Mitosol Generic: When Will Generic Mitomycin 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
Mitosol Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2029 About 2.5 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? May 2029 5 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic mitomycin is expected to be available in May 2029, about 2.5 years away. None is for sale yet.
Why May 2029?
It is when Mitosol’s patent 9,649,428 ends. That patent covers a way of using it, and once it ends, 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.
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 Mitosol 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.
Mitosol 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
- under $10M a yearSmall seller
- FDA approved 2012 February 2012 FDA Orange Book
- Patents listed 5 last runs to May 2029 FDA Orange Book
Mitosol’s Road to a Generic
Mitosol has had the market to itself since the FDA approved it in February 2012 (Glaukos Corp). Its 5 listed patents run to May 2029 (2 already expired).
The first generic of Mitosol is expected in May 2029.
Why that month: patent 9,649,428, on a way of using it, ends 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.
Mitosol Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Mitosol’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: patent 9,649,428, which ends in May 2029, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,186,511 | The product’s formulation | July 2026 | Expired |
| 9,205,075 | The product’s formulation | July 2026 | Expired |
| 9,539,241 | The active ingredient; the product’s formulation; a way of using it (U-2095) | January 2028 | Active |
| 7,806,265 | The product’s formulation | February 2029 | Active |
| 9,649,428 Sets the expected month of generic availability | A way of using it (U-2095) | May 2029 | Active |
Source: FDA Orange Book, application 022572. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Mitomycin
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 Mitosol yet.
Approved by the FDA
Not yet. The FDA has not approved a generic mitomycin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic mitomycin 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).
Mitosol 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 Mitosol, 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.
Mitosol Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.2MG/VIAL | For solution | Topical | February 2012 | Prescription reference product |
Source: FDA Orange Book, Glaukos Corp. Listed for sale today by Mobius Therapeutics LLC (FDA NDC Directory).
Mitosol NDC Codes and Packages
Each Mitosol 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 |
|---|---|---|---|
| 49771-0002-03 | kit | 3 TRAY in 1 CARTON / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS | Mobius Therapeutics LLC |
| 49771-0002-03 | kit | 3 TRAY in 1 CARTON / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS | Mobius Therapeutics LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Mitosol’s own FDA approval (NDA 22572) are listed, never a generic. Some codes belong to companies that repackage Mitosol: it is the same medicine in a different package.
What a Generic Mitosol Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Mitosol 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 Mitosol”. 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 Mitosol
Is there a generic for Mitosol right now?
No. As of October 9, 2026 no generic mitomycin is listed for sale in the FDA NDC Directory.
When will Mitosol go generic?
May 2029 is the expected month, and that is probable but not certain. It is when Mitosol’s patent 9,649,428 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic mitomycin be the same as Mitosol?
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 Mitosol?
Not yet. The FDA Orange Book lists no approved generic version of Mitosol.
When does the Mitosol patent expire?
The FDA Orange Book lists 5 patents for Mitosol; the last runs to May 2029. The one behind the expected month is patent 9,649,428, which ends in May 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 month on this page (May 2029) weighs all of that.
Changes to This Projection
- First generic expected May 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
- KalydecoIvacaftorJanuary to June 2028
- WinleviClascoteroneFebruary 2028
- EohiliaBudesonideFebruary 2031
- OrgovyxRelugolix2034 to 2035
- Auvi-QEpinephrineDecember 2037
- SuflaveMagnesium Sulfate, Polyethylene Glycol 3350, Potassium Chloride, Sodium Chloride, and Sodium SulfateJune 2044
About Mitosol
- Generic name mitomycin
- How it is taken On the skin
- Company Glaukos Corp
- More drugs Brand-name drugs starting with M
- Have a question? A pharmacist answers, free. Ask about Mitosol
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.