |
| September 2026 | $10.38 |
| August 2026 | $10.38 |
| July 2026 | $10.38 |
| June 2026 | $10.38 |
| May 2026 | $10.38 |
| April 2026 | $10.38 |
| March 2026 | $10.38 |
| February 2026 | $10.38 |
| January 2026 | $10.06 |
| February 2024 | $9.39 |
| January 2024 | $9.39 |
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 Cequa today: $10.38 each for Cequa 0.09% 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).
Dollar figures apply FDA’s median drops to the $10.38 pharmacies pay each 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 Cequa
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 Cequa, before manufacturer rebates.
- $22.6M
- January to March 2026, the latest CMS has posted
For 18,294 people, about $846 per prescription fill - $96.6M
- 2025, the whole year
For 37,820 people, about $852 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $22,578,191 | 18,294 | $845.59 |
| 2025 | $96,611,855 | 37,820 | $851.59 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Cequa only, so no generic is counted in it. What CMS says it is used for: Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.
Medicaid Prescriptions by Quarter
34,195 prescriptions in the four quarters to Q1 2026, $25.3M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 8,858 | $6,618,376 |
| Q4 2025 | 9,110 | $6,715,544 |
| Q3 2025 | 9,135 | $6,748,490 |
| Q2 2025 | 7,092 | $5,234,989 |
| Q1 2025 | 6,899 | $5,088,655 |
Source: CMS Medicaid State Drug Utilization Data, over Cequa’s own package codes.
Cequa Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.09% | Solution | Ophthalmic | August 2018 | Prescription reference product |
Source: FDA Orange Book, Sun Pharmaceutical Industries Ltd. Listed for sale today by Sun Pharmaceutical Industries, Inc. (FDA NDC Directory).
Cequa NDC Codes and Packages
Each Cequa 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 |
|---|---|---|---|
| 47335-0506-96 | CYCLOSPORINE .0009 g/mL solution/ drops | box of 6 pouches of 10 vials of .25 mL | Sun Pharmaceutical Industries, Inc. |
| 47335-0506-96 | CYCLOSPORINE .0009 g/mL solution/ drops | box of 6 pouches of 10 vials of .25 mL | Sun Pharmaceutical Industries, Inc. |
| 47335-0507-97 | CYCLOSPORINE .0009 mg/mL solution/ drops | pouch of 10 vials of .25 mL | Sun Pharmaceutical Industries, Inc. |
| 47335-0507-97 | CYCLOSPORINE .0009 mg/mL solution/ drops | pouch of 10 vials of .25 mL | Sun Pharmaceutical Industries, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Cequa’s own FDA approval (NDA 210913) are listed, never a generic. Some codes belong to companies that repackage Cequa: it is the same medicine in a different package.
What a Generic Cequa 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 Cequa
Is there a generic for Cequa right now?
Yes. The FDA NDC Directory lists a generic cyclosporine from 11 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Cequa go generic?
It already has. The FDA NDC Directory lists a generic cyclosporine from 11 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic cyclosporine be the same as Cequa?
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 7 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Cequa?
Yes. The FDA Orange Book lists approved generic versions from 7 companies, the first approved in February 2022: Mylan Pharmaceuticals Inc, Teva Pharmaceuticals USA Inc, Deva Holding As, Saptalis Pharmaceuticals LLC and 3 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 Cequa patent expire?
The FDA Orange Book lists 5 patents for Cequa; the last runs to February 2037. The one behind the expected month is patents 10,918,694 and 11,951,153, which end in February 2037. 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 (February 2037) weighs all of that.
How much does Cequa cost now?
Pharmacies paid about $10.38 each for Cequa 0.09% 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 February 2037 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
- SpinrazaNusinersen2033 to 2034
- VyleesiBremelanotide AcetateNovember 2033
- JoenjaLeniolisib PhosphateJuly 2036
- Onyda XRClonidine HydrochlorideJuly 2041
- ArtesunateArtesunateFebruary 2044
- EmbedaMorphine Sulfate and Naltrexone HydrochlorideTBD no date yet
About Cequa
- Generic name cyclosporine
- How it is taken In the eye
- Company Sun Pharmaceutical Industries Ltd
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Cequa
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.