Inlexzo Generic: When Will Generic Gemcitabine 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
Inlexzo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2038 About 12 years away Why then?
- Has the FDA approved a generic? November 2010 13 companies approved
- When does the brand’s protection end? November 2038 The last of 6 listed patents
- Can you buy a generic today? Yes 14 companies list one in some form
Dr. Brian Staiger Explains
PharmD, BCPS · Clinical pharmacistA generic matching Inlexzo is expected to be available in November 2038, about 12 years away. A generic gemcitabine hydrochloride is already listed for sale in some form by 14 companies, so ask your pharmacy whether one matches Inlexzo.
Why November 2038?
It is when Inlexzo’s patent 12,636,300 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.
Will the generic cost less?
Usually. The FDA has already approved 13 companies to make a generic, and how many of them launch decides how far the price falls. See the price pattern
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Inlexzo, 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.
Inlexzo 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 2025 September 2025 FDA Orange Book
- Patents listed 6 last runs to November 2038 FDA Orange Book
- Generics FDA-approved 13 companies, the first approved November 2010 FDA Orange Book
- Medicare Part D spent $4.2M in 2025, for 29 people CMS Part D Spending by Drug
Inlexzo’s Road to a Generic
Inlexzo has had the market to itself since the FDA approved it in September 2025 (Janssen Biotech Inc). Its FDA protection (new product) runs to September 2028. Its 6 listed patents run to November 2038.
The first generic of Inlexzo is expected in November 2038.
Why that month: patent 12,636,300, 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.
Inlexzo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Inlexzo’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 12,636,300, which ends in November 2038, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 12,403,086 | The product’s formulation | June 2030 | Active |
| 12,576,253 | The product’s formulation | December 2030 | Active |
| 8,679,094 | The product’s formulation | April 2032 | Active |
| 10,729,823 | The product’s formulation | August 2034 | Active |
| 12,447,241 | The product’s formulation | August 2034 | Active |
| 12,636,300 Sets the expected month of generic availability | A way of using it (U-4552) | November 2038 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | September 2028 | Active |
Source: FDA Orange Book, application 219683. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Gemcitabine Hydrochloride
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 Inlexzo, but the FDA has already approved 13 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 13 companies, the first in November 2010. 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 gemcitabine hydrochloride in some form is listed for sale by 14 companies. Ask your pharmacy whether it can fill your prescription with it.
Accord Healthcare Inc., Armas Pharmaceuticals Inc., Athenex Pharmaceutical Division, LLC., Dr. Reddy's Laboratories Limited, Fresenius Kabi USA, LLC, Gland Pharma Limited and 8 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hospira Inc | November 2010 | EQ 2GM BASE/VIAL | AP |
| Fresenius Kabi USA LLC | May 2011 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL, EQ 200MG BASE/VIAL | AP |
| Dr Reddys Laboratories Ltd | July 2011 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL, EQ 200MG BASE/VIAL | AP |
| Hospira Worldwide, Inc | July 2011 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | AP |
| Sun Pharmaceutical Industries Ltd | July 2011 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | AP |
| Teyro Labs Private Ltd | July 2011 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | AP |
| Jiangsu Hansoh Pharmaceutical Group Co Ltd | May 2013 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | AP |
| Sagent Pharmaceuticals Inc | May 2013 | 1GM/26.3ML (38MG/ML), 2GM/52.6ML (38MG/ML), 200MG/5.26ML (38MG/ML), EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | AP |
| Gland Pharma Ltd | January 2016 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | AP |
| Mylan Laboratories Ltd | December 2017 | 1GM/26.3ML (38MG/ML), 2GM/52.6ML (38MG/ML), 200MG/5.26ML (38MG/ML) | AP |
| Adaptis Pharma Private Ltd | February 2019 | 1GM/26.3ML (38MG/ML), 2GM/52.6ML (38MG/ML), 200MG/5.26ML (38MG/ML), EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | AP |
| Meitheal Pharmaceuticals Inc | December 2020 | 1GM/26.3ML (38MG/ML), 2GM/52.6ML (38MG/ML), 200MG/5.26ML (38MG/ML) | AP |
| Hikma Pharmaceuticals International Ltd | March 2023 | 1GM/26.3ML (38MG/ML), 2GM/52.6ML (38MG/ML), 200MG/5.26ML (38MG/ML) | AP |
| Teva Pharmaceuticals USA discontinued | January 2011 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | – |
| Accord Healthcare Inc discontinued | July 2011 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL, EQ 200MG BASE/VIAL | – |
| Actavis Totowa LLC discontinued | July 2011 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL, EQ 200MG BASE/VIAL | – |
| Pharmobedient Consulting LLC discontinued | July 2011 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL, EQ 200MG BASE/VIAL | – |
| Hameln Rds GmbH discontinued | September 2012 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | – |
| Emcure Pharmaceuticals Ltd discontinued | September 2012 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | – |
| American Regent Inc discontinued | May 2013 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | – |
| Actavis Inc discontinued | April 2016 | 1GM/26.3ML (38MG/ML), 2GM/52.6ML (38MG/ML), 200MG/5.26ML (38MG/ML) | – |
| Apotex Inc discontinued | May 2017 | 1GM/26.3ML (38MG/ML), 2GM/52.6ML (38MG/ML), 200MG/5.26ML (38MG/ML) | – |
| Ingenus Pharmaceuticals LLC discontinued | February 2019 | 1GM/26.3ML (38MG/ML), 2GM/52.6ML (38MG/ML), 200MG/5.26ML (38MG/ML) | – |
| Hikma International Pharmaceuticals LLC discontinued | June 2021 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL | – |
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).
Inlexzo 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 Inlexzo, 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.
What Medicare and Medicaid Spend on Inlexzo
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 Inlexzo, before manufacturer rebates.
- $11.8M
- January to March 2026, the latest CMS has posted
For 73 people, about $72,395 per prescription fill - $4.2M
- 2025, the whole year
For 29 people, about $71,321 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $11,800,371 | 73 | $72,394.91 |
| 2025 | $4,207,960 | 29 | $71,321.36 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Inlexzo only, so no generic is counted in it. What CMS says it is used for: This medication implant is used to treat a certain type of cancer (bladder cancer). It works by slowing or stopping the growth of cancer cells.
Inlexzo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 225MG BASE | System | Intravesical | September 2025 | Prescription reference product |
Source: FDA Orange Book, Janssen Biotech Inc. Listed for sale today by Janssen Biotech, Inc (FDA NDC Directory).
Inlexzo NDC Codes and Packages
Each Inlexzo 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 |
|---|---|---|---|
| 57894-0225-01 | GEMCITABINE 225 mg/1 system | box of 1 system | Janssen Biotech, Inc |
| 57894-0225-99 | GEMCITABINE 225 mg/1 system | box of 1 system | Janssen Biotech, Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Inlexzo’s own FDA approval (NDA 219683) are listed, never a generic. Some codes belong to companies that repackage Inlexzo: it is the same medicine in a different package.
What a Generic Inlexzo 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 Inlexzo
Is there a generic for Inlexzo right now?
Yes. The FDA NDC Directory lists a generic gemcitabine hydrochloride in some form from 14 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Inlexzo go generic?
November 2038 is the expected month, and that is probable but not certain. It is when Inlexzo’s patent 12,636,300 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 gemcitabine hydrochloride be the same as Inlexzo?
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 13 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Inlexzo?
Yes. The FDA Orange Book lists approved generic versions from 13 companies, the first approved in November 2010: Hospira Inc, Fresenius Kabi USA LLC, Dr Reddys Laboratories Ltd, Hospira Worldwide, Inc 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 Inlexzo patent expire?
The FDA Orange Book lists 6 patents for Inlexzo; the last runs to November 2038. The one behind the expected month is patent 12,636,300, which ends in November 2038. 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 (November 2038) weighs all of that.
Changes to This Projection
- First generic expected November 2038 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
- FexinidazoleFexinidazoleJuly 2028
- LibervantDiazepamApril 2031
- PiqrayAlpelisibApril 2033
- XyostedTestosterone EnanthateSeptember 2036
- BlujepaGepotidacin Mesylate2038 to 2039
- TembexaBrincidofovirTBD no date yet
About Inlexzo
- Generic name gemcitabine hydrochloride
- How it is taken Into the bladder
- Company Janssen Biotech Inc
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Inlexzo
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, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.